Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

Hemiplegic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01572285
• Other study ID #: 0530/09
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2012
• Last updated: April 5, 2012
• Start date: October 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2012
• Source: University of Sao Paulo General Hospital
• Contact: Joao D Amadera, MD
• Phone: 55 11 92692069
• Email: joao[@]fmusp.org.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegic Shoulder Pain
• Shoulder Pain

Intervention

Procedure:
• transforaminal dexamethasone injection
Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
• Sham
Sham procedure using a non-penetrating needle

Locations

Country	Name	City	State
Brazil	University of São Paulo General Hospital	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS)	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).	1 week and 3 months after treatment	No
Secondary	Algometry in shoulder muscles	Algometry were measured in all shoulder muscles.	1 week and 3 months after treatment	No