Validation of CPR for Manipulation for Neck Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2017-08-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervicalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Manipulation

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

Group Type EXPERIMENTAL

Manipulation

Intervention Type PROCEDURE

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

Exercise

Intervention Type PROCEDURE

Therapeutic exercises to the cervical, thoracic and scapular musculature

Exercise

Patients will receive 5 visits of therapeutic exercises

Group Type OTHER

Exercise

Intervention Type PROCEDURE

Therapeutic exercises to the cervical, thoracic and scapular musculature

Interventions

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Manipulation

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

Intervention Type PROCEDURE

Exercise

Therapeutic exercises to the cervical, thoracic and scapular musculature

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes