Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Hemiplegic Shoulder Pain

Treatments: Procedure: Sham; Procedure: transforaminal dexamethasone injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01572285

0530/09

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Sham

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham

Transforaminal

Experimental group

Description:

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

Treatment:

Procedure: transforaminal dexamethasone injection