Chronic Non-specific Low Back PainNCT02387515
Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain
A study testing intensive rehabilitation program in people with Chronic Non-specific Low Back Pain, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- intensive rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- intensive rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive rehabilitation programOther
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 group | Role | What they receive |
|---|---|---|
| intensive rehabilitation program | Experimental | Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology. Receives: Other: intensive rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The numeric pain rating scale
the numeric pain rating scale (0-10)
Measured: baseline
The numeric pain rating scale
the numeric pain rating scale (0-10)
Measured: week 3
The numeric pain rating scale
the numeric pain rating scale (0-10)months post-intervention.
Measured: week 8
The numeric pain rating scale
the numeric pain rating scale (0-10)
Measured: week 13
The numeric pain rating scale
the numeric pain rating scale (0-10)
Measured: week 18
The numeric pain rating scale
the numeric pain rating scale (0-10)
Measured: week 44
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Measured: baseline
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Measured: week 3
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Measured: week 8
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Measured: week 13
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Measured: week 18
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Measured: week 44
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Measured: baseline
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Measured: week 3
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Measured: week 8
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Measured: week 13
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Measured: week 18
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Measured: week 44
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Measured: baseline
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Measured: week 3
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Measured: week 8
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Measured: week 13
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Measured: week 18
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Measured: week 44
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Measured: baseline
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Measured: week 3
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Measured: week 8
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Measured: week 13
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Measured: week 18
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Measured: week 44
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Measured: baseline
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Measured: week 3
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Measured: week 8
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Measured: week 13
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Measured: week 18
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Measured: week 44
Secondary outcomes (28)
short form 36
Quality of life, SF-36 questionnaire
Measured: baseline
short form 36
Quality of life, SF-36 questionnaire
Measured: week 3
short form 36
Quality of life, SF-36 questionnaire
Measured: week 8
short form 36
Quality of life, SF-36 questionnaire
Measured: week 13
short form 36
Quality of life, SF-36 questionnaire
Measured: week 18
short form 36
Quality of life, SF-36 questionnaire
Measured: week 44
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Measured: baseline
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Measured: week 3
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Measured: week 8
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Measured: week 13
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Measured: week 18
Credibility and expectancy questionnaire
Credibility and expectancy questionnaire
Measured: week 44
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Measured: baseline
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Measured: week 3
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Measured: week 8
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Measured: week 13
Intrinsic motivation inventory form
Intrinsic motivation inventory form
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: week18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Annick Timmermans, Hasselt University
- Investigators
- Thomas Matheve, drs., Study chair, Hasselt Universityannick Timmermans, prof.dr., Principal investigator, Hasselt UniversityGuido Claes, MD, Study chair, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387515
- Sponsor's protocol ID
- PILOT2013TM01
- Status last verified
- Aug 2017
- First submitted
- 13 Dec 2014
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain: Pilot Study
- ClinicalTrials.gov ID
- NCT02387515
- Acronym / sponsor ID
- PILOT2013TM01
- Conditions
- Chronic Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intensive rehabilitation program | Experimental | Other: intensive rehabilitation programPatients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive rehabilitation programPatients 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. | Other | intensive rehabilitation program |
Primary outcome
The numeric pain rating scale
Time frame: baseline
the numeric pain rating scale (0-10)
The numeric pain rating scale
Time frame: week 3
the numeric pain rating scale (0-10)
The numeric pain rating scale
Time frame: week 8
the numeric pain rating scale (0-10)months post-intervention.
The numeric pain rating scale
Time frame: week 13
the numeric pain rating scale (0-10)
The numeric pain rating scale
Time frame: week 18
the numeric pain rating scale (0-10)
The numeric pain rating scale
Time frame: week 44
the numeric pain rating scale (0-10)
Roland Morris Questionnaire (0-24)
Time frame: baseline
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Time frame: week 3
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Time frame: week 8
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Time frame: week 13
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Time frame: week 18
Roland Morris Questionnaire (0-24)
Roland Morris Questionnaire (0-24)
Time frame: week 44
Roland Morris Questionnaire (0-24)
Patient specific functioning scale (0-10)
Time frame: baseline
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Time frame: week 3
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Time frame: week 8
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Time frame: week 13
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Time frame: week 18
Patient specific functioning scale (0-10)
Patient specific functioning scale (0-10)
Time frame: week 44
Patient specific functioning scale (0-10)
Pain self-efficacy questionnaire (0-60)
Time frame: baseline
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Time frame: week 3
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Time frame: week 8
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Time frame: week 13
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Time frame: week 18
Pain self-efficacy questionnaire (0-60)
Pain self-efficacy questionnaire (0-60)
Time frame: week 44
Pain self-efficacy questionnaire (0-60)
the Tampa scale for kinesiophobia (17-68)
Time frame: baseline
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Time frame: week 3
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Time frame: week 8
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Time frame: week 13
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Time frame: week 18
the Tampa scale for kinesiophobia (17-68)
the Tampa scale for kinesiophobia (17-68)
Time frame: week 44
the Tampa scale for kinesiophobia (17-68)
Patient satisfaction with treatment (0-10)
Time frame: baseline
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Time frame: week 3
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Time frame: week 8
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Time frame: week 13
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Time frame: week 18
Patient satisfaction with treatment (0-10)
Patient satisfaction with treatment (0-10)
Time frame: week 44
Patient satisfaction with treatment (0-10)
28 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Matheve, drs. study chair
Hasselt University
annick Timmermans, prof.dr. principal investigator
Hasselt University
Guido Claes, MD study chair
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive rehabilitation program in people with Chronic Non-specific Low Back Pain, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The numeric pain rating scale (time frame: baseline). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.