Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy

September 4, 2017 updated by: University Hospital of North Norway

Alternative Treatment of Rotator Cuff Tendinopathy

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsoe, Norway, 9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arthrocopic acromioplasty
Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression
Procedure: Arthroscopic acromioplasty
Surgical intervention With arthroscopic acromion resection
Active Comparator: Radiofrequency microtenotomy
Surgical intervention With arthroscopic radiofrequency microtenotomy
Procedure: Microtenotomy
Arthroscopic radiofrequency microtenotomy of rotator cuff tendon
No Intervention: Physical therapy
Muscle strength training, home trainings programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in VAS for pain
Time Frame: 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
every 2 weeks. during 6 months
Change from baseline in VAS for pain,
Time Frame: 6 weeks, 6 months, and 12 months
6 weeks, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in functionality measured by constant score
Time Frame: 6 weeks, 6 months and 12 months
6 weeks, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Investigators

  • Principal Investigator: Khaled Meknas, MD, PhD, University Hospital of North Norway. 9038-Tromsø. Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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