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| Name | Class |
|---|---|
| University of Haifa | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| positive CPR: research group | Experimental | physical therapy treatment with aerobic exercise |
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| negative CPR: research group | Experimental | physical therapy treatment with aerobic exercise |
|
| positive CPR: control group | Active Comparator | physical therapy treatment |
|
| negative CPR: control group | Active Comparator | physical therapy treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical therapy treatment with aerobic exercise | Other | neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in Fear Avoidance Beliefs Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gali Dar, PhD | University of Haifa, Department of Physical Therapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clalit Health Service | Nazareth | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24377062 | Background | 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. | |
| 19046448 |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D009043 | Motor Activity |
| D009068 | Movement |
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| physical therapy treatment | Other | neck exercise strengthening program with neck massage |
|
Questionnaire about the individuals fear that his pain is caused due to movement or work
| following 6 weeks of treatment |
| Change from baseline in cervical range of motion | active range of motion using inclinometer | following 6 weeks of treatment |
| long term follow up assessment of VAS | phone assessment of cervical pain severity | 3 months and 6 months |
| long term follow up assessment Neck Disability Index | phone assessment of individuals disability | 3 months and 6 months |
| 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 |
| headache complaints | complains of headache episodes | following 6 weeks of treatment, 3 months and 6 months |
| medication consumption for pain relief | how many medication the patient used | following 6 weeks of treatment, 3 months and 6 months |
| 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. |
| 33730206 | Derived | 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. |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |