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Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain

Primary Purpose

Shoulder Impingement Syndrome, Subacromial Shoulder Pain

Status
Unknown status
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Radial extracorporeal shock wave therapy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring shoulder, subacromial, impingement, tendinopathy, rESWT, shock wave, ESWT, RSWT

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Exclusion criteria cont.
  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

sham rESWT

rESWT

Arm Description

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index (SPADI)

Secondary Outcome Measures

Health-related quality of life (Eq-5d)
Return to work
Pain and function measured on a 11 point Likert type scale

Full Information

First Posted
September 15, 2011
Last Updated
December 17, 2014
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01441830
Brief Title
Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain
Official Title
Treatment of Subacromial Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Subacromial Shoulder Pain
Keywords
shoulder, subacromial, impingement, tendinopathy, rESWT, shock wave, ESWT, RSWT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sham rESWT
Arm Type
Sham Comparator
Arm Title
rESWT
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Radial extracorporeal shock wave therapy
Other Intervention Name(s)
rESWT, ESWT, RSWT, shock wave therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life (Eq-5d)
Time Frame
24 weeks and 1 year
Title
Return to work
Time Frame
6 weeks, 12 weeks, 24 weeks and 1 year
Title
Pain and function measured on a 11 point Likert type scale
Time Frame
6 weeks, 12 weeks, 24 weeks and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Exclusion criteria cont. 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
Facility Information:
Facility Name
Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation
City
Oslo
ZIP/Postal Code
0450
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29157224
Citation
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.
Results Reference
derived
PubMed Identifier
28586628
Citation
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.
Results Reference
derived
PubMed Identifier
26361756
Citation
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.
Results Reference
derived

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Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain

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