Protocol summary
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Study aim
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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.
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Design
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In an upcoming nine-month randomized control trial at Begum Akhtar Rukhsana Memorial Welfare Trust Hospital in Lahore, 48 participants will be conveniently sampled.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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The study will allocate participants into experimental (MET with SI Belt) and control (MET only) groups,
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Main outcome variables
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SF-36, NPRS, and MMT to assess quality of life, pain, and muscle strength, respectively.
General information
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Reason for update
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To update information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220930056062N2
Registration date:
2023-11-22, 1402/09/01
Registration timing:
prospective
Last update:
2023-12-03, 1402/09/12
Update count:
1
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Registration date
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2023-11-22, 1402/09/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-25, 1402/09/04
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Expected recruitment end date
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2024-01-15, 1402/10/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Blinding procedure were meticulously employed in the study to eliminate biases. Participants were kept uninformed about their group assignments (single-blind)
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-15, 1402/08/24
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Ethics committee reference number
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20759
Health conditions studied
1
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Description of health condition studied
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Sacroiliitis
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ICD-10 code
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M46.1
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ICD-10 code description
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Sacroiliitis, not elsewhere classified
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before intervention and after 4 weeks
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Method of measurement
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NPRS
2
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Description
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Strength
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Timepoint
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Before intervention and after 4 weeks
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Method of measurement
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MMT
3
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Description
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Quality of life
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Timepoint
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Before intervention and after 4 weeks
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Method of measurement
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SF-36
Intervention groups
1
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Description
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Intervention group: Group A will slated to undergo Muscle Energy Technique (MET) coupled with a sacroiliac (SI) Bel
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Category
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Rehabilitation
2
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Description
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Control group: Group B will exclusively receive MET.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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No funding was received
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Grant code / Reference number
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No funding was received
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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No funding was received
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Proportion provided by this source
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1
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable