Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SMT, Light Massage.
- Who it may be relevant to
- Registry conditions: Neck Pain. Basic parameters: 18 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Intersegmental and Global Range of Motion [Time frame: 1 hr]
Secondary outcome measures (8)
- Neck pain intensity [Time frame: 1 hr]
- Neck disability [Time frame: 1 hr]
- physical function [Time frame: 1 hr]
- depression [Time frame: 1 hr]
- sleep disturbance [Time frame: 1 hr]
- Pain interference [Time frame: 1 hr]
- Fear of pain assessment [Time frame: 1 hr]
- Overall function assessment [Time frame: 1 hr]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06312696 · PT-2024-32814.