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CompletedNCT02387515Updated Aug 9, 2017

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

An interventional study of intensive rehabilitation program in Chronic Non-specific Low Back Pain, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-09.

Sponsored by Hasselt University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Non-specific Low Back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

Interventions

  • Otherintensive 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.

06

What researchers measure

Primary outcomes

  1. The numeric pain rating scale

    the numeric pain rating scale (0-10)

    Time frame: baseline

  2. The numeric pain rating scale

    the numeric pain rating scale (0-10)

    Time frame: week 3

  3. The numeric pain rating scale

    the numeric pain rating scale (0-10)months post-intervention.

    Time frame: week 8

  4. The numeric pain rating scale

    the numeric pain rating scale (0-10)

    Time frame: week 13

  5. The numeric pain rating scale

    the numeric pain rating scale (0-10)

    Time frame: week 18

  6. The numeric pain rating scale

    the numeric pain rating scale (0-10)

    Time frame: week 44

  7. Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    Time frame: baseline

  8. Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    Time frame: week 3

  9. Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    Time frame: week 8

  10. Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    Time frame: week 13

  11. Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    Time frame: week 18

  12. Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    Time frame: week 44

  13. Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    Time frame: baseline

  14. Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    Time frame: week 3

  15. Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    Time frame: week 8

  16. Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    Time frame: week 13

  17. Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    Time frame: week 18

  18. Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    Time frame: week 44

  19. Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    Time frame: baseline

  20. Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    Time frame: week 3

  21. Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    Time frame: week 8

  22. Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    Time frame: week 13

  23. Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    Time frame: week 18

  24. Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    Time frame: week 44

  25. the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    Time frame: baseline

  26. the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    Time frame: week 3

  27. the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    Time frame: week 8

  28. the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    Time frame: week 13

  29. the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    Time frame: week 18

  30. the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    Time frame: week 44

  31. Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    Time frame: baseline

  32. Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    Time frame: week 3

  33. Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    Time frame: week 8

  34. Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    Time frame: week 13

  35. Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    Time frame: week 18

  36. Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    Time frame: week 44

Secondary outcomes

  1. short form 36

    Quality of life, SF-36 questionnaire

    Time frame: baseline

  2. short form 36

    Quality of life, SF-36 questionnaire

    Time frame: week 3

  3. short form 36

    Quality of life, SF-36 questionnaire

    Time frame: week 8

  4. short form 36

    Quality of life, SF-36 questionnaire

    Time frame: week 13

  5. short form 36

    Quality of life, SF-36 questionnaire

    Time frame: week 18

  6. short form 36

    Quality of life, SF-36 questionnaire

    Time frame: week 44

  7. Credibility and expectancy questionnaire

    Credibility and expectancy questionnaire

    Time frame: baseline

  8. Credibility and expectancy questionnaire

    Credibility and expectancy questionnaire

    Time frame: week 3

  9. Credibility and expectancy questionnaire

    Credibility and expectancy questionnaire

    Time frame: week 8

  10. Credibility and expectancy questionnaire

    Credibility and expectancy questionnaire

    Time frame: week 13

  11. Credibility and expectancy questionnaire

    Credibility and expectancy questionnaire

    Time frame: week 18

  12. Credibility and expectancy questionnaire

    Credibility and expectancy questionnaire

    Time frame: week 44

  13. Intrinsic motivation inventory form

    Intrinsic motivation inventory form

    Time frame: baseline

  14. Intrinsic motivation inventory form

    Intrinsic motivation inventory form

    Time frame: week 3

  15. Intrinsic motivation inventory form

    Intrinsic motivation inventory form

    Time frame: week 8

  16. Intrinsic motivation inventory form

    Intrinsic motivation inventory form

    Time frame: week 13

  17. Intrinsic motivation inventory form

    Intrinsic motivation inventory form

    Time frame: week 18

  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)

    Time frame: baseline

  19. Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Time frame: week 3

  20. Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Time frame: week 8

  21. Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Time frame: week 13

  22. Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Time frame: week 18

  23. Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no)

    Time frame: week 44

  24. 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)

    Time frame: baseline

  25. 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)

    Time frame: week 3

  26. 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)

    Time frame: week 8

  27. 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)

    Time frame: week 13

  28. 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)

    Time frame: week18

07

Study locations

1 site
  • Universiteit Hasselt
    Hasselt, B3830, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02387515
Lead sponsor
Hasselt University
Collaborators
Jessa Hospital
Responsible party
Annick Timmermans (prof. dr., Hasselt University) — Principal investigator
First posted
Mar 13, 2015
Start date
Dec 2013
Primary completion
Mar 2015
Completion
Aug 2015
Last update
Aug 9, 2017

Study contacts

Thomas Matheve, drs.
study chair · Hasselt University
annick Timmermans, prof.dr.
principal investigator · Hasselt University
Guido Claes, MD
study chair · Jessa Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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