Clinical trial NCT02451267: Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
Official title: Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
aerobic exercise
cervical pain
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2015-05-21
Enrollment: 139
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Global Rating of Change (GROC) scale
timeFrame: following 6 weeks of treatment, 3 months and 6 months
Secondary outcomes:
measure: Change from baseline in Neck Disability Index at 6 weeks
timeFrame: following 6 weeks of treatment
measure: Change from baseline in Fear Avoidance Beliefs Questionnaire
timeFrame: following 6 weeks of treatment
measure: Change from baseline in cervical range of motion
timeFrame: following 6 weeks of treatment
measure: long term follow up assessment of VAS
timeFrame: 3 months and 6 months
measure: long term follow up assessment Neck Disability Index
timeFrame: 3 months and 6 months
measure: Change from baseline in Visual Analog Scale (VAS) at 6 weeks
timeFrame: following 6 weeks of treatment
measure: headache complaints
timeFrame: following 6 weeks of treatment, 3 months and 6 months
measure: medication consumption for pain relief
timeFrame: following 6 weeks of treatment, 3 months and 6 months
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Clalit Health Service
Study officials:
affiliation: University of Haifa, Department of Physical Therapy
name: Gali Dar, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.