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

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ClinicalTrials.gov Identifier: NCT02304003
Recruitment Status : Recruiting
First Posted : December 1, 2014
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Sturla Haslerud, Bergen University College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tendinopathy Shoulder Impingement Syndrome Shoulder Pain Subacromial Impingement Other: Structured Physiotherapy Regimen Other: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : April 2014
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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.

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.




Primary Outcome Measures :
  1. Need for surgery [ Time Frame: 12 weeks (end of treatment) and 6 months post treatment ]
    Dichotomised questionnaire yes or no

  2. 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'.

  3. 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. 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.


Secondary Outcome Measures :
  1. Rotator cuff force [ Time Frame: 12 weeks ( end of treatment) ]
    Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .

  2. 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.

  3. Analgesics and corticosteroid injections [ Time Frame: 4 weeks , 12 weeks and 6 months ]
    Analgesics consumption and corticosteroids injections registered on questionaire.

  4. Tendon thickness [ Time Frame: 12 weeks ( end of treatment ) ]
    Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )

  5. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304003


Contacts
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Contact: Jan Magnus Bjordal, Professor 55 58 60 37 ext 0047 Jan.Bjordal@igs.uib.no
Contact: Sturla Haslerud, Msc 93424347 ext 0047 shas@hib.no

Locations
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Norway
Department of Physiotherapy, Hillevaag General Practitioner Practice Recruiting
Stavanger, Norway, 4016
Contact: Sturla Haslerud, Msc    93424347 ext 0047    shas@hib.no   
Contact: Jon Joensen, PhD    55 58 72 31 ext 0047    jon.joensen@hib.no   
Sponsors and Collaborators
Bergen University College
University of Bergen
Investigators
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Study Chair: Jan Magnus Bjordal, Professor University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.

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Responsible Party: Sturla Haslerud, Sturla Haslerud , PT , Msc Orthopedics & Reumatology , PhD candidate, Bergen University College
ClinicalTrials.gov Identifier: NCT02304003     History of Changes
Other Study ID Numbers: BergenUC
2012/2134 ( Other Identifier: Regional Ethics Committee Norway , REK Nord )
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Keywords provided by Sturla Haslerud, Bergen University College:
Shoulder tendinopathy
Subacromial impingement syndrome
Rotator cuff tendinopathy
Supraspinatus tendinopathy
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Shoulder Pain
Tendinopathy
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Shoulder Injuries