Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain

Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain: Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Non-specific Low Back Pain
• Intervention / Treatment: Other: intensive rehabilitation program

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, B3830
    • Universiteit Hasselt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The numeric pain rating scale	the numeric pain rating scale (0-10)	baseline
The numeric pain rating scale	the numeric pain rating scale (0-10)	week 3
The numeric pain rating scale	the numeric pain rating scale (0-10)months post-intervention.	week 8
The numeric pain rating scale	the numeric pain rating scale (0-10)	week 13
The numeric pain rating scale	the numeric pain rating scale (0-10)	week 18
The numeric pain rating scale	the numeric pain rating scale (0-10)	week 44
Roland Morris Questionnaire (0-24)	Roland Morris Questionnaire (0-24)	baseline
Roland Morris Questionnaire (0-24)	Roland Morris Questionnaire (0-24)	week 3
Roland Morris Questionnaire (0-24)	Roland Morris Questionnaire (0-24)	week 8
Roland Morris Questionnaire (0-24)	Roland Morris Questionnaire (0-24)	week 13
Roland Morris Questionnaire (0-24)	Roland Morris Questionnaire (0-24)	week 18
Roland Morris Questionnaire (0-24)	Roland Morris Questionnaire (0-24)	week 44
Patient specific functioning scale (0-10)	Patient specific functioning scale (0-10)	baseline
Patient specific functioning scale (0-10)	Patient specific functioning scale (0-10)	week 3
Patient specific functioning scale (0-10)	Patient specific functioning scale (0-10)	week 8
Patient specific functioning scale (0-10)	Patient specific functioning scale (0-10)	week 13
Patient specific functioning scale (0-10)	Patient specific functioning scale (0-10)	week 18
Patient specific functioning scale (0-10)	Patient specific functioning scale (0-10)	week 44
Pain self-efficacy questionnaire (0-60)	Pain self-efficacy questionnaire (0-60)	baseline
Pain self-efficacy questionnaire (0-60)	Pain self-efficacy questionnaire (0-60)	week 3
Pain self-efficacy questionnaire (0-60)	Pain self-efficacy questionnaire (0-60)	week 8
Pain self-efficacy questionnaire (0-60)	Pain self-efficacy questionnaire (0-60)	week 13
Pain self-efficacy questionnaire (0-60)	Pain self-efficacy questionnaire (0-60)	week 18
Pain self-efficacy questionnaire (0-60)	Pain self-efficacy questionnaire (0-60)	week 44
the Tampa scale for kinesiophobia (17-68)	the Tampa scale for kinesiophobia (17-68)	baseline
the Tampa scale for kinesiophobia (17-68)	the Tampa scale for kinesiophobia (17-68)	week 3
the Tampa scale for kinesiophobia (17-68)	the Tampa scale for kinesiophobia (17-68)	week 8
the Tampa scale for kinesiophobia (17-68)	the Tampa scale for kinesiophobia (17-68)	week 13
the Tampa scale for kinesiophobia (17-68)	the Tampa scale for kinesiophobia (17-68)	week 18
the Tampa scale for kinesiophobia (17-68)	the Tampa scale for kinesiophobia (17-68)	week 44
Patient satisfaction with treatment (0-10)	Patient satisfaction with treatment (0-10)	baseline
Patient satisfaction with treatment (0-10)	Patient satisfaction with treatment (0-10)	week 3
Patient satisfaction with treatment (0-10)	Patient satisfaction with treatment (0-10)	week 8
Patient satisfaction with treatment (0-10)	Patient satisfaction with treatment (0-10)	week 13
Patient satisfaction with treatment (0-10)	Patient satisfaction with treatment (0-10)	week 18
Patient satisfaction with treatment (0-10)	Patient satisfaction with treatment (0-10)	week 44

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Study Chair: Thomas Matheve, drs., Hasselt University; Principal Investigator: annick Timmermans, prof.dr., Hasselt University; Study Chair: Guido Claes, MD, Jessa Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 13, 2014
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PILOT2013TM01