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Validation of CPR for Manipulation for Neck Pain

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287337
Enrollment
86
Registered
2014-11-10
Start date
2015-09-01
Completion date
2017-08-26
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervicalgia

Keywords

Neck pain

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.

Interventions

PROCEDUREManipulation

High velocity low amplitude thrust joint manipulation to cervical spine facet joints

PROCEDUREExercise

Therapeutic exercises to the cervical, thoracic and scapular musculature

Sponsors

University of Nevada, Las Vegas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neck Disability Index6 months10-item patient self-report measure of perceived disability

Secondary

MeasureTime frame
Medication Use6 months
Global Rating of Change Scale6 months
Numeric Pain Rating Scale6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026