Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
Overview
- Phase
- Not Applicable
- Intervention
- No treatment group
- Conditions
- Neck Pain
- Sponsor
- University of Minnesota
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Intersegmental and Global Range of Motion
- Status
- Recruiting
- Last Updated
- 26 days ago
Overview
Brief Summary
The broad long-term objective is to develop an objective biomarker for spinal health based on aberrant or abnormal movement patterns during functional activities to better target spinal manipulation therapy (SMT) and other conservative treatments. The central hypotheses are a) that aberrant spinal motions and their location (area and level) are indicative of underlying spinal dysfunction, and b) that quantified 3D cervical spine intersegmental and global motion patterns during functional tasks can be used as a biomarker for subsequent clinical studies aimed at normalizing cervical kinematics.
Specific Aim: Determine the extent to which SMT can modulate, or normalize, intersegmental motion in patients with neck pain. Rationale: SMT is a force-based biomechanical event whose hypothesized mechanism of action relies on moving the segment into the para-physiological zone, resulting in normalization of spinal kinematic function. Hypothesis: Severity of abnormal or aberrant motion, identified in those with NP, will improve following SMT. Approach: Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Nonspecific, mechanical neck pain equivalent to grades I or II (Bone and Joint Task Force on Neck Pain and Its Associated Disorders classification2 for \>12 weeks
- •Ages 18 to 39
- •Pain intensity \>3 (0-10 scale)
Exclusion Criteria
- •American Society of Anesthesiology Class III conditions and/or serious mental health conditions
- •Botox injections (which resulted in clinical relief) in the past 3 months
- •Chronic opioid use
- •Contraindications to spinal manipulation (e.g. cervical instability; complicating neurological conditions) Spinal manipulation or mobilization of cervical spine in prior 6 months
- •Ongoing non-pharmacological treatment for neck pain
- •History of cervical spine surgery
- •Pregnancy, currently trying to get pregnant, lactation
- •Contraindications to radiation exposure
Arms & Interventions
No treatment group
No Treatment: participants will be placed in a similar position to the other groups for the same duration, but no treatment or touch will be administered.
Pseudo sham group
Light massage group
Intervention: Light Massage
Experimental group
Spinal Manipulative therapy group
Intervention: SMT
Outcomes
Primary Outcomes
Intersegmental and Global Range of Motion
Time Frame: 1 hr
analysis will consist of calculating the percent contribution of each functional spinal unit to the overall global motion. To do that, cervical spine ROM (global and intersegmental), angular change between the beginning and end of motion, will be quantified for all planar bending directions.
Secondary Outcomes
- Neck disability(1 hr)
- physical function(1 hr)
- Overall function assessment(1 hr)
- Neck pain intensity(1 hr)
- depression(1 hr)
- Pain interference(1 hr)
- sleep disturbance(1 hr)
- Fear of pain assessment(1 hr)