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| ID | Type | Description | Link |
|---|---|---|---|
| 63674 | Other Grant/Funding Number | Stiftung Universität Luzern |
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| Name | Class |
|---|---|
| Luzerner Kantonsspital | OTHER |
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The aim of our clinical trial (2024-01285) is to determine how an individualized physical back training program affects physical functioning and back pain. The results will help identify the most effective treatments for low back pain. This feasibility study (2024-01284) aims to conduct a test run of the clinical trial. The main questions are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized physical back training program | Experimental | 4-week personalized physical back training program |
|
| Non-personalized physical back training program | Active Comparator | 4-week non-personalized physical back training program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized physical back training program | Other | The study intervention is a 4-week personalized physical back training program. The study intervention consists of six exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Logistical and operational feasibility: Response time | Response time (in days). | Baseline |
| Logistical and operational feasibility: Recruitment capability | Ratio of invited individuals to included participants. | Baseline |
| Logistical and operational feasibility: Sample characteristics | Analyze sample characteristics (e.g., gender, age) using descriptive statistics. | Baseline to 4 weeks |
| Logistical and operational feasibility: Data collection procedures (Access) | Qualitatively evaluate the access of study personnel to necessary documents and the database through interviews. | Baseline to 4 weeks |
| Logistical and operational feasibility: Data collection procedures (Questionnaire) | Qualitatively evaluate the usability of the questionnaire through interviews. | Baseline to 4 weeks |
| Logistical and operational feasibility: Data collection procedures (Clinical Assessment) | Qualitatively evaluate the usability of the clinical assessment through interviews. | Baseline to 4 weeks |
| Logistical and operational feasibility: Acceptability and suitability of the intervention and study procedures | Qualitatively assess the acceptability and suitability of the intervention and study procedures through interviews. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-rated physical functioning (PSFS) | Change in Patient-specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 10 (able to perform at the same level as before NSLBP). | Baseline to 4 weeks |
| Self-rated physical functioning (RMDQ) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain frequency | Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days. | Baseline to 4 weeks |
| Pain duration | Change in pain duration (e.g., average duration of an episode of NSLBP within the last 7 days). In minutes, hours, or days, with 0 = minimum. Recall period: 7 days. |
Inclusion Criteria: Individuals who
Exclusion Criteria: Individuals who …
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Perret, Prof. | University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft, Frohburgstrasse 3, 6002 Luzern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft | Lucerne | Canton of Lucerne | 6002 | Switzerland |
The investigators plan to make encrypted individual participant data (IPD) available through a repository and/or via publications, such as supplementary materials
Data will be available from the completion of the study for at least 10 years.
Access to the data will be granted according to the repository and/or publisher's criteria.
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|
| Non-personalized physical back training program | Other | The control intervention is a 4-week non-personalized physical back training program. The control intervention consists of six exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment. |
|
| Baseline to 4 weeks |
| Logistical and operational feasibility: Resource management | Qualitatively evaluate the time and personnel required for conducting the study through interviews. | Baseline to 4 weeks |
Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability). |
| Baseline to 4 weeks |
| Health-related quality of life (EQ-VAS) | Change in EQ Visual Analogue Scale (EQ-VAS). Range from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life). | Baseline to 4 weeks |
| Health-related quality of life (EQ-5D-5L) | Change in 5-Level EuroQoL5D version (EQ-5D-5L). Range from 0 (lowest health-related quality of life) to 1 (highest health-related quality of life). | Baseline to 4 weeks |
| Pain intensity (NRS) | Change in pain intensity (11-point Numeric Rating Scale, NRS). Range from 0 (no pain) to 10 (pain as bad as you can imagine). Recall period: 7 days. | Baseline to 4 weeks |
| Intervention-related (serious) adverse events | Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to ClinO, Art. 63, Switzerland). | During the 4 week intervention period |
| Baseline to 4 weeks |
| Pain interference (PEG) | Change in Pain, Enjoyment, and General Activity (PEG) 3-Item Scale. Range from 0 (no pain; does not interfere) to 10 (pain as bad as you can imagine; completely interferes). Recall period: 7 days. | Baseline to 4 weeks |
| Pain extent | Change in pain extent. Percentages of the body with NSLBP, with 0%=minimum | Baseline to 4 weeks |
| Performance-based physical functioning (pressure pain threshold) | Change in pressure pain threshold. kPA, with 0=minimum | Baseline to 4 weeks |
| Performance-based physical functioning (range of motion) | Change in range of motion. Degrees, with 0=minimum | Baseline to 4 weeks |
| Performance-based physical functioning (strength) | Change in strength. Nm, with 0=minimum | Baseline to 4 weeks |
| Performance-based physical functioning (neurodynamics) | Change in neurodynamics. Positive, negative. | Baseline to 4 weeks |
| Performance-based physical functioning (movement control) | Change in movement control. Positive, negative. | Baseline to 4 weeks |
| NSLBP-related work productivity loss | Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss. | Baseline to 4 weeks |
| Participant satisfaction | Change in participant satisfaction (e.g., 1) I am satisfied with the training program I received. 2) I am satisfied with the result of the training program). 5-point Likert scale (strongly agree, agree, uncertain, disagree, strongly disagree). | Baseline to 4 weeks |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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