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Pain Relief in Patients With Chronic Low Back Pain Using HeatTens vs. Standard Care.

NCT03643731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-09-06

No results posted yet for this study

Summary

A two-armed randomized controlled clinical trial with blind assessments and a follow-up period of 4 weeks is developed. The aim of this study is to investigate the effects of the combination of heat and TENS (HeatTENS device) on pain in people with chronic low back pain. A sample of 70 patients will be recruited. Following baseline measurements, subjects will be randomly allocated to the experimental or the control group. The experimental group will be asked to use the device on a daily basis, 30 minutes per day. The control group will have no device. After 4 weeks of FU, measurements will be repeated.

Conditions

  • Chronic Low Back Pain
  • Movement Evoked Pain

Interventions

DEVICE

HeatTens (HV-F311-E)

Patients need to apply the device during 30 minutes.

Sponsors & Collaborators

  • Omron Healthcare Co., Ltd.

    collaborator INDUSTRY

  • Vrije Universiteit Brussel

    lead OTHER

Principal Investigators

  • David Beckwée, PhD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2019-08-09
Completion
2019-08-09

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643731 on ClinicalTrials.gov