Recruiting

Spinal Manipulative Therapy

Sponsor:

University of Minnesota

Code:

NCT06312696

Conditions

Neck Pain

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

SMT

Light Massage

Study Details

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

Study ID

NCT06312696

Start date

Apr 1, 2024

Status verified date

Apr, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

experimental: Experimental group

Spinal Manipulative therapy group

Interventions

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.

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.

Primary outcome measure

  • Intersegmental and Global Range of Motion [ Time Frame: 1 hr ]

Central Contacts and Locations

Central contacts

Stephany Nathe

nathe039@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Stephany Nathe

nathe039@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-04-06.