Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief

April 9, 2026 updated by: Jessica Feda, Baylor University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study's primary objective will examine whether a previously derived clinical prediction rule (CPR) exhibits validity for identifying a subgroup of patients who respond favorably to cervical thrust joint manipulation (C-TJM). The secondary objective will determine if patients who are positive on the derived CPR and receive C-TJM will exhibit reduced downstream healthcare costs. This multicenter randomized clinical trial will enroll 160 patients with primary complaints of neck pain. Participants will be randomized into two groups: (1) 2 sessions of C-TJM followed by 3 sessions of stretching and strengthening exercises, and (2) 2 sessions of low-grade mobilizations followed by 3 sessions of the same stretching and strengthening exercises. The primary outcome is the change in disability measured four weeks post-treatment, with pain as the secondary outcome. Follow-up assessments will occur at one week, 4 weeks, 3 months and 6 months to evaluate both short-term and long-term effects. The exact inclusion and exclusion criteria from the CPR derivation study will be used within this validation study to determine participant eligibility. Data will be collected using standardized self-report measures and physical examination, and statistical analyses will be performed using a linear mixed model with repeated measures. The investigators hypothesize that patients identified by the clinical prediction rule to benefit from C-TJM will show substantial improvements in disability and pain. This study will offer valuable insight into the effectiveness of C-TJM for neck pain. Successful validation of the clinical prediction rule could lead to more efficient and cost-effective patient care, potentially reducing the burden of neck pain on healthcare systems and improving patient outcomes. As PI, responsibilities include protocol development, training, data collection, analysis, manuscript development and dissemination of findings.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
    • New York
    • Texas
      • Waco, Texas, United States, 76798
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54313
        • Recruiting
        • Emplify by Bellin Health Ashwaubenon
        • Contact:
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical Manipulation
Patients will receive cervical manipulation on 2 visits, followed by 3 visits of therapeutic exercise.
Procedure: Cervical Manipulation
High velocity low amplitude thrust joint manipulation to the cervical spine facet joints
Procedure: Exercise
Therapeutic exercises to the cervical, thoracic, and scapular musculature
Other: Exercise and Mobilizations
Patients will receive low-grade cervical mobilizations on 2 visits, followed by 3 visits of therapeutic exercises
Procedure: Exercise
Therapeutic exercises to the cervical, thoracic, and scapular musculature
Procedure: Mobilization
Low velocity, low amplitude movements applied to the cervical spine facet joints (Grade I or II)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: 6 months
10-item patient self-report measure of perceived disability. Each question is scored from 0 to 5. Minimum value of 0 and maximum value of 50. Higher scores indicate worse disability and a poorer outcome.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating of Change Scale
Time Frame: 6 months
A 15-point scale with options ranging from -7 (a great deal worse) to +7 (a great deal better) to determine the magnitude of change in response to intervention. Higher scores indicate a better outcome. Minimum value -7 and maximum value +7.
6 months
Numeric Pain Rating Scale
Time Frame: 6 months
Patients rate their pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst possible. Minimum value 0 and maximum value 10. Higher scores indicate a worse outcome.
6 months
Fear Avoidance Beliefs Questionnaire
Time Frame: 6 months
A 16 question outcome measure scaled from 0 to 6 with a maximum score of 96 - a higher score indicates fear avoidance behaviors. Minimum score 0 and maximum score 96.
6 months
Medication Use
Time Frame: 6 months
Self-report of medication use prior to, during, and after the treatment phase of the study. As this component is a self-report of medication use, scoring is not pertinent.
6 months
Healthcare Utilization
Time Frame: 6 months
Self-report of healthcare use prior to and after the treatment phase of the study. As this component is a self-report of healthcare use, scoring is not pertinent.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor University

Collaborators

Foundation for Physical Therapy Research

Investigators

  • Principal Investigator: Jessica T Feda, DSc, Baylor University
  • Study Director: Emilio J Puentedura, PhD, Baylor University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 29, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2240854-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share IPD with other researchers beyond what will be published within future manuscripts and disseminations. However, if an individual researcher was to request IPD sharing upon completion of data analysis and dissemination, we would certainly consider the request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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