To Develop and Validate a Structured Exercise Protocol and Its Efficacy in Sub Acromial Impingement Patients

NCT06107985 | Unknown DMC

• 2 other identifiers: MRC-01-22-428EC-OA-94-2022
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Shoulder impingement syndrome (SIS) is responsible for 44% to 60% of medical consultations related to shoulder pain with an approximate prevalence of 70-200 per 1000 adults, which implies a remarkable use of health care resources. The cost for society is high and patients with shoulder disorders account for 20% of all disability due to musculoskeletal disorder. The underlying mechanisms are thought to include inflammation, degeneration of the tendons or bursa, dysfunctional scapulothoracic and glenohumeral mechanics, debilitated scapular musculature, joint capsule irregularities, postural abnormalities of the neck and shoulder, and morphological abnormalities of the relevant skeletal elements. There is a need for well-designed structured exercise program in detail considering content, dosage and progression to guide treatment for patients with sub acromial pain. The purpose of this study is to develop and validate a structured exercise protocol and to assess its effectiveness in patients with sub-acromial impingement syndrome. Through the extensive literature review, the exercise program would be proposed. In Phase 1, We will develop and validate a structured exercise programs for sub acromial impingement syndrome using an expert consensus Delphi-based survey technique. In phase 2, a randomized controlled trial will be conducted. Group A (Experimental Group) will receive newly structured exercises for twelve weeks and Group B (control group) will receive conventional exercise program for 12 weeks. Evaluation of the participant will be done at the baseline using Constant Murley Score, shoulder pain and disability Index (SPADI). Shoulder range of motion, shoulder muscles extensibility will be assessed and scapulothoracic ratio will be calculated and documented. T-FAST test will be conducted to score the patients functional performance. Assessment will be done at baseline, 3, 6, 9, and 12 weeks in both the groups. At the end of the study the data will be collected, coded and tabulated using descriptive and inferential statistics.

Conditions

Subacromial Impingement Syndrome

Keywords

Subacromial Impingement; exercise protocol; SPADI

Outcome Measures

Primary Outcomes (4)

• Constant-Murley Score

  This score is a shoulder-specific assessment tool containing objective measures (range of movement and shoulder strength) and subjective measures (activity of daily living and pain). This scale assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objectives: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function). Pain and ADL are answered by the patient; ROM and strength require a physical evaluation and are answered by the physiotherapist.

  Baseline, 3, 6, 9, and 12 weeks

• Visual analouge Scale

  The visual analogue scale (VAS; 0-10) is used to assess the patient's perceived pain intensity at rest, during arm activity and at night during the previous 24 hours at each follow-up. The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain. The distance from 'no pain' to the patient's mark is then measured and this equals the Visual Analouge scale score.

  Baseline, 3, 6, 9, and 12 weeks

• The Shoulder Pain and Disability Index (SPADI)

  The Shoulder Pain and Disability Index is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'. The scores from both dimensions are averaged to derive a total score. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  Baseline, 3, 6, 9, and 12 weeks

• Timed Functional Arm and Shoulder Test

  The Timed Functional Arm and Shoulder Test (TFAST)is a simple battery of physical performance tests for functional task used for shoulder assessment.

  Baseline, 3, 6, 9, and 12 weeks

Secondary Outcomes (1)

• Scapulothoracic ratio Measurement

  Baseline, 3, 6, 9, and 12 weeks

Study Arms (2)

Structured exercise group

EXPERIMENTAL

Group A (Experimental Group) will receive structured exercises protocol, will be given approximately for two days per week for twelve weeks.

Other: Structured exercise program

Conventional Exercise group

ACTIVE COMPARATOR

Group B (control group) will receive conventional exercise program for two days per week for twelve weeks.

Other: Conventional Exercise Program

Interventions

Structured exercise program OTHER

This intervention will be based on shoulder kinetic control, load modification exercises and lumbopelvic stabilization with core stability exercises which is not a part of conventional exercise program for shoulder impingement syndrome patients.

Structured exercise group

Conventional Exercise Program OTHER

Conventional exercise program for shoulder impingement syndrome patients

Conventional Exercise group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group between 18-60 years
• Symptoms for more than three weeks
• Main complaints in the gleno humeral joint region or the proximal arm
• Presence of one of the following signs indicating SAIS: Neer impingement test, Hawkins-Kennedy impingement test, painful arc with active abduction or flexion. Pain with one of the following resistance tests: external rotation, internal rotation, abduction

You may not qualify if:

• Severe pain; pain is \> 7/10 on NRS (0 = no pain)
• Shoulder surgery on affected shoulder
• Traumatic shoulder dislocation/ fracture within the past 3 months
• Previous rehabilitation for this episode of shoulder pain
• Reproduction of shoulder pain with active or passive cervical motion
• Systemic inflammatory joint disease
• Global loss of passive shoulder ROM, indicative of adhesive capsulitis
• Full-thickness rotator cuff tear
• Incompetent adults
• Subjects unable to consent
• Patients who are unfit to undergo the suggested exercises as per the protocol

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Seth Gordhandas Sunderdas Medical College: collaborator

Related Publications (5)

• Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Phys Ther. 2000 Mar;80(3):276-91.

  PMID: 10696154 RESULT

• Shire AR, Staehr TAB, Overby JB, Bastholm Dahl M, Sandell Jacobsen J, Hoyrup Christiansen D. Specific or general exercise strategy for subacromial impingement syndrome-does it matter? A systematic literature review and meta analysis. BMC Musculoskelet Disord. 2017 Apr 17;18(1):158. doi: 10.1186/s12891-017-1518-0.

  PMID: 28416022 RESULT

• Kromer TO, de Bie RA, Bastiaenen CH. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial. BMC Musculoskelet Disord. 2010 Jun 9;11:114. doi: 10.1186/1471-2474-11-114.

  PMID: 20534140 RESULT

• Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.

  PMID: 31726927 RESULT

• Worsley P, Warner M, Mottram S, Gadola S, Veeger HE, Hermens H, Morrissey D, Little P, Cooper C, Carr A, Stokes M. Motor control retraining exercises for shoulder impingement: effects on function, muscle activation, and biomechanics in young adults. J Shoulder Elbow Surg. 2013 Apr;22(4):e11-9. doi: 10.1016/j.jse.2012.06.010. Epub 2012 Sep 1.

  PMID: 22947240 RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Reshma Gurav

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reshma Gurav, MPTh

CONTACT

+97455023509; RGurav@hamad.qa

Bhavana Mhatre, MscPT

CONTACT

+919821712963; 28bhavanamhatre@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy Specialist

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 30, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share