NCT00653081

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 4, 2008

Status Verified

January 1, 2007

Enrollment Period

1.2 years

First QC Date

January 7, 2008

Last Update Submit

April 3, 2008

Conditions

Shoulder Pain

Keywords

Shoulder painSupervised ExercisesRadial Shock Wave Therapy

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain and Disability Index (SPADI)

    Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months

Secondary Outcomes (1)

  • Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.

    Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months

Study Arms (2)

A

ACTIVE COMPARATOR

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

Procedure: Physical therapy method called Supervised Exercises

B

ACTIVE COMPARATOR

Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

Procedure: Radial Extracorporeal Shockwave Therapy

Interventions

Physical therapy method called Supervised ExercisesPROCEDURE

Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks

A
Radial Extracorporeal Shockwave TherapyPROCEDURE

Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for physical medicine and rehabilitation, Ullevaal University Hospital

Oslo, Oslo County, 0407, Norway

Location

Related Publications (3)

  • 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.

    PMID: 21088117DERIVED

  • 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.

    PMID: 20863369DERIVED

  • 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.

    PMID: 19755551DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kaia Engebretsen, PhD

    Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2008

First Posted

April 4, 2008

Study Start

July 1, 2006

Primary Completion

September 1, 2007

Study Completion

December 1, 2008

Last Updated

April 4, 2008

Record last verified: 2007-01

Locations

NO(1)