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

Completed · Not applicable

Conditions studied: Neck Pain

In brief

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.

Key facts

Study ID

NCT01144884

Run by

William J. Hanney

People needed

91

Starts

2009-08-01

Last updated by the study team

2014-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Florida Hospital Sports Medicine & Rehabilitation - Altamonte — Altamonte Springs, Florida, United States
• Brooks Rehabilitation - Monument — Jacksonville, Florida, United States
• Brooks Rehabilitation -Spine Center — Jacksonville, Florida, United States
• Florida Hospital Sports Medicine & Rehabilitation - Kissimmee — Kissimmee, Florida, United States
• Brooks Rehabilitation - Lake Mary — Lake Mary, Florida, United States
• Brooks Rehabilitation - Flemming Island — Orange Park, Florida, United States
• Florida Hospital Sports Medicine & Rehabilitation - RDV — Orlando, Florida, United States
• Brooks Rehabilitation - Waterford — Orlando, Florida, United States
• Florida Hospital Sports Medicine & Rehabilitation - Oviedo — Oviedo, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.