Skip to main content
OpenTrials
Completed

NCT Number: NCT02275689

Radiofrequency Microtenotomy for 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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Impingement Syndrome Joint Diseases Muscular Diseases Musculoskeletal Diseases Shoulder Injuries Tendinopathy Tendon Injuries Wounds and Injuries

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic acromioplasty

Procedure

Surgical intervention With arthroscopic acromion resection

Microtenotomy

Procedure

Arthroscopic radiofrequency microtenotomy of rotator cuff tendon

Primary outcomes

  1. 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

  2. Change from baseline in VAS for pain,

    Time frame: 6 weeks, 6 months, and 12 months

Secondary outcomes

  1. Change from baseline in functionality measured by constant score

    Time frame: 6 weeks, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

Alternative Treatment of Rotator Cuff Tendinopathy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2014
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.