Suprascapular Nerve Block Versus Intraarticular Steroid Injection in Hemiplegic Shoulder Pain
NCT04128605 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2020-01-18
Summary
Suprascapular nerve block versus(vs) intra-articular steroid injection in the management of hemiplegic shoulder pain (HSP): a randomised, double blinded, controlled trial
BACKGROUND Hemiplegic shoulder pain (HSP) is a common complication of stroke. It can happen as early as one week post stroke with a frequency as high as 72%. HSP can result in significant disability as pain and limited shoulder range of motion (ROM) decrease hand function, reduce participation in rehabilitation activity and delay functional recovery of the patients. Management of HSP focused on reducing pain and improving shoulder ROM. Minimally invasive treatment of HSP with intra-articular shoulder steroid (IAS) injection and supra-scapular nerve block (SSNB) have gained interest.
OBJECTIVES
Primary objective:
1. To assess the analgesic effect of SSNB vs IAS in HSP among Malaysian stroke population.
Secondary objectives:
2. To assess the improvement of passive ROM post SSNB versus IAS in HSP.
3. To assess for improvement of functional outcome post SSNB versus IAS in HSP.
METHOD
A prospective, double blinded interventional study will be conducted in the Rehabilitation Medicine Clinic, University of Malaya Medical Centre for a duration of 1 year. Eligible subjects will be enrolled from all referrals of hemiplegic shoulder pain (HSP), following computer-generated randomization they will be allocated to either supra-scapular nerve block (SSNB) (intervention) or intra-articular shoulder steroid injection (IAS) (control) groups. The subjects and assessors are blinded to the intervention received, which will be performed by an experienced interventionist, not participating in randomization or data collection and analysis. Demographics of participants time since stroke, etiology, presence of spasticity, Numerical Rating Score (NRS) pain score at maximal passive ROM, maximum passive ROM of shoulder flexion, abduction, internal and external rotation as well as SDQ and SPADI will recorded prior to injection, 1 hour, 1 month and 3 months post injection. Mann-Whitney U tests and Chi-Square test of association will be used as appropriate to compare groups at baseline. Shoulder ROM and NRS pre and post intervention will be analysed using paired t-test and ANOVA. Functional outcome of SDQ and SPADI pre and post intervention will be analysed using paired t-test as well.
Conditions
- Hemiplegic Shoulder Pain
Interventions
- PROCEDURE
-
Suprascapular nerve block (SSNB)
SSNB is performed using ultrasound guidance by skilled interventionist under ultrasound guidance. Skin area at posterior shoulder is first infiltrated with Lidocaine 1%. Then, a mixture of 5 mls of Bupivacaine, 5 mls Lidocaine 1% and 10 mls of saline are injected at posterior shoulder towards suprascapular notch surrounding suprascapular nerve.
- PROCEDURE
-
Intraarticular shoulder steroid injection (IAS)
IAS is performed using ultrasound guidance by skilled interventionist under ultrasound guidance. Skin area at posterior shoulder is first infiltrated with Lidocaine 1%. IAS is performed by injecting 40 mg of Triamcenolone Acetonide along with 2 ml of Lidocaine 1% into glenohumeral articular space
Sponsors & Collaborators
-
University of Malaya
lead OTHER
Principal Investigators
-
ANWAR BIN SUHAIMI, MBBS · SENIOR LECTURER AND REHABILITATION PHYSICIAN
-
SOO CHIN CHAN, MBBS · LECTURER AND REHABILITATION PHYSICIAN
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-11
- Primary Completion
- 2020-07-31
- Completion
- 2020-12-31
Countries
- Malaysia
Study Locations
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