- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02982382
Effects of Manipulative Therapy and Pain Education in Individuals With CLBP
Neurophysiological and Functional Effects of Manipulative Therapy and Pain Education in Individuals With Chronic Nonspecific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The outcomes will be subjective pain (measured by Numeric Pain Rating Scale), pressure pain threshold (measured by Algometer), disability (measured by Roland-Morris Disability Questionnaire), fear and avoidance beliefs (measured by Fear Avoidance Beliefs Questionnaire), risk of poor prognosis (measured by STarT Back Screening Tool), quality of life (measured by Short Form-12v2) and blood biomarkers (measured by ELISA). The data will be collected by a blinded assessor.
Individuals eligibility is going to be assessed by blinded assessor to determine if they are or not eligible for this research. Then, they will be informed about the objectives of this study and asked to sign the consent form. Afterward, the sociodemographic data will be recorded. The data related to the research outcomes will be collected by the blinded assessor at baseline assessment, after six weeks and three months.
Random Allocation Before the treatment begins, one of the researchers not involved in the recruiting and assessment will allocate the individuals in one of the groups. Block randomization will be used; it is going to generate by randomization.com, this site will create a list with the randomization sequence, which will be only seen by the physical therapists that will treat the individuals.
Statistical Methods
Sample size calculation The sample size calculation was calculated with the A-priori test with the following specifications: Statistical test ANCOVA, the effect size of 0.25, the statistical power of 80%, and an alpha level of 5%. As a result, the study requires a sample size of 64 per group or 128 individuals in total.
Analysis of effects of treatment Our research will use the intention-to-treat principles. The descriptive data and the scores of RMDQ, SBST, FABQ, SF-12v2 and NPRS as well as the pressure pain threshold means and the values of inflammatory biomarkers, before and after interventions, will be tabbed on Microsoft Excel 2010. To see the effect of treatment is going to be used statistical based on intention-to-treat principles, statistical analyses will be used to analyses data of individuals socio-demographics and clinics characteristics, and they will be presented by mean and standard deviation. To compare the groups, Shapiro-Wilk test will be applied to test the normality distribution of data, depending on this distribution will be used ANOVA one-way for parametric data or Kruskal-Wallis test for non-parametric data. To compare groups on the pre-intervention period another ANOVA-one way or another Kruskal-Wallis will be applied.
Covariance analysis (ANCOVA) will be conducted to assess the effect of treatment on the following outcomes: Scores obtained on RMDQ, FABQ, SF-12v2, SBST and NPRS, pressure pain threshold and the blood biomarkers concentrations, utilizing the post-treatment means as dependent variables, the pre-treatment means as co-variables and the group as fixed factor.
To the relationships among the variables must be applied the Pearson correlation coefficient to parametric data and Spearman correlation coefficient to nonparametric data. To classify the relationships will be used the Munro's classification, where values between 0.26 and 0.49 will be low, values between 0.50 and 0.69 will be moderate, between 0.70 and 0.89 will be high values, and between 0.90 and 1.0 will be considered very high. For all of these analyses will be used the Statistical Package for the Social Sciences (IBM SPSS version 20.0, IBM Corp, Armonk, New York).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Santa Catarina
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Florianopolis, Santa Catarina, Brazil, 88040-900
- Santa Catarina Federal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic episodes of nonspecific LBP for at least six months
- Pain on movement for at least one direction (flexion, extension, side bending or rotation of the trunk)
- At least score 3 in NPRS.
Exclusion Criteria:
- 1) Previous history of lumbar myelopathy, rheumatic disease, tumors, peripheral or central neurological disorders
- 2) Historical of trauma, fracture or surgery in lumbar region;
- 3) Nerve root compression signs: important muscle weakness affecting lower limb, decrease or abolish of patellar and calcaneus reflex and decrease of dermatomes sensibility of lower limbs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manipulative Treatment
Subjects will receive Manipulative Therapy
|
Subjects will receive techniques of High Velocity and Low Amplitude (HVLA) or grade V manipulation to the lumbar region (lumbar roll), and pain education based on the biopsychosocial approach.
Other Names:
Individuals will receive pain education based in a biopsychosocial approach
Other Names:
|
Sham Comparator: Pain Education
Subjects will receive Pain Education and manual contact over lumbar region
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Individuals will receive pain education based in a biopsychosocial approach
Other Names:
The individuals will receive a simulation of spinal manipulation (sham) involving manual contact over lumbar region totaling 5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: 6 weeks after randomization
|
Numeric Pain Rating Scale (NPRS)
|
6 weeks after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: Baseline, 6 weeks and 3 months
|
Numeric Pain Rating Scale (NPRS)
|
Baseline, 6 weeks and 3 months
|
Disabilty
Time Frame: baseline, 6 weeks and 3 months
|
Rolland Morris Disability Questionnaire (RMDQ)
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baseline, 6 weeks and 3 months
|
Pressure Pain Threshold
Time Frame: Baseline, 6 weeks and 3 months
|
The pressure pain threshold will be assessed by algometer.
It will be realized three times in each point (Five centimeters of the right and left side of the spinal process of L1, L3 and L5, and on the muscle belly of tibialis anterior).
|
Baseline, 6 weeks and 3 months
|
Fear and Beliefs about pain
Time Frame: Baseline, 6 weeks and 3 months
|
Fear Avoidance Belief Questionnaire (FABQ)
|
Baseline, 6 weeks and 3 months
|
Risk of poor prognosis
Time Frame: Baseline, 6 weeks and 3 months
|
STarT Back Screening Tool (SBST)
|
Baseline, 6 weeks and 3 months
|
Quality of Life
Time Frame: Baseline, 6 weeks and 3 months
|
Short-Form Health Survey 12 version 2 (SF-12v2)
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Baseline, 6 weeks and 3 months
|
Serum Level of Cytokines
Time Frame: Baseline, 6 weeks
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Enzyme Linked Immunosorbent Assay (ELISA) to TNF-α, IL-1β, IL-4, IL-6, IL-8, IL-12, IL-10, IL-15, MIP-4, CCL18, MCP-3 / CCL7, MCP-2 / CCL8, IGP - 10 / CXCL10, Stromal Lymphopoietin Receptor (TSLR), Interferon Gamma and CRP.
|
Baseline, 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Clécio Vier, PhD Student, Santa Catarina Federal University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cvier
- U1111-1190-4899 (Other Identifier: World Health Organization - WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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