Évaluation anatomique du muscle supra-épineux par échographie et mesures biomécaniques après différentes combinaisons de thérapies physiques chez les patients atteints de tendinite du supra-épineux
Évaluation Anatomique du Supra-épineux par Ultrasonographie et Mesures Biomécaniques après Différentes Combinaisons de Thérapies Physiques chez les Patients Souffrant de Tendinite du Supra-épineux
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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:
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Sehat Medical Complex/UOL/UVAS
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Expérimental: Group B (Extracorporeal Shock wave therapy)
10 minutes shocks of 2000 J/session |
10 minutes shocks of 2000 J/session
Autres noms:
|
|
Expérimental: 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
Autres noms:
10 minutes shocks of 2000 J/session
Autres noms:
|
|
Comparateur factice: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Shoulder Joint Range of Motion from 0-180 degree
Délai: 12 weeks
|
shoulder joint ROM will be measured by Goniometer having 360 degree or inclinometer |
12 weeks
|
|
MSK Ultrasound for shoulder
Délai: 12 weeks
|
tendon thickness in long (mm) and short axis (mm) |
12 weeks
|
|
Shoulder Functional scale
Délai: 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
Délai: 12 WEEKS
|
NPRS 0-10 , 10 is the worse imaginable pain and 0 is no pain |
12 WEEKS
|
|
Shoulder Muscle Strength
Délai: 12 weeks
|
Manual muscle testing and Dynamometer |
12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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. 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 434/IRC/BMR/DATED:30/12/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
the study protocol
Délai de partage IPD
12 weeks till the trail is recutting
Critères d'accès au partage IPD
by email, any researcher
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .