Overview

This trial is active, not recruiting.

Condition chronic non-specific low back pain
Treatment intensive rehabilitation program
Sponsor Hasselt University
Collaborator Jessa Hospital
Start date December 2013
End date March 2015
Trial size 10 participants
Trial identifier NCT02387515, PILOT2013TM01

Summary

This clinical pilot trial will investigate the effects of technology-supported exercise therapy for chronic non-specific low back pain. Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology. The technological system consists out of motion tracking sensors that register the movements and position of the lumbar spine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology.
intensive rehabilitation program
Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology. The technological system consists out of motion tracking sensors that register the movements and position of the lumbar spine.

Primary Outcomes

Measure
The numeric pain rating scale
time frame: baseline
The numeric pain rating scale
time frame: week 3
The numeric pain rating scale
time frame: week 8
The numeric pain rating scale
time frame: week 13
The numeric pain rating scale
time frame: week 18
The numeric pain rating scale
time frame: week 44
Roland Morris Questionnaire (0-24)
time frame: baseline
Roland Morris Questionnaire (0-24)
time frame: week 3
Roland Morris Questionnaire (0-24)
time frame: week 8
Roland Morris Questionnaire (0-24)
time frame: week 13
Roland Morris Questionnaire (0-24)
time frame: week 18
Roland Morris Questionnaire (0-24)
time frame: week 44
Patient specific functioning scale (0-10)
time frame: baseline
Patient specific functioning scale (0-10)
time frame: week 3
Patient specific functioning scale (0-10)
time frame: week 8
Patient specific functioning scale (0-10)
time frame: week 13
Patient specific functioning scale (0-10)
time frame: week 18
Patient specific functioning scale (0-10)
time frame: week 44
Pain self-efficacy questionnaire (0-60)
time frame: baseline
Pain self-efficacy questionnaire (0-60)
time frame: week 3
Pain self-efficacy questionnaire (0-60)
time frame: week 8
Pain self-efficacy questionnaire (0-60)
time frame: week 13
Pain self-efficacy questionnaire (0-60)
time frame: week 18
Pain self-efficacy questionnaire (0-60)
time frame: week 44
the Tampa scale for kinesiophobia (17-68)
time frame: baseline
the Tampa scale for kinesiophobia (17-68)
time frame: week 3
the Tampa scale for kinesiophobia (17-68)
time frame: week 8
the Tampa scale for kinesiophobia (17-68)
time frame: week 13
the Tampa scale for kinesiophobia (17-68)
time frame: week 18
the Tampa scale for kinesiophobia (17-68)
time frame: week 44
Patient satisfaction with treatment (0-10)
time frame: baseline
Patient satisfaction with treatment (0-10)
time frame: week 3
Patient satisfaction with treatment (0-10)
time frame: week 8
Patient satisfaction with treatment (0-10)
time frame: week 13
Patient satisfaction with treatment (0-10)
time frame: week 18
Patient satisfaction with treatment (0-10)
time frame: week 44

Secondary Outcomes

Measure
short form 36
time frame: baseline
short form 36
time frame: week 3
short form 36
time frame: week 8
short form 36
time frame: week 13
short form 36
time frame: week 18
short form 36
time frame: week 44
Credibility and expectancy questionnaire
time frame: baseline
Credibility and expectancy questionnaire
time frame: week 3
Credibility and expectancy questionnaire
time frame: week 8
Credibility and expectancy questionnaire
time frame: week 13
Credibility and expectancy questionnaire
time frame: week 18
Credibility and expectancy questionnaire
time frame: week 44
Intrinsic motivation inventory form
time frame: baseline
Intrinsic motivation inventory form
time frame: week 3
Intrinsic motivation inventory form
time frame: week 8
Intrinsic motivation inventory form
time frame: week 13
Intrinsic motivation inventory form
time frame: week 18
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
time frame: baseline
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
time frame: week 3
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
time frame: week 8
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
time frame: week 13
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
time frame: week 18
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
time frame: week 44
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
time frame: baseline
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
time frame: week 3
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
time frame: week 8
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
time frame: week 13
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
time frame: week18

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 18-65 y.o. - Chronic non-specific low back pain, with or without leg pain - Motor control impairment - Sufficient knowledge of the Dutch language to understand instructions Exclusion Criteria: - Spinal surgery in the past - Underlying serious pathologies (tumor, fracture, neurological diseases) - Signs or symptoms of nerve root compression - Pregnancy or less than 1 year post-partum - Known allergy for tape

Additional Information

Official title Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain: Pilot Study
Principal investigator annick Timmermans, prof.dr.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Hasselt University.