The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy

August 22, 2018 updated by: Sturla Haslerud, Bergen University College

The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.

Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sturla Haslerud, Msc
  • Phone Number: 0047 93424347
  • Email: shas@hib.no

Study Locations

  • Norway
      • Stavanger, Norway, 4016
        • Recruiting
        • Department of Physiotherapy, Hillevaag General Practitioner Practice
        • Contact:
          • Sturla Haslerud, Msc
          • Phone Number: 0047 93424347
          • Email: shas@hib.no
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )

  1. Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
  2. Symptom duration of minimum 3 months.

  3. Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:

    • Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop & Veer, 2003)
    • Painful arc during active abduction (Ombregt, Bisschop & Veer, 2003)
    • Positive Neers sign (Neer, 1972 ; Tennent, Beach & Meyers, 2003)
    • Positive Jobes test (Jobe & Moynes, 1982 ; Tennent, Beach & Meyers, 2003)
    • Positive Hawkins-Kennedy impingement test (Hawkins & Kennedy, 1980)

Exclusion Criteria:

  1. Shoulder pain due to trauma, e.g. fall.
  2. Reduced ROM consistent with adhesive capsulitis/frozen shoulder
  3. History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
  4. Full thickness rupture of rotator cuff tendon
  5. OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
  6. Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
  7. Subjects suffering from serious psychiatric illness.
  8. Subjects unable to understand English or Norwegian.
  9. Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Physiotherapy regimen
Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy
Other: Structured Physiotherapy Regimen
Experimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week.
Other: Standard care
Standard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options.
Other: Standard Care
Standard follow up in primary care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for surgery
Time Frame: 12 weeks (end of treatment) and 6 months post treatment
Dichotomised questionnaire yes or no
12 weeks (end of treatment) and 6 months post treatment
Shoulder function
Time Frame: 4 weeks , 12 weeks and 6 months
Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.
4 weeks , 12 weeks and 6 months
Shoulder Pain
Time Frame: 4 weeks , 12 weeks and 6 months
Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
4 weeks , 12 weeks and 6 months
Generic health status
Time Frame: 12 weeks and 6 months
EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
12 weeks and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rotator cuff force
Time Frame: 12 weeks ( end of treatment)
Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .
12 weeks ( end of treatment)
Tendon pain pressure threshold
Time Frame: 12 weeks ( end of treatment )
Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.
12 weeks ( end of treatment )
Analgesics and corticosteroid injections
Time Frame: 4 weeks , 12 weeks and 6 months
Analgesics consumption and corticosteroids injections registered on questionaire.
4 weeks , 12 weeks and 6 months
Tendon thickness
Time Frame: 12 weeks ( end of treatment )
Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )
12 weeks ( end of treatment )
Patient global impression of change
Time Frame: 4 weeks, 12 weeks & 6 months
To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.
4 weeks, 12 weeks & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bergen University College

Collaborators

University of Bergen

Investigators

  • Study Chair: Jan Magnus Bjordal, Professor, University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 1, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BergenUC
  • 2012/2134 (Other Identifier: Regional Ethics Committee Norway , REK Nord)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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