Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

University of Minnesota (UMN)

Status: Enrolling

Conditions: Neck Pain

Treatments: Other: Light Massage; Other: SMT

Study type: Interventional

Funder types: Other

Identifiers

NCT06312696

PT-2024-32814.

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

No treatment group

No Intervention group

Description:

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 group

Description:

Light massage group

Treatment:

Other: Light Massage

Experimental group

Experimental group

Description:

Spinal Manipulative therapy group

Treatment:

Other: SMT