Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
NCT ID: NCT06312696
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-01
2027-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
No interventions assigned to this group
Pseudo sham group
Light massage group
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 group
Spinal Manipulative therapy group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Ages 18 to 39
* Pain intensity \>3 (0-10 scale)
Exclusion Criteria
* 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
18 Years
39 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Arin Ellingson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PT-2024-32814.
Identifier Type: -
Identifier Source: org_study_id
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