Clinical trial NCT06312696: Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
Official title: Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Intersegmental and Global Range of Motion
timeFrame: 1 hr
Secondary outcomes:
measure: Neck pain intensity
timeFrame: 1 hr
measure: Neck disability
timeFrame: 1 hr
measure: physical function
timeFrame: 1 hr
measure: depression
timeFrame: 1 hr
measure: sleep disturbance
timeFrame: 1 hr
measure: Pain interference
timeFrame: 1 hr
measure: Fear of pain assessment
timeFrame: 1 hr
measure: Overall function assessment
timeFrame: 1 hr
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Arin Ellingson, PhD
role: PRINCIPAL_INVESTIGATOR
References: