Actively Recruiting
Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief
Led by Baylor University · Updated on 2026-04-14
160
Participants Needed
4
Research Sites
82 weeks
Total Duration
On this page
Sponsors
B
Baylor University
Lead Sponsor
F
Foundation for Physical Therapy Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- History of whiplash injury within the past 6 weeks
- Diagnosis of cervical spinal stenosis
- Bilateral upper extremity symptoms
- Red flags noted in the Neck Medical Screening Questionnaire (tumor, fracture, rheumatoid arthritis, osteoporosis, severe atherosclerosis, dizziness, diplopia, drop attacks, bilateral numbness, nausea, prolonged steroid use)
- Evidence of central nervous system involvement (hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired facial sensation, altered taste, pathological reflexes)
- Two or more neurological signs of significant nerve root compression (muscle weakness, diminished reflexes, diminished or absent sensation in upper extremity dermatomes)
- Prior neck surgery
- Current pregnancy, pregnancy within 6 months, or currently lactating
- Pending legal action related to neck pain
- Currently receiving manual therapy for neck pain
- Inability to read English at the 8th grade level
- Inability to legally provide informed consent
- Inability to comply with the treatment and follow-up schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
ActivePT
Rochester, Minnesota, United States, 55901
Actively Recruiting
2
PROActivePT
Syracuse, New York, United States, 13201
Actively Recruiting
3
ActiveTherapy Alliance
Waco, Texas, United States, 76798
Actively Recruiting
4
Emplify by Bellin Health Ashwaubenon
Green Bay, Wisconsin, United States, 54313
Actively Recruiting
Research Team
J
Jessica T Feda, DSc
CONTACT
T
Tiffany L Barrett, DSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here