Clinical trial NCT02387515: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-specific Low Back Pain
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2015-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: The numeric pain rating scale
timeFrame: baseline
measure: The numeric pain rating scale
timeFrame: week 3
measure: The numeric pain rating scale
timeFrame: week 8
measure: The numeric pain rating scale
timeFrame: week 13
measure: The numeric pain rating scale
timeFrame: week 18
measure: The numeric pain rating scale
timeFrame: week 44
measure: Roland Morris Questionnaire (0-24)
timeFrame: baseline
measure: Roland Morris Questionnaire (0-24)
timeFrame: week 3
measure: Roland Morris Questionnaire (0-24)
timeFrame: week 8
measure: Roland Morris Questionnaire (0-24)
timeFrame: week 13
measure: Roland Morris Questionnaire (0-24)
timeFrame: week 18
measure: Roland Morris Questionnaire (0-24)
timeFrame: week 44
measure: Patient specific functioning scale (0-10)
timeFrame: baseline
measure: Patient specific functioning scale (0-10)
timeFrame: week 3
measure: Patient specific functioning scale (0-10)
timeFrame: week 8
measure: Patient specific functioning scale (0-10)
timeFrame: week 13
measure: Patient specific functioning scale (0-10)
timeFrame: week 18
measure: Patient specific functioning scale (0-10)
timeFrame: week 44
measure: Pain self-efficacy questionnaire (0-60)
timeFrame: baseline
measure: Pain self-efficacy questionnaire (0-60)
timeFrame: week 3
measure: Pain self-efficacy questionnaire (0-60)
timeFrame: week 8
measure: Pain self-efficacy questionnaire (0-60)
timeFrame: week 13
measure: Pain self-efficacy questionnaire (0-60)
timeFrame: week 18
measure: Pain self-efficacy questionnaire (0-60)
timeFrame: week 44
measure: the Tampa scale for kinesiophobia (17-68)
timeFrame: baseline
measure: the Tampa scale for kinesiophobia (17-68)
timeFrame: week 3
measure: the Tampa scale for kinesiophobia (17-68)
timeFrame: week 8
measure: the Tampa scale for kinesiophobia (17-68)
timeFrame: week 13
measure: the Tampa scale for kinesiophobia (17-68)
timeFrame: week 18
measure: the Tampa scale for kinesiophobia (17-68)
timeFrame: week 44
measure: Patient satisfaction with treatment (0-10)
timeFrame: baseline
measure: Patient satisfaction with treatment (0-10)
timeFrame: week 3
measure: Patient satisfaction with treatment (0-10)
timeFrame: week 8
measure: Patient satisfaction with treatment (0-10)
timeFrame: week 13
measure: Patient satisfaction with treatment (0-10)
timeFrame: week 18
measure: Patient satisfaction with treatment (0-10)
timeFrame: week 44
Secondary outcomes:
measure: short form 36
timeFrame: baseline
measure: short form 36
timeFrame: week 3
measure: short form 36
timeFrame: week 8
measure: short form 36
timeFrame: week 13
measure: short form 36
timeFrame: week 18
measure: short form 36
timeFrame: week 44
measure: Credibility and expectancy questionnaire
timeFrame: baseline
measure: Credibility and expectancy questionnaire
timeFrame: week 3
measure: Credibility and expectancy questionnaire
timeFrame: week 8
measure: Credibility and expectancy questionnaire
timeFrame: week 13
measure: Credibility and expectancy questionnaire
timeFrame: week 18
measure: Credibility and expectancy questionnaire
timeFrame: week 44
measure: Intrinsic motivation inventory form
timeFrame: baseline
measure: Intrinsic motivation inventory form
timeFrame: week 3
measure: Intrinsic motivation inventory form
timeFrame: week 8
measure: Intrinsic motivation inventory form
timeFrame: week 13
measure: Intrinsic motivation inventory form
timeFrame: week 18
measure: Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
timeFrame: baseline
measure: Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
timeFrame: week 3
measure: Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
timeFrame: week 8
measure: Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
timeFrame: week 13
measure: Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
timeFrame: week 18
measure: Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)
timeFrame: week 44
measure: Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
timeFrame: baseline
measure: Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
timeFrame: week 3
measure: Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
timeFrame: week 8
measure: Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
timeFrame: week 13
measure: Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises
timeFrame: week18
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Universiteit Hasselt
Study officials:
affiliation: Hasselt University
name: Thomas Matheve, drs.
role: STUDY_CHAIR
affiliation: Hasselt University
name: annick Timmermans, prof.dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jessa Hospital
name: Guido Claes, MD
role: STUDY_CHAIR
References: