- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06110000
Pragmatic Set of Interventions Versus Scapular Strengthening Exercises on Scapular Dyskinesia in Adhesive Capsulitis
Effects of Pragmatic Set of Interventions Versus Scapular Strengthening Exercises on Scapular Dyskinesia in Adhesive Capsulitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Scapular dyskinesia (SD) is a term that describes a physical impairment in which the scapula's position and motion are altered.Symptoms of SD can be one or a combination of the anterior shoulder pain, Postero-superior scapular pain, superior shoulder pain, proximal lateral arm pain. scapular dyskinesia is commonly found in adhesive capsulitis patients. To determine the scapular dyskinesia with shoulder pain two tests that apply manual assistance to the scapula are lateral scapular slide test and wall push up test.
Pragmatic set of interventions are an important element in rehabilitation, and has improved the treatment of many musculoskeletal and neurological conditions. Scapular strengthening exercises, which aims to improve abnormal scapular movements that commonly occur in people with adhesive capsulitis.
The purpose of this study is to explore the effect of scapular focused exercises on the rehabilitation of adhesive capsulitis, patient with scapular dyskinesia. The importance of scapular rehabilitation in the treatment of scapular dyskinesia and to examine the comparative effect of pragmatic set of intervention with scapular strengthening protocol on scapular dyskinesia.
My study on the effect of a pragmatic set of intervention versus scapular strengthening exercises on scapular dyskinesia in adhesive capsulitis is important because it addresses a gap in the current literature. While both interventions have been shown to improve scapular dyskinesia in patients with adhesive capsulitis, there is a lack of studies comparing the two methods. My study will help determine which intervention is more effective in treating scapular dyskinesia, which will be valuable information for healthcare providers working with patients with adhesive capsulitis
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- Amina welfare and Trust
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Contact:
- Saba Rafique, MSOMPT
- Phone Number: 03034045433
- Email: saba.rafique@riphah.edu.pk
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Principal Investigator:
- Amna Shahzade, MSOMPT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both male and females with age range b/w 25-45
- People with adhesive capsulitis (having pain, stiffness, and decrease movements of - external rotation, forward flexion and abduction)
- Scapular dyskinesia (positive lateral scapular slide with difference of 1.5cm when measurements are compared bilaterally)
Exclusion Criteria:
- History of shoulder surgery or other significant shoulder injury, neurological or musculoskeletal conditions that may affect shoulder function.
- History of significant medical conditions (e.g., heart disease, cancer) that may affect their ability to participate in the study.
- Pregnant or breast feeder, as the exercise program may not be safe or appropriate for them.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: pragmatic set of interventions
The pragmatic set included 6 interventions as follows.
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The pragmatic set included 6 interventions as follows.
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Placebo Comparator: scapular strengthening exercises
Scapular strengthening exercises will be individualised focusing on Serratus anterior, trapezius, Levator scapulae, Rhomboids. Serratus anterior;
Trapezius - Upper trapezius:
Middle trapezius:
Lower trapezius:
Levator Scapulae:
Rhomboids:
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• Subjects in Group B receive strengthening exercises (exercise will perform with 15 repetitions for each set- 3sets/day, 3 days /week for 6 weeks.
In Scapular strengthening exercises, treatment protocol will involve the individualized for focus muscle Serratus anterior (Dynamic hug, Scaption with external rotation, Diagonal PNF (shoulder flexion horizontal flexion, external rotation),Trapezius - Upper trapezius (unilateral shoulder shrug, rowing, forward shoulder flexion, shoulder abduction in scapular plane above 120 degrees, Middle trapezius (prone shoulder horizontal abduction, scaption, horizontal abduction with external rotation), Lower trapezius (Unilateral scapular retraction, prone bilateral shoulder external rotation at 90 degrees of abduction, prone shoulder abduction), Levator Scapulae (horizontal abduction with shrug, horizontal abduction with ER, prone shoulder extension, Rhomboids (ER at 90° of abduction, ER at 0° of abduction, Horizontal abduction, Shoulder extension)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Shoulder Pain and Disability Index (SPADI)
Time Frame: 4th week
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The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting.
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
SPADI was found to have reliability coefficients of ICC ≥ 0.89 in a variety of patient populations.Internal consistency is high with Cronbach α typically exceeding 0.90.
The SPADI demonstrates good construct validity, correlating well with other region-specific shoulder questionnaires.
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4th week
|
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Scapulometer
Time Frame: 4th week
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is a reliable tool to measure scapular medial border and inferior angle prominence.
It is used to measure the distance from the root of the spine (ROS) and the inferior angle (INF) of the scapula to the thorax wall.
The novel scapulometer has excellent reliability and fair validity to quantify medial border and inferior angle prominence of the scapula.
Further research utilizing this instrument is recommended.
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4th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual analogue scale:
Time Frame: 4th week
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This VAS will be used in this study to measure Pain.
Patients were instructed to assess the severity of shoulder pain experienced last week on a 0-10 cm horizontal line (0 = painless and 10 = worst pain imaginable).
The VAS has been shown to have excellent test-retest reliability (ICC = 0.97) and high validity (r with a 5-point verbal descriptive scale = 0.71-0.78) to evaluate pain perception.
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4th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabiya Noor, PhD, Riphah International University
Publications and helpful links
General Publications
- Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
- Mohamed AA, Alawna M. Effect of Adding Vertical Correction to Dynamic Scapular Recognition on Scapular Dyskinesis and Shoulder Disability in Patients With Adhesive Capsulitis: A Randomized Clinical Study. J Chiropr Med. 2022 Jun;21(2):124-135. doi: 10.1016/j.jcm.2022.02.002. Epub 2022 Apr 4.
- Zhu Y, Blundell JE, Holschuh NM, McLean R, Menon RS. Validation of a Mobile App-Based Visual Analog Scale for Appetite Measurement in the Real World: A Randomized Digital Clinical Trial. Nutrients. 2023 Jan 7;15(2):304. doi: 10.3390/nu15020304.
- Lluch-Girbes E, Requejo-Salinas N, Fernandez-Matias R, Revert E, Vila Mejias M, Rezende Camargo P, Jaggi A, Sciascia A, Horsley I, Pontillo M, Gibson J, Richardson E, Johansson F, Maenhout A, Oliver GD, Turgut E, Jayaraman C, Duzgun I, Borms D, Ellenbecker T, Cools A. Kinetic chain revisited: consensus expert opinion on terminology, clinical reasoning, examination, and treatment in people with shoulder pain. J Shoulder Elbow Surg. 2023 Aug;32(8):e415-e428. doi: 10.1016/j.jse.2023.01.018. Epub 2023 Feb 15.
- Dube MO, Desmeules F, Lewis JS, Roy JS. Does the addition of motor control or strengthening exercises to education result in better outcomes for rotator cuff-related shoulder pain? A multiarm randomised controlled trial. Br J Sports Med. 2023 Apr;57(8):457-463. doi: 10.1136/bjsports-2021-105027. Epub 2023 Feb 16.
- Karaagac A, Arslan SA, Keskin ED. Assessment of pain, scapulothoracic muscle strength, endurance and scapular dyskinesis in individuals with and without nonspecific chronic neck pain: A cross-sectional study. J Bodyw Mov Ther. 2023 Jul;35:261-267. doi: 10.1016/j.jbmt.2023.04.008. Epub 2023 Apr 19.
- Ucurum SG, Karabay D, Ozturk BB, Kaya DO. Comparison of scapular position and upper extremity muscle strength in patients with and without lateral epicondylalgia: a case-control study. J Shoulder Elbow Surg. 2019 Jun;28(6):1111-1119. doi: 10.1016/j.jse.2018.12.010. Epub 2019 Mar 26.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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