Suprascapular Nerve Block Versus Intraarticular Steroid Injection in Hemiplegic Shoulder Pain: A Randomized Double Blinded Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Changes in Numerical rating score (NRS) pain score at maximum passive range of motion (ROM) of shoulder flexion, abduction, internal and external rotation
研究概览
简要总结
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:
- 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.
详细描述
- INTRODUCTION
1.1 Research Area
Hemiplegic shoulder pain (HSP) is a common clinical consequence of stroke with reported frequency as high as 72% (1). Onset of HSP is more common at 2-3 months post stroke(2). HSP can reduce participation in rehabilitation activities and reduce quality of life(3). The etiology of HSP includes neurological and mechanical factors, although mechanical factors are more common. Mechanical factors include structural injury from glenohumeral subluxation, or rotator cuff pathology (3). In hemiplegic patients, the nociceptive pain ratio was higher at 86.7% compared to neuropathic pain ratio; 13.3% (4). Management of HSP focused on reducing pain and improving shoulder ROM. Minimally invasive treatment of HSP with intra-articular steroid (IAS) injection and supra-scapular nerve block (SSNB) have lately gained interest. However, 2 studies done so far showed that while both SSNB and IAS showed significant differences in reducing shoulder pain and improving ROM with time, there was no significant difference of these injection method in comparison to conventional treatment. None of the studies done to date documents functional outcome of patients post injection with IAS or SSNB. The main purpose of this study is to assess the analgesic effect of SSNB vs IAS in HSP among Malaysian stroke population as well as to look at the improvement of shoulder ROM and functional outcome measure.
1.2 Research Questions
Does supra-scapular nerve block (SSNB) provide better pain relief, passive range of motion (PROM) and functional outcome compared to intraarticular steroid (IAS) injection in hemiplegic shoulder pain?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded from knowing the intervention they're receiving.
Both suprascapular nerve block and intraarticular shoulder steroid injection will be performed at posterior aspect of shoulder while participant is in seated position and facing forward.
The assessor will also be blinded from knowing which group the participants belong to.
All the medical record related to this study will be inaccessible by the assessor.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brain lesion recognized by CT Brain scan or MRI brain
- •Hemiplegic shoulder pain of at least 2 weeks in duration
- •Failed standard treatment with oral medications and physical modalities
- •Age 20-70 years old
- •Pain score of at least numerical rating scale (NRS) 3/10 at movement
- •Mini Mental State Examination(MMSE) at least 24/30
排除标准
- •Neuropathic pain
- •Severe aphasia affecting communication
- •Previous trauma history to affected shoulder and preexisting shoulder pain/pathology
- •Previous shoulder injection within the past 3 months
结局指标
主要结局
Changes in Numerical rating score (NRS) pain score at maximum passive range of motion (ROM) of shoulder flexion, abduction, internal and external rotation
时间窗: To be collected at baseline, 1 hour, 1 month and 3 months post injection
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
- Shoulder Disability Questionnaire (SDQ)(Measured at baseline, 1 month and 3 months post intervention. *SDQ not measured at 1 hour post injection as it requires the patient to answer questions regarding the painful shoulder in the preceding 24 hours)
- Shoulder Pain and Disability Index (SPADI)(Measured at baseline, 1 month and 3 months post intervention. *SPADI not measured at 1 hour post injection as functional outcome measure are not expected to change within 1 hour.)
- Changes in maximum passive ROM of affected shoulder flexion, abduction, internal and external rotation(Measured at baseline, 1 hour, 1 month and 3 months post injection.)
研究者
Dr Anwar Suhaimi
Senior Lecturer and Rehabilitation Physician
University of Malaya