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Completed

NCT Number: NCT02387515

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

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.

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Key information

Conditions

Chronic Non-Specific Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiteit Hasselt

Hasselt, B3830, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intensive rehabilitation program

Other

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 outcomes

  1. The numeric pain rating scale

    Time frame: baseline

    the numeric pain rating scale (0-10)

  2. The numeric pain rating scale

    Time frame: week 3

    the numeric pain rating scale (0-10)

  3. The numeric pain rating scale

    Time frame: week 8

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

  4. The numeric pain rating scale

    Time frame: week 13

    the numeric pain rating scale (0-10)

  5. The numeric pain rating scale

    Time frame: week 18

    the numeric pain rating scale (0-10)

  6. The numeric pain rating scale

    Time frame: week 44

    the numeric pain rating scale (0-10)

  7. Roland Morris Questionnaire (0-24)

    Time frame: baseline

    Roland Morris Questionnaire (0-24)

  8. Roland Morris Questionnaire (0-24)

    Time frame: week 3

    Roland Morris Questionnaire (0-24)

  9. Roland Morris Questionnaire (0-24)

    Time frame: week 8

    Roland Morris Questionnaire (0-24)

  10. Roland Morris Questionnaire (0-24)

    Time frame: week 13

    Roland Morris Questionnaire (0-24)

  11. Roland Morris Questionnaire (0-24)

    Time frame: week 18

    Roland Morris Questionnaire (0-24)

  12. Roland Morris Questionnaire (0-24)

    Time frame: week 44

    Roland Morris Questionnaire (0-24)

  13. Patient specific functioning scale (0-10)

    Time frame: baseline

    Patient specific functioning scale (0-10)

  14. Patient specific functioning scale (0-10)

    Time frame: week 3

    Patient specific functioning scale (0-10)

  15. Patient specific functioning scale (0-10)

    Time frame: week 8

    Patient specific functioning scale (0-10)

  16. Patient specific functioning scale (0-10)

    Time frame: week 13

    Patient specific functioning scale (0-10)

  17. Patient specific functioning scale (0-10)

    Time frame: week 18

    Patient specific functioning scale (0-10)

  18. Patient specific functioning scale (0-10)

    Time frame: week 44

    Patient specific functioning scale (0-10)

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

    Time frame: baseline

    Pain self-efficacy questionnaire (0-60)

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

    Time frame: week 3

    Pain self-efficacy questionnaire (0-60)

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

    Time frame: week 8

    Pain self-efficacy questionnaire (0-60)

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

    Time frame: week 13

    Pain self-efficacy questionnaire (0-60)

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

    Time frame: week 18

    Pain self-efficacy questionnaire (0-60)

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

    Time frame: week 44

    Pain self-efficacy questionnaire (0-60)

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

    Time frame: baseline

    the Tampa scale for kinesiophobia (17-68)

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

    Time frame: week 3

    the Tampa scale for kinesiophobia (17-68)

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

    Time frame: week 8

    the Tampa scale for kinesiophobia (17-68)

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

    Time frame: week 13

    the Tampa scale for kinesiophobia (17-68)

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

    Time frame: week 18

    the Tampa scale for kinesiophobia (17-68)

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

    Time frame: week 44

    the Tampa scale for kinesiophobia (17-68)

  31. Patient satisfaction with treatment (0-10)

    Time frame: baseline

    Patient satisfaction with treatment (0-10)

  32. Patient satisfaction with treatment (0-10)

    Time frame: week 3

    Patient satisfaction with treatment (0-10)

  33. Patient satisfaction with treatment (0-10)

    Time frame: week 8

    Patient satisfaction with treatment (0-10)

  34. Patient satisfaction with treatment (0-10)

    Time frame: week 13

    Patient satisfaction with treatment (0-10)

  35. Patient satisfaction with treatment (0-10)

    Time frame: week 18

    Patient satisfaction with treatment (0-10)

  36. Patient satisfaction with treatment (0-10)

    Time frame: week 44

    Patient satisfaction with treatment (0-10)

Secondary outcomes

  1. short form 36

    Time frame: baseline

    Quality of life, SF-36 questionnaire

  2. short form 36

    Time frame: week 3

    Quality of life, SF-36 questionnaire

  3. short form 36

    Time frame: week 8

    Quality of life, SF-36 questionnaire

  4. short form 36

    Time frame: week 13

    Quality of life, SF-36 questionnaire

  5. short form 36

    Time frame: week 18

    Quality of life, SF-36 questionnaire

  6. short form 36

    Time frame: week 44

    Quality of life, SF-36 questionnaire

  7. Credibility and expectancy questionnaire

    Time frame: baseline

    Credibility and expectancy questionnaire

  8. Credibility and expectancy questionnaire

    Time frame: week 3

    Credibility and expectancy questionnaire

  9. Credibility and expectancy questionnaire

    Time frame: week 8

    Credibility and expectancy questionnaire

  10. Credibility and expectancy questionnaire

    Time frame: week 13

    Credibility and expectancy questionnaire

  11. Credibility and expectancy questionnaire

    Time frame: week 18

    Credibility and expectancy questionnaire

  12. Credibility and expectancy questionnaire

    Time frame: week 44

    Credibility and expectancy questionnaire

  13. Intrinsic motivation inventory form

    Time frame: baseline

    Intrinsic motivation inventory form

  14. Intrinsic motivation inventory form

    Time frame: week 3

    Intrinsic motivation inventory form

  15. Intrinsic motivation inventory form

    Time frame: week 8

    Intrinsic motivation inventory form

  16. Intrinsic motivation inventory form

    Time frame: week 13

    Intrinsic motivation inventory form

  17. Intrinsic motivation inventory form

    Time frame: week 18

    Intrinsic motivation inventory form

  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)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

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

    Time frame: week 44

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

  24. Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises

    Time frame: baseline

    Adherence to exercise program (number of visits attended, self-reported adherence to home exercises)

  25. 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 (number of visits attended, self-reported adherence to home exercises)

  26. 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 (number of visits attended, self-reported adherence to home exercises)

  27. 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 (number of visits attended, self-reported adherence to home exercises)

  28. Adherence to exercise program assessed by number of visits attended and self-reported adherence to home exercises

    Time frame: week18

    Adherence to exercise program (number of visits attended, self-reported adherence to home exercises)

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2015
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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