Central Mechanisms of Intervention for Low Back Pain

NCT ID: NCT01406847

Last Updated: 2018-04-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-05-01

Brief Summary

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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.

Detailed Description

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170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Spinal Manipulation

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

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

High velocity low amplitude joint-biased intervention

Static Touch

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

Group Type SHAM_COMPARATOR

Static Touch

Intervention Type OTHER

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

Spinal Mobilization

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

Group Type ACTIVE_COMPARATOR

Spinal Mobilization

Intervention Type OTHER

Low velocity, large amplitude oscillating joint biased technique

Interventions

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Spinal Manipulation

High velocity low amplitude joint-biased intervention

Intervention Type OTHER

Spinal Mobilization

Low velocity, large amplitude oscillating joint biased technique

Intervention Type OTHER

Static Touch

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

Intervention Type OTHER

Other Intervention Names

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SMT Mobilization Mobs

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark D Bishop, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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1R01AT006334-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

439-2010

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201602462-N

Identifier Type: -

Identifier Source: org_study_id

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