Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01572285

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hemiplegic Shoulder Pain	Procedure: transforaminal dexamethasone injection Procedure: Sham	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

May 1, 2012

Anticipated Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham Sham arm received a simulation of transforaminal injection using a non-penetrating needle	Procedure: Sham Sham procedure using a non-penetrating needle
Experimental: Transforaminal Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml	Procedure: transforaminal dexamethasone injection Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml Other Names: dexamethasone steroid transforaminal TF TFESI

Arm

Intervention/Treatment

Sham Comparator: Sham

Sham arm received a simulation of transforaminal injection using a non-penetrating needle

Procedure: Sham

Sham procedure using a non-penetrating needle

Experimental: Transforaminal

Subjects received TF with infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml

Procedure: transforaminal dexamethasone injection

Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml

Other Names:

dexamethasone

steroid

transforaminal

TFESI

Outcome Measures

Primary Outcome Measures

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).