Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
physical therapy treatment with aerobic exercise
physical therapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain, aerobic exercise, cervical pain
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
Sites / Locations
- Clalit Health Service
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
positive CPR: research group
negative CPR: research group
positive CPR: control group
negative CPR: control group
Arm Description
physical therapy treatment with aerobic exercise
physical therapy treatment with aerobic exercise
physical therapy treatment
physical therapy treatment
Outcomes
Primary Outcome Measures
Global Rating of Change (GROC) scale
rating pain severity on a scale from -7 to 7
Secondary Outcome Measures
Change from baseline in Neck Disability Index at 6 weeks
Questionnaire assessing the individuals disability due to the neck pain
Change from baseline in Fear Avoidance Beliefs Questionnaire
Questionnaire about the individuals fear that his pain is caused due to movement or work
Change from baseline in cervical range of motion
active range of motion using inclinometer
long term follow up assessment of VAS
phone assessment of cervical pain severity
long term follow up assessment Neck Disability Index
phone assessment of individuals disability
Change from baseline in Visual Analog Scale (VAS) at 6 weeks
rating pain severity on a scale from 0-10
headache complaints
complains of headache episodes
medication consumption for pain relief
how many medication the patient used
Full Information
NCT ID
NCT02451267
First Posted
May 10, 2015
Last Updated
March 12, 2019
Sponsor
Clalit Health Services
Collaborators
University of Haifa
1. Study Identification
Unique Protocol Identification Number
NCT02451267
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clalit Health Services
Collaborators
University of Haifa
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, aerobic exercise, cervical pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
positive CPR: research group
Arm Type
Experimental
Arm Description
physical therapy treatment with aerobic exercise
Arm Title
negative CPR: research group
Arm Type
Experimental
Arm Description
physical therapy treatment with aerobic exercise
Arm Title
positive CPR: control group
Arm Type
Active Comparator
Arm Description
physical therapy treatment
Arm Title
negative CPR: control group
Arm Type
Active Comparator
Arm Description
physical therapy treatment
Intervention Type
Other
Intervention Name(s)
physical therapy treatment with aerobic exercise
Intervention Description
neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)
Intervention Type
Other
Intervention Name(s)
physical therapy treatment
Intervention Description
neck exercise strengthening program with neck massage
Primary Outcome Measure Information:
Title
Global Rating of Change (GROC) scale
Description
rating pain severity on a scale from -7 to 7
Time Frame
following 6 weeks of treatment, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in Neck Disability Index at 6 weeks
Description
Questionnaire assessing the individuals disability due to the neck pain
Time Frame
following 6 weeks of treatment
Title
Change from baseline in Fear Avoidance Beliefs Questionnaire
Description
Questionnaire about the individuals fear that his pain is caused due to movement or work
Time Frame
following 6 weeks of treatment
Title
Change from baseline in cervical range of motion
Description
active range of motion using inclinometer
Time Frame
following 6 weeks of treatment
Title
long term follow up assessment of VAS
Description
phone assessment of cervical pain severity
Time Frame
3 months and 6 months
Title
long term follow up assessment Neck Disability Index
Description
phone assessment of individuals disability
Time Frame
3 months and 6 months
Title
Change from baseline in Visual Analog Scale (VAS) at 6 weeks
Description
rating pain severity on a scale from 0-10
Time Frame
following 6 weeks of treatment
Title
headache complaints
Description
complains of headache episodes
Time Frame
following 6 weeks of treatment, 3 months and 6 months
Title
medication consumption for pain relief
Description
how many medication the patient used
Time Frame
following 6 weeks of treatment, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Organizational Affiliation
University of Haifa, Department of Physical Therapy
Official's Role
Study Director
Facility Information:
Facility Name
Clalit Health Service
City
Nazareth
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
24377062
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.
Results Reference
background
PubMed Identifier
19046448
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.
Results Reference
background
PubMed Identifier
33730206
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.
Results Reference
derived
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Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
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