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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02451267
Enrollment
139
Registered
2015-05-21
Start date
2015-05-31
Completion date
2017-03-31
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

neck pain, aerobic exercise, cervical pain

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

Interventions

OTHERphysical therapy treatment with aerobic exercise

neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)

neck exercise strengthening program with neck massage

Sponsors

University of Haifa
CollaboratorOTHER
Clalit Health Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Global Rating of Change (GROC) scalefollowing 6 weeks of treatment, 3 months and 6 monthsrating pain severity on a scale from -7 to 7

Secondary

MeasureTime frameDescription
Change from baseline in Fear Avoidance Beliefs Questionnairefollowing 6 weeks of treatmentQuestionnaire about the individuals fear that his pain is caused due to movement or work
Change from baseline in cervical range of motionfollowing 6 weeks of treatmentactive range of motion using inclinometer
long term follow up assessment of VAS3 months and 6 monthsphone assessment of cervical pain severity
Change from baseline in Neck Disability Index at 6 weeksfollowing 6 weeks of treatmentQuestionnaire assessing the individuals disability due to the neck pain
Change from baseline in Visual Analog Scale (VAS) at 6 weeksfollowing 6 weeks of treatmentrating pain severity on a scale from 0-10
headache complaintsfollowing 6 weeks of treatment, 3 months and 6 monthscomplains of headache episodes
medication consumption for pain relieffollowing 6 weeks of treatment, 3 months and 6 monthshow many medication the patient used
long term follow up assessment Neck Disability Index3 months and 6 monthsphone assessment of individuals disability

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026