Percussive Therapy Added to Exercise in Shoulder Impingement Syndromesyndrome
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Istanbul, Türkei (türkiye)
- Uskudar university
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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. |
|
Experimental: 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). |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in Disabilities of the Arm, Shoulder and Hand (DASH) score at week 8
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale score at week 8
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Tuba KARACA, Uskudar University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Uskudar54
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .