Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

Last updated: April 15, 2025
Sponsor: University of Minnesota
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neck Pain

Chronic Pain

Treatment

SMT

Light Massage

Clinical Study ID

NCT06312696
PT-2024-32814.
  • Ages 18-39
  • All Genders

Study 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

Inclusion Criteria:

  • Nonspecific, mechanical neck pain equivalent to grades I or II (Bone and Joint TaskForce on Neck Pain and Its Associated Disorders classification2 for >12 weeks

  • Ages 18 to 39

  • Pain intensity >3 (0-10 scale)

Exclusion

Exclusion Criteria:

  • American Society of Anesthesiology Class III conditions and/or serious mental healthconditions

  • Botox injections (which resulted in clinical relief) in the past 3 months

  • Chronic opioid use

  • Contraindications to spinal manipulation (e.g. cervical instability; complicatingneurological conditions) Spinal manipulation or mobilization of cervical spine inprior 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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: SMT
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
April 01, 2027

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

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