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Completed

NCT Number: NCT05358730

Effects of IASTM in the Treatment of Adhesive Capsulitis

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.

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Key information

Conditions

Pain, Shoulder Adhesion; Shoulder Arthralgia Behavior Bursitis Cicatrix Facial Pain Fibrosis Joint Diseases Motor Activity Musculoskeletal Diseases Myofacial Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Tissue Adhesions

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Exercise

Other

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).

Instrument Assisted Soft Tissue Mobilization (IASTM)

Other

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.

Home exercise

Other

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.

Primary outcomes

  1. Upper extremity function

    Time frame: Baseline

    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.

Secondary outcomes

  1. Upper extremity function

    Time frame: At the end of the 3-week intervention

    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.

  2. Upper extremity function

    Time frame: At the end of the 6-week intervention

    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.

  3. The severity of pain

    Time frame: Baseline

    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.

  4. The severity of pain

    Time frame: At the end of the 3-week intervention

    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.

  5. The severity of pain

    Time frame: At the end of the 6-week intervention

    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.

  6. Functional level of shoulder

    Time frame: Baseline

    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.

  7. Functional level of shoulder

    Time frame: At the end of the 3-week intervention

    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.

  8. Functional level of shoulder

    Time frame: At the end of the 6-week intervention

    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.

  9. Range of motion

    Time frame: Baseline

    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.

  10. Range of motion

    Time frame: At the end of the 3-week intervention

    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.

  11. Range of motion

    Time frame: At the end of the 6-week intervention

    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.

  12. Health-related quality of life

    Time frame: Baseline

    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.

  13. Health-related quality of life

    Time frame: At the end of the 3-week intervention

    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.

  14. Health-related quality of life

    Time frame: At the end of the 6-week intervention

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Istanbul Aydın University

Registry information

Official study title

Instrument-assisted Soft Tissue Mobilization to Exercise Programme Improves Outcomes in Patients with Adhesive Capsulitis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 3, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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