Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01572285
First received: April 3, 2012
Last updated: April 5, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Hemiplegic Shoulder Pain
Procedure: transforaminal dexamethasone injection
Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Pain improvement after transforaminal injection using the Visual Analogue Scale (VAS) [ Time Frame: 1 week and 3 months after treatment ] [ Designated as safety issue: No ]
    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:
  • Algometry in shoulder muscles [ Time Frame: 1 week and 3 months after treatment ] [ Designated as safety issue: No ]
    Algometry were measured in all shoulder muscles.


Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572285

Contacts
Contact: Joao D Amadera, MD 55 11 92692069 joao@fmusp.org.br

Locations
Brazil
University of São Paulo General Hospital Recruiting
São Paulo, SP, Brazil, 05408040
Contact: Joao D Amadera, MD    55 11 92692069    joao@fmusp.org.br   
Principal Investigator: Joao D Amadera, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Joao D Amadera, MD University of São Paulo General Hospital
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01572285     History of Changes
Other Study ID Numbers: 0530/09
Study First Received: April 3, 2012
Last Updated: April 5, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Hemiplegic
Shoulder Pain
Transforaminal
Treatment
Interventional

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014