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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary:

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
Sponsor: Clalit Health Services

Current Primary Outcome: Change from baseline in Visual Analog Scale (VAS) at 6 weeks [ Time Frame: following 6 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline in Neck Disability Index at 6 weeks [ Time Frame: following 6 weeks of treatment ]
  Questionnaire assessing the individuals disability due to the neck pain
• Change from baseline in Fear Avoidance Beliefs Questionnaire [ Time Frame: following 6 weeks of treatment ]
  Questionnaire about the individuals fear that his pain is caused due to movement or work
• Change from baseline in cervical range of motion [ Time Frame: following 6 weeks of treatment ]
  active range of motion using inclinometer
• long term follow up assessment of VAS [ Time Frame: 3 months and 6 months ]
  phone assessment of cervical pain severity
• long term follow up assessment Neck Disability Index [ Time Frame: 3 months and 6 months ]
  phone assessment of individuals disability

Original Secondary Outcome: Same as current

Information By: Clalit Health Services

Dates:
Date Received: May 10, 2015
Date Started: October 2015
Date Completion: September 2018
Last Updated: July 20, 2016
Last Verified: July 2016