Chronic Non-specific Low Back Pain Clinical Trial
Official title:
Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain: Pilot Study
| Verified date | August 2017 |
| Source | Hasselt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | August 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Universiteit Hasselt | Hasselt |
| Lead Sponsor | Collaborator |
|---|---|
| Hasselt University | Jessa Hospital |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The numeric pain rating scale | the numeric pain rating scale (0-10) | baseline | |
| Primary | The numeric pain rating scale | the numeric pain rating scale (0-10) | week 3 | |
| Primary | The numeric pain rating scale | the numeric pain rating scale (0-10)months post-intervention. | week 8 | |
| Primary | The numeric pain rating scale | the numeric pain rating scale (0-10) | week 13 | |
| Primary | The numeric pain rating scale | the numeric pain rating scale (0-10) | week 18 | |
| Primary | The numeric pain rating scale | the numeric pain rating scale (0-10) | week 44 | |
| Primary | Roland Morris Questionnaire (0-24) | Roland Morris Questionnaire (0-24) | baseline | |
| Primary | Roland Morris Questionnaire (0-24) | Roland Morris Questionnaire (0-24) | week 3 | |
| Primary | Roland Morris Questionnaire (0-24) | Roland Morris Questionnaire (0-24) | week 8 | |
| Primary | Roland Morris Questionnaire (0-24) | Roland Morris Questionnaire (0-24) | week 13 | |
| Primary | Roland Morris Questionnaire (0-24) | Roland Morris Questionnaire (0-24) | week 18 | |
| Primary | Roland Morris Questionnaire (0-24) | Roland Morris Questionnaire (0-24) | week 44 | |
| Primary | Patient specific functioning scale (0-10) | Patient specific functioning scale (0-10) | baseline | |
| Primary | Patient specific functioning scale (0-10) | Patient specific functioning scale (0-10) | week 3 | |
| Primary | Patient specific functioning scale (0-10) | Patient specific functioning scale (0-10) | week 8 | |
| Primary | Patient specific functioning scale (0-10) | Patient specific functioning scale (0-10) | week 13 | |
| Primary | Patient specific functioning scale (0-10) | Patient specific functioning scale (0-10) | week 18 | |
| Primary | Patient specific functioning scale (0-10) | Patient specific functioning scale (0-10) | week 44 | |
| Primary | Pain self-efficacy questionnaire (0-60) | Pain self-efficacy questionnaire (0-60) | baseline | |
| Primary | Pain self-efficacy questionnaire (0-60) | Pain self-efficacy questionnaire (0-60) | week 3 | |
| Primary | Pain self-efficacy questionnaire (0-60) | Pain self-efficacy questionnaire (0-60) | week 8 | |
| Primary | Pain self-efficacy questionnaire (0-60) | Pain self-efficacy questionnaire (0-60) | week 13 | |
| Primary | Pain self-efficacy questionnaire (0-60) | Pain self-efficacy questionnaire (0-60) | week 18 | |
| Primary | Pain self-efficacy questionnaire (0-60) | Pain self-efficacy questionnaire (0-60) | week 44 | |
| Primary | the Tampa scale for kinesiophobia (17-68) | the Tampa scale for kinesiophobia (17-68) | baseline | |
| Primary | the Tampa scale for kinesiophobia (17-68) | the Tampa scale for kinesiophobia (17-68) | week 3 | |
| Primary | the Tampa scale for kinesiophobia (17-68) | the Tampa scale for kinesiophobia (17-68) | week 8 | |
| Primary | the Tampa scale for kinesiophobia (17-68) | the Tampa scale for kinesiophobia (17-68) | week 13 | |
| Primary | the Tampa scale for kinesiophobia (17-68) | the Tampa scale for kinesiophobia (17-68) | week 18 | |
| Primary | the Tampa scale for kinesiophobia (17-68) | the Tampa scale for kinesiophobia (17-68) | week 44 | |
| Primary | Patient satisfaction with treatment (0-10) | Patient satisfaction with treatment (0-10) | baseline | |
| Primary | Patient satisfaction with treatment (0-10) | Patient satisfaction with treatment (0-10) | week 3 | |
| Primary | Patient satisfaction with treatment (0-10) | Patient satisfaction with treatment (0-10) | week 8 | |
| Primary | Patient satisfaction with treatment (0-10) | Patient satisfaction with treatment (0-10) | week 13 | |
| Primary | Patient satisfaction with treatment (0-10) | Patient satisfaction with treatment (0-10) | week 18 | |
| Primary | Patient satisfaction with treatment (0-10) | Patient satisfaction with treatment (0-10) | week 44 | |
| Secondary | short form 36 | Quality of life, SF-36 questionnaire | baseline | |
| Secondary | short form 36 | Quality of life, SF-36 questionnaire | week 3 | |
| Secondary | short form 36 | Quality of life, SF-36 questionnaire | week 8 | |
| Secondary | short form 36 | Quality of life, SF-36 questionnaire | week 13 | |
| Secondary | short form 36 | Quality of life, SF-36 questionnaire | week 18 | |
| Secondary | short form 36 | Quality of life, SF-36 questionnaire | week 44 | |
| Secondary | Credibility and expectancy questionnaire | Credibility and expectancy questionnaire | baseline | |
| Secondary | Credibility and expectancy questionnaire | Credibility and expectancy questionnaire | week 3 | |
| Secondary | Credibility and expectancy questionnaire | Credibility and expectancy questionnaire | week 8 | |
| Secondary | Credibility and expectancy questionnaire | Credibility and expectancy questionnaire | week 13 | |
| Secondary | Credibility and expectancy questionnaire | Credibility and expectancy questionnaire | week 18 | |
| Secondary | Credibility and expectancy questionnaire | Credibility and expectancy questionnaire | week 44 | |
| Secondary | Intrinsic motivation inventory form | Intrinsic motivation inventory form | baseline | |
| Secondary | Intrinsic motivation inventory form | Intrinsic motivation inventory form | week 3 | |
| Secondary | Intrinsic motivation inventory form | Intrinsic motivation inventory form | week 8 | |
| Secondary | Intrinsic motivation inventory form | Intrinsic motivation inventory form | week 13 | |
| Secondary | Intrinsic motivation inventory form | Intrinsic motivation inventory form | week 18 | |
| Secondary | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | baseline | |
| Secondary | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | week 3 | |
| Secondary | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | week 8 | |
| Secondary | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | week 13 | |
| Secondary | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | week 18 | |
| Secondary | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | Work absenteeism because of LBP (low back pain) (yes (% of absenteeism), no) | week 44 | |
| Secondary | 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) | baseline | |
| Secondary | 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) | week 3 | |
| Secondary | 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) | week 8 | |
| Secondary | 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) | week 13 | |
| Secondary | 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) | week18 |
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