Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT02451267
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2015-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
Sponsor:
Clalit Health Services
Organization:
Study Overview
Official Title:
Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: