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General information
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38
38
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2023-03-10, 1401/12/19
2023-03-10 00:00:00
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2023-08-02, 1402/05/11
2023-08-02 00:00:00
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2023-08-02, 1402/05/11
2023-08-02 00:00:00
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Trial completed
Trial completed
Protocol summary
Study aim
To determine effects of the sub occipital muscle inhibition technique on pain, functional disability, and quality of life in patients with sacroiliac joint pain.
Design
It will be randomized controlled trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
intervention group will receive conventional treatment and suboccipital inhibition technique (performed for 4min)
Main outcome variables
Numeric pain rating (NPRS)
Oswestry Disability Index for disability
Health Questionnaire EQ 5D
General information
Reason for update
Trial completed
Acronym
RCT
IRCT registration information
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
Registration date
2023-04-03, 1402/01/14
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-28, 1401/12/09
Expected recruitment end date
2023-07-30, 1402/05/08
Actual recruitment start date
2023-03-10, 1401/12/19
Actual recruitment end date
2023-08-02, 1402/05/11
Trial completion date
2023-08-02, 1402/05/11
Scientific title
Effects of the suboccipital muscle inhibition technique on pain, functional disability, and quality of life in patients with sacroiliac joint pain
Public title
Physiotherapy effects on SIJ pain
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Single blinded
Blinding description
An in dependent assessor, who will be a senior and experienced physiotherapist and will not be part of the study, will assess patient.
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics Committee
Street address
Riphah International University Lahore, Pakistan
City
Lahore
Postal code
54000
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
REC/RCR & AHS/23/0104
Health conditions studied
1
Description of health condition studied
Sacroiliac joint pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
will be measure on baseline 3 weeks to 6 weeks
Method of measurement
NPRS questionnaire
2
Description
Disability
Timepoint
will be measure on baseline 3 weeks to 6 weeks
Method of measurement
Oswestry Disability Index for disability
3
Description
Quality of life
Timepoint
will be measure on baseline 3 weeks to 6 weeks
Method of measurement
Health Questionnaire EQ 5D
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima memorial hospital-Physical therapy clinic, Pakistan Society Rehabilitation and Disability phy
Full name of responsible person
Dr. Ahmed Jamal
Street address
61 froze purr road Lahore, Pakistan
City
Lahore
Postal code
54000
Phone
+92 312 4222341
Email
Drahmedjamal912@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Dr. Ahmed Jamal
Street address
61 feroz purr road Lahore, Pakistan
City
Lahore
Postal code
54000
Phone
+92 312 4222341
Email
Drahmedjaml912@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
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
Riphah International University
Full name of responsible person
Fareeha Amjad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 312 4222341
Email
drahmedjamal912@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Fareeha Amjad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
riphah international university lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ripah international University
Full name of responsible person
Fareeha Amjad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International university pico road lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available