Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy

Shoulder Impingement Syndrome Clinical Trial

Official title:

Alternative Treatment of Rotator Cuff Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275689
• Other study ID #: 2011/1133
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: September 4, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Tendinopathy

Intervention

Procedure:
• Arthroscopic acromioplasty
Surgical intervention With arthroscopic acromion resection
• Microtenotomy
Arthroscopic radiofrequency microtenotomy of rotator cuff tendon

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsoe

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in VAS for pain	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	every 2 weeks. during 6 months
Primary	Change from baseline in VAS for pain,		6 weeks, 6 months, and 12 months
Secondary	Change from baseline in functionality measured by constant score		6 weeks, 6 months and 12 months