NCT06906107 Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief
| NCT ID | NCT06906107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor University |
| Condition | Neck Pain Musculoskeletal |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, 160 patients with primary complaints of neck pain will be enrolled from 9 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 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
Contact & Investigator
Jessica T Feda, DSc
PRINCIPAL INVESTIGATOR
Baylor University
Frequently Asked Questions
Who can join the NCT06906107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Neck Pain Musculoskeletal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06906107 currently recruiting?
Yes, NCT06906107 is actively recruiting participants. Contact the research team at jessica_feda@baylor.edu for enrollment information.
Where is the NCT06906107 trial being conducted?
This trial is being conducted at Rochester, United States, Syracuse, United States, Waco, United States, Green Bay, United States.
Who is sponsoring the NCT06906107 clinical trial?
NCT06906107 is sponsored by Baylor University. The principal investigator is Jessica T Feda, DSc at Baylor University. The trial plans to enroll 160 participants.