Central Mechanism of Manual Therapy for Low Back Pain

NCT ID: NCT03078114

Last Updated: 2017-03-13

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.

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

Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.

Placebo Spinal Manipulation

Subjects with subacute low back pain. Subjects will be asked to visit the clinic for 6 times. The clinician will go through SM motions but the spine will not actually be manipulated.

Group Type PLACEBO_COMPARATOR

Placebo Spinal Manipulation

Intervention Type OTHER

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.

Interventions

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Spinal Manipulation

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.

Intervention Type OTHER

Placebo Spinal Manipulation

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of subacute low back pain
* Ability to read and understand English

Exclusion Criteria

* Previous low back surgery
* Severe structural spinal deformity
* Neurological compromise resulting in current nerve root entrapment
* Spinal cord compression
* Tumor
* Severe spinal instability
* Severe osteoporosis
* Psychiatric disease
* Head trauma
* Spinal infection
* Known cardiovascular or metabolic disease
* Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions
* Pregnancy
* Mini-Mental State Examination score \< 25
* Body Mass Index (BMI) \< 18 or \> 30
* Pain or paresthesia below the knees
* Systemic illness known to affect sensation i.e. diabetes
* Acute and/or chronic pain condition unrelated to LBP
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Chiropractic Mutual Insurance Company Foundation

UNKNOWN

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University Of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Saint Mary

Leavenworth, Kansas, United States

Site Status

Countries

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United States

References

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Bond BM, Kinslow CD, Yoder AW, Liu W. Effect of spinal manipulative therapy on mechanical pain sensitivity in patients with chronic nonspecific low back pain: a pilot randomized, controlled trial. J Man Manip Ther. 2020 Feb;28(1):15-27. doi: 10.1080/10669817.2019.1572986. Epub 2019 Mar 5.

Reference Type DERIVED
PMID: 30935324 (View on PubMed)

Other Identifiers

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12919

Identifier Type: -

Identifier Source: org_study_id

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