Protocol summary

Study aim
Determining the effectiveness of the researcher made exercises and Williams on pain intensity, quality of life and range of motion of the back after 4 and 8 weeks in patients with failed back surgery syndrome.
Design
The clinical trial has a control group, with parallel groups, a blind strain, randomized, simple method is used for randomization.
Settings and conduct
The first session will be in person at the Neuroscience Clinic of Khatam Hospital, all exercises will be explained and taught, and then the sessions will continue at home. Also, the objectives are fully explained. For the purpose of blinding, all measurements are performed by a physiotherapist who is not aware of the placement of people in the 2 groups.
Participants/Inclusion and exclusion criteria
164 patients (age< 65 years) who has failed back surgery syndrome and have been referred by a surgeon to a pain specialist in Khatam al-Anbia Hospital and do not have surgical problems are selected, and after performing initial evaluations, they are randomly selected (simple randomization) are placed in two groups of 82 subjects. Patients are initially screened for symptoms of failed back surgery syndrome, including pain in the back, neck, or legs. Additionally, screen patients for RED FLAGS, including excessive mechanical pain that may indicate pseudarthrosis or nonunion, that may indicate infectious spine problems.
Intervention groups
In the intervention group, each exercise should be performed 3 times a day for 4 weeks for 20 sets with a set duration of 10 seconds (for each leg/arm). The intervention group has three exercises defined by a pain specialist, including Hip abduction exercise, Shoulder abduction and concurrent hip and shoulder abduction exercise.
Main outcome variables
Pain intensity (Numeric Pain Rating Scale); Health-related quality of life; Lumbar range of motion (bending forward and backward).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240608062042N1
Registration date: 2024-07-09, 1403/04/19
Registration timing: registered_while_recruiting

Last update: 2024-07-09, 1403/04/19
Update count: 0
Registration date
2024-07-09, 1403/04/19
Registrant information
Name
Ardalan Shariat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 861 4772
Email address
ardalansh2002@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-09, 1403/04/19
Expected recruitment end date
2025-07-10, 1404/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tele exercise for patients with failed back surgery syndrome: Randomized clinical trial
Public title
Teleexercise for failed back surgery syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: <65 years old Patients with failed back surgery syndrome They have been referred by a surgeon to a pain specialist in Khatam al-Anbia Hospital.
Exclusion criteria:
Lack of ability to do the exercises. Lack of intention for participation. Having red flags.
Age
To 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 164
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: Using random numbers generated by Google, subjects will be divided into intervention group (doing researcher-made exercises) and control group (doing Williams exercises) with equal numbers and subjects have equal chance to choose. It was agreed from the beginning that the intervention group will be given odd numbers and the control group will be given even numbers. In the random numbers generated by Google, the minimum defined number is 1 and the maximum is set to 164. At the time of using this program, the person who is going to do this process is not aware of the distribution of subjects in these two groups and will not participate in any other phase of the research.
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator is blind about the randomization.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.108

Health conditions studied

1

Description of health condition studied
Failed back surgery syndrome
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Range of motion
Timepoint
Before intervention and 1, 2 months after intervention
Method of measurement
Modified-modified Schober Test

2

Description
Pain intensity
Timepoint
Before intervention and 1, 2 months after intervention
Method of measurement
Numeric Pain Rating Scale

3

Description
Quality of life
Timepoint
Before intervention and 1, 2 months after intervention
Method of measurement
Health-related quality of life

Secondary outcomes

1

Description
Clinical changes
Timepoint
Before intervention and after 1 and 2 month.
Method of measurement
MRI

Intervention groups

1

Description
Intervention group: distance exercises. After 1-2 face-to-face training sessions, a face-to-face visit is performed, ideally with the patient's caregiver or companion, who may later assist the patient with FBSS at home. Then an educational video and poster is sent electronically to the patient and his companion can assist in viewing. After this, remote exercise sessions will begin. The participation of the therapist during the video therapy sessions allows for appropriate intervention and feedback to ensure that the patient performs the exercises safely and effectively. Then the online sessions can continue, focusing on the gradual transition of the patient to perform the exercises alone or with the help of a companion at home. In the intervention group, each exercise should be performed 3 times a day for 4 weeks for 20 sets with a set duration of 10 seconds. (for each leg/hand) The intervention group will perform three exercises defined by the pain specialist, including Hip abduction exercise, Shoulder abduction exercise, and Hip and shoulder abduction exercise.
Category
Treatment - Other

2

Description
The control group will only do Williams exercises. The first session, with movement training, will be attended at the pain clinic of Khatam Hospital in Tehran, and pamphlets and videos on the correct way to perform movements will be provided to the patients. Movements are performed at home for 4 weeks, and after 4 weeks, re-evaluations will be done in person, then to monitor the patient, the patient will perform the movements at home for another 4 weeks (according to the previous instructions) and will be re-evaluated. While a companion is essential for these exercises, we will demonstrate these routines through an online consultation.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatammanbia hospital
Full name of responsible person
Dr.Reza Alizadeh
Street address
Tehran Province, Tehran، Rashid Yasemi Street، Upper than Mirdamad St.، Vali- Asr St.، QC95+J5G
City
Tehran
Province
Tehran
Postal code
1456887157
Phone
+98 21 8888 4040
Email
ardalansh2002@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Street address
Tehran University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 939 861 4772
Email
ardalansh2002@gmail.com
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
Ardalan Shariat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Telehealth
Street address
Tehran University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 939 861 4772
Email
ardalansh2002@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Telehealth
Street address
Tehran University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 939 861 4772
Email
ardalansh2002@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Telehealth
Street address
Tehran University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 939 861 4772
Fax
Email
ardalansh2002@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
No more data.
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
All the data will be shared after removing identification details of participants. We will publish the results as a scientific article without any name from participants.
When the data will become available and for how long
After finish the study, results will be published and will be available permanently.
To whom data/document is available
Data is only available for people working in academic institutions.
Under which criteria data/document could be used
For academic purpose.
From where data/document is obtainable
Ardalansh2002@gmail.com Dr.Ardalan Shariat
What processes are involved for a request to access data/document
Contact me using email.
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