NCT02275689

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 6, 2017

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

October 22, 2014

Last Update Submit

September 4, 2017

Conditions

Shoulder Impingement Syndrome

Keywords

Rotator cuffTendinosisImpingementradiofrequency

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change from baseline in VAS for pain,

    6 weeks, 6 months, and 12 months

Secondary Outcomes (1)

  • Change from baseline in functionality measured by constant score

    6 weeks, 6 months and 12 months

Study Arms (3)

Arthrocopic acromioplasty

ACTIVE COMPARATOR

Surgical intervention with arthroscopic acromioplasty, bursectomy and subacromial decompression

Procedure: Arthroscopic acromioplasty

Radiofrequency microtenotomy

ACTIVE COMPARATOR

Surgical intervention With arthroscopic radiofrequency microtenotomy

Procedure: Microtenotomy

Physical therapy

NO INTERVENTION

Muscle strength training, home trainings programme

Interventions

Arthroscopic acromioplastyPROCEDURE

Surgical intervention With arthroscopic acromion resection

Arthrocopic acromioplasty
MicrotenotomyPROCEDURE

Arthroscopic radiofrequency microtenotomy of rotator cuff tendon

Radiofrequency microtenotomy

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • inflammatory joint disease
  • Other comorbidity in the shoulder as instability, osteoarthritis or rotator cuff tear
  • serious illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeTendinopathy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesMuscular DiseasesTendon Injuries

Study Officials

  • Khaled Meknas, MD, PhD

    University Hospital of North Norway. 9038-Tromsø. Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 27, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 6, 2017

Record last verified: 2016-12

Locations

NO(1)