NCT02982382

Brief Summary

The burden of low back pain more than doubled in the last 20 years, probably caused by biopsychosocial factors. Some noninvasive treatments have been applied in individuals with chronic nonspecific low back pain as spinal manipulation and pain education. However, it is not already clear the neurophysiological effects of these treatments.The purpose of this research is to verify the effects of the technique of spinal manipulation and pain education in individuals with chronic low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable low-back-pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

November 29, 2016

Last Update Submit

February 22, 2019

Conditions

Low Back Pain

Keywords

Low Back PainMusculoskeletal ManipulationsNeurophysiologyEducation

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Numeric Pain Rating Scale (NPRS)

    6 weeks after randomization

Secondary Outcomes (7)

  • Pain Intensity

    Baseline, 6 weeks and 3 months

  • Disabilty

    baseline, 6 weeks and 3 months

  • Pressure Pain Threshold

    Baseline, 6 weeks and 3 months

  • Fear and Beliefs about pain

    Baseline, 6 weeks and 3 months

  • Risk of poor prognosis

    Baseline, 6 weeks and 3 months

  • +2 more secondary outcomes

Study Arms (2)

Manipulative Treatment

EXPERIMENTAL

Subjects will receive Manipulative Therapy

Other: Manipulative TherapyOther: Pain Education

Pain Education

SHAM COMPARATOR

Subjects will receive Pain Education and manual contact over lumbar region

Other: Pain EducationOther: Sham

Interventions

Manipulative TherapyOTHER

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.

Also known as: Manual Therapy, Grade V Manipulation, Spinal Manipulation
Manipulative Treatment
Pain EducationOTHER

Individuals will receive pain education based in a biopsychosocial approach

Also known as: Neuroscience Pain Education
Manipulative TreatmentPain Education
ShamOTHER

The individuals will receive a simulation of spinal manipulation (sham) involving manual contact over lumbar region totaling 5 minutes.

Pain Education

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • \) Previous history of lumbar myelopathy, rheumatic disease, tumors, peripheral or central neurological disorders
  • \) Historical of trauma, fracture or surgery in lumbar region;
  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Catarina Federal University

Florianópolis, Santa Catarina, 88040-900, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal ManipulationsManipulation, Spinalsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Clécio Vier, PhD Student

    Santa Catarina Federal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 5, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

BR(1)