Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy

Not Applicable

Completed

• Conditions: Shoulder Impingement Syndrome
• Interventions: Procedure: Arthroscopic acromioplasty; Procedure: Microtenotomy

• Registration Number: NCT02275689
• Lead Sponsor: University Hospital of North Norway

Brief Summary

This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I) and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.

The outcome of both methods will be compared to the physical therapy treatment (groupIII)

Detailed Description

Rotator cuff tendinosis cause pain and disability of the shoulder. Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic rotator cuff tendinopathy. Important features is a poor intrinsic ability to heal.

Several patients receive treatment for shoulder tendinosis each year. Conservative treatments options include rest, stretching, strengthening, ice and/or physical therapy are used with difference results. A traditional surgical treatments (acromioplasty) have been reported with variable results..

The aim of this study is to evaluate improvement of VAS and functionality using Constant score before and after treatment of rotator cuff tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional acromioplasty and physical therapy.

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-27
• Study Start: 2015-03
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Impingement pain in the shoulder at least 3 months
• MRI of shoulder reveal tendinosis
• Classification of Acromion morphology by RTG and or MRI
• daily pain

Exclusion Criteria

• inflammatory joint disease
• Other comorbidity in the shoulder as instability, osteoarthritis or rotator cuff tear
• serious illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthrocopic acromioplasty	Arthroscopic acromioplasty	Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression
Radiofrequency microtenotomy	Microtenotomy	Surgical intervention With arthroscopic radiofrequency microtenotomy

Primary Outcome Measures

Name	Time	Method
Change from baseline in VAS for pain	every 2 weeks. during 6 months	The patients will have a clinical control 6,12 weeks and 6 months postoperatively. The VAS will be registered every 2 weeks via SMS during 6 months
Change from baseline in VAS for pain,	6 weeks, 6 months, and 12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in functionality measured by constant score	6 weeks, 6 months and 12 months

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsoe, Norway