View Clinical Trial (Medical Research Study)
Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Education and Exercise
| City: |
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Orange Park |
| State: |
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Florida |
| Zip Code: |
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32003 |
| Conditions: |
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Neck Pain |
| Purpose: |
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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.
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| Study Summary: |
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The sample size will consist of 90 subjects ages 18 or above with a primary complaint of
neck pain. The subjects must be able to read and communicate in English in order to
complete the required documentation. No specific conditions are to be included which would
make this a protected population.
Patients will be recruited in one of two ways. First, flyers will be sent to local
referrals announcing the study and request for subjects. Should a patient be interested in
participating they will call the PI at the phone number listed on the flyer. The PI will
inquire about patient location and coordinate a convenient location. Second, patients which
present to a participating clinic with primary complaint of neck pain will be handed a flyer
and asked by the front office if they would be interested to hear more about the study. If
the patient expresses interest in participating they will meet with a clinician trained in
the study to review inclusion and exclusion criterion. Should the patient meet all
inclusion and have no exclusion criterion, the informed consent form will be reviewed with
the patient by a trained clinician. Once the patient has agreed to participate and signed
the informed consent they will be formally enrolled into the study.
All information obtained in this study is strictly confidential unless disclosure is
required by law. Federal Privacy Regulations provide safeguards for privacy, security, and
authorized access. Except when required by law, the patient will not be identified by name,
social security number, address, telephone number, or any other direct personal identifier.
All records pertaining to the patient's involvement in this research study will be stored in
a locked file cabinet. A case number will indicate the patient's identity on these records.
This information will only be accessible to the investigators listed on the first page of
this document and the research study staff.
Methods and Procedures This study will follow a standardized examination and treatment
protocol. All interventions and techniques have been proven to be effective in this patient
population. Once the patient is deemed eligible for the study the informed consent will be
reviewed by an investigator. If the patient agrees to participate in the study they will
sign the informed consent. The patient will complete self report measures which will take
approximately 20 minutes. Self report measures to be completed include the neck disability
index (NDI), fear avoidance beliefs questionnaire (FABQ), global rating of change (GROC),
and numeric pain rating scale (NPRS). An investigator will then perform a standardized
examination which will take approximately 1 hour. Examination findings will be recorded on
the cervical examination form. The patient will then be given an opportunity to undergo a
second examination by a blinded examiner for reliability purposes. This second examination
is optional and must be performed within 48 hours and before treatment is initiated.
Upon completion of the examination the patient will be issued a home care guide which
included educational materials and the standardized exercise program. The patients will be
asked to review the educational information. When the patient returns for follow up visits
the standardized treatment program of education and exercise will be initiated and
progressed. Each subsequent treatment session will last approximately one hour. The
patient will be asked to perform the exercise program 2 times per week for 6 weeks and
perform stretches independently. In order to monitor progress the self report measures will
be completed every two weeks.
When applicable, a portion of the research costs associated with the physical therapy
procedures will be billed to the patient's insurance provider. The patient's co-payments
will be the same as if they were not part of the research study. The procedures will be
documented in their medical/Research record. There will be no additional costs to the
patient outside of the normal delivery of care and no further payment will be offered to the
patient for participation in the study. Participants will be reimbursed a nominal amount
for the time necessary to complete the research documentation. Subject reimbursement is as
follows:
Data Analysis Reliability of the examination variables will be assessed for a blinded
examiner on a second examination. Descriptive statistics will be calculated which include
frequency counts for categorical data and calculation of the mean and standard deviation
(SD) for continuous variables. Cohen k will be used to calculate inter-rater reliability of
categorical data with only 2 response options possible. A weighted k will be used to
calculate the reliability of categorical data with 3 response options. The weight k will be
calculated using a linear weighting method. Intraclass correlation coefficients (ICC) model
2,1 and the 95% confidence intervals will be calculated to determine the inter-rater
reliability for continuous variables. The standard error of measurement (SEM) will be
calculated as SD√ (1-r), where SD is the standard deviation of the observed scores and r is
the reliability coefficient for the measurement. The minimal detectable change (MDC) for
continuous variables will be calculated as 1.96X SEM X √2. The total measure of error will
be calculated for continuous data by mean difference between raters (rater A - rater B) +/-
1.96 X SD. The total measure of error represents the values within which 95% of the
measurements between raters lie. Reliability for categorical variables will be interpreted
as follows; values < 0.10 no agreement; 0.11 to 0.40 slight agreement; 0.41 to 0.60 fair
agreement; 0.61 and 0.80 moderate agreement and values >0.81 substantial agreement.
Reliability for continuous variables will be interpreted as follows: < 0.10 no agreement;
0.11 to 0.40 slight agreement; 0.61 and 0.80 moderate agreement; and values > 0.81
substantial agreement.
Dependent t-tests will be used to analyze each of the primary outcome variables including
Numeric pain rating scale (NPRS), Neck Disability Index (NDI), Fear Avoidance Beliefs
Questionnaire - Physical Activity (FABQ-PA) and Fear Avoidance Beliefs Questionnaire - Work
(FABQ-W). The alpha level will be set at 0.05. Multiple comparisons will be conducted
(baseline - 2 weeks; baseline - 4 weeks; baseline - 6 weeks and baseline - 6 months)
between the paired time frames with a dependent t-test. Bonferroni correction will be used
to establish the significance level at 0.0125 (.05/4).
Potential predictor variables will come from the outcome measures, demographics form,
history and physical assessment. Analysis will be implemented using independent t-tests for
continuous variables and X2 tests for categorical variables to determine differences between
successful and non-success outcomes. Variables with a significance of p<.10 will be
retained as potential prediction variables for each group. This p value will be used to
decrease the likelihood that a potential predictor variable will be missed. Sensitivity and
specificity values will be calculated for continuous variables with a significant univariate
relationship and plotted as a receiver operating characteristics (ROC) curve. The point on
the curve which is closest to the upper left corner represents the values with greatest
diagnostic accuracy. This point will be selected as the cutoff defining a positive test.
Sensitivity, specificity and likelihood ratios will be calculated for retained variables in
the successful and non-successful groups. Potential predictor variables for each group will
then be entered into a separate backward stepwise logistic regression model to identify the
most prudent group of variables for the treatment outcome. Those variables preserved in the
regression model will be used to develop a multivariate CPR for classifying patients likely
to have a successful and non-successful outcome by completing a program of education and
exercise for this sample.
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| Criteria: |
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Inclusion Criteria:
1. Over the age of 18
2. Primary complaint of neck pain with or without unilateral UE symptoms
3. Neck Disability Index (NDI) of 10% or greater.
Exclusion Criteria:
1. Presence of medical "red flags' noted in the Neck Medical Screening Questionnaire.
(i.e. tumor, fracture, etc.)
2. 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.)
3. Spasmodic torticollis
4. Frequent migraine
5. Fibromyalgia
6. Prior Surgery to the neck or thoracic spine
7. Severe psychiatric illness
8. Inability to comply with treatment and follow-up schedule
9. Pending legal action regarding their neck pain
10. Insufficient English language skills to complete all questionnaires.
11. Latex allergies
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| NCT ID: |
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NCT01144884 |
| Primary Contact: |
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Principal Investigator
William Hanney, PT DPT
University of Central Florida
William Hanney, PT DPT
Phone: 407-823-0217
Email: whanney@mail.ucf.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Orange Park, Florida 32003
United States
Jason Kral, PT
Phone: 904-637-0148
Email: Jason.kral@brookshealth.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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