Protocol summary

Study aim
The aim of this study was to evaluate the effectiveness of remote rehabilitation on pain and quality of life in patients with mechanical neck pain and compare it with conventional physiotherapy.
Design
Patients with randomization by Block Randomization method in one of the two groups are treated with physiotherapy in the clinic or physiotherapy through APP. A questionnaire including demographic information, VAS, NDI, SF-12 criteria will be completed by patients and the range of active neck movement will be measured by a goniometer. Patients are evaluated according to the mentioned criteria before the intervention, one month and three months after the start of treatment.
Settings and conduct
This interventional study is performed as a clinical trial in patients with mechanical neck pain who are referred to Imam Reza Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients in the age range of 25 to 60 years who have had pain for more than 6 weeks and have been diagnosed with mechanical neck pain, their VAS level is between 3 and 8 and have a phone with Android operating system. Been. Patients who have undergone treatment or other surgery within three months or whose neck pain is due to a known trauma or is a sign of radiculopathy, paresthesia, focal neurological symptoms or danger signs are excluded from the study.
Intervention groups
neck muscle stretching exercises and strengthening exercises with emphasis on core stabilizer muscles and endurance exercises were considered. The APP group receives the exercises in the form of a video through the software, The physiotherapy group in the clinic also receives oral and written exercises after a routine cervical physiotherapy course.
Main outcome variables
VAS score, NDI, SF-12

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201007048959N1
Registration date: 2021-03-01, 1399/12/11
Registration timing: registered_while_recruiting

Last update: 2021-03-01, 1399/12/11
Update count: 0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Seyed Morteza Tabatabaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 7340
Email address
smt.1368@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-15, 1399/08/25
Expected recruitment end date
2021-11-16, 1400/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Telerehabilitation in comparison to conventional physiotherapy on pain and quality of life of patients with mechanical neck pain
Public title
Evaluating the efficacy of Telerehabilitation in patients with mechanical neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They have been in pain for more than 6 weeks and have been diagnosed with mechanical neck pain VAS score between 3 and 8 cellphone with Android operating system capable of using smartphone
Exclusion criteria:
Have another treatment or surgery within three months Their neck pain is due to a known trauma or symptoms of radiculopathy, paresthesia, focal neurological symptoms red flags such as weight loss, trauma, fever, night sweats, night pain, a history of tuberculosis infections, HIV, cancer, inflammatory diseases, and spinal tenderness
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocating of two groups with the same size of 25 participants (50 patients in total) we used block randomization with different block sizes. The sizes of blocks would be a multiple of 2 and a divisor of 40 (2,4,8). At first, the block sizes were selected randomly. Then, for each block, different permutations for equal group size were determined. Finally, one of the permutations was selected randomly. Random numbers were generated in an independent statistical office using Random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
AJA University of Medical Sciences
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718546
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.AJAUMS.REC.1399.148

Health conditions studied

1

Description of health condition studied
Mechanical neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia

Primary outcomes

1

Description
pain Visual Analogue Scale
Timepoint
0, 1, 3 months after intervention
Method of measurement
10-point visual analogue scale

2

Description
disability Visual Analogue Scale
Timepoint
0, 1, 3 months after intervention
Method of measurement
10-point visual analogue scale

3

Description
Neck Disability Index score
Timepoint
0, 1, 3 months after intervention
Method of measurement
Based on the Neck Disability Index questionnaire to assess a person's inability to neck pain

4

Description
12-Item Short Form Survey score
Timepoint
0, 1, 3 months after intervention
Method of measurement
Based on a questionnaire to assess general health in the last 4 weeks in 8 areas

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group that uses the APP receives the exercises in the form of a video through the software, and the software repeatedly reminds the patient to do the exercises. The software also has the feature that the patient communicates with the therapist in video or audio or text and expresses his problems with the therapist.
Category
Treatment - Other

2

Description
Control group: The physiotherapy group in the clinic also receives oral and written exercises after a routine cervical physiotherapy course.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Tehran
Full name of responsible person
Seyed Morteza Tabatabaee
Street address
No 50, 4th Golestan alley, Nahid street, Marzdaran blv
City
Tehran
Province
Tehran
Postal code
1461643744
Phone
+98 21 4424 7340
Email
Smt.1368@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zashk
Street address
AJA university, Etemad zade street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
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
Artesh University of Medical Sciences
Full name of responsible person
Seyed Morteza Tabatabaee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Morteza Tabatabaee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyed Morteza Tabatabaee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Loading...