Efficacy of Suprascapular Radiofrequency Ablation in Hemiplegic Shoulder Pain
NCT Number: NCT06473389
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiplegic Shoulder Pain
Interventions: PROCEDURE: Suprascapular nerve pulse radiofrequency ablation|PROCEDURE: Suprascapular Nerve Block Group|PROCEDURE: Steroid Group
Sponsor: YBBayır
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-01

Summary:
Stroke, one of the most important causes of disability and death in the world, is an acute focal deficit of the central system caused by vascular origin such as cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Hemiplegic shoulder pain, which is one of the most common complications after stroke, is an important problem affecting extremity rehabilitation. Although there are many factors thought to cause haemiplegic shoulder pain, there is still controversy about its treatment. Although there are many treatment strategies for this complication such as analgesics, antispasmotics, local corticosteroid injections, suprascapular nerve blockade, physical therapy modalities and exercise therapy, sometimes very resistant cases are also seen. For the treatment of persistent haemiplegic shoulder pain unresponsive to conventional treatment modalities, intra-articular injection of corticosteroids into the shoulder joint is commonly used, but its palliative effect has only a relatively short duration.Corticosteroids may also have adverse effects such as allergic reactions, rash, hyperglycaemia, menstrual disorders and adrenal suppression. Suprascapular nerve block is another option to relieve haemiplegic shoulder pain. The suprascapular nerve provides 70% of the sensory innervation of the shoulder joint. Thus, blocking pain transmission through the SS provides effective control of haemiplegic shoulder pain. However, the efficacy of suprascapular nerve block varies according to the study population and depends on the therapeutic modality to which it is compared. In addition, the effect of suprascapular nerve blockade may be limited due to the short duration of action of local anaesthetic agents. Neurolysis may cause permanent paralysis of the supraspinatus and infraspinatus muscles. For this reason, a deconstructive method is not preferred. Pulse RF applications, which is a non-deconstructive, neuromodulatory method, may be preferred in this regard. So far, there are very few studies investigating the efficacy of intra-articular steroid injection, suprascapular block and pulse RF in hemiplegic shoulder pain separately, but there is no study investigating the efficacy of Pulse RF treatment against other treatment methods together. In this study, investigator's aim was to compare the efficacy of suprascapular pulse radiofrequency against USG-guided suprascapular nerve block and intra-articular steroid injections in hemiplegic shoulder pain.

Primary Outcome Measures: Visual Analog Scale (VAS), Shoulder pain.The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score., This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.|painful angle of the shoulder, painful angle of the shoulder, This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Secondary Outcome Measures: range of motion, range of motion (ROM; flexion, abduction, internal and external rotation), This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.|Goal Attainment Scale (GAS), Goal Attainment Scale (GAS) during upper-body dressingIn the functional evaluation, the GAS during upper-body dressing was used to assess the effect of shoulder pain on functional capacity. GAS is a mathematical tech- nique for quantifying the achievement (or otherwise) of goals set, and it can be used in rehabilitation (7). According to this scale, pain during upper extremity dressing was evaluated (-2: severe pain, -1: moderate pain, 0: mild pain, +1: pain at the end of movement, and +2: painless motion. The highest indicating the best score., This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.|Modified Barthel Index, Physical competence and independence in daily living activities will be evaluatedIn the modified Barthel index, the level of functional independence in a total of 10 activities such as transfer, movement, stairs, nutrition, dressing, personal care, bathing, sitting and rising to the toilet, urinary and faecal incontinence is evaluated. The total score varies between 0-100. Zero score indicates complete dependence and 100 score indicates complete independence., This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.|SPADI, Shoulder Pain and Disability Index scoreIt is a 13-item questionnaire categorised into pain and activity limitation. The score ranges from 0-100.The highest indicating the best score., This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.