Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

NCT01506804

Shoulder Bursitis

COMPLETED NA

Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury

NCT04136743

Spinal Cord Injuries Tendinopathy Rotator Cuff Tears +1 more

UNKNOWN PHASE2

Treatment Study of Frozen Shoulder: Corticosteroid Injection in Joint Versus Wait and See Policy

NCT01570985

Shoulder Capsulitis Shoulder Adhesive Capsulitis Frozen Shoulder

UNKNOWN PHASE3

The Effects of 15% Dextrose Solution on Pain and Range of Motion in the Hemiplegic Shoulder

NCT06988228

Hemiplegic Shoulder Pain Stroke

COMPLETED NA

Hypertonic Dextrose Injection and Physical Therapy for Frozen Shoulder

NCT06165926

Frozen Shoulder

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemiplegic Shoulder Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sham

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

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

Sham procedure using a non-penetrating needle

Transforaminal

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

Group Type EXPERIMENTAL

transforaminal dexamethasone injection

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transforaminal dexamethasone injection

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

Intervention Type PROCEDURE

Sham

Sham procedure using a non-penetrating needle

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

dexamethasone steroid transforaminal TF TFESI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No