Validation of CPR for Manipulation for Neck Pain

Cervicalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02287337
• Other study ID #: UNLV-1212-4327
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: August 26, 2017

Study information

• Verified date: October 2019
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: August 26, 2017
• Est. primary completion date: August 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervicalgia
• Neck Pain

Intervention

Procedure:
• Manipulation
High velocity low amplitude thrust joint manipulation to cervical spine facet joints
• Exercise
Therapeutic exercises to the cervical, thoracic and scapular musculature

Locations

Country	Name	City	State
United States	University of Nevada Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index	10-item patient self-report measure of perceived disability	6 months
Secondary	Medication Use		6 months
Secondary	Global Rating of Change Scale		6 months
Secondary	Numeric Pain Rating Scale		6 months