NCT06312696

Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neck Pain

Interventions

Type	Name	Description
OTHER	SMT	SMT will be provided by a licensed chiropractor with at least 5 years' experience. Treatment will last 15 to 20 minutes each and include a brief history and examination of the cervical spine. SMT will consist of low velocity, variable amplitude spinal mobilization to the cervical spine - Maitland grades 3 or 4. Spinal segments will be determined by the chiropractor using manual palpation and the patients' response to care. Drop-table or instrument-assisted SMT will not be allowed.
OTHER	Light Massage	Light Massage will be provided as a pseudo-sham intervention to control for time, attention, and touch by a licensed chiropractor with at least 5 years' experience to control for touch and is intended to be delivered gentler and shorter than recommended for therapeutic massage.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-03-15
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States