search
Back to results

Effects of IASTM in the Treatment of Adhesive Capsulitis

Primary Purpose

Pain, Shoulder, Adhesion; Shoulder, Myofacial Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standard Exercise
Instrument Assisted Soft Tissue Mobilization (IASTM)
Home Exercise
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Shoulder focused on measuring Adhesive capsulitis, Function, Pain, Exercise

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IASTM + Standard Exercise Group

Standard Exercise Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 28, 2022
Last Updated
May 3, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istanbul Aydın University
search

1. Study Identification

Unique Protocol Identification Number
NCT05358730
Brief Title
Effects of IASTM in the Treatment of Adhesive Capsulitis
Official Title
Instrument-assisted Soft Tissue Mobilization to Exercise Programme Improves Outcomes in Patients With Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2019 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istanbul Aydın University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Shoulder, Adhesion; Shoulder, Myofacial Pain
Keywords
Adhesive capsulitis, Function, Pain, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IASTM + Standard Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Exercise Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Exercise
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization (IASTM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home Exercise
Intervention Description
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 Outcome Measure Information:
Title
Upper extremity function
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Upper extremity function
Description
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.
Time Frame
At the end of the 3-week intervention
Title
Upper extremity function
Description
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.
Time Frame
At the end of the 6-week intervention
Title
The severity of pain
Description
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.
Time Frame
Baseline
Title
The severity of pain
Description
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.
Time Frame
At the end of the 3-week intervention
Title
The severity of pain
Description
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.
Time Frame
At the end of the 6-week intervention
Title
Functional level of shoulder
Description
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.
Time Frame
Baseline
Title
Functional level of shoulder
Description
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.
Time Frame
At the end of the 3-week intervention
Title
Functional level of shoulder
Description
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.
Time Frame
At the end of the 6-week intervention
Title
Range of motion
Description
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.
Time Frame
Baseline
Title
Range of motion
Description
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.
Time Frame
At the end of the 3-week intervention
Title
Range of motion
Description
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.
Time Frame
At the end of the 6-week intervention
Title
Health-related quality of life
Description
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.
Time Frame
Baseline
Title
Health-related quality of life
Description
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.
Time Frame
At the end of the 3-week intervention
Title
Health-related quality of life
Description
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.
Time Frame
At the end of the 6-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tansu Birinci, PT, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Bakırkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of IASTM in the Treatment of Adhesive Capsulitis

We'll reach out to this number within 24 hrs