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A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain

NCT ID: NCT00922220

Last Updated: 2011-12-22

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

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).

Detailed Description

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Conditions

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Low Back Pain

Keywords

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low back pain spinal manipulation central sensitization manual therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stationary bike

Participants rode a stationary bike for five minutes

Group Type ACTIVE_COMPARATOR

stationary bike

Intervention Type OTHER

Participants rode a stationary bike for five minutes

lumbar extension exercises

Participants performed four sets of fifteen lumbar extension exercises over five minutes

Group Type ACTIVE_COMPARATOR

lumbar extension exercise

Intervention Type OTHER

Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes

spinal manipulative therapy

Participants received spinal manipulative therapy to the low back

Group Type EXPERIMENTAL

spinal manipulative therapy

Intervention Type OTHER

participants received spinal manipulative therapy to the low back

Interventions

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stationary bike

Participants rode a stationary bike for five minutes

Intervention Type OTHER

lumbar extension exercise

Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes

Intervention Type OTHER

spinal manipulative therapy

participants received spinal manipulative therapy to the low back

Intervention Type OTHER

Other Intervention Names

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press up spinal manipulation manual therapy

Eligibility Criteria

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Inclusion Criteria

* ages eighteen to sixty
* currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months

Exclusion Criteria

* non-English speaking
* systemic medical conditions (e.g. diabetes, hypertension)
* current use of psychiatric medication
* pregnancy
* signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)
* history of surgery to the low back
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Z George, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Florida Department of Physical Therapy

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.

Reference Type RESULT
PMID: 16911795 (View on PubMed)

Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.

Reference Type RESULT
PMID: 19797305 (View on PubMed)

Other Identifiers

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343-2004

Identifier Type: -

Identifier Source: org_study_id