To evaluate and compare the effects of self-myofascial release and Instrument-assisted soft tissue mobilization on pain, hamstrings tightness and functional disability.
Design
A randomized clinical trial was conducted with two parallel groups, a single blinded study of third phase with 17 patients in each group that are 34 in total.
Settings and conduct
Allied Hospital Faisalabad and Madinah Teachning Teaching Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Individuals diagnosed with non-specific lower back pain
Individuals with hamstring tightness
Subjects who voluntarily participated in the study
Who had greater than 20 degrees knee extension lag while performing Active Knee Extension Test
27-46 years of age, male and female subjects.
Exclusion Criteria:
Individuals who had any previous lumbar spine surgeries
Subjects who had any radiating pain or neurological deficit
Subjects who had spine tumors, Ankylosing Spondylitis, or Spondylolisthesis
With any any systemic illnesses, such as TB or spine infection
Intervention groups
Group A
Patients in this group performed self-myofascial release on hamstrings bilaterally using a tennis ball for 4 minutes, 2 minutes per leg. Hot pack was applied for 15 minutes as a baseline treatment in both groups.
Group B
Patients in this group had bilateral soft tissue mobilization of the hamstring muscles using the GT number 1 Graston device.
each participant received 30 repititions for 60 seconds of Graston instrument technique from the gluteal line to the popliteal fossa
Main outcome variables
• Numeric Pain Rating Scale (NPRS): For pain assessment
• Active Knee Extension Test (AKET): For hamstring tightness
• Oswestry Disability Index (ODI): For functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240528061932N1
Registration date:2024-07-31, 1403/05/10
Registration timing:registered_while_recruiting
Last update:2024-07-31, 1403/05/10
Update count:0
Registration date
2024-07-31, 1403/05/10
Registrant information
Name
Nadia Rani
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 2647086
Email address
thenadiarani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-15, 1403/01/27
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of self myofascial release and instrument-assisted soft tissue mobilization on non-specific low back pain patients
Public title
Comparison of self myofascial release and IASTM on non-specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals diagnosed with non-specific lower back pain
Individuals with hamstring tightness
Subjects who voluntarily participated in the study
Who had greater than 20 degrees knee extension lag while performing Active Knee Extension Test
27-46 years of age, male and female subjects.
Exclusion criteria:
Individuals who had any previous lumbar spine surgeries
Subjects who had any radiating pain or neurological deficit
Subjects who had spine tumors, Ankylosing Spondylitis, or Spondylolisthesis
With any any systemic illnesses, such as TB or spine infection
Age
From 27 years old to 46 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by lottery method and individuals were divided into two groups. Participants were blinded. They did not know to which group they were allocated.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blinded in this study. They did not know to which group they were allocated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics/ Technical committee for The University of Faisalabad
Street address
University Avenue, Faisal Town Canal Road
City
Faisalabad
Postal code
38000
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
TUF/DR/SA/MSPP/2024/420
Health conditions studied
1
Description of health condition studied
Non-specific low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain and Hamstring tightness
Timepoint
Before intervention and after 6 weeks of treatment
Method of measurement
NPRS and Active knee Extension Test
Secondary outcomes
1
Description
Functional Disability
Timepoint
Before intervention and at the end of 6 weeks of intervention
Method of measurement
Oswestry Disability Index
Intervention groups
1
Description
Intervention group: Group A received self myofscial release using a tennis ball on both legs.
Category
Treatment - Devices
2
Description
Intervention group: Group B received graston technique on hamstrings of both legs.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Nadia Rani
Street address
Sargodha Road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 301 6167796
Email
thenadiarani@gmail.com
2
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Nadia Rani
Street address
Dr. Tusi Road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 301 6167796
Email
thenadiarani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sidra Majeed
Street address
University Avenue Faisal Town Canal Road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 334 7731241
Email
sidra.majeed@tuf.edu.pk
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
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 Faisalabad
Full name of responsible person
Nadia Rani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mohalah Raza abad street#1/D Jaranwala
City
Jaranwala
Province
Punjab
Postal code
37250
Phone
+92 41 2647086
Email
thenadiarani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Nadia Rani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Street 1/D Mohallah Razabad, 240 mor Jaranwala
City
Jaranwala
Province
Punjab
Postal code
37250
Phone
+92 41 2647086
Email
thenadiarani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Nadia Rani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Street 1/D Mohallah Razabad, 240 mor Jaranwala
City
Jaranwala
Province
Punjab
Postal code
37250
Phone
+92 41 2647086
Email
thenadiarani@gmail.com
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
No - There is not 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
Comparative Effects of Self Myofascial Release and Instrument-assisted Soft Tissue Mobilization in Non-specific Low Back Pain Patients
When the data will become available and for how long
Starting 6 months after publication and it will remain available for everyone.
To whom data/document is available
This will be available for everyone.
Under which criteria data/document could be used
thenadiarani@gmail.com 0092 3016167796
From where data/document is obtainable
thenadiarani@gmail.com 0092 3016167796
What processes are involved for a request to access data/document
Any applicant just need to contact for data, contact through email at thenadiarani@gmail.com