An interventional study of SMT and Light Massage in Neck Pain, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University of Minnesota · Not applicable, Interventional, and Diagnostic
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Light massage group
Other: Light Massage
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.
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.
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.
Time frame: 1 hr
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 hr
Overall function assessment
The Short Form-36 (SF-36) will also be collected to assess overall function.
Time frame: 1 hr
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