Hemiplegic Shoulder Pain
Conditions
Keywords
Hemiplegic, Shoulder Pain, Transforaminal, Treatment, Interventional
Brief summary
The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.
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.
Interventions
PROCEDUREtransforaminal dexamethasone injection
Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
PROCEDURESham
Sham procedure using a non-penetrating needle
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Algometry in shoulder muscles | 1 week and 3 months after treatment | Algometry were measured in all shoulder muscles. |
Countries
Brazil
Contacts
Primary ContactJoao D Amadera, MD
Outcome results
None listed