Effects of IASTM in the Treatment of Adhesive Capsulitis

Study Overview
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Brief Summary
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This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. In the first group exercise programme (Group 1) and in the second group IASTM in combination with exercise programme (Group 2) were applied for twelve sessions (two days per week for six week). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score and secondary outcomes were the visual analogue scale (VAS), the range of motion (ROM), The Constant score and Short- Form-36 (SF-36). Outcome measures were performed at baseline, after the 6th session and the 12th session.

Detailed Description
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Instrument Assisted Soft Tissue Mobilization (IASTM) is a popular treatment for myofascial restriction based on the logic developed by James Cyriax. IASTM is applied using specially designed instruments to provide a mobilizing effect on soft tissue (eg scar tissue, myofascial adhesion) to reduce pain, improve joint range of motion and function. IASTM can help improve fibroblast proliferation and promote normal collagen sequencing, however, there is no enough study evaluating the results of IASTM use in patients with frozen shoulders in the literature. This study aimed to determine the effects of IASTM in combination with exercise in the treatment of frozen shoulder. Therefore, it was hypothesized that exercise programme combined with IASTM are more effective in improving pain, range of motion (ROM), and functionality than are the exercise programme alone.

Official Title
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Instrument-assisted Soft Tissue Mobilization to Exercise Programme Improves Outcomes in Patients With Adhesive Capsulitis

Conditions
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Pain, Shoulder, Adhesion; Shoulder, Myofacial Pain

Intervention / Treatment
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* Other: Standard Exercise
* Other: Instrument Assisted Soft Tissue Mobilization (IASTM)
* Other: Home Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 30 and 65 years; Duration of complaint of more than three months ROM in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions Exclusion Criteria: Having cervical radiculopathy Thoracic outlet syndrome Rheumatological disorders Fractures or tumors of either upper extremity Corticosteroid injections in the affected shoulder within the previous 4 weeks

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IASTM + Standard Exercise Group<br>Patients were applied IASTM in combination with standard exercise program two days a week for six weeks. The IASTM technique was performed using six titanium-plated instruments in different sizes, shapes and treatment styles. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment. | Other: Standard Exercise<br>* Glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises were performed under the supervision of a physiotherapist two days per week for six weeks at the clinical setting (Celik and Kaya Mutlu, 2016).<br>Other: Instrument Assisted Soft Tissue Mobilization (IASTM)<br>* IASTM treatment was applied to the posterior-anterior-middle deltoid, latissimus dorsi, teres major, teres minor, supraspinatus and infraspinatus muscle fibers, superficial and deep fascia. IASTM was applied in parallel and vertical direction to the muscle fibers treated with the instrument at a 45° angle, each technique (SWEEP, BRUSH (straight short steps) techniques) for 20 seconds (Ikeda, Otsuka, Kawanishi, and Kawakami, 2019). It was performed two days per week for six weeks.<br>Other: Home Exercise<br>* Hme exercise program consisted of glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises. It was asked to perform two days per week for six weeks.<br>|
| Active Comparator: Standard Exercise Group<br>Patients were given a standard exercise program two days a week for six weeks. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment. | Other: Standard Exercise<br>* Glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises were performed under the supervision of a physiotherapist two days per week for six weeks at the clinical setting (Celik and Kaya Mutlu, 2016).<br>Other: Home Exercise<br>* Hme exercise program consisted of glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises. It was asked to perform two days per week for six weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper extremity function | DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper extremity function | DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section. | At the end of the 3-week intervention | 
| Upper extremity function | DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section. | At the end of the 6-week intervention | 
| The severity of pain | The severity of pain that people feel on their shoulders at rest, during activity and at night was evaluated using the Visual Analogue Scale (VAS). The patients were told that 0 number shows no pain and 10 number shows most excruciating pain on the visual analog scale, and the participant was asked to position the pain feeling in this range by drawing a line. | Baseline | 
| The severity of pain | The severity of pain that people feel on their shoulders at rest, during activity and at night was evaluated using the Visual Analogue Scale (VAS). The patients were told that 0 number shows no pain and 10 number shows most excruciating pain on the visual analog scale, and the participant was asked to position the pain feeling in this range by drawing a line. | At the end of the 3-week intervention | 
| The severity of pain | The severity of pain that people feel on their shoulders at rest, during activity and at night was evaluated using the Visual Analogue Scale (VAS). The patients were told that 0 number shows no pain and 10 number shows most excruciating pain on the visual analog scale, and the participant was asked to position the pain feeling in this range by drawing a line. | At the end of the 6-week intervention | 
| Functional level of shoulder | The modified constant shoulder score assesses pain, position, daily living activities, ROM and strength. Scoring consists of pain (15 points), daily activities (20 points), active range of motion (AROM) (40 points) and strength (25 points). The total Constant score is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). Turkish validity and reliability study of modified constant score. | Baseline | 
| Functional level of shoulder | The modified constant shoulder score assesses pain, position, daily living activities, ROM and strength. Scoring consists of pain (15 points), daily activities (20 points), active range of motion (AROM) (40 points) and strength (25 points). The total Constant score is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). Turkish validity and reliability study of modified constant score. | At the end of the 3-week intervention | 
| Functional level of shoulder | The modified constant shoulder score assesses pain, position, daily living activities, ROM and strength. Scoring consists of pain (15 points), daily activities (20 points), active range of motion (AROM) (40 points) and strength (25 points). The total Constant score is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). Turkish validity and reliability study of modified constant score. | At the end of the 6-week intervention | 
| Range of motion | Shoulder flexion, abduction, internal rotation and external rotation ROM were actively and passively measured using a universal goniometer while the participant was in the supine position. All shoulder ROMs were repeated 3 times and the average of the angular values obtained was recorded in degrees. | Baseline | 
| Range of motion | Shoulder flexion, abduction, internal rotation and external rotation ROM were actively and passively measured using a universal goniometer while the participant was in the supine position. All shoulder ROMs were repeated 3 times and the average of the angular values obtained was recorded in degrees. | At the end of the 3-week intervention | 
| Range of motion | Shoulder flexion, abduction, internal rotation and external rotation ROM were actively and passively measured using a universal goniometer while the participant was in the supine position. All shoulder ROMs were repeated 3 times and the average of the angular values obtained was recorded in degrees. | At the end of the 6-week intervention | 
| Health-related quality of life | In order to evaluate the quality of life, the Short Form-36 (SF-36) was used, which consists of 36 items evaluating 2 main (physical and mental component) and 8 sub-parameters (physical, emotional and social function, physical role, mental health, pain, general health and vitality). The scale evaluating the score of each subgroup between 0-100; 0 indicates bad health, 100 indicates good health. In our study, SF-36 health control scale scoring was calculated on the internet address http://www.rand36calculator.com with the percentage values given as a result of marking the answers in the form. | Baseline | 
| Health-related quality of life | In order to evaluate the quality of life, the Short Form-36 (SF-36) was used, which consists of 36 items evaluating 2 main (physical and mental component) and 8 sub-parameters (physical, emotional and social function, physical role, mental health, pain, general health and vitality). The scale evaluating the score of each subgroup between 0-100; 0 indicates bad health, 100 indicates good health. In our study, SF-36 health control scale scoring was calculated on the internet address http://www.rand36calculator.com with the percentage values given as a result of marking the answers in the form. | At the end of the 3-week intervention | 
| Health-related quality of life | In order to evaluate the quality of life, the Short Form-36 (SF-36) was used, which consists of 36 items evaluating 2 main (physical and mental component) and 8 sub-parameters (physical, emotional and social function, physical role, mental health, pain, general health and vitality). The scale evaluating the score of each subgroup between 0-100; 0 indicates bad health, 100 indicates good health. In our study, SF-36 health control scale scoring was calculated on the internet address http://www.rand36calculator.com with the percentage values given as a result of marking the answers in the form. | At the end of the 6-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesive capsulitis, Function, Pain, Exercise