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Effect of Myofascial Relaxation on Individuals With Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Treatment
Myofascial Release Treatment
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring muscle relaxation, quality of life, range of motion, shoulder pain, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being diagnosed with adhesive capsulitis
  • Being 18 years or older
  • Agree to voluntarily participate in research

Exclusion Criteria:

  • Cervical disc hernias
  • Neuromuscular diseases
  • Full thickness rotator cuff tears
  • Shoulder impingement syndrome
  • Individuals with corticosteroid injection into the shoulder joint
  • Individuals who have undergone surgical procedures on the shoulder joint
  • Individuals with bone tumors or other malignant diseases
  • Having mental and cognitive problems
  • Physiotherapy or manual therapy on the same shoulder 6 months ago

Sites / Locations

  • Private Levent Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Group

Myofascial Release Group

Arm Description

The treatment of 21 individuals in the conventional group will be done by the researcher. Among the conservative treatment methods, hot pack(15 minutes) around the glenohumeral joint, conventional TENS(15 minutes) for painful points, ultrasound(1.5 watt / cm² power, 5 minutes) and exercise(passive and active range of motion) approaches will be applied. Individuals will be asked to come to the center where the research will be conducted for a total of fifteen sessions for three weeks, five times a week.

Treatment of 21 individuals in the Myofascial Release group will be done by the researcher. Among the conservative treatment methods, hot pack(15 minutes) around the glenohumeral joint, conventional TENS(15 minutes) for painful points, ultrasound(1.5 watt / cm² power, 5 minutes),exercise(passive and active range of motion) and myofascial release to subscapularis and serratus anterior muscles approaches will be applied. Individuals will be asked to come to the center where the research will be conducted for a total of fifteen sessions for three weeks, five times a week. Myofascial release will be done in the first five sessions of treatment programs.

Outcomes

Primary Outcome Measures

Visual Analog Scale
Pain sensations are scored between 0 and 10. 0 is the lowest pain, 10 the highest pain.
Range of motion (ROM) with Goniometer
Shoulder joint range of motion, The range of motion is measured between 0-180 degrees of flexion, 0-60 degrees of extension, 0-180 degrees of abduction, 0-50 degrees of abduction, internal rotation 0-90 degrees, external rotation 0-90 degrees.
Arm, Shoulder and Hand Problems Questionnaire (DASH)
Upper extremity functionality levels, a value from 0 to 100 is obtained. The higher the score, the higher the degree of disability.
Shoulder Pain and Disability Index (SPADI)
Specific shoulder pain and functions, all scores add up. The higher the score, the higher the degree of disability.
Pittsburgh Sleep Quality Index (PUKİ)
Sleep quality, the scoring of the scale, which is evaluated by scoring each item between zero and three, is between 0-20. A total score higher than five indicates poor sleep quality.
Short Form-36 (SF-36)
Quality of life, scoring of the scale is between 0-100. 100 is the highest score, 0 is the lowest.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2021
Last Updated
May 6, 2021
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT04756167
Brief Title
Effect of Myofascial Relaxation on Individuals With Adhesive Capsulitis
Official Title
The Effect of Myofascial Relaxation on Pain, Functionality and Quality of Life in Individuals With Adhesive Capsulitis: A Randomized Controlled Single-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

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

5. Study Description

Brief Summary
In the study, the investigators aimed to investigate the effects of myofascial release method on pain, functionality and quality of life in individuals with adhesive capsulitis. 42 individuals willing to participate in the study will be included. Participants will be randomly divided into two groups, the conventional group and the myofascial release group. Evaluations will be made by another physiotherapist with a single eye blindness. Hotpack, TENS, ultrasound and exercise will be applied jointly to both groups in the study. In addition to the myofascial release group, myofascial release will be applied on the subscapularis and serratus anterior muscles. Individuals will be asked to come to the center where the research will be conducted for a total of fifteen sessions for three weeks, five times a week. Myofascial release will be done in the first five sessions of treatment programs. Participants' pain before the first treatment, at the end of the 5th treatment and after the 15th treatment with Visual Analogue Scale (VAS), shoulder joint range of motion (ROM) with Goniometer, upper extremity functionality level Arm, Shoulder and Hand Problems Questionnaire (DASH) specific shoulder pain and functions will be evaluated with the Shoulder Pain and Disability Index (SPADI), sleep quality with Pittsburgh Sleep Quality Index (PSQI), and quality of life with Short Form-36 (SF-36). Statistical analysis to be used in the investigators study will be made with the Statistical Package for the Social Sciences 20.0 package program.
Detailed Description
Adhesive capsulitis is a shoulder pathology characterized by pain persisting for more than three months due to fibrosis and contractures in the glenohumeral joint capsule, active and passive joint motion limitation and functional insufficiency. Although there are many factors that trigger this pathology, also known as frozen shoulder, its etiology is not known precisely. The clinical findings, course and prognosis are known with the researches. Although its incidence in the general population is %2-5, it is more likely to be seen in women between the ages of 40-70 and more than men. There are two types, primary and secondary. Primary frozen shoulder is idiopathic. Secondary frozen shoulder develops secondary to trauma, immobilization, rotator cuff tears, diabetes, biceps tendinitis, myocardial infarction, cerebrovascular event, psychological disorders, and post-surgical causes. Soft tissue contracture and adhesions in the capsule and axillary space are also seen in the pathogenesis. It is examined clinically in three stages. The first phase lasts about 0-3 months, when the intensity of the pain is high and the limitation of shoulder movements begins gradually. In the second stage, the severity of the pain slightly decreases, but the limitation of joint motion gradually increases, functionality decreases and lasts for about 3-9 months. In the third stage, the severity of the pain decreases, the joint movement limitations begin to recover slowly and gradually and lasts about 9-15 months. The treatment program shaped according to the characteristics of the stages; It includes conservative treatment approaches consisting of patient education, prevention, medical treatment, physiotherapy and exercises, and may require surgical treatment depending on the severity of the prognosis. Patient education in conservative treatment, hot packs, Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US), Laser, Iontophoresis etc. Electrotherapy agents, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, taping, joint and soft tissue mobilizations, manual therapy techniques and therapeutic exercises such as stretching exercises, range of motion exercises, proprioceptive neuromuscular facilitation techniques are frequently used. Restriction in shoulder movements is quite evident especially in flexion, abduction and external rotation movements. Contracture of the ligaments in the shoulder reduces the volume of the capsule. The capsule decreasing in volume causes limitation of movement. However, the pain is not only due to the tension in the capsular and ligaments, but also due to the tension in the muscles and fascia and trigger toxins. Many therapeutic methods are used to relieve these trigger points and facial tensions. One of these methods is the "myofascial release technique" that focuses on soft tissues that are particularly tense and in spasm. This technique is a treatment method aimed at resolving fascial adhesions, restoring the optimal length of the muscle, reducing pain and increasing functionality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
muscle relaxation, quality of life, range of motion, shoulder pain, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The individuals are randomly allocated into conventional and myofascial release groups
Masking
Outcomes Assessor
Masking Description
The researcher who will make the measurements will not know the treatment groups of the individuals.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
The treatment of 21 individuals in the conventional group will be done by the researcher. Among the conservative treatment methods, hot pack(15 minutes) around the glenohumeral joint, conventional TENS(15 minutes) for painful points, ultrasound(1.5 watt / cm² power, 5 minutes) and exercise(passive and active range of motion) approaches will be applied. Individuals will be asked to come to the center where the research will be conducted for a total of fifteen sessions for three weeks, five times a week.
Arm Title
Myofascial Release Group
Arm Type
Active Comparator
Arm Description
Treatment of 21 individuals in the Myofascial Release group will be done by the researcher. Among the conservative treatment methods, hot pack(15 minutes) around the glenohumeral joint, conventional TENS(15 minutes) for painful points, ultrasound(1.5 watt / cm² power, 5 minutes),exercise(passive and active range of motion) and myofascial release to subscapularis and serratus anterior muscles approaches will be applied. Individuals will be asked to come to the center where the research will be conducted for a total of fifteen sessions for three weeks, five times a week. Myofascial release will be done in the first five sessions of treatment programs.
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
Hotpack, TENS, ultrasound and exercise
Intervention Type
Other
Intervention Name(s)
Myofascial Release Treatment
Intervention Description
Hotpack, TENS, ultrasound, exercise and myofascial release therapy for subscapularis and serratus anterior muscles
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Pain sensations are scored between 0 and 10. 0 is the lowest pain, 10 the highest pain.
Time Frame
Change between baseline and first and 3 weeks
Title
Range of motion (ROM) with Goniometer
Description
Shoulder joint range of motion, The range of motion is measured between 0-180 degrees of flexion, 0-60 degrees of extension, 0-180 degrees of abduction, 0-50 degrees of abduction, internal rotation 0-90 degrees, external rotation 0-90 degrees.
Time Frame
Change between baseline and first and 3 weeks
Title
Arm, Shoulder and Hand Problems Questionnaire (DASH)
Description
Upper extremity functionality levels, a value from 0 to 100 is obtained. The higher the score, the higher the degree of disability.
Time Frame
Change between baseline and first and 3 weeks
Title
Shoulder Pain and Disability Index (SPADI)
Description
Specific shoulder pain and functions, all scores add up. The higher the score, the higher the degree of disability.
Time Frame
Change between baseline and first and 3 weeks
Title
Pittsburgh Sleep Quality Index (PUKİ)
Description
Sleep quality, the scoring of the scale, which is evaluated by scoring each item between zero and three, is between 0-20. A total score higher than five indicates poor sleep quality.
Time Frame
Change between baseline and first and 3 weeks
Title
Short Form-36 (SF-36)
Description
Quality of life, scoring of the scale is between 0-100. 100 is the highest score, 0 is the lowest.
Time Frame
Change between baseline and first and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with adhesive capsulitis Being 18 years or older Agree to voluntarily participate in research Exclusion Criteria: Cervical disc hernias Neuromuscular diseases Full thickness rotator cuff tears Shoulder impingement syndrome Individuals with corticosteroid injection into the shoulder joint Individuals who have undergone surgical procedures on the shoulder joint Individuals with bone tumors or other malignant diseases Having mental and cognitive problems Physiotherapy or manual therapy on the same shoulder 6 months ago
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla Ataş Balcı, Assist Prof
Organizational Affiliation
Bahçeşehir University
Official's Role
Study Director
Facility Information:
Facility Name
Private Levent Hospital
City
Istanbul
State/Province
Kağıthane
ZIP/Postal Code
34394
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Myofascial Relaxation on Individuals With Adhesive Capsulitis

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