Protocol summary
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Study aim
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To determine effects of the sub occipital muscle inhibition technique on pain, functional disability, and quality of life in patients with sacroiliac joint pain.
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Design
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It will be randomized controlled trial
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Settings and conduct
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The study will be conducted in Fatima memorial hospital – Physical therapy clinic and Pakistan Society Rehabilitation and Disability physiotherapy clinic, Nur International University Rehabilitation clinic.
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Participants/Inclusion and exclusion criteria
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INCLUSION CRITERIA
• Both genders will be included in this study.
• Patients between the age of 18 to 25 years.
• Sacroiliac pain of chronic level with the duration more than 3months.
• Patients with positive Leslett’s criteria (The Leslett’s criteria consist of 5 pain provocation test names as Compression test, Distraction test, thigh thrust, Gaenlsen test and Faber test. According to the criteria out of these five tests, if any of the three test indicates positive findings than it is labelled as sacroiliac pain.
• The patient with ODI score between 20-40%.
• Patients with NPRS score more than 3 points.
EXCLUSION CRITERIA
• Subjects who had signs of recent surgery
• Lumbar spine pathologies like radiculopathies disc herniation, spondylolisthesis, sensory changes in lower back region, osteoporosis
• Deformities like torticollis, forward head posture.
• Any neurological defect
• Any inflammatory or malignant type of pain
• Any systemic disease
• Pregnancy
• Infection
• Fractures in the spine
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Intervention groups
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intervention group will receive conventional treatment and suboccipital inhibition technique (performed for 4min)
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Main outcome variables
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Numeric pain rating (NPRS)
Oswestry Disability Index for disability
Health Questionnaire EQ 5D
General information
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Reason for update
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Trial completed
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Acronym
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RCT
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IRCT registration information
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IRCT registration number:
IRCT20190717044238N8
Registration date:
2023-04-03, 1402/01/14
Registration timing:
registered_while_recruiting
Last update:
2023-08-08, 1402/05/17
Update count:
1
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Registration date
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2023-04-03, 1402/01/14
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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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2023-02-28, 1401/12/09
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Expected recruitment end date
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2023-07-30, 1402/05/08
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Actual recruitment start date
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2023-03-10, 1401/12/19
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Actual recruitment end date
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2023-08-02, 1402/05/11
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Trial completion date
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2023-08-02, 1402/05/11
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Scientific title
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Effects of the suboccipital muscle inhibition technique on pain, functional disability, and quality of life in patients with sacroiliac joint pain
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Public title
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Physiotherapy effects on SIJ pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Both gender
Age 18-25 years old
Sacroiliac pain of chronic level with the duration more than 3months
Patients with positive Leslett’s criteria (The Leslett’s criteria consist of 5 pain provocation test names as Compression test, Distraction test, thigh thrust, Gaenlsen test and Faber test) According to the criteria out of these five tests, if any of the three test indicates positive findings than it is labelled as sacroiliac pain.
The patient with ODI score between 20-40%.• Patients with NPRS score more than 3 points.
Exclusion criteria:
Subjects who had signs of recent surgery
Lumbar spine pathologies like radiculopathies disc herniation, spondylolisthesis, sensory changes in lower back region, osteoporosis
Deformities like torticollis, forward head posture.
Any neurological defect
Any inflammatory or malignant type of pain
Any systemic disease
Pregnancy
Infection
Fractures in the spine
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Age
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From 18 years old to 25 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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No information
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Sample size
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Target sample size:
38
Actual sample size reached:
38
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned into 2 groups using a computer generated random number table. All those random numbers will be enclosed in sealed envelopes. A third person (who will further not be a part of research) will open envelopes and the patient will be allocated to the mentioned group accordingly
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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An in dependent assessor, who will be a senior and experienced physiotherapist and will not be part of the study, will assess patient.
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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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no
Ethics committees
1
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Ethics committee
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Approval date
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2023-01-02, 1401/10/12
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Ethics committee reference number
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REC/RCR & AHS/23/0104
Health conditions studied
1
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Description of health condition studied
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Sacroiliac joint pain
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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will be measure on baseline 3 weeks to 6 weeks
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Method of measurement
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NPRS questionnaire
2
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Description
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Disability
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Timepoint
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will be measure on baseline 3 weeks to 6 weeks
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Method of measurement
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Oswestry Disability Index for disability
3
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Description
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Quality of life
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Timepoint
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will be measure on baseline 3 weeks to 6 weeks
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Method of measurement
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Health Questionnaire EQ 5D
Intervention groups
1
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Description
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Control group: Group A will receive conventional treatment only which is hot pack for 10 minutes, transcutaneous electrical nerve stimulator (TENS) with 3hz frequency of burst mode for time duration of 10 minutes, therapeutic ultrasound with frequency of 1MHz for a time duration of 5 minutes and muscle energy techniques (2sets, 5repitions, 10 sec hold), will be given to the subject.
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Category
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Treatment - Other
2
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Description
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Intervention group: : Group B will receive conventional treatment which is hot pack for 10 minutes, transcutaneous electrical nerve stimulator (TENS) with 3hz frequency of burst mode for time duration of 10 minutes, therapeutic ultrasound with frequency of 1MHz for a time duration of 5 minutes and muscle energy techniques (2sets, 5repitions, 10 sec hold), will be given to the subject and new treatment which is sub occipital inhibition technique (performed for 4min until the tissues and muscles were relaxed. During the procedure, patients were asked to keep their eyes closed to avoid eye movements that affect the sub occipital muscle tone)
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Riphah International University
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Proportion provided by this source
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100
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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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Academic
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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available