The effect of physiotherapy , hydrotherapy and combination methods on pain and Functional Disability in patients with Chronic Low Back Pain due to Lumbar Disc Herniation
Comparison of the effect of three methods of physiotherapy, hydrotherapy and combination on pain and functional disability in patients with chronic low back due to Lumbar Disc Herniation
Design
A Single blind randomized clinical trial with parallel groups and an eight-week follow-up. The sample size was obtained according to the results of similar studies and using G power software; 20 people in each group.
Settings and conduct
According to the inclusion criteria, patients are called to the physiotherapy clinic by referring a doctor and then are randomly assigned to one of the groups. This is a Single blind clinical study in which the evaluator does not know which group the patients belong to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men with chronic low back pain due to lumbar disc herniation with a history of pain of more than three months; Age range 25 to 50 years; Body mass index between 20-25; Having moderate pain means pain of at least 4 and at most 7 with the characteristic of visual pain scale. Conditions of absence: history of lumbar surgery; Use of special medications and painkillers; History of underlying diseases such as heart disease, respiratory disease, diabetes and etc.
Intervention groups
Intervention group 1: using electrotherapy and exercise therapy for eight weeks and three times a week.Intervention group 2: Performing exercises in water with a temperature of 32 degrees Celsius for eight weeks and three times a week. Intervention group 3: use of electrotherapy and exercise therapy in the first four weeks and three times a week and use of hydrotherapy in the second four weeks.Control group:This group is told to take an absolute break at this time
Main outcome variables
Pain, functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200302046675N1
Registration date:2020-11-05, 1399/08/15
Registration timing:prospective
Last update:2020-11-05, 1399/08/15
Update count:0
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
mohammad shamstabarkami
Name of organization / entity
The university of shams
Country
Iran (Islamic Republic of)
Phone
+98 11 3252 3403
Email address
m_shamskamangir14@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physiotherapy , hydrotherapy and combination methods on pain and Functional Disability in patients with Chronic Low Back Pain due to Lumbar Disc Herniation
Public title
The effect of physiotherapy , hydrotherapy and combination methods on patients with Lumbar Disc Herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mass Index between 20-25
Having moderate pain means a minimum of 4 and a maximum of 7 with a Visual Analouge Scale index
Men with chronic low back pain caused by a lumbar disc herniation with a history of pain of more than three months
Exclusion criteria:
History of lumbar surgery
Use of special medications and painkillers
History of underlying diseases such as heart disease, respiratory disease, diabetes, etc.
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization in that a number of cards are considered by the researcher as the first group (physiotherapy) and the same number of cards for other groups (hydrotherapy, combination and control group); Then, by merging the cards together, a card is taken out and its allocation is recorded and returned to the other cards. The cards are then merged again and another card is removed. Also, the number of cards is not necessarily equal to the total number of samples.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a Single blind clinical trial in which a expert physiotherapist will perform intervention and other physiotherapists will perform the Assessment. As a result, the Assessor will not know which group the patient belongs to.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of babol University of Medical Sciences
Street address
University of Medical Sciences,Ganj Afrooz St,Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2020-08-15, 1399/05/25
Ethics committee reference number
IR.MUBABOL.REC.1399.228
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
M51
ICD-10 code description
Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders
Primary outcomes
1
Description
Pain
Timepoint
Before treatment, the eighth week of treatment
Method of measurement
Visual analog scale
2
Description
Functional disability
Timepoint
Before treatment, the eighth week of treatment
Method of measurement
Oswestry Disability Questionnaire (ODQ)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1 : The physiotherapy protocol includes TENS method and exercise therapy. TENS method performed with a multistim device model 735M made by Novin company and exercise therapy is performed in accordance with the evaluation and prescribing instructions of the American School of Sports Medicine. This intervention is performed for 8 weeks and 3 times a week for 60 minutes each time.
Category
Treatment - Devices
2
Description
intervention group 2 : Hydrotherapy, These exercises were performed in water with a depth of 1 to 2 meters and a temperature of 28 to 32 degrees Celsius. Exercises three times a week for 8 weeks, each time for 60 minutes.
Category
Treatment - Devices
3
Description
Intervention group 3 : combination group , Treatment in this group was a combination of physiotherapy and hydrotherapy. Thus, in the first month, three sessions per week and 60 minutes per session, physiotherapy and in the second month, three sessions per week and each session 60 minutes, hydrotherapy is performed.
Category
Treatment - Devices
4
Description
Control group : Patients are told not to use any treatment model for eight weeks and to rest completely.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Iman
Full name of responsible person
Mohammad Shams Tabar Kami
Street address
Next to Saba Laboratory , Danesh Alley 4 , In front of Shahid Beheshti Hospital , Keshvari Square, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۴۸۷۱۱۶۷
Phone
+98 11 3225 6141
Email
m_shamskamangir14@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Sciences , Ganj Afrooz St.,Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۴۸۷۱۱۶۷
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
The University of Shams
Full name of responsible person
Mohammad Shams Tabar Kami
Position
University Student
Latest degree
Master
Other areas of specialty/work
Sport Pathology
Street address
No. 62, Ghaem St., Khoshroudpy, Babol
City
Babol
Province
Mazandaran
Postal code
4733155987
Phone
+98 11 3252 9427
Email
m_shamskamangir14@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of shams
Full name of responsible person
Mohammad Shams Tabar Kami
Position
Physical education
Latest degree
Master
Other areas of specialty/work
Sport pathology
Street address
No. 62, Ghaem St., Khoshroudpi, Babol
City
Babol
Province
Mazandaran
Postal code
4733155987
Phone
+98 11 3252 3403
Fax
Email
m_shamskamangir14@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Shams
Full name of responsible person
Mohammad Shams Tabar Kami
Position
Physical education
Latest degree
Master
Other areas of specialty/work
Sport pathology
Street address
No. 62, Ghaem St., Khoshroudpi, Babol
City
Babol
Province
Mazandaran
Postal code
4733155987
Phone
+98 11 3252 3403
Fax
Email
m_shamskamangir14@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
If needed by researchers and their request, the raw data of research and it's analysis will be available to researchers
When the data will become available and for how long
After the publication of articles resulting from the research
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data are available only to other researchers to study and evaluate treatment outcomes.
From where data/document is obtainable
By sending an email to the corresponding author
What processes are involved for a request to access data/document
Send an email and the request will be answered shortly after review.