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The comparison between the effects of online pain education interventions with online and face to face exercise on pain, disability, psychological factors and function in participants with chronic non-specific neck pain

Protocol summary

Study aim
The aim of this study was to compare the effect of online and face-to-face pain education interventions on pain, disability, psychological factors and function in people with chronic nonspecific neck.
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 2 on 120 patients. Pre-prepared numbers 1 to 120 are used for randomization.
Settings and conduct
This study is performed in the city of Babol on people with chronic nonspecific neck pain. Data evaluators and analyzers are blind to the participants in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: men and women aged 18-65 years, VAS scale <3 in these people, minimum neck pain 12 weeks and three days a week, referring to medical centers to treat neck pain, not starting treatment or taking medication Exclusion criteria Pregnancy, dissatisfaction with participation in research, lack of regular participation in training sessions, spinal osteoporosis, history of tumor in the spine, participation in training courses for the treatment of neck pain in the past three years, severe spinal discopathy, having any fractures and Spinal surgery in the last three years, if injured during interventions
Intervention groups
For all participants in the two experimental groups, 3 sessions of familiarity with teaching pain management approaches as well as how to perform quarterly exercises (three sessions per week, each session approximately 20 to 30 minutes) will be explained. For the participants in the control group, biomedical content is explained with a focus on neck biomechanics, as well as three months of training for corrective neck pain movements.
Main outcome variables
pain; disability; psychological factors and function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150503022068N5
Registration date: 2021-09-27, 1400/07/05
Registration timing: registered_while_recruiting

Last update: 2021-09-27, 1400/07/05
Update count: 0
Registration date
2021-09-27, 1400/07/05
Registrant information
Name
amir letafatkar
Name of organization / entity
kharazmi university
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 8084
Email address
amir.letafatkar@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between the effects of online pain education interventions with online and face to face exercise on pain, disability, psychological factors and function in participants with chronic non-specific neck pain
Public title
The effects of online pain education interventionon pain, disability, psychological factors and function in participants with chronic non-specific neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women 18-65 years. VAS scale <3 in these individuals. Minimum history of neck pain 12 weeks and three days a week. Go to medical centers to treat neck pain. Do not start treatment or take medication
Exclusion criteria:
Pregnancy. Dissatisfaction with participating in the research Lack of regular participation in training sessions People with spinal osteoporosis. People with a history of spinal tumors Participate in exercise therapy courses to treat neck pain in the last three years. Having criteria for referral to surgery such as severe cervical vertebral discopathy. Having any fractures and surgery in the cervical spine in the last three years. In case of injury during the interventions
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomized into two active treatment groups and one passive control group, by drawing a number, from 1 to 120, prepared in advance by the trainer and placed in sealed envelopes in a box.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor data analyzer were blinded to group allocation. participants were not blinded to exercise study however they were not aware which treatment was considered to be therapeutic.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Kharazmi University of Medical Science (IR.KHU.REC.1400.013).
Street address
postal code 4714744751, Isar 1 ded end, 17 Meraj St., Khorshid KolaT Babol
City
Babol
Province
Mazandaran
Postal code
4714744751
Approval date
2021-07-11, 1400/04/20
Ethics committee reference number
IR.KHU.REC.1400.013

Health conditions studied

1

Description of health condition studied
chronic none specific neck pain
ICD-10 code
ICD-10 code description
neck pain

Primary outcomes

1

Description
the effects of online pain education interventions with online and face to face exercise on pain in participants with chronic non-specific neck pain between 3 and 7 using Numerical Rating Scale
Timepoint
Measurement of pain at the beginning of the study and after three months of exercise.
Method of measurement
Numerical Rating Scale

Secondary outcomes

1

Description
The effetcs of online pain education interventions with online and face to face exercise on pain, disability, psychological factors and function in participants with chronic non-specific neck pain
Timepoint
The effects of online pain education interventions with online and face to face exercise on pain, disability, psychological factors and function in participants with chronic non-specific neck pain before and after three months of interventions
Method of measurement
Comparison of the effects of online training of pain interventions with online and face-to-face exercises on pain, disability, psychological factors and performance in people with chronic nonspecific neck before and after three months of training using pain rating scale, neck disability index, Depression, Anxiety and Stress Scale -21 And after three exercises

Intervention groups

1

Description
Intervention group: For all participants in the two experimental groups, 3 introductory sessions will be held to teach pain management approaches as well as how to perform the exercises over a period of approximately three months. In this study, 3 training sessions will be held in 2 weeks, which will be conducted by the researcher. The schedule is the same for all three treatment groups. The first session will be a group session (duration 30 minutes to an hour) with a maximum of 6 participants in each group, led by a researcher using a PowerPoint presentation. Participants will then be asked to read an instruction booklet containing the same information at home. The second session is home-based online e-learning, which includes 3 explanatory videos. These videos explain the same PowerPoint that was shown during the first session along with its screening. Therefore, in the second session, which is held online, the same issue discussed in the first group session will be explained again. After each clip, participants are asked to complete a questionnaire that will assess their understanding and opinion of the film. The third session will include a 30-minute one-on-one conversation focusing on patients' personal needs: The questions in the second session questionnaire will be analyzed. And how to use this information in the patient's daily life is discussed
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yayanezhad Hospital
Full name of responsible person
Zohreh khosrokiani
Street address
Isar 1 Daed End, Meraj 17 St., Khorshid Kola, Babol
City
Babol
Province
Mazandaran
Postal code
4714744751
Phone
+98 11 3231 3040
Email
Amir.letafatkar@khu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Amir Letafatkar
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15447-33111
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Zohreh Khosrokiani
Position
PH.d student
Latest degree
Master
Other areas of specialty/work
Corrective movements and prevention of sports injuries
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15447-33111
Phone
+98 21 2222 8001
Email
zohreh.khosrokiani@khu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Zohreh Khosrokiani
Position
Ph.d student
Latest degree
Master
Other areas of specialty/work
Corrective exercise and Sports Injery Prevension
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15447-33111
Phone
+98 21 2222 8001
Email
zohreh.khosrokiani@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Zohreh Khosrokiani
Position
Ph.d Student
Latest degree
Master
Other areas of specialty/work
Corrective movements and prevention of sports injuries
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15447-33111
Phone
+98 21 2222 8001
Email
zohreh.khosrokiani@khu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as the dependent variables, The average of all samples, can be shared in scientific articles.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Personal information is confidential and general results are available to anyone in the article
Under which criteria data/document could be used
Information is not available to anyone. general results are available to anyone in the article
From where data/document is obtainable
Zohreh Khosrokiani; 00989112133552- Email:zohreh.khosrokiani@khu.ac.ir
What processes are involved for a request to access data/document
Zohreh Khosrokiani; 00989112133552- Email:zohreh.khosrokiani@khu.ac.ir
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