Validation of CPR for Manipulation for Neck Pain

Nevada System of Higher Education (NSHE)

Status: Terminated

Conditions: Cervicalgia

Treatments: Procedure: Exercise; Procedure: Manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02287337

UNLV-1212-4327

Details and patient eligibility

About

The purpose of this study is to see if a recently developed clinical prediction rule (CPR) will successfully identify which patients with neck pain will respond rapidly and favorably to manipulation of their cervical spine.

Full description

Consenting patients with a primary complaint of neck pain will be screened for contraindications to cervical spine manipulation and if eligible to participate in the study, will undergo a detailed subjective (history) and objective (physical) examination. At the completion of the examination, they will be assigned to one of two treatment arms - cervical manipulation and exercise or exercise only. They will receive up to 5 treatment sessions and be followed at 1 month, 3 months and 6 months after initial visit.

Enrollment: 86 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary complaint of mechanical neck pain with or without unilateral upper extremity symptoms (mechanical neck pain is defined as neck pain/ symptoms that are altered/ affected by activity, movement and posture)
• NDI score at least 10 points out of 50.

Exclusion criteria

• Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
• History of whiplash injury within the past six weeks
• Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
• 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), etc.
• Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: a. Muscle weakness involving a major muscle group of the upper extremity b. Diminished upper extremity muscle stretch reflex (biceps brachii, Brachioradialis, or triceps reflex) c. Diminished or absent sensation to pinprick in any upper extremity dermatome
• Prior surgery to the neck or thoracic spine
• Pending legal action regarding their neck pain
• Insufficient English language skills to complete all questionnaires
• Inability to comply with treatment and follow-up schedule

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

86 participants in 2 patient groups

Manipulation

Experimental group

Description:

Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises

Treatment:

Procedure: Exercise

Procedure: Manipulation

Exercise

Other group

Description:

Patients will receive 5 visits of therapeutic exercises

Treatment:

Procedure: Exercise