Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

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

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

Study Overview

• Status: Unknown
• Conditions: Hemiplegic Shoulder Pain
• Intervention / Treatment: Procedure: Sham; Procedure: transforaminal dexamethasone injection

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joao D Amadera, MD; Phone Number: 55 11 92692069; Email: joao@fmusp.org.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05408040
      • Recruiting
      • University of Sao Paulo General Hospital
      • Contact: Joao D Amadera, MD; Phone Number: 55 11 92692069; Email: joao@fmusp.org.br
      • Principal Investigator: Joao D Amadera, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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; TFESI; steroid; TF; transforaminal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometry in shoulder muscles	Algometry were measured in all shoulder muscles.	1 week and 3 months after treatment

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Joao D Amadera, MD, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2012
• Study Completion (ANTICIPATED): November 1, 2012

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (ESTIMATE): April 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 6, 2012
• Last Update Submitted That Met QC Criteria: April 5, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Treatment; Shoulder Pain; Interventional; Transforaminal; Hemiplegic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 0530/09