NCT01406847

Brief Summary

Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Aug 2012

Longer than P75 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

July 26, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

4.8 years

First QC Date

July 26, 2011

Last Update Submit

April 4, 2018

Conditions

Low Back Pain

Keywords

Spinal ManipulationBody-based interventionExperimental pain

Outcome Measures

Primary Outcomes (2)

  • Immediate change in temporal sensory summation

    We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.

    10 minutes post-intervention

  • Change in temporal sensory summation

    The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention

    48 hours post-intervention

Secondary Outcomes (1)

  • Change in Physical Impairment Index

    48 hours post-intervention

Study Arms (3)

Spinal Manipulation

EXPERIMENTAL

High-velocity manual technique applied to the pelvis with the participant in supine

Other: Spinal Manipulation

Static Touch

SHAM COMPARATOR

Practitioner hands are placed on the lumbar spine with the participant in prone.

Other: Static Touch

Spinal Mobilization

ACTIVE COMPARATOR

Oscillation of the third lumbar level performed with the participant in prone

Other: Spinal Mobilization

Interventions

Spinal ManipulationOTHER

High velocity low amplitude joint-biased intervention

Also known as: SMT
Spinal Manipulation
Spinal MobilizationOTHER

Low velocity, large amplitude oscillating joint biased technique

Also known as: Mobilization, Mobs
Spinal Mobilization
Static TouchOTHER

The investigators maintains hand contact with both hands over the lumbar area of the participant

Static Touch

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18 to 40 years
  • able to read and understand spoken English

You may not qualify if:

  • Previous participation in a conditioning program specific to trunk extensors in the past 6 months
  • Any report of back or leg pain in the past 3 months
  • Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder
  • History of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction
  • Consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation
  • Performance of any intervention for symptoms induced by exercise and before the termination of their participation or the protocol
  • Recent illness
  • Any contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible (e.g. aneurysm clip), pregnancy and severe claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610-0154, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Mark D Bishop, PT, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 1, 2011

Study Start

August 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(1)