Clinical trial NCT01441830: Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain
Official title: Treatment of Subacromial Shoulder Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Shoulder Impingement Syndrome
Subacromial Shoulder Pain
Keywords: shoulder
subacromial
impingement
tendinopathy
rESWT
shock wave
ESWT
RSWT
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Health-related quality of life (Eq-5d)
timeFrame: 24 weeks and 1 year
measure: Return to work
timeFrame: 6 weeks, 12 weeks, 24 weeks and 1 year
measure: Pain and function measured on a 11 point Likert type scale
timeFrame: 6 weeks, 12 weeks, 24 weeks and 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation
Study officials:
References:
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.
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.
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.