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AzTrials

Supraspinatus TendinitisNCT07470190

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

A study testing Blood flow Restriction therapy and ESWT in people with Supraspinatus Tendinitis, run by Sehat Medical Complex at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Supraspinatus Tendinitis
What is being tested?
Blood flow Restriction therapy and ESWT
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 sitePakistan
Study dates
23 Feb 2026to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Sehat Medical Complex/UOL/UVAS

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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).

Read the 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:

Being tested
Blood flow Restriction therapy, ESWT, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood flow Restriction therapyOther

    Also called BFRT, ESWT

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

  • ESWTDevice

    Also called Shock wave therapy

    10 minutes shocks of 2000 J/session

  • ControlOther

    Also called Routine physical therapy

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

Study groups in NCT07470190
Study groupRoleWhat they receive
Group A (Blood Flow Restriction Therapy)Experimental4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley
Receives: Other: Blood flow Restriction therapy
Group B (Extracorporeal Shock wave therapy)Experimental10 minutes shocks of 2000 J/session
Receives: Device: ESWT
Group C (Combination of BFRT+ESWT)ExperimentalInterventional study group Combination therapy
Receives: Other: Blood flow Restriction therapy; Device: ESWT
Control Group DSham comparatorControl group with routine physical therapy
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shoulder Joint Range of Motion from 0-180 degree

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

    Measured: 12 weeks

  2. MSK Ultrasound for shoulder

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

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

  4. Shoulder Joint PAIN

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

    Measured: 12 WEEKS

  5. Shoulder Muscle Strength

    Manual muscle testing and Dynamometer

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start23 Feb 2026
  3. Primary completion10 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 arm RCT parallels study design
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07470190
Sponsor's protocol ID
434/IRC/BMR/DATED:30/12/2025
Status last verified
Sep 2026
First submitted
25 Feb 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: the study protocol

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 39567090

  • 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.

    PubMed 8002167

  • 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.

    PubMed 11679125

  • 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.

    PubMed 11936384

  • 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.

    PubMed 11395602

  • 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.

    PubMed 8924735

  • 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.

    PubMed 8111677

  • Adler RS. Musculoskeletal ultrasound: a technical and historical perspective. J Ultrason. 2023 Nov 23;23(95):e172-e187. doi: 10.15557/jou.2023.0027. eCollection 2023 Oct.

    PubMed 38020513

Questions about this trial

What is this clinical trial studying?

A study testing Blood flow Restriction therapy and ESWT in people with Supraspinatus Tendinitis, run by Sehat Medical Complex at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Joint Range of Motion from 0-180 degree (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07470190, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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