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
|Condition or disease||Intervention/treatment||Phase|
|Tendinopathy Shoulder Impingement Syndrome Shoulder Pain Subacromial Impingement||Other: Structured Physiotherapy Regimen Other: Standard Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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 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.
- Need for surgery [ Time Frame: 12 weeks (end of treatment) and 6 months post treatment ]Dichotomised questionnaire yes or no
- 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'.
- 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 .
- 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.
- Rotator cuff force [ Time Frame: 12 weeks ( end of treatment) ]Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .
- 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.
- Analgesics and corticosteroid injections [ Time Frame: 4 weeks , 12 weeks and 6 months ]Analgesics consumption and corticosteroids injections registered on questionaire.
- Tendon thickness [ Time Frame: 12 weeks ( end of treatment ) ]Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )
- 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.
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
|Contact: Jan Magnus Bjordal, Professor||55 58 60 37 ext 0047||Jan.Bjordal@igs.uib.no|
|Contact: Sturla Haslerud, Msc||93424347 ext email@example.com|
|Department of Physiotherapy, Hillevaag General Practitioner Practice||Recruiting|
|Stavanger, Norway, 4016|
|Contact: Sturla Haslerud, Msc 93424347 ext 0047 firstname.lastname@example.org|
|Contact: Jon Joensen, PhD 55 58 72 31 ext 0047 email@example.com|
|Study Chair:||Jan Magnus Bjordal, Professor||University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.|