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

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: physical therapy treatment with aerobic exercise; Other: physical therapy treatment

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Nazareth, Israel
    • Clalit Health Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clalit Health Services
• Collaborators: University of Haifa
• Investigators: Study Director: Gali Dar, PhD, University of Haifa, Department of Physical Therapy

Publications and helpful links

General Publications

• Hanney WJ, Kolber MJ, George SZ, Young I, Patel CK, Cleland JA. Development of a preliminary clinical prediction rule to identify patients with neck pain that may benefit from a standardized program of stretching and muscle performance exercise: a prospective cohort study. Int J Sports Phys Ther. 2013 Dec;8(6):756-76.
• Holth HS, Werpen HK, Zwart JA, Hagen K. Physical inactivity is associated with chronic musculoskeletal complaints 11 years later: results from the Nord-Trondelag Health Study. BMC Musculoskelet Disord. 2008 Dec 1;9:159. doi: 10.1186/1471-2474-9-159.
• Daher A, Dar G, Carel R. Effectiveness of combined aerobic exercise and neck-specific exercise compared to neck-specific exercise alone on work ability in neck pain patients: a secondary analysis of data from a randomized controlled trial. Int Arch Occup Environ Health. 2021 Oct;94(7):1739-1750. doi: 10.1007/s00420-021-01684-0. Epub 2021 Mar 17.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 10, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: neck pain; aerobic exercise; cervical pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: COM-0016-15