- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470190
Anatomical Evaluation of Supraspinatus Through Ultrasonography and Biomechanical Measurements Following Different Combinations of Physical Therapies in Patients of Supraspinatus Tendinitis
Study Overview
Status
Conditions
Intervention / Treatment
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:
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: imran Ghafoor, M Phil
- Phone Number: +923344292887
- Email: imran.ghafoor64@gmail.com
Study Contact Backup
- Name: Sahar Ijaz, PhD Anatomy
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Sehat Medical Complex/UOL/UVAS
-
Contact:
- Imran Ghafoor
- Phone Number: 03344292887
- Email: imran.ghafoor64@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Blood Flow Restriction Therapy)
4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley
|
BFRT 4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley ESWT 10 minutes shocks of 2000 J/session
Other Names:
|
|
Experimental: Group B (Extracorporeal Shock wave therapy)
10 minutes shocks of 2000 J/session
|
10 minutes shocks of 2000 J/session
Other Names:
|
|
Experimental: Group C (Combination of BFRT+ESWT)
Interventional study group Combination 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
Other Names:
10 minutes shocks of 2000 J/session
Other Names:
|
|
Sham Comparator: Control Group D
Control group with routine physical therapy
|
Electric heating pad (Besmed, Taiwan) 10 minutes, TENS (Comfy Stim, Taiwan Model #: EV-806) 10 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Joint Range of Motion from 0-180 degree
Time Frame: 12 weeks
|
shoulder joint ROM will be measured by Goniometer having 360 degree or inclinometer
|
12 weeks
|
|
MSK Ultrasound for shoulder
Time Frame: 12 weeks
|
tendon thickness in long (mm) and short axis (mm)
|
12 weeks
|
|
Shoulder Functional scale
Time Frame: 12 weeks
|
Quick-DASH (Quick-Disability of arm shoulder and hand) functional scale, it is 11 items scale with response range 0-5 on.
0 is no disability and 100 shows severe disability.
The scale have 5 response options much worse, somewhat worse, unchanged, somewhat better, much better
|
12 weeks
|
|
Shoulder Joint PAIN
Time Frame: 12 WEEKS
|
NPRS 0-10 , 10 is the worse imaginable pain and 0 is no pain
|
12 WEEKS
|
|
Shoulder Muscle Strength
Time Frame: 12 weeks
|
Manual muscle testing and Dynamometer
|
12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- De Misa RF, Azana JM, Bellas C, Perez B, Rocamora A, Ledo A. Mycosis fungoides with signet-ring cells and monoclonal gammopathy. Int J Dermatol. 1994 Sep;33(9):652-3. doi: 10.1111/j.1365-4362.1994.tb02930.x. No abstract available.
- Shulman CE, Marshall T, Dorman EK, Bulmer JN, Cutts F, Peshu N, Marsh K. Malaria in pregnancy: adverse effects on haemoglobin levels and birthweight in primigravidae and multigravidae. Trop Med Int Health. 2001 Oct;6(10):770-8. doi: 10.1046/j.1365-3156.2001.00786.x.
- Mini E, Grassi F, Cherubino P, Nobili S, Periti P. Preliminary results of a survey of the use of antimicrobial agents as prophylaxis in orthopedic surgery. J Chemother. 2001 Nov;13 Spec No 1(1):73-9. doi: 10.1179/joc.2001.13.Supplement-2.73.
- Skimming JW, Banner MJ, Spalding HK, Jaeger MJ, Burchfield DJ, Davenport PW. Nitric oxide inhalation increases alveolar gas exchange by decreasing deadspace volume. Crit Care Med. 2001 Jun;29(6):1195-200. doi: 10.1097/00003246-200106000-00022.
- Matsunaga H, Iida T, Fukushima T, Santa T, Homma H, Imai K. Boron trifluoride-etherate (Lewis acid) as an efficient acid at cyclization/cleavage reaction of D/L-amino acids affording the retention of their original configuration in the Edman sequencing method of peptides. Biomed Chromatogr. 1996 Mar-Apr;10(2):95-6. doi: 10.1002/(SICI)1099-0801(199603)10:23.0.CO;2-H.
- Gagnon F, Dagenais GR, Robitaille NM, Lupien PJ. Impact of systolic and diastolic blood pressure on ischemic vascular diseases in French-Canadian men from 1974 to 1990. Can J Cardiol. 1994 Jan-Feb;10(1):97-105.
- Adler RS
- Abdul-Karim S,Abdul-Hamid MS,Ho CA,Ling J
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 434/IRC/BMR/DATED:30/12/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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