Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

Not Applicable

• Conditions: Hemiplegic Shoulder Pain
• Interventions: Procedure: Sham; Procedure: transforaminal dexamethasone injection

• Registration Number: NCT01572285
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.

Detailed Description

Shoulder pain is the most common complication in hemiplegia after Stroke (CVA). Almost three quarters of all patients with hemiplegia will suffer from shoulder pain in the first twelve months after stroke. Because of the lack of effective treatment today, the optimal management of hemiplegic shoulder pain is prevention. Although widely studied, all clinical trials for shoulder pain in stroke fail to show efficacy. TF was never investigated to treat Hemiplegic Shoulder Pain (HSP). The investigators hypothesize that injecting the epidural space at the C6 level via transforaminal would desensitize both central medullary components of pain as peripheral sensitized structures such as the suprascapular nerve of the affected shoulder.

To test this hypothesis, the investigators developed a treatment protocol consisting of two C6 transforaminal epidural steroid injection with dexamethasone (TF with 0.5mL of lidocaine 1% and 1.5mL of Dexamethasone 10mg/ml). This procedure was compared to a sham intervention.

Study Timeline

• Study Start: 2011-10
• Status Verified: 2012-03
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-05
• Last Update Submitted: 2012-04-05
• Study First Posted: 2012-04-06
• Last Update Posted: 2012-04-06
• Primary Completion: 2012-05
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 3 months of shoulder pain following a stroke
• hemiplegia or paresis after a cerebral stroke for at least 6 months
• Shoulder pain greater than 4 in a visual analogue scale
• 50 to 65 years old

Exclusion Criteria

• inability to understand or answer the tools in the study
• local inflammation or infection
• History of malignancy
• use of cardiac pacemaker
• allergy to lidocaine or dexamethasone
• disorders of coagulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham	Sham arm received a simulation of transforaminal injection using a non-penetrating needle
Transforaminal	transforaminal dexamethasone injection	Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml

Primary Outcome Measures

Name	Time	Method
Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS)	1 week and 3 months after treatment	The primary outcome measures were pain measured using a visual analogue scale (VAS on a scale of 0≈10cm; where 0=no pain and 10=highest pain level during the last week).

Secondary Outcome Measures

Name	Time	Method
Algometry in shoulder muscles	1 week and 3 months after treatment	Algometry were measured in all shoulder muscles.

Trial Locations

Locations (1)

University of São Paulo General Hospital; 🇧🇷 São Paulo, SP, Brazil