Chronic Shoulder Pain Clinical Trial
Official title:
Pulsed Radiofrequency of Suprascapular Nerve and Shoulder Joint for Chronic Shoulder Pain: A Randomized Blind Active -Controlled Study
Background: The suprascapular nerve block is frequently used to treat chronic shoulder pain. The nerve blockade provides probably only a short-term relief, and more compelling approaches have been investigated. Pulsed radiofrequency stimulation of suprascapular nerve has been reported as safe and reliable method for pain treatment. However, formal efficacy study for pRF stimulation of the shoulder joint has not been published. Evidence-based validation of a new method is necessary for both scholastic and practical purposes. Methods: This study is a randomized active controlled blind trial. Lidocaine injections alone and pRF stimulation with two different combinations will be performed. Participants will be followed during 6 months, and subjective and objective outcome variables will be recorded. Patients are randomly allocated for suprascapular nerve block (n=50), for suprascapular nerve pRF stimulation (n=50) or for both suprascapular nerve blocks and humeroscapular joint pRF stimulation (n=50). All patients will receive standardized physical therapy at the unit of physical medicine and rehabilitation. Results: Pulsed radiofrequency is thought to be a non-neurolytic neuromodulation method with some effectiveness in relieving of both experimental and clinical neuropathic pain. Our earlier results suggest additional therapeutic benefit obtained when pRF was performed in addition to physiotherapy (TAU). In a review, Chan et al. (2016) concluded that SSNB treatment could be more effective in treating pain in patients with longstanding rheumatoid arthritis when compared to intra-articular injection of corticosteroid. Also short-term pain reduction occurred in patients with chronic rotator cuff lesions. With regard to adhesive capsulitis, SSNB treatment showed a greater effect in relieving pain but on functional outcome, the results were inconclusive. Discussion: In summary, this study investigate effects of pRF for patients with chronic shoulder pain from arthritis, frozen shoulder and/or degenerative shoulder disease. PRF can be performed in an outpatient department and provides the clinician with an alternative or additional approach to oral drug treatment and intra-articular injection. Further, it may prove to be a useful treatment for patients who are unfit or unwilling to consider surgical intervention.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: shoulder joint pain >3 moths Exclusion Criteria: Other ethiology as cervical root leasion or cancer.- |
Country | Name | City | State |
---|---|---|---|
Finland | dep of physical medicine and rehabilitation Satasairaala | Pori |
Lead Sponsor | Collaborator |
---|---|
Satasairaala |
Finland,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SPADI change is being assessed | Shoulder Pain and Disability Index change from baseline is being assessed at 2 and 6 months . Disability, pain and total scores 0-100% when 100 is worst. | 0, 2, 6 months | |
Primary | Active maximal shoulder adduction movement change is being assessed | Active shoulder joint adduction min 0- max 180. Change from baseline is being assessed at 2 and 6 months | 0,2,6 months | |
Primary | Active maximal shoulder flexion movement change is being assessed | Active Shoulder joint flexion min 0 -max 180. Change from baseline is being assessed at 2 and 6 months | 0,2,6 months | |
Secondary | HQoL 15 d change is being assessed | measure of health-related quality of life 15 items. Change from baseline is being assessed at 6 months. Questionnaire result in index, Minimum 0 and maximum1. | 0,6 months | |
Secondary | EQ5D change is being aseessed | measure of health-related quality of life. Change from baseline is being assessed at 6 months. Questionnaire result in index, Minimum 0 and maximum1. | 0, 6 months |
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