Using fMRI to Determine if Cerebral Hemodynamic Responses to Pain Change Following Thoracic Spine Manipulation in Individuals With Mechanical Neck Pain

NCT ID: NCT01862705

Last Updated: 2015-05-13

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-10-31

Brief Summary

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Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in the management of patients with neck pain. However the mechanisms for pain relief associated with this intervention remain largely unexplained. Recent evidence suggests structures within the brain may have a role in creating responses of pain relief. This study aims to use functional magnetic resonance imaging (fMRI) to determine if there is a change in blood flow to structures within the brain following TSM in patients with neck pain. All patients will undergo fMRI while receiving painful stimuli directed to two separate sites, the cuticle of the index finger and the great toe. Subjects will then receive either TSM or sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful stimuli. The primary outcome of interest is the shift in blood flow within the brain before and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD) technology. This study will be the first to examine this type of response to manual therapy within the brain in patients with neck pain.

Detailed Description

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Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Thoracic spine manipulation thrust

Thoracic spine manipulation thrust

Group Type EXPERIMENTAL

Thoracic spine manipulation

Intervention Type OTHER

TSM thrust or non-thrust

Thoracic spine manipulation non-thrust

Thoracic spine manipulation non-thrust

Group Type SHAM_COMPARATOR

Thoracic spine manipulation

Intervention Type OTHER

TSM thrust or non-thrust

Interventions

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Thoracic spine manipulation

TSM thrust or non-thrust

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary complaint of mechanical neck pain of less than 6 weeks in duration as identified in the patient's initial physical examination. Mechanical neck pain is defined as generalized neck and/or shoulder, peri-scapular pain with symptoms provoked by neck postures, neck movements, or palpation of the cervical musculature

Exclusion Criteria

* Any medical red flags suggestive of non-musculoskeletal origin of pain, such as metabolic disorders, osteoporosis, tumor, and/or rheumatoid arthritis
* No contraindications to spinal mobilization
* No contraindications to MRI (claustrophobia, presence of cardiac pacemakers, cochlear implants, metal implants, implanted hearing aids, and previous injuries caused by bullets or shrapnel, pregnancy or thought to be pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OSF Healthcare System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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449272-1

Identifier Type: -

Identifier Source: org_study_id

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