Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients
NCT ID: NCT02063503
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-09-30
2017-12-31
Brief Summary
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Objectives for this trial is to possibly identify prognostic indicators for treatment response to three forms of exercise therapy for patients with nonspecific chronic low back pain (CLBP).
The study design is a multicenter cohort design. Patients with nonspecific low back pain of more than three months duration are recruited in two different hospitals (Antwerp University Hospital and Sint Vincentius Hospital). After examination patients are assigned to one of three intervention groups: motor control therapy, isometric training therapy and a combination therapy. All patients will undergo eighteen treatment sessions during nine weeks. Measurements will be taken at baseline and after nine weeks of treatment.
The primary outcome used is the Modified Oswestry Disability Questionnaire (MDQ). For each type of exercise therapy prognostic indicators will be investigated.
Never before a multi-arm design was performed for the identification of prognostic indicators for exercise therapy in patients with nonspecific CLBP.
Detailed Description
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Ethical approval (B300201215600) was obtained from the local ethics committees of the Antwerp University Hospital.
Study design In the identification of prognostic indicators is derived from a number of variables that have predictive potential for therapy outcome. These variables are obtained from baseline measurements and have a multidimensional character (impairments, activities/participation and contextual factors).
Patient recruitment Patients will be recruited by doctors at the service of two settings located in Antwerp namely the Antwerp University Hospital (UZA) and the Sint-Vincentius Hospital. Treatment and measurements will be performed at the site where the patient has been recruited.
Inclusion criteria: Current nonspecific LBP persisting at least three months, consulted a medical doctor during the last month because of the persistent low back pain, age between 18 and 60, sufficient fluency in Dutch to follow treatment instructions and answer survey questions.
Exclusion criteria: spinal canal stenosis, spondylolisthesis and spondylitis, large herniated disc sciatica, radiating pain below the knee, previous back surgery, a history of known spinal fractures, malignancy, known muscle-, nerve-, skin-, or joint diseases, pregnancy and lack of consent.
Measurements
Baseline testing As primary (dependent) outcome measure the Modified Oswestry Disability Questionnaire is used (MDQ). The MDQ is a disease specific questionnaire to measure disability in LBP patients \[21-23\].
As secondary (independent) outcome measures the following tests are used:
First, Measurement of impairments: duration of the LBP/ pelvis impairments / respiratory impairments (all three items through anamnesis). Prone instability test, Straight Leg Raise, Beighton scale, Active Straight Leg Raise, sitting knee extension test, waiters bow, pelvic tilt, side support test, extensor endurance test, active sit-up, Visual Analogue Scale for pain (VAS).
Second, measurement of limitations in activities and participation: hours of physical activity/week (trough anamnesis). Short Form 36 Health Survey (SF36), Roland Morris Disability Questionnaire (RMDQ).
Third, measurement of contextual factors: gender/ age / height / weight / body mass index / smoking / profession / underwent previous therapy / comorbidity (trough anamnesis). Tampa scale for kinesiophobia, Fear Avoidance Belief Questionnaire (FABQ), We performed a literature search to select all used clinical tests based on their reliability and validity \[24\]. The Baseline testing takes about 30 minutes.
Follow-up
Follow up takes place after completion of the treatment program at nine weeks. All patient reported outcome measures (PROMs) from the baseline testing will be re-evaluated at this moment.
Randomization \& blinding
In the Sint-Vincentius Hospital, all included patients will follow the combination treatment since this is the only intervention group which is being organized in this hospital.
In the UZA, patients will be randomly assigned into one of the two treatment groups (motor control or isometric training) after baseline testing. The responsible researcher will use a randomization list generated with Microsoft ® Excel ® software (version 14.3.9, 2010 © Microsoft Corporation).
Intervention
During the nine weeks intervention, patients will be treated two times a week. Patients will be assigned randomly into one of three intervention groups (motor control therapy, isometric training therapy or combination therapy). Each intervention will take about seventy minutes. Ten minutes warming up and cooling down will be the same in each treatment regime. Each group receives fifty minutes of therapy specific intervention. Previously trained physiotherapists will give the treatment. To ensure that all therapists provide the same exercises, a treatment protocol for each treatment group was developed and a treatment diary will be filled out after each session.
Interventions in derivation and validation phase are similar.
Power analysis
This study describes the identification of prognostic indicators in which the therapeutic effect of the interventions cannot be predicted. Therefore, a two-tailed hypothesis was used to calculate the power. A pilot study showed that the standard deviation of the primary outcome measure, MDQ, is set at 10.53.6 Given these estimates, 54 patients were needed to detect a minimum clinically important difference (MCID, effect size 0.84) with 90% power. Consequently, three groups of 18 patients were needed to complete the trial.
Data analysis
Prognostic indicators aim to detect potential predictive variables for treatment success (dichotomous, yes/no) in a set of baseline measurements. A minimal decrease in the MDQ score of 9 points is considered as treatment success.
Potential predictive variables are selected as follows: first, individual variables from the self-reports, history, and physical examination are tested for their bivariate association with the reference standard using independent sample t tests, Mann-Whitney U tests or Chi-square tests based on the nature of the data. Variables with a significance level of P \< 0.10 are retained as potential prediction variables. We choose a more liberal significance level at this stage to avoid excluding potential predictive variables.
This statistical analysis is performed for each treatment group (motor control therapy, general active exercise therapy and isometric training therapy).
Information form and informed consent
If patients meet the in- and exclusion criteria they are scheduled for an interview with one of our researchers to be informed about the trial. If patients decide to participate they will sign an informed consent. Information form and informed consent are made and have been approved by the ethics committee of the University of Antwerp.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Motor control therapy
physiotherapy
physiotherapy
every group receives 2 treatments every week during 9 consecutive weeks
Isometric training therapy
physiotherapy
physiotherapy
every group receives 2 treatments every week during 9 consecutive weeks
Combination therapy
physiotherapy
physiotherapy
every group receives 2 treatments every week during 9 consecutive weeks
Interventions
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physiotherapy
every group receives 2 treatments every week during 9 consecutive weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* consulted a medical doctor during last month because of persistent low back pain
* age between 18 - 60
Exclusion Criteria
* a history of known spinal fractures
* spondylolysis and spondylolisthesis
* radiating pain below the knee
* muscle, nerve, skin, joint diseases
* pregnancy
18 Years
60 Years
ALL
No
Sponsors
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Universiteit Antwerpen
OTHER
Responsible Party
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Denteneer Lenie
Dra. Denteneer Lenie
Principal Investigators
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Ulrike Van Daele, Professor
Role: STUDY_DIRECTOR
Universiteit Antwerpen
Gaetane Stassijns, Professor
Role: STUDY_DIRECTOR
Universiteit Antwerpen, Universitair Ziekenhuis Antwerpen
Lenie Denteneer, phd student
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium
Countries
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Central Contacts
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Facility Contacts
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Lenie Denteneer, Dra, Pt
Role: primary
Ulrike Van Daele, Prof, Pt, Mt
Role: backup
References
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Denteneer L, Stassijns G, De Hertogh W, Truijen S, Jansen N, Van Daele U. Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial. Trials. 2015 Jan 6;16:4. doi: 10.1186/1745-6215-16-4.
Related Links
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official website of the University of Antwerp
Other Identifiers
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B300201215600
Identifier Type: -
Identifier Source: org_study_id