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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451267
• Other study ID #: COM-0016-15
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2019
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• physical therapy treatment with aerobic exercise
neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)
• physical therapy treatment
neck exercise strengthening program with neck massage

Locations

Country	Name	City	State
Israel	Clalit Health Service	Nazareth

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

Holth HS, Werpen HK, Zwart JA, Hagen K. Physical inactivity is associated with chronic musculoskeletal complaints 11 years later: results from the Nord-Trøndelag Health Study. BMC Musculoskelet Disord. 2008 Dec 1;9:159. doi: 10.1186/1471-2474-9-159. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline in cervical range of motion	active range of motion using inclinometer	following 6 weeks of treatment
Secondary	long term follow up assessment of VAS	phone assessment of cervical pain severity	3 months and 6 months
Secondary	long term follow up assessment Neck Disability Index	phone assessment of individuals disability	3 months and 6 months
Secondary	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
Secondary	headache complaints	complains of headache episodes	following 6 weeks of treatment, 3 months and 6 months
Secondary	medication consumption for pain relief	how many medication the patient used	following 6 weeks of treatment, 3 months and 6 months