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Central Mechanisms of Intervention for Low Back Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Spinal Manipulation

Spinal Mobilization

Static Touch

About this trial

This is an interventional basic science trial for Low Back Pain focused on measuring Spinal Manipulation, Body-based intervention, Experimental pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Spinal Manipulation

Static Touch

Spinal Mobilization

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Immediate change in temporal sensory summation

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

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

Secondary Outcome Measures

Change in Physical Impairment Index

Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance

Full Information

NCT ID

NCT01406847

First Posted

July 26, 2011

Last Updated

April 4, 2018

Sponsor

University of Florida

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT01406847

Brief Title

Central Mechanisms of Intervention for Low Back Pain

Official Title

Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

May 1, 2017 (Actual)

Study Completion Date

May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Spinal Manipulation, Body-based intervention, Experimental pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Spinal Manipulation

Arm Type

Experimental

Arm Description

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

Arm Title

Static Touch

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Spinal Mobilization

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Spinal Manipulation

Other Intervention Name(s)

SMT

Intervention Description

High velocity low amplitude joint-biased intervention

Intervention Type

Other

Intervention Name(s)

Spinal Mobilization

Other Intervention Name(s)

Mobilization, Mobs

Intervention Description

Low velocity, large amplitude oscillating joint biased technique

Intervention Type

Other

Intervention Name(s)

Static Touch

Intervention Description

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

Primary Outcome Measure Information:

Title

Immediate change in temporal sensory summation

Description

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

Time Frame

10 minutes post-intervention

Title

Change in temporal sensory summation

Description

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

Time Frame

48 hours post-intervention

Secondary Outcome Measure Information:

Title

Change in Physical Impairment Index

Description

Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance

Time Frame

48 hours post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark D Bishop, PT, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610-0154

Country

United States

12. IPD Sharing Statement

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Central Mechanisms of Intervention for Low Back Pain

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