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Comparison of the effectiveness of preventive exercise therapy delivered by health care providers with the control group on the incidence of neck pain in adults

Protocol summary

Study aim
Comparison of the effectiveness of preventive exercise therapy delivered by health care providers with the control group on the incidence, prevalence, disability and costs of neck pain in adults
Design
A pragmatic trial including two groups (control and exercise). Single blinded with 4000 participants in total (2000 each group) and randomized on health centers level.
Settings and conduct
The training will be provided to the health care providers by a Sports Medicine specialist. The health care providers will then provide the training to the participants through pamphlets and interviews. The data will be collected by caregivers using questionnaires, after obtaining informed consent from the individuals. Considering the kind of intervention (exercise), the participants and educator (health care provider) can not be blinded. The data will be blinded using coding for the purpose of collection, analyses, and interpretation.
Participants/Inclusion and exclusion criteria
Inclusion: Participants under the coverage of rural health network of Tehran University of Medical Sciences 18 to 60 years old Exclusion: Diagnosed neoplasm Diagnosed remarkable psychiatric disorders Diagnosed cognitive impairment Unwillingness to participate/continue with participation
Intervention groups
Intervention group: Participants who, based on center randomization, are placed in intervention centers will be educated on preventive neck pain exercise by health care providers. Participants will be followed up on new episodes or changes in previous neck pain and will be compared with the control group. Control group: Participants who, based on center randomization, are placed in control centers will only be followed up, without any interventions, on new episodes or changes in previous neck pain, and will be compared with the intervention group.
Main outcome variables
Incidence, prevalence, disability, and costs of neck pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200708048058N1
Registration date: 2020-08-02, 1399/05/12
Registration timing: prospective

Last update: 2020-08-02, 1399/05/12
Update count: 0
Registration date
2020-08-02, 1399/05/12
Registrant information
Name
Amir Ahmadzadeh Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0953
Email address
amir.amzd93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of preventive exercise therapy delivered by health care providers with the control group on the incidence of neck pain in adults
Public title
Evaluation of the effectiveness of preventive exercise therapy on neck pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Participants under the coverage of rural health network of Tehran University of Medical Sciences 18 to 60 year-old participants
Exclusion criteria:
Diagnosed neoplasm Diagnosed remarkable psychiatric disorders Diagnosed cognitive impairment Unwillingness to participate/continue with participation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 4000
Randomization (investigator's opinion)
Randomized
Randomization description
In order to prevent statistical contamination, randomization will be done in the cluster form at the level of health bases. Eight health bases with equal coverage population will enter simple randomization processes in Excel software and will be divided into two groups of control and exercise intervention. The randomization method is simple randomization, the unit is cluster randomization, and non-stratified randomization is used to better represent the reality of our target community. In this study, Excel statistical software will be used for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, considering the type of intervention (exercise), blinding cannot be carried out on the participants and the health care providers (who are responsible for educating people and collecting data). The data analyst is blinded to the grouping of each individual.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor in research affairs- Tehran University of Medical Sciences
Street address
Keshavarz Blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.TUMS.VCR.REC.1397.039

Health conditions studied

1

Description of health condition studied
Neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia (Neck pain)

Primary outcomes

1

Description
Neck pain incidence
Timepoint
after 12 months since first visit
Method of measurement
Translated Neck pain and disability score (NPDS) questionnaires and participants' electronic health records (SIB)

Secondary outcomes

1

Description
Disability caused by neck pain
Timepoint
after 3, 6, and12 months since first visit
Method of measurement
NPDS questionnaire

2

Description
Treatment cost
Timepoint
after 12 months since first visit
Method of measurement
Participants' electronic health records (SIB)

3

Description
Prevalence of neck pain
Timepoint
after 3, 6, and12 months since first visit
Method of measurement
NPDS questionnaire

Intervention groups

1

Description
Control group: Without exercise intervention. Participants will be followed by health care providers and relevant data (incidence, prevalence, disability and the costs of treating neck pain) will be collected from them.
Category
N/A

2

Description
Intervention group: Neck exercise group, a sum of 10 simple stretch and strength exercises to strengthen the neck muscles and stabilize the posture which are practicable by the public at home, without any tools, while standing, sitting, and laying down. The training will emphasize on the neck's motion in different directions and also necks stability against force. These exercises, which will be taught to primary health care providers by Sports medicine specialists before the trial begins, will be taught to the Intervention group by primary health care providers in one session interviews, and pamphlets. This study aims to assess the effectiveness of exercises taught by the primary care providers to the study population.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences Health Network
Full name of responsible person
Ramin Kordi
Street address
District 6, Jalal-e-Al-e-Ahmad Hwy, No. 7
City
Tehran
Province
Tehran
Postal code
14395578
Phone
+98 21 8863 0227
Email
ramin_kordi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
TUMS Central Organization, Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
14395578
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
14
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
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Sport Medicine
Street address
District 6, Jalal-e-Al-e-Ahmad Hwy, No. 7
City
Tehran`
Province
Tehran
Postal code
14395578
Phone
+98 21 8863 0227
Email
ramin_kordi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Sport Medicine
Street address
District 6, Jalal-e-Al-e-Ahmad Hwy, No. 7
City
Tehran
Province
Tehran
Postal code
14395578
Phone
+98 21 8863 0227
Email
ramin_kordi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Ahmadzadeh Amiri
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
District 6, Jalal-e-Al-e-Ahmad Hwy, No. 7
City
Tehran
Province
Tehran
Postal code
14395578
Phone
+98 21 8863 0227
Email
amir.amzd93@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Comparison of the effectiveness of preventive exercise therapy delivered by health care providers with the control group on the incidence of neck pain in adults
When the data will become available and for how long
Starting in January 2022 for 5 years
To whom data/document is available
Researchers and policymakers in the field of public health and sports medicine
Under which criteria data/document could be used
Systematic review/Meta-analysis
From where data/document is obtainable
Tehran University of Medical Sciences (TUMS) Sports Medicine Research Center (SMRC)
What processes are involved for a request to access data/document
Contacting the author for correspondence with reasonable request
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