Validation of CPR for Manipulation for Neck Pain

Not Applicable

Terminated

• Conditions: Cervicalgia
• Interventions: Procedure: Manipulation; Procedure: Exercise

• Registration Number: NCT02287337
• Lead Sponsor: University of Nevada, Las Vegas

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-10
• Study Start: 2015-09-01
• Primary Completion: 2017-08-26
• Study Completion: 2017-08-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manipulation	Manipulation	Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises
Manipulation	Exercise	Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises
Exercise	Exercise	Patients will receive 5 visits of therapeutic exercises

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	6 months	10-item patient self-report measure of perceived disability

Secondary Outcome Measures

Name	Time	Method
Medication Use	6 months
Global Rating of Change Scale	6 months
Numeric Pain Rating Scale	6 months

Trial Locations

Locations (1)

University of Nevada Las Vegas; 🇺🇸 Las Vegas, Nevada, United States