The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome

The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome Randomized Controlled Trial

BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after presenting in primary healthcare. Functional limitations, in addition to pain, are widespread and can interfere with job, hobbies, social, and sporting activities. They may also relate to psychological discomfort and a lower quality of life. Continuous computer uses without a break, awkward postures, and the duration and frequency of laptop use have all been identified as risk factors for musculoskeletal diseases. The most prevalent cause, accounting for 70% of cases, is rotator cuff dysfunction. Rotator cuff disorders are frequently associated with short and long-term impairment and discomfort, with approximately fifty percent of patients experiencing pain or functional restrictions for up to two years. The majority of shoulder pain concerns are treated in primary care by physiotherapists and general practitioners. Myofascial release is a common hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex with promising results in improving functional level.

OBJECTIVE: The purpose of this study is to investigate the effect of myofascial release in patient with rotator cuff tendinopathy.

METHOD: The design of this study is a double blinded Randomize control trail. Forty-two participants will be divided into one of two groups, group one will have strengthening exercises, range of motion exercise, and ice application, group two will perform the same exercises with ice application plus myofascial release. Patient will be followed for one month, two session per week and the session duration will be 30-45 mins. Assessment and re-assessment will be done by independent physical therapist. All patients will be assessed by using quick DASH, VAS, ROM, and Kessler psychological distress scale.

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Other: Myofascial Release

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Makkah
    • Taif, Makkah, Saudi Arabia, 11099
      • Taif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. are aged between 20-60 years old,
2. have one or more than one positive finding in one of the following categories: (1) painful arc of movement during flexion or abduction; (2) Neer (sensitivity 0.78, specificity 0.58) or Kennedy-Hawkins (sensitivity 0.74, specificity 0.57) impingement signs[28]; and (3) pain during resisted external rotation, abduction or empty can test (sensitivity 0.69, specificity 0.62).[29] A combination of positive results to these clinical tests has values ≥ 0.74 for sensitivity and specificity for SIS.

Exclusion Criteria:

1. have a history of glenohumeral luxation in the last 12 months or any fracture to the shoulder girdle.
2. have a shoulder pain reproduced by cervical movements. had a previous shoulder surgery, adhesive capsulitis, defined as loss of passive shoulder ROM greater than 50%, and
3. have a clinical sign of full-thickness tears of any rotator cuff muscles identified by lag signs [30]: drop sign (sensitivity 0.73, specificity 0.77), external rotation sign (sensitivity 0.46, specificity 0.94) and internal rotation sign (sensitivity 1.00, specificity 0.84).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; 18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins
Experimental: experimental group; 18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins, with adding Myofascial Release	Other: Myofascial Release; Myofascial release is a popular hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex (directly or indirectly), with the goal of restoring appropriate length, decreasing discomfort, and improving range of motion, muscle recovery, and physical performance in healthy persons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	The pain intensity will be assessed using the visual analogue scale (VAS) which assess pain from 0 (no pain) to 10 (most severe pain) and has good reliability and validity	one month
disability	The disability will be assessed using Quick DASH. The Arabic Q-DASH questionnaire consist of eleven questions that measures the disability of upper extremity, ranges from 0-100 a higher score indicates a higher disability, and it is a reliable and valid upper extremity outcome measure for assessing patients with various upper extremity disorders	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rang of motion	ROM will be measured in standing position for shoulder flexion, extension, and abduction, supine position for internal rotation, and external rotation with a two-arm standard goniometer with a good reliability	one month
psychological distress, and health-related quality of life (HRQoL)	HRQoL will be assessed using Kessler psychological distress scale, the questionnaire consists of ten questions, and scoring from 10-50 while 10 means likely will and 50 means likely to have a sever disorder, and it is valid and reliable	one month

Collaborators and Investigators

• Sponsor: Taif University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): March 2, 2024

Study Registration Dates

• First Submitted: March 2, 2024
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: Taif university

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No