- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye)
- Uskudar university
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv 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. |
|
Experimentell: 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). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in Disabilities of the Arm, Shoulder and Hand (DASH) score at week 8
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale score at week 8
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Tuba KARACA, Uskudar University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
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Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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- Uskudar54
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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.
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