ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

NCT04319679 | Terminated

• 1 other identifier: ESWTSCIPain
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.

Conditions

Spastic Tetraplegia; Pain; Myelopathy Cervical

Keywords

Extracorporeal shockwave therapy; Cervical myelopathy; Spasticity; Pain

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (NRS)

  Pain intensity (0-10, ordinal scale)

  Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)

Secondary Outcomes (3)

• Modified Ashworth scale (MAS)

  Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)

• Range of motion (ROM)

  Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)

• Grasp power

  Up to 4 weeks (baseline, 2 weeks, 4 weeks)

Study Arms (2)

Experimental group

EXPERIMENTAL

3,000 pulses per time, low energy under 0.3 mJ/mm\^2, tolerable range

Device: Extracorporeal shockwave therapy

Control group

SHAM COMPARATOR

Sham therapy

Device: Sham therapy

Interventions

Extracorporeal shockwave therapy DEVICE

6 times during 2 weeks

Experimental group

Sham therapy DEVICE

6 times during 2 weeks

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal cord damage confirmed in the spinal cord image
• month after spinal cord injury
• Spasticity of upper extremities
• Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
• Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
• Age: 20 and older
• Person who has agreed in writing to decide his or her participation and comply with the precautions

You may not qualify if:

• Pain due to trauma
• Injection treatments two weeks before participating in the study
• Severe coagulopathy (excluding antiplatelet use)
• Impaired cognition

Sponsors & Collaborators

• Bundang CHA Hospital: lead

Study Sites (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center,

Seongnam, 13496, South Korea

Location

MeSH Terms

Conditions

Quadriplegia; Pain; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kyunghoon Min, MD, PhD

  Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

  PRINCIPAL INVESTIGATOR

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: Principal Professor of Rehabilitation Medicine

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 24, 2020
• Study Start: June 5, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 13, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KR (1)