RECRUITING

Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

Quick Facts

Study Start:2024-04-01
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06312696

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Ages 18 to 39
  3. * Pain intensity \>3 (0-10 scale)
  1. * American Society of Anesthesiology Class III conditions and/or serious mental health conditions
  2. * Botox injections (which resulted in clinical relief) in the past 3 months
  3. * Chronic opioid use
  4. * Contraindications to spinal manipulation (e.g. cervical instability; complicating neurological conditions) Spinal manipulation or mobilization of cervical spine in prior 6 months
  5. * Ongoing non-pharmacological treatment for neck pain
  6. * History of cervical spine surgery
  7. * Pregnancy, currently trying to get pregnant, lactation
  8. * Contraindications to radiation exposure

Contacts and Locations

Study Contact

Stephany Nathe
CONTACT
nathe039@umn.edu

Principal Investigator

Arin Ellingson, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Arin Ellingson, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2027-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Neck Pain