- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT06006351
Percussive Therapy Added to Exercise in Shoulder Impingement Syndrome
Effects of Theragun PRO Plus Percussive Therapy Added to Exercise on Upper-Extremity Function and Activities of Daily Living in Individuals With Shoulder Impingement Syndrome: A Randomized Controlled Trial
This randomized controlled trial investigates whether adding percussive massage therapy with a hand-held device (Theragun PRO Plus) to a standardized exercise program provides additional benefit for upper-extremity function and instrumental activities of daily living in adults aged 25-50 years with shoulder impingement syndrome. Sixty participants are randomly allocated (1:1) to exercise alone or exercise plus percussive therapy. Both groups receive the same supervised exercise program three times per week for eight weeks (24 sessions, approximately 30-35 minutes per session). The combined group additionally receives 6 minutes of percussive therapy (2 minutes each over the posterior deltoid, infraspinatus, and upper trapezius) after each exercise session. Outcomes are assessed at baseline and at the end of week 8 by an assessor blinded to group allocation. The primary outcome is the Disabilities of the Arm, Shoulder and Hand (DASH) score; the secondary outcome is the Lawton-Brody Instrumental Activities of Daily Living scale.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Design: single-center, two-arm, parallel-group, assessor-blinded randomized controlled trial with 1:1 allocation. Randomization: computer-generated sequence with randomly ordered permuted blocks of 4 and 6, prepared by an independent investigator; allocation concealed in sequentially numbered, opaque, sealed envelopes opened after baseline assessment.
Exercise program (both groups): pendulum exercises (2 × 30 s per direction), posterior capsule cross-body stretch (3 × 30 s), sleeper stretch (3 × 20 s; omitted if it increases anterior shoulder pain), scapular wall push-up plus (2 × 10), external and internal rotation with elastic band (2 × 12 each), scapular retraction row with band (2 × 12), and scaption (2 × 10). Resistance is progressed every two weeks (weeks 1-2: low resistance, 2 × 10-12; weeks 3-4: light-to-moderate, 2 × 12; weeks 5-6: moderate, 3 × 10-12; weeks 7-8: highest tolerated, 3 × 12).
Percussive therapy (combined group only): Theragun PRO Plus (Therabody, Inc.) with the standard soft round attachment, level 1 (approximately 29 Hz, 1750 percussions per minute), applied with light pressure and continuous gliding movements over the muscle bellies of the posterior deltoid, infraspinatus, and upper trapezius for 2 minutes each (6 minutes per session), immediately after exercise, three days per week for eight weeks. Bony prominences, tender tendon sites, the axilla, the anterior/lateral neck, and neurovascular structures are avoided. Adverse events are monitored at every session.
Sample size: a priori calculation in G*Power 3.1 (two independent means, two-tailed, d = 0.80 as a planning assumption, alpha 0.05, power 0.80) gave 26 per group; 30 per group were enrolled to allow for 13% attrition. Primary analysis: ANCOVA of week-8 DASH with baseline DASH as covariate.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Istanbul, Turkije (Türkiye)
- Uskudar university
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age 25-50 years
- Clinical diagnosis of shoulder impingement syndrome (positive Neer and/or Hawkins-Kennedy test) confirmed by a physician
- Shoulder pain for at least 1 month
- Pain intensity ≥3 on a 0-10 visual analogue scale at screening
- Medically fit to participate in an exercise program
- Written informed consent
Exclusion Criteria:
- History of shoulder surgery
- Full-thickness rotator cuff tear or marked glenohumeral instability
- Serious neurological or rheumatological disease affecting shoulder function
- Any contraindication to percussive massage or exercise
- Shoulder injection within the previous [3] months or concurrent participation in another shoulder rehabilitation program
- Cognitive, mental, or psychological condition preventing completion of the assessments
- Refusal to participate
Exclusion Criteria:
- Having cognitive, mental or psychological problems.
- Having a condition that prevents him from exercising.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Exercise alone
Standardized supervised exercise program for shoulder impingement syndrome (stretching, scapular control, and progressive rotator cuff strengthening), approximately 30-35 minutes per session, 3 sessions per week for 8 weeks (24 sessions). |
Pendulum exercises, posterior capsule (cross-body) stretch, sleeper stretch, scapular wall push-up plus, external and internal rotation with elastic band, scapular retraction (row) with band, and scaption. Resistance progressed every two weeks according to tolerance. Delivered individually under physiotherapist supervision. |
|
Experimenteel: Exercise plus percussive therapy
The same standardized exercise program plus 6 minutes of percussive massage therapy with the Theragun PRO Plus device (level 1, approximately 29 Hz; 2 minutes each over the posterior deltoid, infraspinatus, and upper trapezius) applied immediately after each exercise session, 3 sessions per week for 8 weeks. |
Pendulum exercises, posterior capsule (cross-body) stretch, sleeper stretch, scapular wall push-up plus, external and internal rotation with elastic band, scapular retraction (row) with band, and scaption. Resistance progressed every two weeks according to tolerance. Delivered individually under physiotherapist supervision. Hand-held percussive massage device (Theragun PRO Plus, Therabody, Inc.) with standard soft round attachment, level 1 (approximately 29.2 Hz, 1750 percussions/min), applied with light pressure and gliding movements over the posterior deltoid, infraspinatus, and upper trapezius muscle bellies, 2 minutes each (6 minutes total), after exercise, 3 days/week for 8 weeks (24 sessions). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in Disabilities of the Arm, Shoulder and Hand (DASH) score at week 8
Tijdsspanne: Baseline and end of week 8 (immediately after the 8-week intervention)
|
The DASH is a 30-item self-reported questionnaire of upper-extremity symptoms and function. Items are scored 1-5 and transformed to a 0-100 scale; higher scores indicate greater disability. The Turkish version is used. Week-8 scores are analyzed with ANCOVA adjusted for baseline score. |
Baseline and end of week 8 (immediately after the 8-week intervention)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale score at week 8
Tijdsspanne: Baseline and end of week 8
|
Eight-item scale covering telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and finances; each item scored 0 (dependent) or 1 (independent); total 0-8, higher scores indicate greater independence. Turkish version is used. |
Baseline and end of week 8
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Tuba KARACA, Uskudar University
Publicaties en nuttige links
Algemene publicaties
- Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
- Consigliere P, Haddo O, Levy O, Sforza G. Subacromial impingement syndrome: management challenges. Orthop Res Rev. 2018 Oct 23;10:83-91. doi: 10.2147/ORR.S157864. eCollection 2018.
- Ellenbecker TS, Cools A. Rehabilitation of shoulder impingement syndrome and rotator cuff injuries: an evidence-based review. Br J Sports Med. 2010 Apr;44(5):319-27. doi: 10.1136/bjsm.2009.058875.
- Marik TL, Roll SC. Effectiveness of Occupational Therapy Interventions for Musculoskeletal Shoulder Conditions: A Systematic Review. Am J Occup Ther. 2017 Jan/Feb;71(1):7101180020p1-7101180020p11. doi: 10.5014/ajot.2017.023127.
- Gebremariam L, Hay EM, van der Sande R, Rinkel WD, Koes BW, Huisstede BM. Subacromial impingement syndrome--effectiveness of physiotherapy and manual therapy. Br J Sports Med. 2014 Aug;48(16):1202-8. doi: 10.1136/bjsports-2012-091802. Epub 2013 Nov 11.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Uskudar54
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data will not be shared publicly because of ethical and privacy restrictions; de-identified data may be available from the principal investigator upon reasonable request.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .