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IRCT20210607051508N1 IRCT 2021-06-21 Ahvaz University of Medical Sciences The effect of pain neuroscience education on the treatment of chronic neck pain PNE The effect of pain neuroscience education with and without conventional physical therapy on psychosocial factors, function and pain in people with chronic neck pain - a clinical trial 2021-06-19 anticipated 50 Complete https://irct.ir/trial/56783 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed by Random Allocation computer software (version 1.1 of Isfahan University of Medical Sciences, Iran) by a statistician Which has no role in the study in such a way that a random order of two letters A (intervention) and B (control) in blocks will be made with random numbers 4 and 6 (For example ABBA and ABABA). A research assistant then puts them in sealed envelopes. Before starting the intervention, one of the researchers opens one of the envelopes and thus the person will be placed in one of the two intervention groups (conventional physiotherapy with pain neuroscience education) or control (conventional physiotherapy), Blinding description: A physiotherapist who has no information about patients' allocation and treatment will perform the assessments. The participants will receive information about their treatment program, but they will not be informed if they are in intervention or control group, and for this purpose we will make arrangements so that patients do not see each other. Patients in the intervention group receive treatment on even days and the control group receives treatment on odd days. A statistician who has no information about patients' allocation will perform the statistical analysis. N/A Neck pain. Intervention 1: Control group: conventional physiotherapy treatment, Individuals 12 sessions of therapy (4 weeks of frequency therapy 3 times a week) including 1-20 minutes of TENS and hot packs 2- Exercises to improve mobility (stretching exercises) 3- Exercises that aim to use deep muscles 4- Endurance exercises (Endurance) 5- They will receive strengthening exercises. Intervention 2: Intervention group: conventional physiotherapy treatment with pain neuroscience education. In this study, people will be received 12 sessions of treatment (4 weeks of treatment with frequency 3 times a week), in the first 4 sessions of treatment, conventional physiotherapy treatment with pain neuroscience education in addition to conventional physiotherapy treatment, will be received pain neuroscience education. Yes - There is a plan to make this available What will be shared: This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists. When: If the journal has requested access to the data at any time, the data will be provided. To whom: Journal editors and Reviewers Conditions: Sometimes for re-analysis or for use in meta-analysis studies Where to obtain: Project manager How to obtain: It should be send email to project manager and after reviewing the reason for requesting the data, they will be send Comments:
public Hosein Kouhzad Mohammadi
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3101 kouhzad@yahoo.com Ahvaz University of Medical Sciences scientific Hosein Kouhzad Mohammadi
Khozestan
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3101 kouhzad@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 years Nonspecific neck pain with a history of at least 12 weeks (chronic) Ability to understanding, speaking and writing in Persian Has not used any other treatment 6 weeks before participating in this project and during it. (To get steady state) Minimum visual analog scale (VAS) 30 of100 mm Confirmation of central sensitization in people with CSI questionnaire (score above 40 CSI questionnaire is the reason for central sensitization) 18 years 65 years Both Cancer, fracture, metabolic diseases, rheumatism, cardiovascular, neurological disorders and osteoporosis Neck radiculopathy, myelopathy and dizziness People with widespread pain disorders such as fibromyalgia syndrome or chronic fatigue syndrome Psychiatric disorders M50.9 Cervical disc disorder, unspecified Treatment - Other Treatment - Other Control group: conventional physiotherapy treatment, Individuals 12 sessions of therapy (4 weeks of frequency therapy 3 times a week) including 1-20 minutes of TENS and hot packs 2- Exercises to improve mobility (stretching exercises) 3- Exercises that aim to use deep muscles 4- Endurance exercises (Endurance) 5- They will receive strengthening exercises. Intervention group: conventional physiotherapy treatment with pain neuroscience education. In this study, people will be received 12 sessions of treatment (4 weeks of treatment with frequency 3 times a week), in the first 4 sessions of treatment, conventional physiotherapy treatment with pain neuroscience education in addition to conventional physiotherapy treatment, will be received pain neuroscience education. Score of 100 mm visual analog scale to assess pain intensity. Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Visual Analogue Scale. Central Sensitization Inventory questionnaire to assess central sensitivity. Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Central Sensitization Inventory questionnaire score. Lutron Model 5020 Digital Tensile and pressure Algometer for Measuring Pressure Pain Threshold (PPT). Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Digital Tensile and pressure Algometer. Score of Neurophysiology of Pain Questionnaire to evaluate the concept of biological mechanism of pain. Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Neurophysiology of Pain Questionnaire. Neck Disability Index questionnaire for disability evaluation. Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Neck Disability Index questionnaire score. Pain Catastrophizing Scale to assess pain catastrophizing. Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Pain Catastrophizing Scale score. Tampa Scale for Kinesiophobia Questionnaire to assess fear of movement. Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Tampa Scale for Kinesiophobia Questionnaire score. Pain Awareness and Vigilance questionnaire to assess pain awareness and alertness. Timepoint: Pre intervention, Post intervention, one month and 3 months after baseline. Method of measurement: Pain Awareness and Vigilance questionnaire score. Quality of life score. Timepoint: Pre Intervention, Post Intervention, one month and three months after baseline. Method of measurement: Score of SF3 6 questionnaires to assess the quality of life. Score of a person's perception of their illness. Timepoint: Pre Intervention, Post Intervention, one month and three months after baseline. Method of measurement: Score of Brief illness perception questionnaire to assess a person's perception of their illness. General measurement of the rate of change. Timepoint: Pre Intervention, Post Intervention, one month and three months after baseline. Method of measurement: General review of the amount of changes with the general form of the amount of changes. Ahvaz University of Medical Sciences Approved 2021-05-16 Ahvaz Jundishapur University of Medical Sciences No.5, Yas Ave., Shahrak Aghajari Area., Ahvaz City ŮŽAhvaz Khouzestan Iran (Islamic Republic of)