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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Impingement Syndrome; Subacromial Shoulder Pain	Device: Radial extracorporeal shock wave therapy	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Treatment of Subacromial Shoulder Pain
Study Start Date :	September 2011
Estimated Primary Completion Date :	May 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Sham Comparator: sham rESWT	Device: Radial extracorporeal shock wave therapy; 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; Other Names: rESWT; ESWT; RSWT; shock wave therapy
Active Comparator: rESWT	Device: Radial extracorporeal shock wave therapy; 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; Other Names: rESWT; ESWT; RSWT; shock wave therapy

Outcome Measures

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Primary Outcome Measures :

1. Shoulder Pain and Disability Index (SPADI) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. Health-related quality of life (Eq-5d) [ Time Frame: 24 weeks and 1 year ]
2. Return to work [ Time Frame: 6 weeks, 12 weeks, 24 weeks and 1 year ]
3. Pain and function measured on a 11 point Likert type scale [ Time Frame: 6 weeks, 12 weeks, 24 weeks and 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	25 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Norway
Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation
Oslo, Norway, 0450

Sponsors and Collaborators

Oslo University Hospital

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Kvalvaag E, Brox JI, Engebretsen KB, Søberg HL, Bautz-Holter E, Røe 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.

Responsible Party:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT01441830 History of Changes
Other Study ID Numbers:	2011/5347
First Posted:	September 28, 2011
Last Update Posted:	December 18, 2014
Last Verified:	December 2014

Keywords provided by Oslo University Hospital:

shoulder; subacromial; impingement; tendinopathy	rESWT; shock wave; ESWT; RSWT

Additional relevant MeSH terms:

Shoulder Pain; Shoulder Impingement Syndrome; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain	Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Shoulder Injuries; Wounds and Injuries