Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

NCT06312696 | Recruiting

• 1 other identifier: PT-2024-32814.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Intersegmental and Global Range of Motion

  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.

  1 hr

Secondary Outcomes (8)

• Neck pain intensity

  1 hr

• Neck disability

  1 hr

• physical function

  1 hr

• depression

  1 hr

• sleep disturbance

  1 hr

Study Arms (3)

No treatment group

NO INTERVENTION

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

SHAM COMPARATOR

Light massage group

Other: Light Massage

Experimental group

EXPERIMENTAL

Spinal Manipulative therapy group

Other: SMT

Interventions

SMT OTHER

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.

Experimental group

Light Massage OTHER

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.

Pseudo sham group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arin Ellingson, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephany Nathe

CONTACT

nathe039@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

US (1)