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Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Arthroscopic acromioplasty
Microtenotomy
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Rotator cuff, Tendinosis, Impingement, radiofrequency

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Arthrocopic acromioplasty

Radiofrequency microtenotomy

Physical therapy

Arm Description

Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression

Surgical intervention With arthroscopic radiofrequency microtenotomy

Muscle strength training, home trainings programme

Outcomes

Primary Outcome Measures

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
Change from baseline in VAS for pain,

Secondary Outcome Measures

Change from baseline in functionality measured by constant score

Full Information

First Posted
October 22, 2014
Last Updated
September 4, 2017
Sponsor
University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT02275689
Brief Title
Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy
Official Title
Alternative Treatment of Rotator Cuff Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
Rotator cuff, Tendinosis, Impingement, radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthrocopic acromioplasty
Arm Type
Active Comparator
Arm Description
Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression
Arm Title
Radiofrequency microtenotomy
Arm Type
Active Comparator
Arm Description
Surgical intervention With arthroscopic radiofrequency microtenotomy
Arm Title
Physical therapy
Arm Type
No Intervention
Arm Description
Muscle strength training, home trainings programme
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic acromioplasty
Intervention Description
Surgical intervention With arthroscopic acromion resection
Intervention Type
Procedure
Intervention Name(s)
Microtenotomy
Intervention Description
Arthroscopic radiofrequency microtenotomy of rotator cuff tendon
Primary Outcome Measure Information:
Title
Change from baseline in VAS for pain
Description
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
Time Frame
every 2 weeks. during 6 months
Title
Change from baseline in VAS for pain,
Time Frame
6 weeks, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in functionality measured by constant score
Time Frame
6 weeks, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Meknas, MD, PhD
Organizational Affiliation
University Hospital of North Norway. 9038-Tromsø. Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsoe
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

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Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy

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