Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
3. april 2008 opdateret af: Ullevaal University Hospital
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.
Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).
The study is designed as a randomised, single blind clinical controlled study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
104
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Oslo, Norge, 0407
- Department for physical medicine and rehabilitation, Ullevaal 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:
- Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
- Dysfunction or pain on abduction
- Had a normal passive glenohumeral range of movement
- Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
- Positive Hawkins-Kennedys test.
Exclusion Criteria:
- Shoulder pain bilateral (both shoulders required treatment)
- Earlier operated in affected shoulder
- Had multidirectional instability
- Had the cervical syndrome
- Rheumatoid arthritis
- Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
- Not able to understand spoken or written Norwegian
- Considerable emotional distress
- Needed anticoagulant medicine
- Being pregnant
- Had had Shock Wave Therapy or Supervised Exercises before.
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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Aktiv komparator: A
Supervised Exercises performed at ulleval Hospital for patients with shoulder pain.
Dosage: 45 minutes each time, max 2-3 times a week in max 12 weeks
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Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
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Aktiv komparator: B
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
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Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Shoulder Pain and Disability Index (SPADI)
Tidsramme: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.
Tidsramme: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kaia Engebretsen, PhD, Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
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.
Generelle publikationer
- Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011 Jan;91(1):37-47. doi: 10.2522/ptj.20090338. Epub 2010 Nov 18.
- Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Brox JI. Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain. BMC Musculoskelet Disord. 2010 Sep 23;11:218. doi: 10.1186/1471-2474-11-218.
- Engebretsen K, Grotle M, Bautz-Holter E, Sandvik L, Juel NG, Ekeberg OM, Brox JI. Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study. BMJ. 2009 Sep 15;339:b3360. doi: 10.1136/bmj.b3360.
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. juli 2006
Primær færdiggørelse (Faktiske)
1. september 2007
Studieafslutning (Forventet)
1. december 2008
Datoer for studieregistrering
Først indsendt
7. januar 2008
Først indsendt, der opfyldte QC-kriterier
3. april 2008
Først opslået (Skøn)
4. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. april 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. april 2008
Sidst verificeret
1. januar 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VT
- rESWT
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 .