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NCT Number: NCT02451267

Clinical Prediction Rules 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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clalit Health Service

Nazareth, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical therapy treatment with aerobic exercise

Other

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

physical therapy treatment

Other

neck exercise strengthening program with neck massage

Primary outcomes

  1. Global Rating of Change (GROC) scale

    Time frame: following 6 weeks of treatment, 3 months and 6 months

    rating pain severity on a scale from -7 to 7

Secondary outcomes

  1. 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

  2. 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

  3. Change from baseline in cervical range of motion

    Time frame: following 6 weeks of treatment

    active range of motion using inclinometer

  4. long term follow up assessment of VAS

    Time frame: 3 months and 6 months

    phone assessment of cervical pain severity

  5. long term follow up assessment Neck Disability Index

    Time frame: 3 months and 6 months

    phone assessment of individuals disability

  6. Change from baseline in Visual Analog Scale (VAS) at 6 weeks

    Time frame: following 6 weeks of treatment

    rating pain severity on a scale from 0-10

  7. headache complaints

    Time frame: following 6 weeks of treatment, 3 months and 6 months

    complains of headache episodes

  8. medication consumption for pain relief

    Time frame: following 6 weeks of treatment, 3 months and 6 months

    how many medication the patient used

Sponsors and collaborators

Lead sponsor

Clalit Health Services

Other

Collaborators

  • University of Haifa

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 21, 2015
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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