The effect of soft tissue release of the thoracic on the improvement of pain, disability, and quality of life in patients with failed back surgery syndrome
The effect of soft tissue release of the thoracic on the improvement of pain, disability, and quality of life in patients with failed back surgery syndrome
Design
Clinical trial with control group, with parallel groups, randomized, on 30 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
After matching the entry criteria of the subjects with the research entry criteria, the treatment conditions are fully explained to the patient and if desired, the informed consent form is completed by the subjects. The selected people are placed in two control and control groups randomly. Both groups receive a common physiotherapy treatment, and the control group receives thoracic soft tissue release as much as the patient can tolerate, 90 seconds per repetition and three repetitions for 5 minutes for each side and rolling massage for 10-20 minutes; And the control group receives common physiotherapy. The place of the study is the physiotherapy center located in the comprehensive rehabilitation center and some private centers that cooperate in this field.
Participants/Inclusion and exclusion criteria
People who have problems after surgery due to failed lumbar surgery.
Intervention groups
ّّFailed back surgery syndrome
Main outcome variables
Pain, disability and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230212057390N3
Registration date:2023-10-12, 1402/07/20
Registration timing:prospective
Last update:2023-10-12, 1402/07/20
Update count:0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Majid Shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6710
Email address
shahbazim2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of soft tissue release of the thoracic on the improvement of pain, disability, and quality of life in patients with failed back surgery syndrome
Public title
The effect of soft tissue release of the thoracic on the improvement of pain, in patients with failed back surgery syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
failed back surgery
Not using drugs affecting the functioning of the automatic nervous system
Exclusion criteria:
1. Patients with a history of spinal fracture
2. Patients with spine abnormalities
3. Patients with fear of light
4. Patients with dysfunctional autonomic nervous system
5. Patients with skin sensitivity
6. Patients with alcohol addiction
7. Patients with Horner's syndrome
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2023-09-10, 1402/06/19
Ethics committee reference number
IR.MUMS.REC.1402.165
Health conditions studied
1
Description of health condition studied
failed back surgery syndrome
ICD-10 code
S24.6
ICD-10 code description
آسیب به اعصاب سمپاتیک پشت
Primary outcomes
1
Description
pain
Timepoint
At the start of the trial, five days later, ten days later, and one month afterwards.
Method of measurement
Visual analog scale of pain
2
Description
Disability
Timepoint
At the start of the trial, five days later, ten days later, and one month afterwards.
Method of measurement
Oswestry Disability Index
3
Description
Quality of Life
Timepoint
At the start of the trial, five days later, ten days later, and one month afterwards.
Method of measurement
Functional rating index
4
Description
Blood pressure
Timepoint
At the start of the trial, five days later, ten days later, and one month afterwards.
Method of measurement
Sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient is lying on the stomach and the hands are turned inward and attached to the patient's trunk, then the therapist is placed near the patient and places the palms of the hands in a crosswise manner on the soft tissue on both sides of the back spine and in opposite directions with equal pressure. The patient's tolerance to two opposite sides performs the release of the soft tissue. The duration of treatment is 90 seconds and three times for each treatment session, and the duration of the treatment is 5 minutes (21-23). To perform skin rolling, the patient lies on his stomach and then the therapist performs the massage technique from the bottom up by rolling the soft tissue between the thumb and other fingers. The duration of the technique is between 10 and 20 minutes (24, 25). In addition to receiving intervention, patients benefit from a current physiotherapy with the following characteristics: TENS: frequency 80Hz, deflection 250 microseconds US: pulse for 5 minutes HP: 15 minutes
Category
Treatment - Other
2
Description
Control group: Control group patients benefit from a current physiotherapy with the following characteristics: TENS: frequency 80Hz, deflection 250 microseconds US: pulse for 5 minutes HP: 15 minutes
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز فیزیوتراپی واقع در مرکز جامع توانبخشی و بعضی از مراکز خصوصی که در این زمینه همکاری می کنند.
Full name of responsible person
مجید شهبازی
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Shahbazi
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Shahbazi
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Shahbazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Shahbazi
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic, scientific and industrial institutions
Under which criteria data/document could be used
Those who make a written request and their written request is approved by the university.
From where data/document is obtainable
Refer to the Department of Physiotherapy of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
A written request will be given to the physiotherapy department and will be given to the requester if it does not comply with the university rules.