Comparison of the effect of sustained traction with Over-the-door home traction unit and Air neck traction device on neck pain, range of motion and disability level in cervical osteoarthritis.
The aim of this study is to compare the effect of sustained traction by 'Over-the-door home traction unit' and 'Air neck traction device' on neck pain, range of motion and disability level in cervical osteoarthritis. The patients randomly will be assigned to two groups. Total sample is determined 26 cases and will be chosen from the patients with cervical osteoarthritis aged from 30-70 and with more or equal to 2 neck pain grade and the positivity of 'Compression & Distraction' test. The patients with the history of neck surgery or trauma, Grade 4 osteoarthritis and complications like rheumatoid arthritis and osteoporosis will be excluded from the study.
Similar physical treatments will be received in both group in each session including common physiotherapy modalities such as hot pack, TENS, Ultrasound therapy and exercises. In the end of each session, first group of patients will be treated by the “Over-the-door home traction unit” and the second group will be treated by "Air neck traction device". Treatment intervention lasted 10 sessions (2 weeks) for each individual and the intensity of pain, range of motion and disability level will be measured in the beginning of the first session and in the end of the last session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081118762N1
Registration date:2014-10-05, 1393/07/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-05, 1393/07/13
Registrant information
Name
Mojtaba Kamyab
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
kamyab.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sustained traction with Over-the-door home traction unit and Air neck traction device on neck pain, range of motion and disability level in cervical osteoarthritis.
Public title
The effect of traction on cervical osteoarthritis symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 30-70 year-old; Chief complaint: Cervical pain with or without any upper limb symptoms; Grade 1-3 osteoarthritis diagnosis from radio-graphs; Obtaining more or equal to 10% points in “Neck Disability Index” Questionnaire; More or equal to 2 points from 10 in “Numerical Pain Rating Scale”; Positive result from “Cervical Distraction & Compression” test.
Exclusion criteria: History of cervical or upper thoracic(T1-T6) trauma; History of cervical surgery; Patients with severe cervical osteoarthritis (Grade 4) diagnosis based on radio-graphs; Spinal cord canal stenosis; non-skeletal symptoms; History of cervical spine fracture or sever vertebral osteoporosis; Rheumatoid arthritis; Visible congenital deformity of cervical spine; dysfunction of vertebral artery; Pregnancy; History of failed traction treatment; Considering any cervical physical therapies in the recent last 6 weeks.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Commettee of Iran University of Medical Sciences
Street address
Between the cross-road of Sheykh Fazlolah and Shahid Chamran, Shahid Hemmat Highway
City
Tehran
Postal code
Approval date
2014-06-23, 1393/04/02
Ethics committee reference number
105/1433/د/93
Health conditions studied
1
Description of health condition studied
Cervical arthrosis
ICD-10 code
M47
ICD-10 code description
arthrosis of spine
Primary outcomes
1
Description
Neck pain
Timepoint
Before of first treatment session and in the end of last session
Method of measurement
Mean of total score- Numerical pain rating scale
2
Description
Cervical range of motion
Timepoint
Before of first treatment session and in the end of last session
Method of measurement
Inclinometer-Degree
3
Description
Neck disability index
Timepoint
Before of first treatment session and in the end of last session
Method of measurement
percent of total score-Neck disability index questioner
4
Description
Pain relife drug and Non-steroidal anti-inflammatory drug
Timepoint
Before of first treatment session and in the end of last session
Method of measurement
Numbers-counting
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Common physiotherapy treatments including hot pack for 20 minutes, TENS for 20 minutes, Ultrasound therapy for 5 minutes, isometric and isotonic neck exercises 20 times a day each time with 10 seconds of holding position and shoulder girdle isotonic exercises 60 times a day with 10 seconds of holding position. These treatments will be followed by 20 minutes of traction by the “Over-the-door home traction unit”.
Category
Rehabilitation
2
Description
Second intervention group: Common physiotherapy treatments including hot pack for 20 minutes, TENS for 20 minutes, Ultrasound therapy for 5 minutes, isometric and isotonic neck exercises 20 times a day each time with 10 seconds of holding position and shoulder girdle isotonic exercises 60 times a day with 10 seconds of holding position. These treatments will be followed by 20 minutes of traction by the “Air neck traction device”
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Akram Hospital
Full name of responsible person
Dr. Ali Amiri
Street address
Department of Physiotherapy, The Seventh Floor, Seyedol Shohada Building, Hazrat Rasoul Akram Hospital, Niayesh St. Satar Khan Blv.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Naserbakht
Street address
Between the cross-road of Sheykh Fazlolah and Shahid Chamran, Shahid Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Batoul Bagheripour
Position
MSc. Student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
Bagheripourb.TO@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Mojtaba Kamyab
Position
Phd.
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Postal code
Phone
+98 21 2222 0947
Fax
Email
Mojtaba.Kamyab@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Batoul Bagheripour
Position
MSc. Student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Postal code
Phone
00
Fax
Email
Bagheripourb.TO@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)