- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00653081
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Oslo, Norge, 0407
- Department for physical medicine and rehabilitation, Ullevaal University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
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
|
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
|
Aktiv komparator: B
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
|
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Shoulder Pain and Disability Index (SPADI)
Tidsramme: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
|
Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
|
Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kaia Engebretsen, PhD, Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VT
- rESWT
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Skuldersmerte
-
East Carolina UniversityTilbaketrukket
-
Wake Forest University Health SciencesRekruttering
-
Cairo UniversityFullførtCervical Myofascial Pain SyndromeEgypt
-
Dilşad SindelFullførtKvinnelige pasienter med Myofascial Pain Syndrome (MPS) relatert til øvre Trapezius Active Trigger Points (TP)
-
Brugmann University HospitalTilbaketrukketPhantom Limb Pain (PLP) | Primær/sekundær arrhyperalgesiBelgia
-
Oslo University HospitalUniversity of Oslo; Fysiofondet; Oslo Metropolitan UniversityRekrutteringGluteal tendinopati | Trochanterisk bursitt | Lateral hoftesmerter | GTPS - Greater Trochanteric Pain SyndromeNorge
-
University of JazanRekrutteringOvervekt | Kroppsvekt | Smarttelefonavhengighet | Cervical Myofascial Pain SyndromeSaudi-Arabia
-
Mustafa Kemal UniversityRekrutteringEffekten av Dextrose Prolotherapy i Myofascial Pain SyndromeTyrkia
-
University Hospitals, LeicesterFullførtMagesmerter | Abdominal Myofascial Pain Syndrome (AMPS) | Abdominal Plane Blocks (APB)Storbritannia
-
Yuzuncu Yıl UniversityFullførtMyofascial Pain Dysfunction Syndrome, Temporomandibulært leddTyrkia