Anatomical Evaluation of Supraspinatus Through Ultrasonography and Biomechanical Measurements Following Different Combinations of Physical Therapies in Patients of Supraspinatus Tendinitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood flow Restriction therapy, ESWT, Control.
- Who it may be relevant to
- Registry conditions: Supraspinatus Tendinitis. Basic parameters: 40 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A randomized controlled trial will be conducted to get the expected outcomes. Patients of both gender groups with unilateral shoulder pain will be selected with age range 40-60 years from Sehat medical complex and randomly allocated into four groups (Group A, B, C and D) of two different trials (Trial I and Trial II). The sample size will be 120 patients for both trials. Musculoskeletal ultrasound, goniometry, pain pressure threshold, dynamometer and functional indices will be used to measure the tendon thickness, range of motion, pain, muscle strength and function level. The group A will get BFRT, Group B will get ESWT, group c will get the combination of both and group D will be the Control group (Routine physical therapy). In Trial II the group A will get BFRT, Group B will get Eccentric Training, Group C will get combination of both A \& B and group D will be control group. data will be collected at baseline, 4th week, 8th week and 12 week of interventions. For data analysis SPSS version 25 will be used. Repeated measures ANOVA will be applied to compare the quantitative data within and between the groups. Post-Hoc test Tukey and Bonferroni correction will be used. The level of significance will be set at 5% (P\<0.05).
Detailed description
Musculoskeletal (MSK) disorders affect 1.71 billion people globally. In Pakistan 3.7-20% people are suffering from shoulder pain and while other rotator cuff muscles have been targeted with various therapies singly, neither supraspinatus tendinitis has received its due attention nor has the effect of combination of therapies been explored on it. Additionally, using the technique of MSK ultrasound will give us an objective quantitative basis for the anatomical evaluation. The tendon dimensions and biomechanical measurements of the supraspinatus show marked and differential improvement under the influence of different combinations of physical therapies compared to any single therapy.
Objectives:
Interventions
- Other Blood flow Restriction therapy
BFRT 4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley ESWT 10 minutes shocks of 2000 J/session - Device ESWT
10 minutes shocks of 2000 J/session - Other Control
Electric heating pad (Besmed, Taiwan) 10 minutes, TENS (Comfy Stim, Taiwan Model #: EV-806) 10 minutes
Primary outcome measures
- Shoulder Joint Range of Motion from 0-180 degree [Time frame: 12 weeks]
- MSK Ultrasound for shoulder [Time frame: 12 weeks]
- Shoulder Functional scale [Time frame: 12 weeks]
- Shoulder Joint PAIN [Time frame: 12 WEEKS]
- Shoulder Muscle Strength [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- unilateral shoulder pain
- both gender group
- two positive tests of (Neer impingement test, Hawkins-Kendy test, Empty can test),
- shoulder pain history up to 3 months
- not receiving any physiotherapy last 3 months.
- not receiving pain medications (NSAIDS) for last 15 days.
Exclusion criteria
- referred shoulder pain
- limited shoulder ROM less then 90 degree
- previous shoulder surgery, intra articular injection or nerve block last 6 months.
- patient with 180 mmHg blood pressure/uncontrolled BP
- upper limb fracture, uncontrolled diabetes, open wounds, fistula and vascular surgery.
- pregnant woman or 6 month history of pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Sehat Medical Complex/UOL/UVAS — Lahore
Publications
- Lambert B, Hedt C, Daum J, Taft C, Chaliki K, Epner E, McCulloch P. Blood Flow Restriction Training for the Shoulder: A Case for Proximal Benefit. Am J Sports Med. 2021 Aug;49(10):2716-2728. doi: 10.1177/03635465211017524. Epub 2021 Jun 10. PMID 34110960
- Yoshiura K, Stamatakis HC, Welander U, McDavid WD, Shi XQ, Ban S, Kawazu T, Tatsumi M, Kanda S. Physical evaluation of a system for direct digital intra-oral radiography based on a charge-coupled device. Dentomaxillofac Radiol. 1999 Sep;28(5):277-83. doi: 10.1038/sj/dmfr/4600457. PMID 10490745
- Kara D, Ozcakar L, Demirci S, Huri G, Duzgun I. Blood Flow Restriction Training in Patients With Rotator Cuff Tendinopathy: A Randomized, Assessor-Blinded, Controlled Trial. Clin J Sport Med. 2024 Jan 1;34(1):10-16. doi: 10.1097/JSM.0000000000001191. Epub 2023 Sep 14. PMID 37706671
- Jones JW, McCullough LB. Consent for an intraoperative video record. J Vasc Surg. 2001 Dec;34(6):1133-4. doi: 10.1067/mva.2001.119949. No abstract available. PMID 11743574
- Ackmann T, Schneider KN, Schorn D, Rickert C, Gosheger G, Liem D. Comparison of efficacy of supraspinatus tendon tears diagnostic tests: a prospective study on the "full-can," the "empty-can," and the "Whipple" tests. Musculoskelet Surg. 2021 Aug;105(2):149-153. doi: 10.1007/s12306-019-00631-0. Epub 2019 Nov 5. PMID 31691179
- Harrer J, Lonsky V, Dominik J, Zacek P, Sistek J, Harrerova L, Knap J. [Coronary revascularization in diffuse atherosclerosis of the anterior descending coronary artery]. Rozhl Chir. 1997 Jul;76(7):342-8. Czech. PMID 9446250
- Dube MO, Ingwersen KG, Roy JS, Desmeules F, Lewis J, Juul-Kristensen B, Vobbe J, Jensen SL, McCreesh K. Do therapeutic exercises impact supraspinatus tendon thickness? Secondary analyses of the combined dataset from two randomized controlled trials in patients with rotator cuff-related shoulder pain. J Shoulder Elbow Surg. 2024 Sep;33(9):1918-1927. doi: 10.1016/j.jse.2024.03.055. Epub 2024 May 16. PMID 38762149
- Chew E, Lee Day A, Nazarian LN, Kohler M. Basic Musculoskeletal Ultrasound. Med Clin North Am. 2025 Jan;109(1):137-161. doi: 10.1016/j.mcna.2024.06.007. Epub 2024 Aug 3. PMID 39567090
Identifiers
NCT: NCT07470190 · 434/IRC/BMR/DATED:30/12/2025