RECRUITING

Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief in 140 Participants With Neck Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06906107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18 to 70
  2. * Primary complaint of neck pain with or without unilateral upper extremity symptoms
  3. * Neck Disability Index (NDI) score of 10 or greater
  4. * Numeric Pain Rating Scale score of 2 or greater
  1. * History of whiplash injury within the past 6 weeks
  2. * Diagnosis of cervical spinal stenosis
  3. * Bilateral upper extremity symptoms
  4. * 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)
  5. * 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)
  6. * Two or more positive neurological signs consistent with significant nerve root compression, including any two of the following:
  7. 1. Muscle weakness involving a major muscle group of the upper extremity
  8. 2. Diminished upper extremity muscle stretch reflex (biceps, triceps, or brachioradialis)
  9. 3. Diminished or absent sensation to pinprick or light touch in any upper extremity dermatome
  10. * Prior neck surgery
  11. * Current pregnancy, pregnancy within 6 months, or currently lactating
  12. * Pending legal action pertaining to their neck pain
  13. * Inability to read English at the 8th grade reading level
  14. * Inability to legally provide informed consent for any other reason
  15. * Inability to comply with the treatment and follow-up schedule

Contacts and Locations

Study Contact

Jessica T Feda, DSc
CONTACT
5079906446
jessica_feda@baylor.edu
Tiffany L Barrett, DSc
CONTACT
702-321-2144
Tiffany.Barrett@augie.edu

Principal Investigator

Jessica T Feda, DSc
PRINCIPAL_INVESTIGATOR
Baylor University
Emilio J Puentedura, PhD
STUDY_DIRECTOR
Baylor University

Study Locations (Sites)

ActivePT
Rochester, Minnesota, 55901
United States
PROActivePT
Syracuse, New York, 13201
United States
ActiveTherapy Alliance
Waco, Texas, 76798
United States

Collaborators and Investigators

Sponsor: Baylor University

  • Jessica T Feda, DSc, PRINCIPAL_INVESTIGATOR, Baylor University
  • Emilio J Puentedura, PhD, STUDY_DIRECTOR, Baylor University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-06-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • neck pain
  • manual therapy
  • physical therapy

Additional Relevant MeSH Terms

  • Neck Pain Musculoskeletal
  • Neck Pain Treatment
  • Cervicalgia