Control trial of the effect of ergonomic latex pillow on pain and disability, range of motion, cervical flexor muscles endurance and head and neck posture in patients with cervical spondylosis
The aim of this study is to investigate the effect of ergonomic latex pillow in patients with cervical spondylosis. This study is randomized control trial, single center and single blinded.
Inclusion criteria: cervical spondylosis patients.
Exclusion criteria: Trauma or disease affecting the cervical and cervicothoracic spine in the preceding year or a history of cervical surgery; Any change (increase or decrease) in head and neck support or people who use more than one pillow; Subjects normally using no pillow or anything other than a conventional pillow (which is common in Iranian culture like feather or cotton pillow) or if they have a history of using a cervical ruff or pillow (medical pillow); Subjects who received physiotherapy for neck pain during last three months; Wearing collar; Spinal cord canal stenosis. Sample size of the population is consisted of 42 patients. Subjects are divided into 2 groups that intervention group will receive ergonomic latex pillow and physiotherapy while control group will receive only physiotherapy for 4 weeks. Primary outcome measures: short cervical flexor muscles endurance, craniovertebral angle, pain, range of motion, disability. Secondary outcome measures: cervical extensor muscles endurance and the amount of satisfaction from ergonomic latex pillow.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021916643N1
Registration date:2016-12-28, 1395/10/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-28, 1395/10/08
Registrant information
Name
Behshid Farahmand
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
farahmand.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2017-01-17, 1395/10/28
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Control trial of the effect of ergonomic latex pillow on pain and disability, range of motion, cervical flexor muscles endurance and head and neck posture in patients with cervical spondylosis
Public title
The effect of ergonomic latex pillow on neck arthrosis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people at the age of 30 to 60 year; Reporting a chronic and/or dull pain in the neck, with or without a radicular pain through the upper limbs; Grade 2 and 3 cervical spondylosis with at least two out of four of the following radiographic changes in the cervical region: Intervertebral disc space narrowing; Sclerosis of subchondral bone; Osteophyt formation between adjacent vertebral bodies or articular facets; The narrowing of the space between articular processes (facet joints); Positive compression and distraction test; Score ≥ 2 of 10 in Numerical Pasin Rating Scale (NPRS); Score ≥ 20% in Neck Disability Index (NDI) questionnaire.
Exclusion criteria: Other non-specific neck pain lesions, acute neck strain, postural neck ache, or whiplash; Metabolic diseases, Paget’s disease, osteoporosis, gout, or pseudo-gout; Inflammatory disease—rheumatoid arthritis, ankylosing spondylitis, or polymyalgia rheumatic; Infections—osteomyelitis or tuberculosis; tumors; Fibromyalgia and psychogenic neck pain; Temporomandibular joint surgery or disorder; Trauma or disease affecting the cervical and cervicothoracic spine in the preceding year or a history of cervical surgery; Spinal cord canal stenosis; Congenital anomalies involving the spine (cervical, thoracic, lumbar and scoliosis); Pregnancy or breast-feeding; Persistent respiratory difficulties over the last 5 years that have necessitated absence from work, have required long-term medication, or have interfered with daily activities; Recurrent middle ear infections over the last 5 years or any hearing impairment requiring the use of a hearing aid; Any change (increase or decrease) in head and neck support or people who use more than one pillow; Patients who don’t complete a 12-sessions therapeutic period, or follow up evaluation; Subjects normally using no pillow or anything other than a conventional pillow (which is common in Iranian culture like feather or cotton pillow) or if they have a history of using a cervical ruff or pillow (medical pillow); Subjects who received physiotherapy or manipulation because of the neck pain during last three months; Wearing collar.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
closed pockets
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Chamran and Sheikh Fazlolah Junction, Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.IUMS. REC. 1394.9311502004
Health conditions studied
1
Description of health condition studied
cervical spondylosis
ICD-10 code
M47.8
ICD-10 code description
arthrosis or osteoarthritis of spine degeneration of facet joints
Primary outcomes
1
Description
range of motion
Timepoint
preintervention and post intervention
Method of measurement
inclinometer
2
Description
The amount of craniovertebral angle
Timepoint
Preintervention and post intervention
Method of measurement
Photo will be taken from patient and then the photo will be entered into the Adobe Acrobat Professional and craniovertebral angle will be calculated
3
Description
the amount of cervical short flexor muscles endurance
Timepoint
preintervention and post intervention
Method of measurement
the subject lying supine on bed then he/she gets his/her head up meanwhile retracting chin. The time of maintaining of this position is calculated by stop watch.
4
Description
Pain.
Timepoint
Before intervention, 1, 2 and 3 weeks later when intervention was applied and finally post intervention when treatment was done.
Method of measurement
Numerical Pain Rating Scale (The patient scores).
5
Description
The amount of disability caused by neck pain.
Timepoint
Before intervention, 1, 2 and 3 weeks later when intervention was applied and finally post intervention when treatment was done.
Method of measurement
Persian translation of Neck Disability Index questionnaire.
Secondary outcomes
1
Description
the amount of cervical extensor muscles endurance
Timepoint
preintervention and post intervention
Method of measurement
The subject lying prone on bed with their head and neck initially supported over the end while a 105 gr wheight suspended from his/her head then he/she extends his/her neck. The time of maintaining of this position is calculated by stop watch.
2
Description
The amount of satisfaction from ergonomic latex pillow
Timepoint
post intervention
Method of measurement
self-made questionnaire
Intervention groups
1
Description
Intervention group: physiotherapy + ergonomic latex pillow.
Patients in this group sleep on ergonomic latex pillow for 4 weeks and will receive physiotherapy 3 sessions a week (12 sessions) for 30-45 minutes.
Category
Lifestyle
2
Description
Control group: physiotherapy + his/her usual pillow.
Patients in this group sleep on their usual pillow for 4 weeks and will receive physiotherapy 3 sessions a week (12 sessions) for 30-45 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Ali Amiri; Physiotherapy PhD; Assistant Professor
Street address
Rasool Akram Hospital, next to Mansouri St, Niyayesh St, Sattarkhan St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi, Research Vice Chancellor of Iran University of Medical Sciences.
Street address
Iran University of Medical Sciences, Chamran and Sheikh Fazlolah Junction, Hemmat Highway, Tehran
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
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Master of science/lecturer/ Orthotics and Prosthetics Faculty member
Other areas of specialty/work
Street address
Rehabilitation Faculty, Shahnazari St., Mirdamad Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
farahmandb1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Fazli
Position
BS in orthotics and prosthetics
Other areas of specialty/work
Street address
Rehabilitation Faculty, Shahnazari St., Mirdamad Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
fatemehfazli89@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Fazli
Position
BS in orthotics and prosthetics
Other areas of specialty/work
Street address
Rehabilitation Faculty Shahnazari St., Mirdamad Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
fatemehfazli89@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)