Clinical trial NCT06107985: To Develop and Validate a Structured Exercise Protocol and Its Efficacy in Sub Acromial Impingement Patients
Official title: To Develop and Validate a Structured Exercise Protocol and to Assess Its Effectiveness in Patients With Sub Acromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: Subacromial Impingement
exercise protocol
SPADI
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Seth Gordhandas Sunderdas Medical College
First posted: 2023-10-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Shoulder pain is very common with an annual population prevalence of up to 46.7%, and a lifetime prevalence of up to 67%.1 In primary care, shoulder pain is the third most common musculoskeletal presentation. 1, 2 Shoulder pain may have an unfavourable outcome, with only about 50% of all new episodes of shoulder complaints presenting in physiotherapy practice showing a complete recovery within 6 months. Symptoms may be disabling in terms of the patient's ability to carry out daily activities at home and at the workplace. The most frequent shoulder diagnosis is subacromial pain syndrome, affecting about half of all shoulder patients, both in general practice and in secondary care. Shoulder impingement syndrome (SIS) is responsible for 44% to 60% of medical consultations related to shoulder pain 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 diagnosis of SIS is therefore mainly based on functional aspects and on an affected anatomical structure and requires a thorough history and clinical examination, including aspects such as activity and participation restrictions, aggravating and easing factors, or the "patients' perspective on the situation". Physiotherapy assessment has a very significant role to find out the structural and functional impairments and accordingly set the goals of management. Diagnosing the cause and identifying the source or affected structure is of utmost importance in Physiotherapy management. Apart from focusing only on structures, physiotherapy assessment emphasizes on movement dysfunctions and biomechanical derangements commonly seen in patients with impingement. Correction of the biomechanical faults would off load the sub acromial space and reduce the pain. The technique used to correct the biomechanics is called "load modification or Shoulder symptom modification process" and involves techniques: Alterations to thoracic kyphosis, Scapular positioning techniques, Humeral head positioning procedures and pain and symptom neuromodulation procedure. Current evidence for the physiotherapeutic treatment of SIS, summarized in systematic reviews through the last years, supports the specific and structured exercise program. Furthermore, these studies used either different types of exercises in their groups as a basic treatment, or applied a pre-defined set of manual techniques to all patients without considering the individual situation of the patient. Reasons for the selection or the combination of the exercises or the manual techniques used varied considerably between studies, were often not explained and thus remained unclear. Recent systematic review and meta-analysis conducted by Louis Pieter and Jeremy Lewis in 2020 concluded that continued research is needed to more fully understand the uncertainty around the optimal type, dose, and duration of exercise for sub-acromial shoulder pain. Thus, nearly all current systematic reviews emphasize the need for more high quality trials of physiotherapy interventions to optimize the dosimetry of exercise program. The term conventional physiotherapy is uninterpretable and inconclusive especially because there is presumption of how exactly the exercise program is formed. Many of the exercise program do not provide adequate information of what and why interventions are used. There are many varieties of exercises with different rationale and techniques. Hence, it is mandatory to have an adequate description of techniques making up the intervention and rationale for dosage is essential i.e. the number of sessions, intensity, and duration of intervention as per the TIDieR checklist (Template for Intervention description and replication). 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. This demands developing a specific guidance on how exercise interventions should be reported in clinical trials depending on what structure is affected in intrinsic and extrinsic mechanisms of subacromial impingement syndrome. 4 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. We will develop and evaluate a structured exercise programs for sub acromial impingement syndrome using an expert consensus Delphi-based survey technique. Structured exercise program will be formed as per the guidelines of TIDieR items which will include the name of the intervention; intervention rationale for essential elements; intervention materials and details about how to access them; description of the intervention procedures; details of intervention providers; mode of delivery of intervention; location of intervention delivery and key infrastructure; details about the number, duration, intensity, and dose of intervention sessions; details of any intervention tailoring; any intervention modifications throughout the study; and details of intervention assessment, monitoring, and level achieved. 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. The study will be conducted in two phases. Phase 1 will be to develop and validate a structured exercise program and phase 2 is to evaluate efficacy of structured exercises on pain, range of motion and shoulder functions using Constant Murley score and Shoulder Pain and Disability Index (SPADI) and functional performance using timed functional arm and shoulder test. A randomized controlled trial will be conducted. Group A (Experimental Group) will receive 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. The data will be analyzed to see the efficacy of newly developed structured exercise program versus conventional exercise program.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Constant-Murley Score
timeFrame: Baseline, 3, 6, 9, and 12 weeks
measure: Visual analouge Scale
timeFrame: Baseline, 3, 6, 9, and 12 weeks
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline, 3, 6, 9, and 12 weeks
measure: Timed Functional Arm and Shoulder Test
timeFrame: Baseline, 3, 6, 9, and 12 weeks
Secondary outcomes:
measure: Scapulothoracic ratio Measurement
timeFrame: Baseline, 3, 6, 9, and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hamad Medical Corporation
name: Reshma Gurav
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.