Using a checklist to guide cervical manipulation and exercises for neck pain relief
Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spinal Manipulation: A Randomized Clinical Trial
This project will try to see if a clinical prediction rule (a simple checklist) can pick people with neck pain who get more improvement from cervical spine thrust manipulation followed by exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Baylor University Academic / other |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Trial ID | NCT06906107 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial will enroll 160 adults with primary neck pain and use the exact inclusion criteria from a previously derived clinical prediction rule to identify likely responders. Participants will be randomized to two sessions of cervical thrust joint manipulation followed by three sessions of stretching and strengthening exercises, or two sessions of low‑grade mobilizations followed by the same exercises. The primary outcome is change in disability (Neck Disability Index) at four weeks, with pain as a secondary outcome and follow-ups at 1 week, 4 weeks, 3 months, and 6 months. Secondary analyses include downstream healthcare costs and statistical testing using linear mixed models with repeated measures.
Who should consider this trial
Good fit: Adults aged 18–70 with a primary complaint of neck pain (NDI ≥10 and pain ≥2) who meet the specific clinical prediction rule criteria and have no red-flag findings or recent whiplash within six weeks.
Not a fit: Patients with cervical spinal stenosis, bilateral upper-extremity symptoms, signs of central nervous system involvement, recent serious neck trauma, or other red-flag conditions are unlikely to benefit from the tested manipulation approach.
Why it matters
Potential benefit: If successful, clinicians could target cervical manipulation to patients most likely to benefit, improving disability and pain while avoiding ineffective treatments.
How similar studies have performed: A prior derivation study produced the clinical prediction rule and showed promising results, but prospective multicenter randomized validation has been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * History of whiplash injury within the past 6 weeks * Diagnosis of cervical spinal stenosis * Bilateral upper extremity symptoms * Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, rheumatoid arthritis, osteoporosis, severe atherosclerosis, dizziness, diplopia, drop attacks, bilateral numbness, nausea, prolonged history of steroid use) * Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes) * Two or more positive neurological signs consistent with significant nerve root compression, including any two of the following: 1. Muscle weakness involving a major muscle group of the upper extremity 2. Diminished upper extremity muscle stretch reflex (biceps, triceps, or brachioradialis) 3. Diminished or absent sensation to pinprick or light touch in any upper extremity dermatome * Prior neck surgery * Current pregnancy, pregnancy within 6 months, or currently lactating * Pending legal action pertaining to their neck pain * Currently receiving manual therapy treatment for neck pain through chiropractic or physical therapy care * Inability to read English at the 8th grade reading level * Inability to legally provide informed consent for any other reason * Inability to comply with the treatment and follow-up schedule
Where this trial is running
Rochester, Minnesota and 3 other locations
- ActivePT — Rochester, Minnesota, United States (Recruiting)
- PROActivePT — Syracuse, New York, United States (Recruiting)
- ActiveTherapy Alliance — Waco, Texas, United States (Recruiting)
- Emplify by Bellin Health Ashwaubenon — Green Bay, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Jessica T Feda, DSc — Baylor University
- Study coordinator: Jessica T Feda, DSc
- Email: jessica_feda@baylor.edu
- Phone: 5079906446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.