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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Blood Flow Restriction Therapy) | Experimental | 4 Sets of exercise with restriction cuff 30,15,15,15 with cable system pulley |
|
| Group B (Extracorporeal Shock wave therapy) | Experimental | 10 minutes shocks of 2000 J/session |
|
| Group C (Combination of BFRT+ESWT) | Experimental | Interventional study group Combination therapy |
|
| Control Group D | Sham Comparator | Control group with routine physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| imran Ghafoor, M Phil | Contact | +923344292887 | imran.ghafoor64@gmail.com | |
| Sahar Ijaz, PhD Anatomy | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sehat Medical Complex/UOL/UVAS | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34110960 | Background | 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. | |
| 10490745 | Background | 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. |
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the study protocol
12 weeks till the trail is recutting
by email, any researcher
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 30, 2025 | Feb 25, 2026 |
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4 arm RCT parallels study design
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|
| ESWT | Device | 10 minutes shocks of 2000 J/session |
|
|
| Control | Other | Electric heating pad (Besmed, Taiwan) 10 minutes, TENS (Comfy Stim, Taiwan Model #: EV-806) 10 minutes |
|
|
| 37706671 | Background | 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. |
| 11743574 | Background | 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. |
| 31691179 | Background | 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. |
| 9446250 | Background | 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. |
| 38762149 | 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. |
| 39567090 | Background | 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. |
| 8002167 | Background | 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. |
| 11679125 | Background | 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. |
| 11936384 | Background | 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. |
| 11395602 | Background | 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. |
| 8924735 | Background | 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. |
| 8111677 | Background | 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. |
| 38020513 | Background | 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. |
| 37064621 | Background | Abdul-Karim S, Abdul-Hamid MS, Ho CA, Ling J. Validity, Reliability and Responsiveness of the Malay Shoulder Pain and Disability Index (M-SPADI) for Patients with Shoulder Pain. Malays Orthop J. 2023 Mar;17(1):160-171. doi: 10.5704/MOJ.2303.019. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
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