Comparative study of the effect of using a mobile phone-based application to manage the exercise program of patients with chronic back pain referring to the physical medicine clinic of Imam Khomeini Hospital with the conventional method
Determining the effect of using a mobile phone-based application to manage the exercise program of patients with chronic back pain referring to the physical medicine clinic comparing the conventional method
Design
A controlled, randomized, parallel-group clinical trial on 98 patients.
Randomization using the blocked randomization method
Settings and conduct
An application will be designed. Patients at the physical medicine clinic of Imam Khomeini Hospital of Tehran will log in daily and receive the exercises, and provide feedback after each exercise. Exercises are taught to patients using videos along with explanations, and the patient performs the exercises for 12 weeks.
The control group are taught the usual method in the clinic and are provided with an pamphlet and an 84-cell chart to assess patient adherence.
Participants/Inclusion and exclusion criteria
Inclusion: Adults over 18 with chronic low back pain lasting more than 12 weeks, with or without radicular symptoms; whit persistent pain (at least 3 on a numerical rating scale); with regular (weekly) use of an internet-connected device; and fluency in Persian (spoken&written)
Exclusion:
Any spinal surgery within the past 12 months; evidence of spinal cord compression or cauda equina; severe spinal stenosis as evidenced by signs of neurogenic claudication (grade 3-4); fibromyalgia or systemic/inflammatory disorders; concurrent health conditions that prevent active participation in increased levels of physical activity, Cardiopulmonary disease; back pain resulting from an accident in the past 12 months or ongoing litigation; current or planned pregnancy
Intervention groups
Group using an app to manage their training program.
Group whose training program is managed by traditional approach.
Main outcome variables
visual analog scale (VAS) score, Modified Oswestry Disability Index (MODI) score, adherence score, Satisfaction level
General information
Reason for update
Acronym
LBP
IRCT registration information
IRCT registration number:IRCT20260202068736N1
Registration date:2026-07-26, 1405/05/04
Registration timing:prospective
Last update:2026-07-26, 1405/05/04
Update count:0
Registration date
2026-07-26, 1405/05/04
Registrant information
Name
Mehrshad Mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 5500
Email address
mehrshadmp97@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of using a mobile phone-based application to manage the exercise program of patients with chronic back pain referring to the physical medicine clinic of Imam Khomeini Hospital with the conventional method
Public title
Comparative study of the effect of using a mobile application to manage the exercise program of patients with chronic low back pain with the conventional method
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with chronic back pain
Exclusion criteria:
Any type of spinal surgery in the past 12 months
Evidence of spinal cord compression or cauda equina syndrome
Severe spinal stenosis as evidenced by signs of neurogenic claudication (grade 3 to 4)
Fibromyalgia or systemic/inflammatory disorders
Co-existing medical conditions that prevent active participation in increased levels of physical activity
Cardiopulmonary diseases
Back pain resulting from a traffic accident in the past 12 months or ongoing litigation
Current or planned pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups (intervention group and control group). The randomization process will be performed by an independent person from the study who is not involved in any of the assessment or intervention phases, and will be performed using a random block design with variable block sizes (e.g., 4 or 6). The randomization sequence will be generated by computer software and the allocation results will be kept in opaque, sealed, numbered envelopes. These envelopes will only be opened at the time of patient allocation to the group and after baseline assessments have been completed to prevent allocation bias (allocation concealment).
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
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, corner of Qods, Tehran University of Medical Sciences Headquarters, 6th floor.
City
Tehran
Province
Tehran
Postal code
1417913191
Approval date
2025-07-29, 1404/05/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1404.245
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Percentage of adherence to the exercise program
Timepoint
Before the start of the intervention and 12 weeks after the intervention
Method of measurement
Checking the days the patient exercised through the app
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will register in the app with the mobile number they provided at the clinic and it will set a daily reminder for exercise time. They will then log in to the app daily and receive the exercises for that day and give feedback after each exercise. The patient's exercise program is personalized based on the feedback provided. The exercises are taught to the patients with GIFs along with Persian explanations, and then the patient performs the exercises in the amount prescribed by the app for 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Mehrshad Mohammadpour
Street address
End of Keshavarz Boulevard, Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1625
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Keshavarz Boulevard, corner of Qods Street, Central University Organization, 6th Floor, Vice President for Research and Technology
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://ikhc.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
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
Tehran University of Medical Sciences
Full name of responsible person
Mehrshad Mohammadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 14 borhani alley, north karegar street
City
Tehran
Province
Tehran
Postal code
1417913191
Phone
+98 21 6696 5500
Fax
Email
Mehrshadmp97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Ghahveh Chi Akbari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1415748291
Phone
+98 21 8163 3698
Email
masood.ghahvechi63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrshad Mohammadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 14 borhani alley, north karegar street
City
Tehran
Province
Tehran
Postal code
1417913191
Phone
+98 21 6696 5500
Fax
Email
Mehrshadmp97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Respecting the privacy of patients
Study Protocol
No - There is not 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