Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy

NCT ID: NCT02275689

Last Updated: 2017-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Shoulder Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arthrocopic acromioplasty

Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression

Group Type ACTIVE_COMPARATOR

Arthroscopic acromioplasty

Intervention Type PROCEDURE

Surgical intervention With arthroscopic acromion resection

Radiofrequency microtenotomy

Surgical intervention With arthroscopic radiofrequency microtenotomy

Group Type ACTIVE_COMPARATOR

Microtenotomy

Intervention Type PROCEDURE

Arthroscopic radiofrequency microtenotomy of rotator cuff tendon

Physical therapy

Muscle strength training, home trainings programme

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arthroscopic acromioplasty

Surgical intervention With arthroscopic acromion resection

Intervention Type PROCEDURE

Microtenotomy

Arthroscopic radiofrequency microtenotomy of rotator cuff tendon

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khaled Meknas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway. 9038-Tromsø. Norway

Locations

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University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2011/1133

Identifier Type: -

Identifier Source: org_study_id

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