Hemiplegic Shoulder Pain Management Using Shoulder pRF and Corticosteroid Injection

NCT05563571 | Unknown

• 1 other identifier: SATSHP/697/13.01/2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: hemiplegic shoulder pain (HSP) in a common post-stroke condition, that can lead to poor motor and functional recovery and lower quality of life. Interventions like intra-articular corticosteroid injection (ICI) and suprascapularis nerve (SSN) pulsed radiofrecuenfy treatment (PRF) has been used to treat the pain. Methods: in this single-center, prospective, randomized controlled study, we included 20 consecutive patients with hemiplegic shoulder pain in subacute stroke phase (2-12 months after diagnosis). Subjects were randomly assigned to the PRF (SSN and shoulder joint) and ICI treatment groups (n = 10 in each). Primary outcome is hemiplegic shoulder pain severity, measured by numeric rating scale, active shoulder range of motion and Fugl-Meyer upper limb assessment. Secondary outcome is shoulder joint and cervicocephalic kinesthetic sensibility. Outcome measurements were assessed at baseline and one, two and six months after each procedure.

Conditions

Stroke; Shoulder Pain

Keywords

intra-articular cortisone injection, pulsed radiofrequency

Outcome Measures

Primary Outcomes (7)

• Pain intensity

  Numerical Rating Scale

  Change in pain intensity in one, two and six months after the procedure

• Pain at night

  "yes" or "no"

  Change in pain in one, two and six months after the procedure

• Pain at rest

  "yes" or "no"

  Change in pain in one, two and six months after the procedure

• Pain at performing ADL

  "yes" or "no"

  Change in pain in one, two and six months after the procedure

• Pain in special movement

  "yes" or "no"

  Change in pain in one, two and six months after the procedure

• Range of motion

  Active flexion, active abduction and active lateral rotation measured by robotic device

  Change in active movement in one, two and six months after the procedure

• Fugl-Meyer Upper limb Assessment

  upper limb function assessed from 0 to 66, with 66 being normal neurological finding of upper limb

  Change in function in one, two and six months after the procedure

Secondary Outcomes (1)

• Shoulder Joint And Neck Kinesthetic Sensibility

  Change in one, two and six months after the procedure

Study Arms (2)

Intra-articular cortisone injection

ACTIVE COMPARATOR

Ultra-sound guided single injection of Methylprednisolon 40 mg (1 ml) + 1 ml 10 % Lidocaine to shoulder joint

Other: Pulsed radiofrequency, Lidocaine

pulsed radiofrequency of shoulder joint and suprascapular nerve

ACTIVE COMPARATOR

Ultra-sound guided single treatment of shoulder joint and suprascapular nerve with pulsed radiofrequency (PRF) STP (Sluijter Teixeira pulse) 45 V 4 minutes each with 1 ml 10% Lidocaine to both shoulder joint and suprascapular nerve.

Drug: Methylprednisolon, Lidocaine

Interventions

Methylprednisolon, Lidocaine DRUG

Intra-articular cortisone injection

pulsed radiofrequency of shoulder joint and suprascapular nerve

Pulsed radiofrequency, Lidocaine OTHER

pulsed radiofrequency of shoulder joint and suprascapular nerve

Intra-articular cortisone injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subacute stroke, duration 2-12 months
• presence of hemiparesis caused by stroke and at least some active movement from the shoulder joint
• significant shoulder pain with a minimum score of four on the numeric rating scale (NRS, where "0" indicates no pain and "10" indicates the most severe pain) persistent for at least one month with adequate other pain treatment modalities (pain killers, physical exercise).

You may not qualify if:

• patients not willing to participate
• significant other undelying shoulder pathology at the hemiparetic side
• severe aphasia or cognitive dysfunction that significantly affects the understaning of procedures and co-operation

Sponsors & Collaborators

• Satasairaala: lead

Study Sites (1)

dep of physical medicine and rehabilitation Satasairaala

Pori, 28100, Finland

RECRUITING

MeSH Terms

Conditions

Stroke; Shoulder Pain

Interventions

Methylprednisolone; Lidocaine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 3, 2022
• Study Start: April 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

FI (1)