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

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.

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:

• Muscle weakness involving a major muscle group of the upper extremity
• Diminished upper extremity muscle stretch reflex (biceps, triceps, or brachioradialis)
• 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