We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Identify Patients With Neck Pain Likely to Benefit From Education and Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01144884
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : May 20, 2014
Sponsor:
Collaborators:
Nova Southeastern University
Franklin Pierce University
Florida Hospital
Information provided by (Responsible Party):
William J. Hanney, University of Central Florida

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.

Condition or disease Intervention/treatment
Neck Pain Other: Procedure (education and exercise)

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Education and Exercise
Study Start Date : August 2009
Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Single arm trial

Education: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

Other: Procedure (education and exercise)
education/exercise



Primary Outcome Measures :
  1. Perceived Disability as measured by the Neck Disability Index [ Time Frame: 6 weeks ]
  2. Perceived pain intensity as measure by the Numeric pain rating scale [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 6 months ]
  3. Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire [ Time Frame: 6 weeks ]
  4. Perceived rating of change as measure by the Global Rating of Change [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Disability as measured by the Neck Disability Index [ Time Frame: baseline, 2 weeks, 4 weeks, 6 months ]
  2. Perceived pain intensity as measure by the Numeric pain rating scale [ Time Frame: baseline, 2 weeks, 4 weeks, 6 months ]
  3. Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire [ Time Frame: baseline, 2 weeks, 4 weeks, 6 months ]
  4. Perceived rating of change as measure by the Global Rating of Change [ Time Frame: 2 weeks, 4 weeks, 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144884


Locations
United States, Florida
Florida Hospital Sports Medicine & Rehabilitation - Altamonte
Altamonte Springs, Florida, United States, 32701
Brooks Rehabilitation - Monument
Jacksonville, Florida, United States, 32225
Brooks Rehabilitation -Spine Center
Jacksonville, Florida, United States, 32225
Florida Hospital Sports Medicine & Rehabilitation - Kissimmee
Kissimmee, Florida, United States, 34741
Brooks Rehabilitation - Lake Mary
Lake Mary, Florida, United States, 32746
Brooks Rehabilitation - Flemming Island
Orange Park, Florida, United States, 32003
Florida Hospital Sports Medicine & Rehabilitation - RDV
Orlando, Florida, United States, 32810
Brooks Rehabilitation - Waterford
Orlando, Florida, United States, 32828
Florida Hospital Sports Medicine & Rehabilitation - Oviedo
Oviedo, Florida, United States, 32765
Sponsors and Collaborators
William J. Hanney
Nova Southeastern University
Franklin Pierce University
Florida Hospital
Investigators
Principal Investigator: William Hanney, PT DPT University of Central Florida

Responsible Party: William J. Hanney, Assistant Professor, University of Central Florida
ClinicalTrials.gov Identifier: NCT01144884     History of Changes
Other Study ID Numbers: 18808040
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by William J. Hanney, University of Central Florida:
Neck pain
education
exercise
clinical prediction rule

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms