Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy.
Robert S Wainner, Julie M Fritz, James J Irrgang...
https://pubmed.ncbi.nlm.nih.gov/12544957/Actively Recruiting
Led by Baylor University · Updated on 2026-04-14
160
Participants Needed
4
Research Sites
N/A
Total Duration
Researchers are investigating neck pain, a common problem that can cause lasting disability and missed work. The study aims to test a method that identifies patients likely to benefit from a physical therapy technique called cervical spine thrust joint manipulation. This multicenter randomized trial will enroll 160 patients to see if the method can reliably predict who will improve most with this treatment compared to another approach. Participants will be randomly assigned to one of two groups one will receive 2 sessions of cervical spine manipulation followed by 3 sessions of therapeutic exercises, while the other will receive 2 sessions of gentle low-grade cervical mobilizations followed by the same 3 sessions of exercises. Treatments focus on the neck and surrounding muscles using manual techniques. The study includes follow-ups at 1 week, 4 weeks, 3 months, and 6 months to assess both immediate and long-term effects. During the trial, participants will complete self-report measures and physical exams to track changes in disability and pain. Researchers will measure outcomes primarily through the Neck Disability Index over 6 months. Additional assessments include pain rating scales, global change ratings, medication use, healthcare use, and fear avoidance beliefs. The study is designed to provide clearer guidance on who may benefit from cervical manipulation and improve care for neck pain sufferers.
CONDITIONS
Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief
J
Jessica T Feda, DSc
T
Tiffany L Barrett, DSc
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Baylor University
Lead Sponsor
Foundation for Physical Therapy Research
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Manipulative Thrust Technique | Therapeutic Exercise + Gentle Mobilization |
|---|---|---|
| What it is | A manual therapy intervention using high velocity, low amplitude thrusts applied by a clinician to the cervical facet joints, intended to increase mobility and reduce pain. | A combined approach of targeted neck, thoracic, and scapular exercises with gentle, low velocity cervical spine mobilizations performed by a therapist. |
| Role in the trial | Serves as the experimental intervention, aiming to validate a clinical prediction rule for manual therapy in neck pain. | Acts as the active comparator arm representing established exercise and mobilization therapy for neck pain relief. |
| Primary use | Intended to improve neck mobility and reduce pain severity in patients with musculoskeletal neck pain. | Used to enhance muscular strength, flexibility, and control while decreasing neck pain and improving daily function. |
| How it is performed | Manual thrusts delivered by a trained professional, focusing on cervical facet joints, typically during clinic visits. | Therapist guides participants through targeted exercises and applies gentle, low velocity mobilizations to the neck vertebrae during scheduled sessions. |
| Evidence status | Clinical prediction rules and guidelines recommend cervical manipulation for carefully selected cases, with multiple studies showing benefit in pain reduction and function for some neck pain patients. | Exercise therapy and gentle mobilization are widely supported by guidelines and systematic reviews for improving pain and function in musculoskeletal neck pain, with robust evidence across diverse patient groups. |
| Important limitations | Manipulative thrust is not suitable for patients with certain risk factors such as spinal instability, neurological signs, or recent trauma. The technique requires clinical expertise and careful patient selection, and benefits are not universal. | Response to exercise and mobilization may vary, with some patients needing more intensive or customized therapies. Not all patients achieve optimal pain relief or function improvement. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 visits over 2 to 3 weeks
Participants receive 2 visits of cervical spinal manipulation or low-grade mobilizations, followed by 3 visits of therapeutic exercises targeting the neck and surrounding musculature.
5 visits (in-person)
Duration - 6 months
Participants complete follow-up assessments to evaluate treatment effects on neck disability, pain, and other health outcomes.
Assessments at 1 week, 4 weeks, 3 months, and 6 months post-treatment
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/19521015/Baylor University
Lead Sponsor
Foundation for Physical Therapy Research
Collaborating Sponsor