Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain
Primary Purpose
Chronic Non-specific Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
intensive rehabilitation program
Sponsored by
About this trial
This is an interventional other trial for Chronic Non-specific Low Back Pain
Eligibility Criteria
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
Sites / Locations
- Universiteit Hasselt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intensive rehabilitation program
Arm Description
Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology.
Outcomes
Primary Outcome Measures
The numeric pain rating scale
the numeric pain rating scale (0-10)
The numeric pain rating scale
the numeric pain rating scale (0-10)
The numeric pain rating scale
the numeric pain rating scale (0-10)months post-intervention.
The numeric pain rating scale
the numeric pain rating scale (0-10)
The numeric pain rating scale
the numeric pain rating scale (0-10)
The numeric pain rating scale
the numeric pain rating scale (0-10)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Secondary Outcome Measures
short form 36
Quality of life, SF-36 questionnaire
short form 36
Quality of life, SF-36 questionnaire
short form 36
Quality of life, SF-36 questionnaire
short form 36
Quality of life, SF-36 questionnaire
short form 36
Quality of life, SF-36 questionnaire
short form 36
Quality of life, SF-36 questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
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)
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)
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)
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)
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)
Full Information
NCT ID
NCT02387515
First Posted
December 13, 2014
Last Updated
August 8, 2017
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02387515
Brief Title
Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain
Official Title
Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Low Back Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intensive rehabilitation program
Arm Type
Experimental
Arm Description
Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology.
Intervention Type
Other
Intervention Name(s)
intensive rehabilitation program
Intervention Description
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 Outcome Measure Information:
Title
The numeric pain rating scale
Description
the numeric pain rating scale (0-10)
Time Frame
baseline
Title
The numeric pain rating scale
Description
the numeric pain rating scale (0-10)
Time Frame
week 3
Title
The numeric pain rating scale
Description
the numeric pain rating scale (0-10)months post-intervention.
Time Frame
week 8
Title
The numeric pain rating scale
Description
the numeric pain rating scale (0-10)
Time Frame
week 13
Title
The numeric pain rating scale
Description
the numeric pain rating scale (0-10)
Time Frame
week 18
Title
The numeric pain rating scale
Description
the numeric pain rating scale (0-10)
Time Frame
week 44
Title
Roland Morris Questionnaire (0-24)
Description
Roland Morris Questionnaire (0-24)
Time Frame
baseline
Title
Roland Morris Questionnaire (0-24)
Description
Roland Morris Questionnaire (0-24)
Time Frame
week 3
Title
Roland Morris Questionnaire (0-24)
Description
Roland Morris Questionnaire (0-24)
Time Frame
week 8
Title
Roland Morris Questionnaire (0-24)
Description
Roland Morris Questionnaire (0-24)
Time Frame
week 13
Title
Roland Morris Questionnaire (0-24)
Description
Roland Morris Questionnaire (0-24)
Time Frame
week 18
Title
Roland Morris Questionnaire (0-24)
Description
Roland Morris Questionnaire (0-24)
Time Frame
week 44
Title
Patient specific functioning scale (0-10)
Description
Patient specific functioning scale (0-10)
Time Frame
baseline
Title
Patient specific functioning scale (0-10)
Description
Patient specific functioning scale (0-10)
Time Frame
week 3
Title
Patient specific functioning scale (0-10)
Description
Patient specific functioning scale (0-10)
Time Frame
week 8
Title
Patient specific functioning scale (0-10)
Description
Patient specific functioning scale (0-10)
Time Frame
week 13
Title
Patient specific functioning scale (0-10)
Description
Patient specific functioning scale (0-10)
Time Frame
week 18
Title
Patient specific functioning scale (0-10)
Description
Patient specific functioning scale (0-10)
Time Frame
week 44
Title
Pain self-efficacy questionnaire (0-60)
Description
Pain self-efficacy questionnaire (0-60)
Time Frame
baseline
Title
Pain self-efficacy questionnaire (0-60)
Description
Pain self-efficacy questionnaire (0-60)
Time Frame
week 3
Title
Pain self-efficacy questionnaire (0-60)
Description
Pain self-efficacy questionnaire (0-60)
Time Frame
week 8
Title
Pain self-efficacy questionnaire (0-60)
Description
Pain self-efficacy questionnaire (0-60)
Time Frame
week 13
Title
Pain self-efficacy questionnaire (0-60)
Description
Pain self-efficacy questionnaire (0-60)
Time Frame
week 18
Title
Pain self-efficacy questionnaire (0-60)
Description
Pain self-efficacy questionnaire (0-60)
Time Frame
week 44
Title
the Tampa scale for kinesiophobia (17-68)
Description
the Tampa scale for kinesiophobia (17-68)
Time Frame
baseline
Title
the Tampa scale for kinesiophobia (17-68)
Description
the Tampa scale for kinesiophobia (17-68)
Time Frame
week 3
Title
the Tampa scale for kinesiophobia (17-68)
Description
the Tampa scale for kinesiophobia (17-68)
Time Frame
week 8
Title
the Tampa scale for kinesiophobia (17-68)
Description
the Tampa scale for kinesiophobia (17-68)
Time Frame
week 13
Title
the Tampa scale for kinesiophobia (17-68)
Description
the Tampa scale for kinesiophobia (17-68)
Time Frame
week 18
Title
the Tampa scale for kinesiophobia (17-68)
Description
the Tampa scale for kinesiophobia (17-68)
Time Frame
week 44
Title
Patient satisfaction with treatment (0-10)
Description
Patient satisfaction with treatment (0-10)
Time Frame
baseline
Title
Patient satisfaction with treatment (0-10)
Description
Patient satisfaction with treatment (0-10)
Time Frame
week 3
Title
Patient satisfaction with treatment (0-10)
Description
Patient satisfaction with treatment (0-10)
Time Frame
week 8
Title
Patient satisfaction with treatment (0-10)
Description
Patient satisfaction with treatment (0-10)
Time Frame
week 13
Title
Patient satisfaction with treatment (0-10)
Description
Patient satisfaction with treatment (0-10)
Time Frame
week 18
Title
Patient satisfaction with treatment (0-10)
Description
Patient satisfaction with treatment (0-10)
Time Frame
week 44
Secondary Outcome Measure Information:
Title
short form 36
Description
Quality of life, SF-36 questionnaire
Time Frame
baseline
Title
short form 36
Description
Quality of life, SF-36 questionnaire
Time Frame
week 3
Title
short form 36
Description
Quality of life, SF-36 questionnaire
Time Frame
week 8
Title
short form 36
Description
Quality of life, SF-36 questionnaire
Time Frame
week 13
Title
short form 36
Description
Quality of life, SF-36 questionnaire
Time Frame
week 18
Title
short form 36
Description
Quality of life, SF-36 questionnaire
Time Frame
week 44
Title
Credibility and expectancy questionnaire
Description
Credibility and expectancy questionnaire
Time Frame
baseline
Title
Credibility and expectancy questionnaire
Description
Credibility and expectancy questionnaire
Time Frame
week 3
Title
Credibility and expectancy questionnaire
Description
Credibility and expectancy questionnaire
Time Frame
week 8
Title
Credibility and expectancy questionnaire
Description
Credibility and expectancy questionnaire
Time Frame
week 13
Title
Credibility and expectancy questionnaire
Description
Credibility and expectancy questionnaire
Time Frame
week 18
Title
Credibility and expectancy questionnaire
Description
Credibility and expectancy questionnaire
Time Frame
week 44
Title
Intrinsic motivation inventory form
Description
Intrinsic motivation inventory form
Time Frame
baseline
Title
Intrinsic motivation inventory form
Description
Intrinsic motivation inventory form
Time Frame
week 3
Title
Intrinsic motivation inventory form
Description
Intrinsic motivation inventory form
Time Frame
week 8
Title
Intrinsic motivation inventory form
Description
Intrinsic motivation inventory form
Time Frame
week 13
Title
Intrinsic motivation inventory form
Description
Intrinsic motivation inventory form
Time Frame
week 18
Title
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Description
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Time Frame
baseline
Title
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Description
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Time Frame
week 3
Title
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Description
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Time Frame
week 8
Title
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Description
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Time Frame
week 13
Title
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Description
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Time Frame
week 18
Title
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Description
Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
Time Frame
week 44
Title
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
Description
Adherence to exercise program (number of visits attended, self-reported adherence to home exercises)
Time Frame
baseline
Title
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
Description
Adherence to exercise program (number of visits attended, self-reported adherence to home exercises)
Time Frame
week 3
Title
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
Description
Adherence to exercise program (number of visits attended, self-reported adherence to home exercises)
Time Frame
week 8
Title
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
Description
Adherence to exercise program (number of visits attended, self-reported adherence to home exercises)
Time Frame
week 13
Title
Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
Description
Adherence to exercise program (number of visits attended, self-reported adherence to home exercises)
Time Frame
week18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Matheve, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
annick Timmermans, prof.dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guido Claes, MD
Organizational Affiliation
Jessa Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Universiteit Hasselt
City
Hasselt
ZIP/Postal Code
B3830
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain
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