Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. The research group will receive neck exercise program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. In addition, clinical prediction rule (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment program will be defined.

Detailed Description
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Background:Recently, Hanney et al (2013) derived a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise-based treatment program. These CPRs of neck exercise has not considered aerobic exercise (AE) on NP treatment. Aims of this study: 1) To investigate the effect of aerobic exercise on chronic neck pain;2) To derive a clinical prediction rule for identifying patients with neck pain who may benefit from aerobic treatment program; 3) To determine the prevalence of neck pain in Israel. Study Design: Double Blind Randomized controlled trial setting: Outpatients physical therapy clinics of Clalit Health Services in Haifa and Western Galilee area. Participants: Patients referred to physical therapy with a primary diagnosis of chronic non-specific NP. Methods: Following a baseline examination in which the subjects' status on the CPR will be determined, the subjects (CPR positive and negative) will be randomized, divided into a research group and control group. The CPR status will be determined according to Hanney's paper (e.g.: neck disability Index score < 18/50 ,shoulder protraction, cervical side bending < 32°,Fear avoidance belief questionnaire-physical activity score < 15, not active on a regular basis on bicycle training). Positive CPR is accordance of having 4/5 these points. The baseline examination will include: active and passive cervical range of motion, neurological exam (reflex, sensation, muscle testing), cervical segmental mobility (accessory movement), neck muscle length, cervical manual muscle test and posture assessment. The research group will receive neck exercise program with neck massage and AE (leg bicycling with relaxed shoulders) and the control group will receive neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. Immediate examination will be used at the last treatment (10 treatments), and at 3 and 6 month follow up examination for long-term effects. In addition, Data collecting from physiotherapy department in Clalit Health Services about statistic of patients with NP who referred to physical therapy including: Prevalence, demographic and profile data

Official Title
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Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise

Conditions
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Neck Pain

Intervention / Treatment
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* Other: physical therapy treatment with aerobic exercise
* Other: physical therapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic neck pain (> 30 days) neck disability index >10 not physical active on a daily basis Exclusion Criteria: past history of whiplash injury or cervical surgery pain radiates to the upper limb with neurological deficit (reduced reflex, sensation, muscle strength) complain of vertigo cervical spine diseases: Spondylosis, Spondylolisthesis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positive CPR: research group<br>physical therapy treatment with aerobic exercise | Other: physical therapy treatment with aerobic exercise<br>* neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)<br>|
| Experimental: negative CPR: research group<br>physical therapy treatment with aerobic exercise | Other: physical therapy treatment with aerobic exercise<br>* neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)<br>|
| Active Comparator: positive CPR: control group<br>physical therapy treatment | Other: physical therapy treatment<br>* neck exercise strengthening program with neck massage<br>|
| Active Comparator: negative CPR: control group<br>physical therapy treatment | Other: physical therapy treatment<br>* neck exercise strengthening program with neck massage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change (GROC) scale | rating pain severity on a scale from -7 to 7 | following 6 weeks of treatment, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Neck Disability Index at 6 weeks | Questionnaire assessing the individuals disability due to the neck pain | following 6 weeks of treatment | 
| Change from baseline in Fear Avoidance Beliefs Questionnaire | Questionnaire about the individuals fear that his pain is caused due to movement or work | following 6 weeks of treatment | 
| Change from baseline in cervical range of motion | active range of motion using inclinometer | following 6 weeks of treatment | 
| long term follow up assessment of VAS | phone assessment of cervical pain severity | 3 months and 6 months | 
| long term follow up assessment Neck Disability Index | phone assessment of individuals disability | 3 months and 6 months | 
| Change from baseline in Visual Analog Scale (VAS) at 6 weeks | rating pain severity on a scale from 0-10 | following 6 weeks of treatment | 
| headache complaints | complains of headache episodes | following 6 weeks of treatment, 3 months and 6 months | 
| medication consumption for pain relief | how many medication the patient used | following 6 weeks of treatment, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, aerobic exercise, cervical pain