Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Other: Light Massage; Other: SMT

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephany Nathe; Email: nathe039@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Stephany Nathe; Email: nathe039@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Sham Comparator: Pseudo sham group; Light massage group	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.
Experimental: Experimental group; Spinal Manipulative therapy group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck pain intensity	will be measured using the 11-box numerical rating scale (NRS). The NRS is a reliable and valid outcome measure for individuals with pain and is recommended by both the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) group and the NIH task force on research standards for back pain.	1 hr
Neck disability	will be measured using the Neck Disability Index (NDI), an instrument previously shown to be reliable and valid for adults with neck pain.	1 hr
physical function	will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain.	1 hr
depression	will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain.	1 hr
sleep disturbance	will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain.	1 hr
Pain interference	will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain.	1 hr
Fear of pain assessment	Fear-Avoidance Beliefs Questionnaire (FABQ) 68 will also be collected to assess fear of pain and aversion to physical activity/movement.	1 hr
Overall function assessment	The Short Form-36 (SF-36) will also be collected to assess overall function.	1 hr

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Arin Ellingson, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neck Pain
• Other Study ID Numbers: PT-2024-32814.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No