The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

NCT ID: NCT01168999

Last Updated: 2015-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-01-31

Brief Summary

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The purpose of this study is to determine whether a novel placebo for comparison to spinal manipulation is believable and creates similar expectation for treatment effectiveness as the studied spinal manipulation technique. Additionally, we wish to compare outcomes related to low back pain, function, and pain sensitivity between people receiving the placebo, spinal manipulation, and no therapy.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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spinal manipulation

a spinal manipulation known to be effective in the treatment of low back pain for some individuals

Group Type ACTIVE_COMPARATOR

spinal manipulation

Intervention Type OTHER

Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain

sham spinal manipulation

a sham spinal manipulation intended to mimic the studied spinal manipulation

Group Type PLACEBO_COMPARATOR

sham spinal manipulation

Intervention Type OTHER

Sham spinal manipulation intended to mimic the studied spinal manipulation

natural history

No intervention is provided to participants in this arm of the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Enhanced sham spinal manipulation

a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"

Group Type PLACEBO_COMPARATOR

Enhanced sham spinal manipulation

Intervention Type OTHER

Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"

Interventions

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spinal manipulation

Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain

Intervention Type OTHER

sham spinal manipulation

Sham spinal manipulation intended to mimic the studied spinal manipulation

Intervention Type OTHER

Enhanced sham spinal manipulation

Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* currently experiencing low back pain which does not extend below the knees
* rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
* appropriate for conservative management of low back pain
* english speaking

Exclusion Criteria

* surgery to the low back over the past 6 months
* systemic disease known to effect sensation
* other chronic pain condition unrelated to low back pain
* fracture as a cause of low back pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Joel Bialosky, 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

References

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Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.

Reference Type DERIVED
PMID: 24361109 (View on PubMed)

Other Identifiers

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345-2009

Identifier Type: -

Identifier Source: org_study_id

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