Effect of Myofascial Relaxation on Individuals With Adhesive Capsulitis

NCT04756167 | Completed DMC

• 1 other identifier: 1508796
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis

Keywords

muscle relaxation; quality of life; range of motion; shoulder pain; sleep

Outcome Measures

Primary Outcomes (6)

• Visual Analog Scale

  Pain sensations are scored between 0 and 10. 0 is the lowest pain, 10 the highest pain.

  Change between baseline and first and 3 weeks

• 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.

  Change between baseline and first and 3 weeks

• 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.

  Change between baseline and first and 3 weeks

• 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.

  Change between baseline and first and 3 weeks

• 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.

  Change between baseline and first and 3 weeks

• 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.

  Change between baseline and first and 3 weeks

Study Arms (2)

Conventional Group

ACTIVE COMPARATOR

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.

Other: Conventional Treatment

Myofascial Release Group

ACTIVE COMPARATOR

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.

Other: Myofascial Release Treatment

Interventions

Conventional Treatment OTHER

Hotpack, TENS, ultrasound and exercise

Conventional Group

Myofascial Release Treatment OTHER

Hotpack, TENS, ultrasound, exercise and myofascial release therapy for subscapularis and serratus anterior muscles

Myofascial Release Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Private Levent Hospital

Istanbul, Kağıthane, 34394, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Leyla Ataş Balcı, Assist Prof

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who will make the measurements will not know the treatment groups of the individuals.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: The individuals are randomly allocated into conventional and myofascial release groups

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 16, 2021
• Study Start: February 1, 2021
• Primary Completion: February 28, 2021
• Study Completion: May 1, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)