Back to resultsValidation of CPR for Manipulation for Neck Pain
Primary Purpose
Cervicalgia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manipulation
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cervicalgia focused on measuring Neck pain
Eligibility Criteria
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
Sites / Locations
- University of Nevada Las Vegas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Manipulation
Exercise
Arm Description
Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises
Patients will receive 5 visits of therapeutic exercises
Outcomes
Primary Outcome Measures
Neck Disability Index
10-item patient self-report measure of perceived disability
Secondary Outcome Measures
Medication Use
Global Rating of Change Scale
Numeric Pain Rating Scale
Full Information
NCT ID
NCT02287337
First Posted
November 3, 2014
Last Updated
October 18, 2019
Sponsor
University of Nevada, Las Vegas
1. Study Identification
Unique Protocol Identification Number
NCT02287337
Brief Title
Validation of CPR for Manipulation for Neck Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
IRB approval expired when PI left UNLV
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
August 26, 2017 (Actual)
Study Completion Date
August 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicalgia
Keywords
Neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manipulation
Arm Type
Experimental
Arm Description
Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises
Arm Title
Exercise
Arm Type
Other
Arm Description
Patients will receive 5 visits of therapeutic exercises
Intervention Type
Procedure
Intervention Name(s)
Manipulation
Intervention Description
High velocity low amplitude thrust joint manipulation to cervical spine facet joints
Intervention Type
Procedure
Intervention Name(s)
Exercise
Intervention Description
Therapeutic exercises to the cervical, thoracic and scapular musculature
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
10-item patient self-report measure of perceived disability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Medication Use
Time Frame
6 months
Title
Global Rating of Change Scale
Time Frame
6 months
Title
Numeric Pain Rating Scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Nevada Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89178
Country
United States
12. IPD Sharing Statement
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Validation of CPR for Manipulation for Neck Pain
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