Effects of Muscle Energy Technique with and without sacroiliac belt on pain, muscle strength and quality of life in patients with sacroiliac joint dysfunction - A randomized clinical trial
To assess the influence of muscle energy technique with and without the application of a sacroiliac belt on pain levels, muscle strength, and the overall quality of life in individuals with sacroiliac joint dysfunction.
Design
In an upcoming nine-month randomized control trial at Begum Akhtar Rukhsana Memorial Welfare Trust Hospital in Lahore, 48 participants will be conveniently sampled.
Settings and conduct
Setting: Begum Akhtar Rukhsana Memorial trust Hospital, Lahore.
Participants in the trial will be blinded, unaware of their group assignments or the nature of interventions, to minimize potential biases in behavior and reporting.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Participants aged 30 to 50 years of both genders; Individuals with persistent pain in the lower back, gluteal, and groin regions, and lower extremity pain lasting between four weeks and one year; Participants testing positive on pain provocation tests.
Exclusion Criteria: Pregnant females; Individuals with health issues hindering exercise, such as SLE, Multiple Sclerosis, and Chronic Fatigue Syndrome; Those with osteoporosis affecting the pelvic and spine region, inflammatory pathologies (Ankylosing Spondylitis, Osteoarthritis Hip, Degenerative Arthritis), a history of hip fracture, or any spinal surgery.
Intervention groups
The study will allocate participants into experimental (MET with SI Belt) and control (MET only) groups,
Main outcome variables
SF-36, NPRS, and MMT to assess quality of life, pain, and muscle strength, respectively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220930056062N2
Registration date:2023-11-22, 1402/09/01
Registration timing:registered_while_recruiting
Last update:2023-11-22, 1402/09/01
Update count:1
Registration date
2023-11-22, 1402/09/01
Registrant information
Name
Kaiynat Shafique
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 334 6925051
Email address
kaiynatshafique@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-18, 1402/08/27
Expected recruitment end date
2024-01-15, 1402/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Muscle Energy Technique with and without sacroiliac belt on pain, muscle strength and quality of life in patients with sacroiliac joint dysfunction - A randomized clinical trial
Public title
Effects of Muscle Energy Technique with and without sacroiliac belt on pain, muscle strength and quality of life in patients with sacroiliac joint dysfunction - A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
participants aged between thirty and fifty years.
Both genders
Individuals with persistent pain in the lower back, gluteal, and groin regions
Participants experienced lower extremity pain for more than four weeks but less than a year
individuals who tested positive on pain provocation tests
Exclusion criteria:
Pregnant females
Patients facing health issues hindering exercise, such as Systemic Lupus Erythematous (SLE), Multiple Sclerosis, and Chronic Fatigue Syndrome
Individuals with osteoporosis affecting the pelvic and spine region
Patients with inflammatory pathologies, including Ankylosing Spondylitis, Osteoarthritis Hip, and Degenerative Arthritis
Those with a history of hip fracture or any spinal surgery
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the specified selection criteria were allocated into two distinct groups, denoted as group A and group B. The allocation process was executed through a randomization method, employing the lottery approach to ensure a fair and unbiased distribution among the groups. This random division was implemented to minimize potential biases and enhance the validity of the study results
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding procedure were meticulously employed in the study to eliminate biases. Participants were kept uninformed about their group assignments (single-blind)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Lahore
Street address
KM Defence Road, Lahore
City
Lahore
Postal code
54000
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
20759
Health conditions studied
1
Description of health condition studied
Sacroiliitis
ICD-10 code
M46.1
ICD-10 code description
Sacroiliitis, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and after 4 weeks
Method of measurement
NPRS
2
Description
Strength
Timepoint
Before intervention and after 4 weeks
Method of measurement
MMT
3
Description
Quality of life
Timepoint
Before intervention and after 4 weeks
Method of measurement
SF-36
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A will slated to undergo Muscle Energy Technique (MET) coupled with a sacroiliac (SI) Bel
Category
Rehabilitation
2
Description
Control group: Group B will exclusively receive MET.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Begum Akhtar Rukhsana Memorial welfare trust Hospital, Lahore.
Full name of responsible person
Gulraiz Enderyas
Street address
Lahore
City
Lahore
Postal code
54000
Phone
+92 300 8573142
Email
gulraizpt@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Gulraiz Enderyas
Street address
KM Defence Road, Lahore
City
Lahore
Postal code
54000
Phone
+92 300 8573142
Email
gulraizpt@gmail.com
Grant name
No funding was received
Grant code / Reference number
No funding was received
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No funding was received
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Gulraiz Enderyas
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
KM Defence Road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 300 8573142
Email
gulraizpt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Gulraiz Enderyas
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
KM Defence Road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 300 8573142
Email
gulraizpt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Gulraiz Enderyas
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
KM Defence Road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 300 8573142
Email
gulraizpt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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