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Frozen shoulder has been considered a self-limiting and benign disease with complete resolution of pain and ROM, but this can sometimes last for years. This prolonged pain and disability deprives patients of their routine life, occupational and recreational activities. Although appropriate treatment is needed so that they can quickly return to their lives, definitive treatment strategies have not been established and many different management strategies are used. The aim of this study is to investigate whether pain education and sensory education applied together with conventional physiotherapy are more effective than conventional physiotherapy alone.In this study, 21 people diagnosed with frozen shoulder who were referred by the doctor of Esenler Medipol Hospital, Department of Physical Therapy and Rehabilitation will be included in the study.
Outcome measures: Pain Beliefs Scale, Pain Catastrophizing Scale, PainDetect Questionnaire, Tampa Kinesiophobia Scale, Shoulder Pain and Disability Index, Visual Analog Scale, Electrogoniometer, Two-point discrimination test, Numeric Rating Sleep Scale and Right/ Left Judgement Task.
This study was designed as a prospective randomized controlled trial. 21 people were included in the study. Participants were randomly divided into two groups: Conventional physiotherapy group (CP group) (n=11), Conventional physiotherapy plus central nervous system focused treatment group (CP+CNS group) (n=10). Conventional physiotherapy was applied to both groups for 45-60 minutes, 5 days a week for 4 weeks.
The CP group treatment session will take place as follows: Scapular mobilization, passive stretches, stick exercises, pendulum exercises and shoulder flexion, extension, internal rotation, external rotation, horizontal abduction/ adduction strengthening exercises.
The CP+CNS group received central nervous system focused therapy that included chronic pain education, localization training, graphesthesia, graded motor imagery and mirror therapy in addition to conventional physiotherapy.
The IG group protocol includes:
First week:
Second week:
Third week:
Fourth week:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional physiotherapy plus central nervous system focused treatment group (CP+CNS group) | Experimental | For the patients participating in the study, a protocol focused on the central nervous system and aimed at reducing hypersensitivity was applied with pain, graded sensory discrimination and graded motor imagery (GMI) training in addition to conventional physiotherapy. Graded sensory dicrimination training includes localization training level 1, localization training level 2 and graphesthesia training. GMI training includes right/left discrimination training, visual imagery, isometric and functional exercises, and mirror therapy. The treatment was applied in 20 sessions, for 45-60 minutes, 5 days a week. |
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| Conventional Physiotherapy Group (CP Group) | Active Comparator | In the conventional physiotherapy group of the study, in addition to physiotherapy modalities for 20 sessions, 5 days a week, for 45-60 minutes each session, 5 days a week, electrotherapy, scapular mobilization, passive stretching, stick exercises, finger ladder exercises, pendulum exercises and shoulder flexion, extension, abduction, internal rotation, external rotation strengthening exercises were applied. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group (IG) | Other | Participants randomized to this treatment will receive a central nervous system-focused intervention consisting of a 20-session treatment program delivered in 30-45-minute sessions scheduled 5 days a week over a 4-week period and standard physical therapy will be continued.
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| Measure | Description | Time Frame |
|---|---|---|
| The Pain Catastrophizing Scale | The PCS is used to evaluate the patient's feelings, thoughts, and emotions related to pain and catastrophizing. it is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points | Change from The Pain Catastrophizing Scale at 4 weeks |
| Visual Analog Scale (VAS) | It is used to assess pain. Although pain has been defined in many different ways, the most widely accepted is the International Association for the Study of Pain (IASP); It is a definition of "sensory, emotional, unpleasant feeling related to the past experiences of the person, whether due to an organic cause originating from any part of the body or not" (20). Visual Analogue Scale (VAS) is a reliable and valid pain measurement method in the evaluation of the severity of chronic pain (21). There is a numeric horizontal line between zero and ten. Zero means "no pain" and ten means "unbearable pain". Below the horizontal scale are facial expressions. | Change from Visual Analog Scale (VAS) at 4 weeks |
| Electrogoniometer | Normal joint movements measurement is evaluated with active or passive movements. The most used instrument for the objective evaluation of these movements is the electrogoniometer. All joints are placed according to the anatomical position before measurement and this position is considered as the zero initial position. The electrogoniometer should not touch the body during measurement and should be placed lateral to the joint. In this study, shoulder joint electrogoniometer measurements will be made. Shoulder flexion, abduction, internal rotation, external rotation will be measured at the beginning and at the end of the 4th week, with an electrogoniometer, normal range of motion will be measured. | Change from electrogoniometer at 4 weeks |
| Two Point Discrimination Test |
| Measure | Description | Time Frame |
|---|---|---|
| Tampa Kinesiophobia Scale (TKS) | The Tampa Kinesiophobia Scale (TKS) was originally developed by Miller, Kopri, and Todd in 1991 but was not published. Vlaeyen et al. republished the original 17-question scale in 1995 with permission from the researchers who developed it. The validity and reliability study of the Turkish version was conducted by Yılmaz et al. in 2011. TKS is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. A 4-point Likert scoring (1=I totally disagree, 4=I totally agree) is used in the scale. After reversing the 4th, 8th, 12th and 16th items, the total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayşe GÜRLÜK, MSc | Medipol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University Esenler Hospital | Istanbul | Istanbul | 34230 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group (CG) | Other | The control group will receive only conventional physiotherapy. Conventional physiotherapy will be 5 days a week. The conventional physiotherapy treatment session will take place as follows.
Conventional physiotherapy intervention is planned for 45-60 minutes a day, five days a week for both groups. |
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The two-point discrimination test is the evaluation of the ability to perceive stimuli applied from two different points at the same time. A commercially available mechanical caliper will be used to measure two-point separation on the non-dominant and dominant shoulders. These areas within the shoulder will correspond to the C5, C6 and C7 dermatomes. Participants will be instructed to report to the tester if they repeatedly feel two points or if the pressure is greater than a light touch.Care should be taken that the warning given while performing the test does not cause pain. Evaluation will be made with the aid of an esthesiometer. The esthesiometer is used to measure the person's 2-point sensory threshold on the skin. The ruler opens until you feel the 2 points and the value is recorded. |
| Change from two point discrimination test at 4 weeks |
| Pain Beliefs Scale | It was developed by Edwards et al. in 1992. They mention that the most important purpose of developing the scale is to understand the psychological and organic attributions of chronic pain patients to the origin of pain, which have not been investigated until that time. In the original form of this scale, there are a total of 20 items covering beliefs about the sources of pain and the treatment method. Two subtests were created: Organic Beliefs subtest consisting of 8 items and Psychological Beliefs subtest consisting of 4 items. Scores range from 1 to 6 for each item. The total score for each subtest is calculated by adding the scores obtained from the items in that subtest and dividing by the number of items belonging to that subtest. | Change from pain beliefs scale at 4 weeks |
| Right/left Judgement Task | For laterality assessment, SSDG was assessed with the Neuro Orthopedic Institute (NOI) Recognise Shoulderâ„¢ online program using an iPad. In order to gain familiarity, individuals were asked to mark whether 15 photos from the rapid test category belonged to the right or left shoulder. In the actual assessment, they were asked to answer 30 shoulder photos from the rapid test category as right and left as soon as possible. Mean response times (RT) in milliseconds (ms) and percentage of correct responses were reported separately for both the affected and unaffected shoulder region as the two main outcome measures. Responses below 500 ms and above 15000 ms were considered invalid. | Change from right/left judgement task at 4 weeks |
| Change from tampa kinesiophobia scale (TKS) at 4 weeks |
| Shoulder Pain and Disability Index (SPADI) | The functional status of the patients was evaluated using the "Shoulder Pain and Disability Index". Shoulder pain and disability index is a questionnaire developed to measure shoulder pain-related pain and disability, consisting of two parts, pain and disability, and containing a total of 13 questions. There are 5 questions in the subgroup of the questionnaire that evaluates pain, and the patient is asked to express the severity of his pain during different activities in the last week by scoring between zero (no pain) and 10 (the most severe pain). In the subgroup in which disability is evaluated, there are 8 questions and the patient is asked to rate how much difficulty he has had during the different activities he has done in the last week, between zero (no difficulty) and 10 (receiving help). A total score of zero indicates maximum well-being, and 130 points indicate maximum ill health. | Change from shoulder pain and disability index (SPADI) at 4 weeks |
| Pain Detect (PD-Q) | The PD-Q is a simple questionnaire that allows the detection of neuropathic pain components in patients with chronic pain. PD-Q consists of four main parts. In the first part, it evaluates the intensity of current pain, the average and maximum pain intensity over the past 4 weeks. In the second part, patients are asked to mark one of the four graphs that best describe their pain course patterns. The third section includes a sensory map representing the homunculus, a bidirectional item about the presence of radiating pain, and questions that attempt to mark the area of pain with an arrow pointing in the direction of the radiating pain. In the last part, there are seven Likert-type items asking the intensity of the sensation marked on the homunculus. This last section provides scores between 0 and 35 points. The final score is obtained by adding the total scores of the last three sections from -1 to 38. PD-Q uses two cut-off values. | Change from shoulder pain detect (PD-Q)at 4 weeks |
| Graded Chronic Pain Scale-Revised | Persons with chronic pain are placed at grades 1, 2, or 3. Among persons with chronic pain, those who report that pain limits their life activities or work on most days or every day in the past 3 months (item 2) are placed at grade 3 (high-impact chronic pain). Among the remaining persons with chronic pain, those with a PEG total score of 12 or greater are placed at grade 2 (bothersome chronic pain). Those with chronic pain that is not high impact and whose PEG score is less than 12 are placed at grade 1 (mild chronic pain). | Change from graded chronic pain scale-revised at 4 weeks |
| Sleep Scale | A scale of zero to ten points will be used to assess sleep quality. The person will be asked to score between 0-10 points for sleep quality, considering how many hours they sleep, how easily they fall asleep, how often they wake up at night (except to go to the bathroom), how often they wake up early in the morning without having to, and how refreshing their sleep is. 0 means "terrible", 1-2-3 means "poor", 4-5-6 means "balanced", 7-8-9 means "good", 10 means "great". | Change from sleep scale at 4 weeks |
| D008722 | Methods |