Identify Patients With Neck Pain Likely to Benefit From Education and Exercise
Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Education and Exercise
1 other identifier
interventional
91
1 country
9
Brief Summary
The annual incidence of neck pain has been reported to be 14.6%. Other studies outline a wide disparity in the lifetime incidence of neck pain ranging from 22% to 70%. Numerous treatment options exist for the management of neck pain however, there is limited evidence to support which interventions are most effective. Exercise based interventions are commonly used in the treatment of patients with neck pain however; it is not clear which patients are most likely to benefit from this type of treatment. The purpose of this project is to develop a clinical prediction rule (CPR) to identify which patients with neck pain have a greater probability of benefiting from a standardized program of education and exercise. Ninety (90) patients referred to physical therapy will undergo a standardized examination to assess potential predictor variables. Upon completion of the examination a standardized treatment program of education and exercise will be administered regardless of examination findings. Self report measures will be administered on the initial examination and on follow up visits at 2, 4, and 6 weeks. A questionnaire and outcome measures will be also mailed out 6 months after initiation of treatment to assess long-term change. Once the treatment plan is completed, patients will be classified as having either a successful or non-successful response. Subjects which rated their perceived recovery on the Global Rating of Chance (GROC) as "a very great deal better", "a great deal better", "quite a bit better", or "moderately better" (i.e., a score of +4 or greater) will be categorized as having a successful outcome. The primary endpoints to determine the outcome will be analyzed at 6 weeks and 6 months. The result of this study will assist physical therapists to identify sub-groups of patients likely to benefit from a program of education and exercise. The categorization of patients in groups based on beneficial treatments may help to provide improved outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedMay 20, 2014
May 1, 2014
3.3 years
June 9, 2010
May 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Perceived Disability as measured by the Neck Disability Index
6 weeks
Perceived pain intensity as measure by the Numeric pain rating scale
Baseline, 2 weeks, 4 weeks, 6 weeks, 6 months
Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire
6 weeks
Perceived rating of change as measure by the Global Rating of Change
6 weeks
Secondary Outcomes (4)
Disability as measured by the Neck Disability Index
baseline, 2 weeks, 4 weeks, 6 months
Perceived pain intensity as measure by the Numeric pain rating scale
baseline, 2 weeks, 4 weeks, 6 months
Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire
baseline, 2 weeks, 4 weeks, 6 months
Perceived rating of change as measure by the Global Rating of Change
2 weeks, 4 weeks, 6 months
Study Arms (1)
Single arm trial
OTHEREducation:To standardize, treatment education will consist of counsel to stay active. Details will be given to subjects verbally \& reinforced in the home booklet. Posture:Facilitation of proper posture has been show to increase recruitment of the lumbar multifidus \& deep neck flexors. Instruction will be given verbally \& in writing. Stretching:Stretching exercises will be targeted to address these common impairments. Patients will be introduced to proper stretching procedures. Each stretch will be held for 30s \& repeated two times,each side as applicable. The following stretches will be performed: Upper trap Anterior/medial Scalene Suboccipital Pectoralis Muscular Performance: Muscle performance will be trained incorporating components of strength, endurance and motor control. Each of the exercises listed below are outlined based on progressions. Isometric Cervical Extension Craniocervical flexion Seated Row Seated "T" Palms Up Seated Side Arm Raises
Interventions
Eligibility Criteria
You may qualify if:
- Over the age of 18
- Primary complaint of neck pain with or without unilateral UE symptoms
- Neck Disability Index (NDI) of 10% or greater.
You may not qualify if:
- Presence of medical "red flags' noted in the Neck Medical Screening Questionnaire. (i.e. tumor, fracture, etc.)
- Evidence of central nervous system (CNS) involvement (i.e. 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 such as Hoffman's or Babinski reflexes, etc.)
- Spasmodic torticollis
- Frequent migraine
- Fibromyalgia
- Prior Surgery to the neck or thoracic spine
- Severe psychiatric illness
- Inability to comply with treatment and follow-up schedule
- Pending legal action regarding their neck pain
- Insufficient English language skills to complete all questionnaires.
- Latex allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- William J. Hanneylead
- Nova Southeastern Universitycollaborator
- Franklin Pierce Universitycollaborator
- AdventHealthcollaborator
Study Sites (9)
Florida Hospital Sports Medicine & Rehabilitation - Altamonte
Altamonte Springs, Florida, 32701, United States
Brooks Rehabilitation - Monument
Jacksonville, Florida, 32225, United States
Brooks Rehabilitation -Spine Center
Jacksonville, Florida, 32225, United States
Florida Hospital Sports Medicine & Rehabilitation - Kissimmee
Kissimmee, Florida, 34741, United States
Brooks Rehabilitation - Lake Mary
Lake Mary, Florida, 32746, United States
Brooks Rehabilitation - Flemming Island
Orange Park, Florida, 32003, United States
Florida Hospital Sports Medicine & Rehabilitation - RDV
Orlando, Florida, 32810, United States
Brooks Rehabilitation - Waterford
Orlando, Florida, 32828, United States
Florida Hospital Sports Medicine & Rehabilitation - Oviedo
Oviedo, Florida, 32765, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Hanney, PT DPT
University of Central Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 9, 2010
First Posted
June 16, 2010
Study Start
August 1, 2009
Primary Completion
December 1, 2012
Last Updated
May 20, 2014
Record last verified: 2014-05