The effect of eight-weeks of reflexology and stretching exercises on ground reaction and electrical activity of lower limb muscles during walking in people with back pain.
The purpose of this study was to investigate the effect of eight weeks of reflexology and stretching exercises on ground reaction force and electrical activity of lower limb muscles in people with back pain.
Design
Clinical trial has: control group, with parallel groups, unblinded, randomized, on 30 patients. RAND function of Excel software was used for randomization.
Settings and conduct
Mohagheg Ardabili University Health Center, located in the Faculty of Educational Sciences and Psychology.
The subjects were randomly divided into three groups of ten people. From two devices:
Electromyography, FORCE PLATE was used, and the results were analyzed by the necessary software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants must have back pain.
Exclusion criteria: have an acute complication in the back area.
Intervention groups
The intervention group included reflexology massage and stretching exercises, and the control group had no activity
Main outcome variables
Ground reaction force and electrical activity of lower limb muscles.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190302042881N5
Registration date:2024-03-29, 1403/01/10
Registration timing:prospective
Last update:2024-03-29, 1403/01/10
Update count:0
Registration date
2024-03-29, 1403/01/10
Registrant information
Name
Mohsen Barghamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5652
Email address
barghamadi@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight-weeks of reflexology and stretching exercises on ground reaction and electrical activity of lower limb muscles during walking in people with back pain.
Public title
The effect of reflexology and stretching exercises on back pain.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All people who have had back pain for more than three months
All people who do not have serious problems such as back disc
Exclusion criteria:
People who have a history of back surgery
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We put the names of all subjects with back pain in a bag and select them one by one. And we randomly divide into three groups of stretching exercises, massage and control.
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 Ardabil University of Medical Sciences
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Approval date
2023-11-30, 1402/09/09
Ethics committee reference number
IR.UMA.REC.1402.063
Health conditions studied
1
Description of health condition studied
Healthy students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Components of ground reaction force
Timepoint
Pre-test before training and post-test eight weeks after training
Method of measurement
Ground reaction force variables using the force plane device.
2
Description
Electrical activity of muscles
Timepoint
Pre-test before training and post-test eight weeks after training.
Method of measurement
The electrical activity of the muscles was measured by an Electromyography device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Reflexology massage and stretching exercises including: exercise program for 8 weeks and three sessions per week and each session for 15 minutes including warming up for 5 minutes.
Category
Diagnosis
2
Description
Control group: There was no intervention in the control group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohagheg Ardabili University Health Center
Full name of responsible person
Mohsen Barghamadi
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Fahad Pourfarzi
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
F.pourfarzi@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mohaghegh Ardabili University
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
Mohaghegh Ardabili University
Full name of responsible person
Mohsen Barghamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Mohsen Barghamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Mohsen Barghamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Average ground reaction forces and electrical activity of lower limb muscles
When the data will become available and for how long
6 months after publication
To whom data/document is available
All people
Under which criteria data/document could be used
It is free
From where data/document is obtainable
barghamadi@uma.ac.ir
What processes are involved for a request to access data/document