- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01022827
Shoulder Muscle Massage Shoulder Stiffness
3. januar 2012 opdateret af: National Taiwan University Hospital
Effects and Predictors of Effectiveness of Shoulder Muscle Massage for Patients With Posterior Shoulder Stiffness
The investigators investigated the effect and predictors of effectiveness of massage in the treatment of patients with posterior shoulder stiffness.
This is a randomized controlled trial study- massage and control (hand touch) two times a week for 4 weeks.
A total of 60 patients with posterior shoulder tightness were randomized into 2 groups; 52 of them completed this study (29 for the massage and 23 for the control).
Patient sex, age, body mass index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional status, and muscle stiffness were recorded.
Additionally, for the massage group, patients with glenohumeral internal rotation improvement of 20 degrees after massage were considered responsive, and the others were considered nonresponsive.
The influences of the aftermentioned factors on the effectiveness of massage were analyzed by multivariate logistric regression.
The overall mean internal rotation ROM increased significantly after massage (from 31.9° to 54.9°; P < 0.001) compared to the control (from 28.7° to 34.9°; P > 0.05).
There were 22 patients in the responsive group and 7 in the nonresponsive group.
Among the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were significant predictors of effectiveness of massage.
Massage was an effective treatment for subjects with posterior shoulder stiffness, but was less effective in patients with longer duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
52
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan
- National Taiwan University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- a limited ROM of internal rotation (internal rotation ROM < 20% to the sound side), and
- pain and stiffness in the shoulder region for at least 3 months.
Exclusion Criteria:
- surgery on the particular shoulder,
- rheumatoid arthritis,
- stroke with residual shoulder involvement,
- fracture of the shoulder complex,
- rotator cuff deficiency, and
- resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: posterior shoulder stiffness massage group
The inclusion criteria of patients with glenohumeral internal rotation limitation and posterior shoulder stiffness were: [1] limitation of internal rotation ROM compared to the sound side; [2] mild glenohumeral joint hypomobility according to joint play assessment; [3] stiffness in the posterior shoulder region.
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For the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes [about 6 minutes for each muscle and order was random] two times a week for 4 weeks.
The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues
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Placebo komparator: posterior shoulder stiffness placebo group
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For the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes [about 6 minutes for each muscle and order was random] two times a week for 4 weeks.
The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Range of Motion
Tidsramme: pre and post-massage
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pre and post-massage
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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muscle stiffness
Tidsramme: pre and post-massage
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pre and post-massage
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functional disability
Tidsramme: pre and post-massage
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pre and post-massage
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jiu-jenq Lin, PhD, School of Physical Therapy, National Taiwan University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2009
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. marts 2011
Datoer for studieregistrering
Først indsendt
25. november 2009
Først indsendt, der opfyldte QC-kriterier
30. november 2009
Først opslået (Skøn)
1. december 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. januar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2012
Sidst verificeret
1. november 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 200905041R
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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