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Participants experienced data collection issues when using the eDiary, these issues increased the burden and lowered compliance. Updates to the eDiary were unsuccessful at resolving the issues so the decision was taken to terminate the Investigation.
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| Name | Class |
|---|---|
| SynteractHCR Deutschland GmbH | UNKNOWN |
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This was an open-label, single-centre, parallel-group clinical investigation, to evaluate the effectiveness and in-use tolerability of a range of four orthotic insoles on target areas of pain in the lower body, associated with musculoskeletal stress, experienced by those who spend most of their working day on their feet
This was an open-label, single-centre, parallel-group clinical investigation, to evaluate the effectiveness and in-use tolerability of a range of four orthotic insoles on target areas of pain in the lower body, associated with musculoskeletal stress, experienced by those who spend most of their working day on their feet.
The investigation design included two periods; 'run-in' period and 'treatment' period. The treatment period comprised of two sub-periods; a 'breaking-in' period and the 'full use' period. The breaking-in period was intended to allow time for the subjects' feet to accustom to wearing the insoles. The full-use period was used to determine effectiveness of the insoles. These periods constitute lengths of time defined for the purpose of the investigation as "working episodes". Working episodes were defined as at least 3 (up to 6) consecutive working days of at least 6 hours each at work, following at least 2 consecutive non-working days.
Eligible subjects at Visit 1 (screening) were enrolled into the run-in period, where subjects were assessed prior to treatment with the insoles under investigation. During the run-in period, consisting of one working episode, subjects self-reported their pain without using insoles on a daily basis (Q3-9 of the Brief Pain Inventory (BPI)), in order to provide the baseline data to which the insoles were compared. Eligible subjects were enrolled into the treatment period at Visit 2 and assigned the insole relevant to the target pain area/pain area combination. Insole use was built up gradually during a breaking-in period, which constituted one working episode, with at least one nonworking day prior to the start of the working episode. Following the breaking-in period, the full-use period commenced. During the treatment period, subjects wore the insoles on working days and as much as possible on non-working days, self-reporting their pain daily (BPI Questions 3 - 9 inclusive).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Lower back pain associated with musculoskeletal stress | Experimental | Subjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced lower back pain; the subjects selection was corroborated by a physiotherapist. |
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| Experimental: Heel pain associated with musculoskeletal stress | Experimental | Subjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced pain in the heels of their feet; the subjects selection was corroborated by a physiotherapist. |
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| Experimental: Knee to Heel pain associated with musculoskeletal stress | Experimental | Subjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced Knee to Heel pain; the subjects selection was corroborated by a physiotherapist. |
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| Experimental: Arch pain associated with musculoskeletal stress | Experimental | Subjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced pain in the arch of their feet; the subjects selection was corroborated by a physiotherapist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthotic Insole: Lower Back | Device | This Insole is a full-length shaped orthotic insole, with a heel cup and an arch support. The insole can cover several shoe sizes and can be cut to the correct size to fit in the shoe. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress. Assessed though the change in pain, measured by the Brief Pain Inventory questionnaire score. (For each of the four orthotic insoles separately.) | The average change from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain) when compared to the first three days of the last working episode. To account for differences in subjects working patterns a definition was created, a valid working episode was considered to be two non-working days followed by at least three and up to five working days. (this definition was used for all outcomes) The baseline was defined as the first three consecutive working days of baseline working episode (Days 0-3). The first three days of the last working episode could occur from Days 27-30 for subjects that worked 3 consecutive working days up to Days 44-47 for subjects that worked five consecutive working days For each of the four orthotic insoles separately. | Time frame is dependent on working pattern Days 0-5 compared to Days 44-47 and Days 0-3 compared to Days 27-30 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress over the first three days of each working episode. Assessed though change in pain, measured by the BPI. (For each of the four orthotic insoles) | The average change from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), during the first three consecutive working days of each working episode (WE) of the treatment period The baseline WE was defined as the first three consecutive working days of (Days 0-3):
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress during the first three days of the break-in working episode. As assessed by the change in BPI questionnaire. (For each of the four orthotic insoles) | The average change from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), during the first three consecutive working days of the working episode (WE)of the breaking-in period. The baseline WE first 3 up to 5 consecutive working days (CWD) of baseline working episode therefore in the context of this endpoint the baseline assessment is an average of the responses Day 0-3 or Days 0-5 depending on the working pattern of the subjects. The break- in period was defined as the first working episode where the subject was provided with the device, it started with at least one non-working and included three up to five consecutive working days. For this endpoint the first three days would take place over Day 7-10. The average pain during the break-in period was compared to the baseline. |
Inclusion Criteria:
Those who gave informed consent.
Those who understood the purpose of the investigation, cooperate with the investigation procedures and tasks and were to attend the investigational site for all investigation assessments.
Those were willing to continue with their normal daily activities, including any cosmetic foot care regimens (including the use of products) throughout the investigation and not partake in exercise which is not normal for them and which would be deemed by the Investigator to impact study assessments, or any new foot care or podiatric treatments unless agreed in advance with the Investigator.
Those who wore the same or similar type of standard shoe during their working day/shift for at least the 4 weeks prior to enrolment (Visit 1) (or they have worn a different shoe which cause no change to their pain) and who were able to wear the same standard* shoe during their working day / shift for the duration of the investigation.
Eligibility regarding this criterion was confirmed at Visit 1 but will also confirmed by the physiotherapist at Visit 2, following their assessment.
*A standard shoe was defined as closed shoe, ≤2-inch heel, with an adequate sole, upper and toe box to accommodate the orthotic insole, as determined by the physiotherapist. Shoes with orthotic-type internal contouring (as determined by the physiotherapist to include features which could alter gait) or shoes with an arch support greater than 12 mm would not be permitted. Odour-eaters cannot be used during the treatment period.
Male and female subjects from the age of 18 years and a BMI of 18.5-29.9 kg/m² inclusive.
Those who had access to a mobile device (iOS or Android smart phone or tablet), with access to the internet, and are able to operate an app.
Those with a shoe size between 4.5 to 11 (UK).
Those who worked at least 30 hours per week which usually involved "working episodes"
(defined as at least 3 (up to 6) consecutive working days (of at least 6 hours each at work) following at least 2 consecutive non-working days), which were expected to continue throughout their involvement in the investigation, and included at least 4 working episodes during the 4 (up to 5)-week treatment period.
These working episodes should be non-complex in the opinion of the Investigator, to ensure continued eligibility.
Those who spent most (at least three quarters) of their working day on their feet, and remained in their current employment/work environment throughout the investigation period.
Those who have experienced pain associated with musculoskeletal stress during working episodes, for at least 4 weeks prior to enrolment (Visit 1) that they can distinguish as being in one of the following primary areas of pain or combination thereof, that the Investigator or designee considers could be treated with the relevant insole to be used in the investigation:
Eligibility regarding this criterion will also be confirmed by the physiotherapist at Visit 2, following their assessment.
Those who scored an average of 5 (±1) on the BPI average pain item (question 5) over the first three consecutive working days of the run-in period working episode**, when assessed specifically in their primary target pain area/pain area combination, as confirmed at Visit 2.
Exclusion Criteria:
Those who had a current medical condition that is contraindicated by the use of the orthotic insoles (e.g. peripheral vascular disease, sensory neuropathy or diabetes).
Those who currently use prescribed orthotics for biomechanical or other issues, or have received and used prescribed orthotics within the last 12 months or over-the-counter (OTC) orthotics in the last 6 months (odour-eaters and any non-structured/non-orthotic shock-absorber insole were permitted).
Those with any significant medical history which in the opinion of the Investigator could have interfered with the assessments of the investigation. For example; structural conditions (e.g. bunion or bunionette), lower limb or foot injury, rheumatic disease (e.g. rheumatoid arthritis, scleroderma, polymyalgia rheumatica), fibromyalgia, neurological disease or moderate to severe depression.
Those who were taking any of the following medications:
Those who are taking regular medication for targeted pain (including OTC pain relief, in excess of 2g paracetamol daily) which is either beyond the maximum recommended daily dose according to the SmPC or which the Investigator deems inappropriate for the subject to continue at the same dose throughout the investigation.
Those who were pregnant or who had given birth within the past 6 months.
Females of child-bearing potential who were unwilling to use a minimum of an "acceptable" (as defined by the Clinical Trials Facilitation Group (CFTG; 2014) recommendations) level of birth control, for the entire duration of the investigation.
Suitable methods of birth control (in accordance with "highly effective" and "acceptable" methods of birth control defined by the CTFG) included:
Females who were considered to be of child-bearing potential were those who were fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause (Clinical Trials Facilitation Group, 2014).
Those who suffered from allergies or sensitivities to the raw material of the insoles (as detailed in the Investigator Brochure).
Those who had participated in another clinical investigation within the 3 months prior to enrolment into the run-in period.
Employee at the investigational site, or a partner or first degree relative of the Investigator or member of the investigation team at the site.
Those, in the opinion of the Investigator, who were not deemed suitable or were unable to comply fully with the investigation requirements, for any other reason.
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Crawford, BSc (Hons), MBChB | Gordon.crawford@cpsresearch.co.uk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPS Research | Glasgow | Scotland | G20 0XA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27231116 | Background | Almeida JS, Vanderlei FM, Pastre EC, Martins RA, Padovani CR, Filho GC. Comparison of Two Types of Insoles on Musculoskeletal Symptoms and Plantar Pressure Distribution in a Work Environment: A Randomized Clinical Trial. Clin Med Res. 2016 Jun;14(2):67-74. doi: 10.3121/cmr.2016.1301. Epub 2016 May 26. | |
| 24335153 | Background |
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An open-label, single-centre, parallel-group clinical investigation
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| Orthotic Insole: Heel | Device | This Insole is a horseshoe shaped flexible heel cup with a softer area where the heel would be expected. |
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| Orthotic Insole: Knee to Heel | Device | This Insole is a ¾ length rigid orthotic insole with a softer area where the heel would be expected. Each insole will cover several shoe sizes. |
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| Orthotic Insole: Arch | Device | This Insole is a ¾ length shaped medical device with a softer area incorporated into the ball of foot and heel area and an external arch. support and 6-8 mm metatarsal dome. The slim fit insole runs from the heel along under the arch of the foot and reaches to just behind the toes to prevent squashing the toes in tight fitting shoes. |
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| Days 0-5 compared to Days 23-26, Days 30-33, Days 37-40, Days 0-3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 consecutive working days |
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress over each working episode. Assessed though change in pain, measured by the BPI questionnaire.(For each of the four orthotic insoles) | The change from baseline in the composite score of the worse, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), completed at the end of each working episode (WE) of the treatment period. The baseline WE was defined as Days 0-3 or Days 0-5 depending on the working pattern of the subjects:
| Days 0-5 compared to Day 23-28, Day 30-35, Day 37-42, Day 44-49 for subjects that worked five consecutive working days, Days 0-3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 consecutive working days |
| Proportion of subjects who achieve a change of ≥1 unit from baseline Assessed though the change in pain, measured by the Brief Pain Inventory questionnaire score. (For each of the four orthotic insoles separately.) | The overall proportion of subjects who achieve a change of ≥1 unit from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), during the first three consecutive working days of the last working episode of the treatment period. For each of the four orthotic insoles separately. To account for differences in subjects working patterns a definition was created, a valid working episode was considered to be two non-working days followed by at least three and up to five working days . The baseline was defined as the first three consecutive working days of baseline working episode (Days 0-3). The first three days of the last working episode could occur from Days 27-30 for subjects that worked 3 consecutive working days up to Days 44-47 for subjects that worked five consecutive working days | Days 0-5 compared to Days 44-47 for subjects that worked 5 consecutive working days, Days 0-3 compared to Days 27-30 for subjects that worked 3 consecutive working days |
| Subject impression of change in pain (Visual Analogue Scale) (For each of the four orthotic insoles separately.) | Subjects' rating of overall improvement in pain since pre-treatment, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. Scored on a scale of -3 to +3 with 0 indicating no change in pain, a positive number indicating an improvement and negative indicating an increase in the pain | Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern. |
| Investigator impression of change in subjects' pain (Visual Analogue Scale) (For each of the four orthotic insoles separately.) | Investigator's rating of the subjects' overall improvement in pain since pre-treatment, completed following the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. Scored on a scale of -3 to +3 with 0 indicating no change in pain, a positive number indicating an improvement and negative indicating an increase in the pain | Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern. |
| Change in quality of life, associated with improvement pain as assessed by the Brief Pain Inventory questionnaire. (For each of the four orthotic insoles separately.) | The change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the Brief Pain Inventory pain (BPI) interference scores (Question 9; composite (average) score), completed at the end of each working episode (WE) of the treatment period. The baseline WE was defined as Day 3 or Days 5 depending on the working pattern:
| Day 5 compared to Day 23-28, Day 30-35, Days 37-42 Day 44-49 for subjects that worked 5 CWD or Day 3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 CWD |
| Change in quality of life, associated with improvement in pain as assessed by the EQ-5D-5L (questionaire) (For each of the four orthotic insoles separately.) | Change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the EQ-5D-5L, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. The baseline was defined as the first three up to five consecutive working days of baseline working episode therefore in the context of this endpoint the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. Compared to the responses at the end of last working episode which could occur from Day 30 for subjects that worked 3 consecutive working days up to Day 49 for subjects that worked five consecutive working days. The EuroQol-5 dimension-5 Level (EQ-5D-5L), is made up of 5 questions scored 1 to 5 from these questions an index is created with a range between zero and 1 with a zero being death and 1 being perfect quality of life. | Day 3 up to 5 compared to Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Change in work productivity and activity as assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (For each of the four orthotic insoles separately.) | Change from baseline in work productivity and activity, assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), completed at the end of last working episode of the treatment period. For each of the four orthotic insoles separately. The baseline was defined as the first 3 up to 5 consecutive working days (CWD) of baseline working episode therefore in the context of this endpoint the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. Compared to the responses at the end of last working episode which could occur from Day 30 for subjects that worked 3 CWD up to Day 49 for subjects that worked 5 CWD. The WPAI:SHP six questions on the subjects productivity and activity Impairment. Questions comprised of information on employment, including hours at work, hours missed from work and reasons for work missed. As well as the effect that pain had on their daily activities. | Quality of life on Day 3 up to 5 compared to Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Subject impression of change in their work productivity and activity. (Visual Analogue Scale) (For each of the four orthotic insoles separately.) | Subjects' rating of overall improvement in their quality of life and work productivity and activity since pre-treatment, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. The last working day is therefore different for each subjects working pattern this could occur from Day 30 for subjects that worked 3 consecutive working days (CWD) up to Day 49 for subjects that worked 5 CWD. This assessment was scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating an improvement and negative indicating an increase in quality of life | Quality of life improvement assessed on Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Investigator impression of change in quality of life (Visual Analogue Scale) (For each of the four orthotic insoles separately.) | Investigator's rating of the subjects' overall improvement in their quality of life since pre-treatment, following the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. The last working day is therefore different for each subjects working pattern this could occur from Day 30 for subjects that worked 3 consecutive working days up to Day 49 for subjects that worked five consecutive working days. This assessment was scored on a scale of -3 to +3 with 0 indicating no change in quality of life, a positive number indicating an improvement and negative indicating an increase in quality of life | Quality of life improvement assessed on Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Safety and tolerability of the device (For each of the four orthotic insoles separately.) | Overall proportion of subjects with AEs and adverse device effects (ADEs), i.e. the occurrence of one or more AEs/ADEs per subject. For each of the four orthotic insoles separately. | through to study completion, from point of informed consent (Day 1) up to Visit 3 (Day 50) |
| Average pain on Days 0-3 compared to Days 7-10 for subjects that worked three consecutive working days, Average pain on Days 0-5 compared to Days 9-14 for subjects that worked five consecutive working days |
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress during the break-in working episode. As assessed by the change in the BPI score. (For each of the four orthotic insoles separately) | The change from baseline in the composite score of the worse, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), completed at the end of the working episode of the breaking-in period. For each of the four orthotic insoles separately. The baseline WE defined as the first 3 up to 5 consecutive working days (CWD) of baseline working episode therefore the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. The break- in period was defined as the first working episode where the subject was provided with the device, at least one non-working and included three up to five CWD. For this endpoint the end of the working episode would occur on Day 10 or Day 14 depending on the working pattern of the subjects. The average pain at the end of the break-in period was compared to the baseline. | Average pain on Days 3 was compared that on Day 10 for subjects that worked three consecutive working days, Average pain on Days 5 compared to Day 14 for subjects that worked five consecutive working days. |
| Change in quality of life, associated with improvement pain as assessed by the Brief Pain Inventory questionnaire following the break-in period (For each of the four orthotic insoles separately) | The change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the Brief Pain Inventory (BPI) pain interference scores (Question 9; composite (average) score), completed at the end of the working episode of the breaking-in period. For each of the four orthotic insoles separately. The baseline WE occurred on Day 3 or Days 5 depending on the working pattern:
| Day 5 compared to Day 23-28, Day 30-35, Days 37-42, Day 44-49 for subjects that worked five CWD or Day 3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 CWD |
| Subject perceived improvement of symptoms (questionnaire) (For each of the four orthotic insoles separately) | Improvement of symptoms as a result of wearing the insoles, recorded through a Subject Perceived Questions, daily for the first ten days of the treatment period. For each of the four orthotic insoles separately. This assessment was scored on five statements with the subject selecting the most appropriate statement with statement 1 being no change and statement 5 being completely better. | Days 11-21 of the full-use period for subjects that worked 3 consecutive working days. Days 22-32 of the full-use period for subjects that worked 5 consecutive working days. |
| Subjects impressions of comfort and impact of insoles (questionnaire) (For each of the four orthotic insoles separately) | Comfort of the insole and impact on daily activity, recorded through Subject Perceived Questions on a daily basis throughout the treatment period. For each of the four orthotic insoles separately. This assessment was scored on a scale of 0 to 10 with 0 being very uncomfortable and 10 very comfortable. | Daily though out the treatment period. Day 11 to Day 30 of the full-use period for subjects that worked 3 consecutive working days. Day 21 to 49 for subjects that worked 5 consecutive working days. |
| Subjects impressions tolerability (Visual Analogue Scale) (For each of the four orthotic insoles separately) | Subject impression of tolerability, as assessed through comfort, irritation and ADEs, completed at the end of the last working episode of the treatment period. This assessment was scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating well tolerated and negative indicating an not well tolerated. | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days. |
| Subject experience and satisfaction of insoles (Visual Analogue Scale) | Overall subject experience and satisfaction completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. Experience and satisfaction assessed as separately as two questions and scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating an improvement and negative number indicating a negative experience/ satisfaction. | Daily though out the treatment period. Day 11 to Day 30 of the full-use period for subjects that worked 3 consecutive working days. Day 21 to 49 for subjects that worked 5 consecutive working days. |
| Investigator impression of tolerability (Visual Analogue Scale) (For each of the four orthotic insoles separately) | Overall subject experience and satisfaction, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. Experience and satisfaction assessed as separately as two questions and scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating an improvement and negative number indicating an negative experience/ satisfaction. | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days |
| Investigator global impression of tolerability (Statement) (For each of the four orthotic insoles separately) | Investigator global impression of tolerability, as assessed through comfort, irritation and ADEs across the investigation, completed following the end of the last working episode of the treatment period for the last subject. For each of the four orthotic insoles separately. Statement from the Investigator included within the Clinical Investigation Report | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days |
| Subjects impressions (questionnaire) | End of study Subject Perceived Questions, completed on the day of Visit 3. For each of the four orthotic insoles separately. Subjects answered questions with each question having five levels of agreement (strongly disagree to strongly agree), the subjects selected the most appropriate statement. | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days |
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress. Assessed though the change in pain, measured by the Brief Pain Inventory questionnaire. (analysed for all insoles collectively) | The average change from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), during the first three consecutive working days of the last working episode of the treatment period. To account for differences in subjects working patterns a definition was created, a valid working episode was considered to be two non-working days followed by at least three and up to five working days . The baseline was defined as the first three consecutive working days of baseline working episode (Days 0-3). The first three days of the last working episode could occur from Days 27-30 for subjects that worked 3 consecutive working days up to Days 44-47 for subjects that worked five consecutive working days | Time frame is dependent on working pattern Days 0-5 compared to Days 44-47 and Days 0-3 compared to Days 27-30 |
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress over the first three days of each working episode. Assessed change in pain, measured by the BPI questionnaire. (analysed for all insoles) | The average change from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), during the first three consecutive working days of each working episode (WE) of the treatment period The baseline WE was defined as the first three consecutive working days of (Days 0-3):
| Days 0-5 compared to Days 23-26, Days 30-33, Days 37-40, Days 0-3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 consecutive working days |
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress over each working episode. Assessed though the change in pain, measured by the BPI questionnaire.(analysed for all insoles collectively) | The change from baseline in the composite score of the worse, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), completed at the end of each working episode (WE) of the treatment period. The baseline WE was defined as Days 0-3 or Days 0-5 depending on the working pattern of the subjects:
| Days 0-5 compared to Day 23-28, Day 30-35, Day 37-42, Day 44-49 for subjects that worked five consecutive working days, Days 0-3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 consecutive working days |
| Proportion of subjects who achieve a change of ≥1 unit from baseline.Assessed though the change in pain, measured by the Brief Pain Inventory questionnaire. (analysed for all insoles collectively) | The overall proportion of subjects who achieve a change of ≥1 unit from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), during the first three consecutive working days of the last working episode of the treatment period. To account for differences in subjects working patterns a definition was created, a valid working episode was considered to be two non-working days followed by at least three and up to five working days . The baseline was defined as the first three consecutive working days of baseline working episode (Days 0-3). The first three days of the last working episode could occur from Days 27-30 for subjects that worked 3 consecutive working days up to Days 44-47 for subjects that worked five consecutive working days | Days 0-5 compared to Days 44-47 for subjects that worked 5 consecutive working days, Days 0-3 compared to Days 27-30 for subjects that worked 3 consecutive working days |
| Subject impression of change in pain (Visual Analogue Scale) (analysed for all insoles collectively) | Subjects' rating of overall improvement in pain since pre-treatment, completed at the end of the last working episode of the treatment period. Analysed for all insoles collectively. Scored on a scale of -3 to +3 with 0 indicating no change in pain, a positive number indicating an improvement and negative indicating an increase in the pain | Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern. |
| Investigator impression of change in subjects' pain (Visual Analogue Scale) (analysed for all insoles collectively) | Investigator's rating of the subjects' overall improvement in pain since pre-treatment, completed following the end of the last working episode of the treatment period. Scored on a scale of -3 to +3 with 0 indicating no change in pain, a positive number indicating an improvement and negative indicating an increase in the pain Analysed for all insoles collectively. | Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern. |
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress during the first three days of the break-in working episode. Assessed change in pain, measured by the BPI questionnaire. (analysed for all insoles) | The average change from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), during the first three consecutive working days of the working episode (WE)of the breaking-in period. The baseline WE first 3 up to 5 consecutive working days (CWD) of baseline working episode therefore in the context of this endpoint the baseline assessment is an average of the responses Day 0-3 or Days 0-5 depending on the working pattern of the subjects. The break- in period was defined as the first working episode where the subject was provided with the device, it started with at least one non-working and included three up to five consecutive working days. For this endpoint the first three days would take place over Day 7-10. The average pain during the break-in period was compared to the baseline. | Average pain on Days 0-3 compared to Days 7-10 for subjects that worked three consecutive working days, Average pain on Days 0-5 compared to Days 9-14 for subjects that worked five consecutive working days |
| Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress during the break-in working episode Assessed though the change in pain, measured by the BPI questionnaire.(analysed for all insoles collectively) | The change from baseline in the composite score of the worse, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain), completed at the end of the working episode of the breaking-in period. For each of the four orthotic insoles separately. The baseline WE defined as the first 3 up to 5 consecutive working days (CWD) of baseline working episode therefore the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. The break- in period was defined as the first working episode where the subject was provided with the device, at least one non-working and included three up to five CWD. For this endpoint the end of the working episode would occur on Day 10 or Day 14 depending on the working pattern of the subjects. The average pain at the end of the break-in period was compared to the baseline. | Average pain on Days 3 was compared that on Day 10 for subjects that worked three consecutive working days, Average pain on Days 5 compared to Day 14 for subjects that worked five consecutive working days. |
| Change in quality of life, associated with improvement pain as assessed by the Brief Pain Inventory questionnaire (analysed for all insoles collectively) | The change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the Brief Pain Inventory pain (BPI) interference scores (Question 9; composite (average) score), completed at the end of each working episode (WE) of the treatment period. The baseline WE was defined as Day 3 or Days 5 depending on the working pattern:
| Day 5 compared to Day 23-28, Day 30-35, Days 37-42 Day 44-49 for subjects that worked 5 CWD or Day 3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 CWD |
| Change in quality of life, associated with improvement in pain as assessed by the EQ-5D-5L questionnaire (analysed for all insoles collectively) | Change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the EQ-5D-5L, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. The baseline was defined as the first three up to five consecutive working days of baseline working episode therefore in the context of this endpoint the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. Compared to the responses at the end of last working episode which could occur from Day 30 for subjects that worked 3 consecutive working days up to Day 49 for subjects that worked five consecutive working days. The EuroQol- 5 dimension - 5 level (EQ-5D-5L), is made up of 5 questions scored 1 to 5 from these questions an index is created with a range between zero and 1 with a zero being death and 1 being perfect quality of life. | Day 3 up to 5 compared to Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Change in work productivity and activity as assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (analysed for all insoles collectively) | Change from baseline in work productivity and activity, assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), completed at the end of last working episode of the treatment period. For each of the four orthotic insoles separately. The baseline was defined as the first 3 up to 5 consecutive working days (CWD) of baseline working episode therefore in the context of this endpoint the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. Compared to the responses at the end of last working episode which could occur from Day 30 for subjects that worked 3 CWD up to Day 49 for subjects that worked 5 CWD. The WPAI:SHP six questions on the subjects productivity and activity Impairment. Questions comprised of information on employment, including hours at work, hours missed from work and reasons for work missed. As well as the effect that pain had on their daily activities.. | Quality of life on Day 3 up to 5 compared to Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Subject impression of change in their work productivity and activity. (Visual Analogue Scale) (analysed for all insoles collectively) | Subjects' rating of overall improvement in their quality of life and work productivity and activity since pre-treatment, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. The last working day is different for each subject working pattern this could occur from Day 30 for subjects that worked 3 consecutive working days (CWD) up to Day 49 for subjects that worked 5 CWD. This assessment was scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating an improvement and negative indicating an increase in quality of life | Quality of life improvement assessed on Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Investigator impression of change in quality of life (Visual Analogue Scale) (analysed for all insoles collectively) | Investigator's rating of the subjects' overall improvement in their quality of life since pre-treatment, following the end of the last working episode of the treatment period. For each of the four orthotic insoles separately. The last working day is therefore different for each subjects working pattern this could occur from Day 30 for subjects that worked 3 consecutive working days up to Day 49 for subjects that worked five consecutive working days. This assessment was scored on a scale of -3 to +3 with 0 indicating no change in quality of life, a positive number indicating an improvement and negative indicating an increase in quality of life | Quality of life improvement assessed on Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days |
| Safety and tolerability of the device (analysed for all insoles collectively) | Overall proportion of subjects with AEs and adverse device effects (ADEs), i.e. the occurrence of one or more AEs/ADEs per subject. Analysed for all insoles collectively. | through study completion, from point of informed consent (Day 1) up to Visit 3 (Day 50) |
| Change in quality of life, associated with improvement pain as assessed by the Brief Pain Inventory following the break-in period (analysed for all insoles collectively) | The change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the Brief Pain Inventory (BPI) pain interference scores (Question 9; composite (average) score), completed at the end of the working episode of the breaking-in period. For each of the four orthotic insoles separately. The baseline WE occurred on Day 3 or Days 5 depending on the working pattern:
| Day 5 compared to Day 23-28, Day 30-35, Days 37-42, Day 44-49 for subjects that worked five CWD or Day 3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 CWD |
| Subject perceived improvement of symptoms (questionnaire) (analysed for all insoles collectively) | Improvement of symptoms as a result of wearing the insoles, recorded through a Subject Perceived Questions, daily for the first ten days of the treatment period. Analysed for all insoles collectively. This assessment was scored on five statements with the subject selecting the most appropriate statement with statement 1 being no change and statement 5 being completely better. | Days 11-21 of the full-use period for subjects that worked 3 consecutive working days. Days 22-32 of the full-use period for subjects that worked 5 consecutive working days. |
| Subjects impressions of comfort and impact of insoles (questionnaire) (analysed for all insoles collectively) | Comfort of the insole and impact on daily activity, recorded through Subject Perceived Questions on a daily basis throughout the treatment period. Analysed for all insoles collectively. This assessment was scored on a scale of 0 to 10 with 0 being very uncomfortable and 10 very comfortable. | Daily though out the treatment period. Day 11 to Day 30 of the full-use period for subjects that worked 3 consecutive working days. Day 21 to 49 for subjects that worked 5 consecutive working days. |
| Subjects impressions of tolerability (Visual Analogue Scale) (analysed for all insoles collectively) | Subject impression of tolerability, as assessed through comfort, irritation and ADEs, completed at the end of the last working episode of the treatment period. Analysed for all insoles collectively. This assessment was scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating well tolerated and negative indicating an not well tolerated. | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days. |
| Subjects experience and satisfaction of insoles (Visual Analogue Scale) (analysed for all insoles collectively) | Overall subject experience and satisfaction, completed at the end of the last working episode of the treatment period. Analysed for all insoles collectively. Experience and satisfaction assessed as separately as two questions and scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating an improvement and negative number indicating an negative experience/ satisfaction. | Daily though out the treatment period. Day 11 to Day 30 of the full-use period for subjects that worked 3 consecutive working days. Day 21 to 49 for subjects that worked 5 consecutive working days. |
| Investigator impression of tolerability (Visual Analogue Scale) (analysed for all insoles collectively) | Investigator impression of tolerability, as assessed through comfort, irritation and ADEs, completed following the end of the last working episode of the treatment period for each subject. Analysed for all insoles collectively. This assessment was scored on a scale of -3 to +3 with 0 indicating no change indifferent, a positive number indicating well tolerated and negative indicating not well tolerated | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days |
| Investigator global impression of tolerability(Statement) (analysed for all insoles collectively) | Investigator global impression of tolerability, as assessed through comfort, irritation and ADEs across the investigation, completed following the end of the last working episode of the treatment period for the last subject. Analysed for all insoles collectively. Statement from the Investigator included within the Clinical Investigation Report | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days |
| Subjects impressions (Questionnaires) (analysed for all insoles collectively) | End of study Subject Perceived Questions, completed on the day of Visit 3. Analysed for all insoles collectively. Subjects answered questions with each question having five levels of agreement (strongly disagree to strongly agree), the subjects selected the most appropriate statement. | Day 31 for subjects that worked 3 consecutive working days. Day 50 for subjects that worked 5 consecutive working days |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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