NCT06301490

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

March 2, 2024

Last Update Submit

April 22, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • rang of motion

    one month

  • psychological distress, and health-related quality of life (HRQoL)

    one month

Study Arms (2)

control group

NO INTERVENTION

18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins

experimental group

EXPERIMENTAL

18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins, with adding Myofascial Release

Other: Myofascial Release

Interventions

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.

experimental group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • are aged between 20-60 years old,
  • 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.

You may not qualify if:

  • have a history of glenohumeral luxation in the last 12 months or any fracture to the shoulder girdle.
  • 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
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taif University

Ta'if, Mecca Region, 11099, Saudi Arabia

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 8, 2024

Study Start

January 11, 2024

Primary Completion

February 15, 2024

Study Completion

March 2, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations