Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00852657

Enrollment

103

Registered

2009-02-27

Start date

2004-09-30

Completion date

2023-03-31

Last updated

2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tear, surgical repair, Physiotherapy, Treatment benefit, Surgery

Brief summary

The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.

Detailed description

Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies. In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.

Interventions

PROCEDURETendon repair with acromioplasty

Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps

PROCEDUREPhysiotherapy

According to a rehabilitation program which was established prior to study start.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical history and imaging findings of a rotator cuff tear

Exclusion criteria

* Presence of other local or systemic diseases influencing on shoulder function * History of earlier rotator cuff surgery * Medical contraindications for surgery

Design outcomes

Primary

Measure	Time frame
Constant score	baseline, 6 months, 1, 2, 5, 10, 15 years

Secondary

Measure	Time frame
self report section of the American Shoulder and Elbow Surgeons score (ASES)	baseline, 6 months, 1, 2, 5, 10, 15 years
Short Form 36 Health Survey (SF-36)	baseline, 6 months, 1, 2, 5, 10, 15 years
Patient satisfaction	1, 2, 5, 10, 15 years

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026