NCT01441830

Brief Summary

The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave therapy) combined with supervised exercises will improve function and reduce pain in subacromial shoulder pain compared with supervised exercises alone.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

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

September 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

3.7 years

First QC Date

September 15, 2011

Last Update Submit

December 17, 2014

Conditions

Shoulder Impingement SyndromeSubacromial Shoulder Pain

Keywords

shouldersubacromialimpingementtendinopathyrESWTshock waveESWTRSWT

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain and Disability Index (SPADI)

    24 weeks

Secondary Outcomes (3)

  • Health-related quality of life (Eq-5d)

    24 weeks and 1 year

  • Return to work

    6 weeks, 12 weeks, 24 weeks and 1 year

  • Pain and function measured on a 11 point Likert type scale

    6 weeks, 12 weeks, 24 weeks and 1 year

Study Arms (2)

sham rESWT

SHAM COMPARATOR
Device: Radial extracorporeal shock wave therapy

rESWT

ACTIVE COMPARATOR
Device: Radial extracorporeal shock wave therapy

Interventions

Radial extracorporeal shock wave therapyDEVICE

The shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar

Also known as: rESWT, ESWT, RSWT, shock wave therapy
rESWTsham rESWT

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dysfunction or pain on abduction
  • Pain on one of two isometric tests (abduction or external rotation)
  • Positive Hawkins sign
  • Normal passive glenohumeral range of motion

You may not qualify if:

  • Previous surgery on affected shoulder
  • Instability
  • Total rupture of the rotator cuff (evaluated clinically or by US)
  • Clinical signs of a cervical syndrome
  • Infection in the area
  • Patients considered unable to fill out questionnaires or to go through the treatment
  • Use of anticoagulant drugs or bleeding disorder
  • Pregnancy
  • Previous experience of one of the study interventions
  • Corticosteroid injection in the past 6 weeks.
  • SPADI \< 20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation

Oslo, Oslo County, 0450, Norway

Location

Related Publications (3)

  • Kvalvaag E, Anvar M, Karlberg AC, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study. BMC Musculoskelet Disord. 2017 Nov 21;18(1):469. doi: 10.1186/s12891-017-1827-3.

    PMID: 29157224DERIVED

  • Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Effectiveness of Radial Extracorporeal Shock Wave Therapy (rESWT) When Combined With Supervised Exercises in Patients With Subacromial Shoulder Pain: A Double-Masked, Randomized, Sham-Controlled Trial. Am J Sports Med. 2017 Sep;45(11):2547-2554. doi: 10.1177/0363546517707505. Epub 2017 Jun 6.

    PMID: 28586628DERIVED

  • Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Bautz-Holter E, Roe C. Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial. BMC Musculoskelet Disord. 2015 Sep 11;16:248. doi: 10.1186/s12891-015-0712-1.

    PMID: 26361756DERIVED

MeSH Terms

Conditions

Shoulder Impingement SyndromeTendinopathy

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesMuscular DiseasesTendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 28, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2015

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

NO(1)