NCT02387515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 13, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

December 13, 2014

Last Update Submit

August 8, 2017

Conditions

Chronic Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (36)

  • The numeric pain rating scale

    the numeric pain rating scale (0-10)

    baseline

  • The numeric pain rating scale

    the numeric pain rating scale (0-10)

    week 3

  • The numeric pain rating scale

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

    week 8

  • The numeric pain rating scale

    the numeric pain rating scale (0-10)

    week 13

  • The numeric pain rating scale

    the numeric pain rating scale (0-10)

    week 18

  • The numeric pain rating scale

    the numeric pain rating scale (0-10)

    week 44

  • Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    baseline

  • Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    week 3

  • Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    week 8

  • Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    week 13

  • Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    week 18

  • Roland Morris Questionnaire (0-24)

    Roland Morris Questionnaire (0-24)

    week 44

  • Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    baseline

  • Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    week 3

  • Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    week 8

  • Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    week 13

  • Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    week 18

  • Patient specific functioning scale (0-10)

    Patient specific functioning scale (0-10)

    week 44

  • Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    baseline

  • Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    week 3

  • Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    week 8

  • Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    week 13

  • Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    week 18

  • Pain self-efficacy questionnaire (0-60)

    Pain self-efficacy questionnaire (0-60)

    week 44

  • the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    baseline

  • the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    week 3

  • the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    week 8

  • the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    week 13

  • the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    week 18

  • the Tampa scale for kinesiophobia (17-68)

    the Tampa scale for kinesiophobia (17-68)

    week 44

  • Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    baseline

  • Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    week 3

  • Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    week 8

  • Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    week 13

  • Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    week 18

  • Patient satisfaction with treatment (0-10)

    Patient satisfaction with treatment (0-10)

    week 44

Secondary Outcomes (28)

  • short form 36

    baseline

  • short form 36

    week 3

  • short form 36

    week 8

  • short form 36

    week 13

  • short form 36

    week 18

  • +23 more secondary outcomes

Study Arms (1)

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.

Other: intensive rehabilitation program

Interventions

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.

intensive rehabilitation program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiteit Hasselt

Hasselt, B3830, Belgium

Location

Study Officials

  • Thomas Matheve, drs.

    Hasselt University

    STUDY CHAIR

  • annick Timmermans, prof.dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Guido Claes, MD

    Jessa Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

December 13, 2014

First Posted

March 13, 2015

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

BE(1)