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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862705
• Other study ID #: 449272-1
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: May 12, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Thoracic spine manipulation
TSM thrust or non-thrust

Locations

Country	Name	City	State
United States	OSF Saint Francis Medical Center	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD response to noxious stimuli	shift in blood flow within the brain before and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD) technology, as measured by fMRI.	Immediately following TSM or sham-manipulation. Time frame to initiate MR scanning following thrust or sham-manipulation not to exceed 5 minutes.	No