Neck Pain Clinical Trial
Official title:
Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
NCT number | NCT02451267 |
Other study ID # | COM-0016-15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | March 2017 |
Verified date | March 2019 |
Source | Clalit Health Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Clalit Health Service | Nazareth |
Lead Sponsor | Collaborator |
---|---|
Clalit Health Services | University of Haifa |
Israel,
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
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 |
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