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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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 follow up in primary care.
Department of Physiotherapy, Hillevaag General Practitioner Practice
Stavanger, Norway
RECRUITINGNeed for surgery
Dichotomised questionnaire yes or no
Time frame: 12 weeks (end of treatment) and 6 months post treatment
Shoulder function
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'.
Time frame: 4 weeks , 12 weeks and 6 months
Shoulder Pain
Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
Time frame: 4 weeks , 12 weeks and 6 months
Generic health status
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.
Time frame: 12 weeks and 6 months
Rotator cuff force
Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .
Time frame: 12 weeks ( end of treatment)
Tendon pain pressure threshold
Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.
Time frame: 12 weeks ( end of treatment )
Analgesics and corticosteroid injections
Analgesics consumption and corticosteroids injections registered on questionaire.
Time frame: 4 weeks , 12 weeks and 6 months
Tendon thickness
Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )
Time frame: 12 weeks ( end of treatment )
Patient global impression of change
To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.
Time frame: 4 weeks, 12 weeks & 6 months
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