Anatomical Evaluation of Supraspinatus Through Ultrasonography and Biomechanical Measurements Following Different Combinations of Physical Therapies in Patients of Supraspinatus Tendinitis

NCT07470190 | Recruiting

• 1 other identifier: 434/IRC/BMR/DATED:30/12/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Supraspinatus Tendinitis

Outcome Measures

Primary Outcomes (5)

• Shoulder Joint Range of Motion from 0-180 degree

  shoulder joint ROM will be measured by Goniometer having 360 degree or inclinometer

  12 weeks

• MSK Ultrasound for shoulder

  tendon thickness in long (mm) and short axis (mm)

  12 weeks

• Shoulder Functional scale

  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

  NPRS 0-10 , 10 is the worse imaginable pain and 0 is no pain

  12 WEEKS

• Shoulder Muscle Strength

  Manual muscle testing and Dynamometer

  12 weeks

Study Arms (4)

Group A (Blood Flow Restriction Therapy)

EXPERIMENTAL

4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley

Other: Blood flow Restriction therapy

Group B (Extracorporeal Shock wave therapy)

EXPERIMENTAL

10 minutes shocks of 2000 J/session

Device: ESWT

Group C (Combination of BFRT+ESWT)

EXPERIMENTAL

Interventional study group Combination therapy

Other: Blood flow Restriction therapy; Device: ESWT

Control Group D

SHAM COMPARATOR

Control group with routine physical therapy

Other: Control

Interventions

Blood flow Restriction therapy OTHER

BFRT 4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley ESWT 10 minutes shocks of 2000 J/session

Also known as: BFRT, ESWT

Group A (Blood Flow Restriction Therapy); Group C (Combination of BFRT+ESWT)

ESWT DEVICE

10 minutes shocks of 2000 J/session

Also known as: Shock wave therapy

Group B (Extracorporeal Shock wave therapy); Group C (Combination of BFRT+ESWT)

Control OTHER

Electric heating pad (Besmed, Taiwan) 10 minutes, TENS (Comfy Stim, Taiwan Model #: EV-806) 10 minutes

Also known as: Routine physical therapy

Control Group D

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sehat Medical Complex: lead

Study Sites (1)

Sehat Medical Complex/UOL/UVAS

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (16)

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  PMID: 34110960 BACKGROUND

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• 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.

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  PMID: 9446250 BACKGROUND

• 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.

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• Adler RS

  BACKGROUND

• Abdul-Karim S,Abdul-Hamid MS,Ho CA,Ling J

  BACKGROUND

MeSH Terms

Interventions

Blood Flow Restriction Therapy; Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced

Central Study Contacts

imran Ghafoor, M Phil

CONTACT

+923344292887; imran.ghafoor64@gmail.com

Sahar Ijaz, PhD Anatomy

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 arm RCT parallels study design

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 13, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): August 23, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 weeks till the trail is recutting
• Access Criteria: by email, any researcher

Locations

PA (1)