Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spinal Manipulation: A Randomized Clinical Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Neck pain is a common issue that can lead to long-term disability and lost work time for many individuals. Despite numerous studies, finding effective treatment strategies has been challenging. One possible reason for this is that treatments may not have been tested on the specific groups of people who would benefit most. A method was developed to identify people with neck pain who are likely to see significant improvements from a manipulation technique used by physical therapists, called cervical spine thrust joint manipulation. The investigators believe that patients identified as likely responders to cervical spine manipulation will show greater improvements in disability. The investigators aim to test whether this method works with different patients and therapists across the country through a multicenter randomized clinical trial. In this study, 140 patients with primary complaints of neck pain will be enrolled from 20 clinical sites. Designed with stringent criteria for inclusion, this study is a testament to our commitment to participant safety and the effectiveness of the treatment. Participants will be randomly assigned to one of two groups: (1) one group will receive 2 sessions of cervical spine manipulation followed by 3 sessions of exercise, and (2) the other group will receive 2 sessions of gentle hands-on treatment followed by 3 sessions of exercise. The primary goal is to measure changes in disability 4 weeks after starting treatment, with follow-ups after one week, 4 weeks, 3 months, and 6 months to assess both immediate and long-term effects. By providing crucial data on the reliability of our method in identifying patients who will benefit most from cervical spine manipulation, this study has the potential to significantly enhance decision-making leading to rapid improvement. Results from this study will provide clearer guidelines on the optimal use of cervical spine manipulation, potentially revolutionizing the way patients recover from neck pain.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Ages 18 to 70

• Primary complaint of neck pain with or without unilateral upper extremity symptoms

• Neck Disability Index (NDI) score of 10 or greater

• Numeric Pain Rating Scale score of 2 or greater

Locations
United States
Minnesota
ActivePT
RECRUITING
Rochester
New York
PROActivePT
RECRUITING
Syracuse
Texas
ActiveTherapy Alliance
RECRUITING
Waco
Contact Information
Primary
Jessica T Feda, DSc
jessica_feda@baylor.edu
5079906446
Backup
Tiffany L Barrett, DSc
Tiffany.Barrett@augie.edu
702-321-2144
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 140
Treatments
Experimental: Cervical Manipulation
Patients will receive cervical manipulation on 2 visits, followed by 3 visits of therapeutic exercise.
Other: Exercise and Mobilizations
Patients will receive low-grade cervical mobilizations on 2 visits, followed by 3 visits of therapeutic exercises
Related Therapeutic Areas
Sponsors
Leads: Baylor University
Collaborators: Foundation for Physical Therapy Research

This content was sourced from clinicaltrials.gov