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

Not Applicable

Not yet recruiting

• Conditions: Neck Pain Musculoskeletal; Neck Pain Treatment; Cervicalgia

• Registration Number: NCT06906107
• Lead Sponsor: Baylor University

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, 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.

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 140 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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-29
• Last Update Submitted: 2025-03-29
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-06-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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

• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	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.

Secondary Outcome Measures

Name	Time	Method
Global Rating of Change Scale	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.
Numeric Pain Rating Scale	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.
Fear Avoidance Beliefs Questionnaire	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.
Medication Use	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.
Healthcare Utilization	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.