Effect of Quadratus Lumborum Muscle Energy Technique in Sacroilliac Joint Dysfunction.
Primary Purpose
Sacroiliac Disorder
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Disorder focused on measuring MET, Quadratus lumborum, Sacroilliac joint
Eligibility Criteria
Inclusion Criteria:
• Subjects with unilateral non-specific LBP
- The Subjects having at least 3 pain provocative tests of SIJ positive out of 5.
- Age 30-50 years. Both male and female.
- Pain history greater than six weeks.
- SIJ diagnostic scoring cut off point 4.
- VAS cut off point mild to moderate.
Exclusion Criteria:
- Radiating pain with sensory or motor deficits.
- History of fracture or any spinal surgery
- Trauma
- Any dysfunction of hip or knee
- Any systemic disease.
- Pregnancy
Sites / Locations
- Institute of physical medicine and rehabilitation, Dow University of health sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Comparator
Arm Description
Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes. i. MET Quadratus lumborum ii. Ultrasound iii. Gluteus medius exercises iv. Hamstring stretch Posture advice and home exercise program
Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes. i. Ultrasound ii.Gluteus medius exercises iii.Hamstring stretch
Outcomes
Primary Outcome Measures
visual analog scale to measure the change in level of Pain intensity
A Visual Analogue ScalE is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end ranging from no pain to severe pain.
Oswestry Disability Index to measure change in level of disability
Change in level of disability as evaluated by means of Oswestry Disability Index 2.0 (ODI)
SF-36 QUALITY OF LIFE to measure change in general health
SF-36 measure 8 different health concepts including general health, physical functioning, role functioning, bodily pain, mental health, emotional functioning, vitality, and social functioning.
Secondary Outcome Measures
Hand Held Dynamometer to check gluteus medius muscle strength
The strength of the gluteus medius muscle was assessed on the dominant side using the Microfet2 hand-held dynamometer (MicroFET 2, Hoogan Health Industries, West Jordan, UT, USA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04161443
Brief Title
Effect of Quadratus Lumborum Muscle Energy Technique in Sacroilliac Joint Dysfunction.
Official Title
Effect of Quadratus Lumborum Muscle Energy Technique Along With Gluteus Medius Strengthening Verus Gluteus Medius Strengthening Alone in the Management of Sacroilliac Joint Dysfunction.; A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
December 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sacroiliac joint as a potential source of low back pain is an overlooked problem. Yet, in the existing years there has been an increasing interest in sacroiliac joint as a pain originator and more attention is being paid into its assessment and treatment in the current literature. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring; however the role of quadratus lumborum working on compensatory mechanism and its treatment effect in the management of sacroiliac joint dysfunction is yet not discovered.
Detailed Description
Going through current literature, it is evident that sacroiliac joint dysfunction as a postural dysfunction is highly prevalent among adult population. This dysfunction due to major muscle imbalances if not treated timely can result in serious consequences later in life where it becomes the permanent dysfunction involving the major changes in the joint itself. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring; however the role of quadratus lumborum working on compensatory mechanism and its treatment effect in the management of sacroiliac joint dysfunction is yet not discovered. All patients will be assessed and screened by consultants as indicated and will refer to physiotherapy with diagnosed non- specific chronic back pain.Patients will further be screened for SIJ dysfunction by physiotherapist.Only those patients who fulfill the criteria of Quadratus lumborum tightness & Gulteus medius weakness will randomly be selected and the sample of 70 will finally be selected for intervention.Written consent form will be taken from all study participants.Simple randomization technique will be used through "Randomization Main" software and randomization sheet will be generated. Patients will be further be assigned equally into two groups as per randomization sheet.Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary. The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Disorder
Keywords
MET, Quadratus lumborum, Sacroilliac joint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double blinding will be used as the subjects and the assessor both will be blinded for the treatment used.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes.
i. MET Quadratus lumborum ii. Ultrasound iii. Gluteus medius exercises iv. Hamstring stretch Posture advice and home exercise program
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes.
i. Ultrasound ii.Gluteus medius exercises iii.Hamstring stretch
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary.
The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention).
Primary Outcome Measure Information:
Title
visual analog scale to measure the change in level of Pain intensity
Description
A Visual Analogue ScalE is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end ranging from no pain to severe pain.
Time Frame
Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
Title
Oswestry Disability Index to measure change in level of disability
Description
Change in level of disability as evaluated by means of Oswestry Disability Index 2.0 (ODI)
Time Frame
Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
Title
SF-36 QUALITY OF LIFE to measure change in general health
Description
SF-36 measure 8 different health concepts including general health, physical functioning, role functioning, bodily pain, mental health, emotional functioning, vitality, and social functioning.
Time Frame
Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline and 12th session at the end of 4th week.
Secondary Outcome Measure Information:
Title
Hand Held Dynamometer to check gluteus medius muscle strength
Description
The strength of the gluteus medius muscle was assessed on the dominant side using the Microfet2 hand-held dynamometer (MicroFET 2, Hoogan Health Industries, West Jordan, UT, USA).
Time Frame
Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Subjects with unilateral non-specific LBP
The Subjects having at least 3 pain provocative tests of SIJ positive out of 5.
Age 30-50 years. Both male and female.
Pain history greater than six weeks.
SIJ diagnostic scoring cut off point 4.
VAS cut off point mild to moderate.
Exclusion Criteria:
Radiating pain with sensory or motor deficits.
History of fracture or any spinal surgery
Trauma
Any dysfunction of hip or knee
Any systemic disease.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabail Soomro
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hussain Kari mi
Organizational Affiliation
University of Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of physical medicine and rehabilitation, Dow University of health sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Quadratus Lumborum Muscle Energy Technique in Sacroilliac Joint Dysfunction.
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