Frozen Shoulder Clinical Trial
Official title:
Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial
This is a study on the treatment of frozen shoulder with injection of cortisone into the shoulder joint. The purpose of the study is to evaluate whether injection with stretching of the shoulder capsule or plain injection is more effective than no specific treatment.
Shoulder capsulitis or frozen shoulder is a painful condition causing limitations of
shoulder movements. Its incidence is about 2%, comprising mostly women. There is a need for
more controlled trials on frozen shoulder preferably in general practice, without using
technical guiding instruments for injections as MRI or computer tomography, because the
condition is routinely treated in general practice. It was therefore important to conduct
this study as similar as possible to current practice. The procedure should be simple, safe
and less time consuming.
Patients will be allocated to the study groups by computerized block-randomization with
three permutations per block. Group 1 consists of patients receiving Triamcinolone 20 mg
intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution. Group 2
patients will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and the rest with
physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up
to 20 ml. Group 3 will serve as a control group and patients in this group could receive any
other treatment other than corticosteroid injections or per oral corticosteroid medication.
The control group will remain without treatment with corticosteroids, in injection or tablet
form till 61 days, which is also the last day of the outcome measurements. The time interval
between the 1st and 2nd treatment will be 7 days, between the 2nd and 3rd treatment 10 days,
and between the 3rd and 4th treatment 14 days. Patients will also receive a follow-up by
mail 6 and 12 months after the inclusion, where pain and function (SPADI) is investigated.
The patients will be explained and instructed in filling out schema for SPADI, NPRS, pain
figure, for sleep Bergen Insomnia Scale (BIS), EPQ-N to measure neuroticism, and Subjective
Health Complaints (SHC).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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