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IRCT2014021916643N1 IRCT 2016-12-28 Iran University of Medical Sciences The effect of ergonomic latex pillow on neck arthrosis treatment 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 2017-01-17 anticipated 42 Complete https://irct.ir/trial/15525 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: closed pockets. 2 cervical spondylosis. Intervention 1: 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. Intervention 2: 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.
public Behshid Farahmand
Rehabilitation Faculty, Shahnazari St., Mirdamad Blv, Tehran
Tehran Iran (Islamic Republic of) +98 21 2222 8051 farahmandb1@yahoo.com Iran University of Medical Sciences scientific Fatemeh Fazli
Rehabilitation Faculty, Shahnazari St., Mirdamad Blv, Tehran
Tehran Iran (Islamic Republic of) +98 21 2222 8051 fatemehfazli89@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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. 30 years 60 years Both M47.8 arthrosis or osteoarthritis of spine degeneration of facet joints Lifestyle Rehabilitation 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. 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. Range of motion. Timepoint: preintervention and post intervention. Method of measurement: inclinometer. 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. 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. 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). 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. 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. The amount of satisfaction from ergonomic latex pillow. Timepoint: post intervention. Method of measurement: self-made questionnaire. Iran University of Medical Sciences Approved 2016-02-15 Ethics committee of Iran University of Medical Sciences Shahid Chamran and Sheikh Fazlolah Junction, Hemmat Highway, Tehran Tehran Iran (Islamic Republic of)