- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280963
Posterior Innominate Mobilization Versus Muscle Energy Technique on Lumbopelvic Angles in Sacroiliac Joint Dysfunction (MET)
the goal of this clinical trial study is to compare between posterior innominate mobilization and muscle energy techniqueon lumbopelvic angles in sacroiliac joint dysfunction patients.
the main questions they aim to answer are
- are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on lumbopelvic angles in sacroiliac joint dysfunction patients ?
are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on pain intensity level in sacroiliac joint dysfunction patients ?
- purpose of the study is to measure the effect of muscle energy technique versus posterior innominate mobilization on lumbopelvic angles in sacroiliac joint dysfunction
Study Overview
Status
Conditions
Detailed Description
Sacroiliac joint dysfunction ( SIJ ) refers to a state of altered biomechanics of the SIJ. The sacrum does not exhibit muscle motion with respect to the ilium and SIJs are slackened only during pregnancy. Excessive or restricted motion may affect extra-articular structures surrounding the SIJs (such as the sacrotuberous, sacrospinus, and/or iliolumbar ligaments) and results in pain.
Sacroiliac (SI) joint dysfunction is a common cause of low back pain and accurate diagnosis can be challenging. A complete history and physical examination are critical in differentiating other diagnosis that may have similar signs and symptoms. Positive response to at least three physical provocation tests suggest sacroiliac joint dysfunction.
Muscle Energy Technique (MET) is an active technique in which the patient is also an active participant. MET is based on the concepts of Autogenic Inhibition and Reciprocal Inhibition. If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET, and if a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.
SIJ mobilization is a method of physical therapy. The advantages of the SIJ mobilization are reported in many aspects, such as decrease of LBP, decrease lumbar spinal stress by restoring normal function of innominate, promote pelvic symmetry, correct the sacroiliac joint dysfunction and relax surrounding muscles of the SIJ delimitations are
- Patients suffering from SIJ dysfunction with age between 25 and 45
- Patients with pain in gluteal region and around SIJ.
Patients testing positive in at least 3 of the following test:
- Gaenslen's test
- . Standing forward bending test
- . Sacroiliac distraction test
- . Sacroiliac compression test
- . Patrick and fabric test
Patients with visual analogue scale more than 3.\ lumbopelvic angles are four spinopelvic parameters which are
- Lumbar lordotic angle: The angle between the upper plate of the first lumbar and first sacral vertebral bodies .Mean value of lumber lordotic angle is 65.4
Pelvic incidence: Through the intersection of the line perpendicular to the sacral plate at its midpoint and the line connecting the point to the middle axis of the femoral heads .
Mean value of pelvic incidence is 51.50
- Pelvic tilt: Assessed by the intersection of the lines that cross the midpoint of both centers of the femoral heads and the mid-point of the sacral plateau with the line perpendicular to the ground. Mean value of pelvic tilt is 12.32
- Sacral slope: Through the intersection of lines parallel to the sacral plateau and parallel to the ground . Mean value of sacral slope is 39.17 * CorelDraw: is a family of software programs used for editing vector graphics, illustration and design. It is used in health care to measure spinopelvic angles after taking photos of them from their x-rays on mobile.
inclusion criteria : Subjects with sacroiliac joint dysfunction of both sexes with all the following criteria:
- Internal torsion of ilium on sacrum in sacroiliac joint dysfunction patients
- Normal weight - BMI greater than or equal to 18.5 to 24.9 kg/m^2
- Patients with age from 25 to 45
- Patients with VAS more than 3
- Pain around SIJ and groin area
- Patients testing positive at least 3 of six SIJ pain provocation tests (Gaenslen's test, Distraction test, Compression test, Thigh thrust test, Sacral thrust test, Patrick and fabric test)
Exclusion criteria: Patients will be excluded if they exhibited any of the following:
- Underlying neuro defects in leg
- Sacroiliitis
- Spondylolisthesis
- prediagnosed disease of central or peripheral nervous system
- Current pregnancy
- Rheumatological disease
- History of major surgery of lower extremity or spine
- Osteoporosis
- Recent injection of corticosteroids in SIJ
evaluation instruments :
- visual analogue scale (VAS) : a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount the amount of pain he or she feels . It will be used to assess current level of sacroiliac joint pain. Once subjects reported a pain level more than 3 on the visual analog scale [VAS], it will be included in the study. It has a Moderate to good reliability in patients with chronic musculoskeletal pain
- X-rays are form of electromagnetic radiation, similar to visible light. Unlike light, however, x-rays have higher energy and can pass through most objects, including the body. Medical x-rays are used to generate images of tissues and structures inside the body. If x-rays traveling through the body also pass through an x-ray detector on the other side of the patient, an image will be formed that represents the "shadows" formed by the objects inside of the body. One type of x-ray detector is photographic film, but there are many other types of detectors that are used to produce digital images. The x-ray images that result from this process are called radiographs.
- CorelDraw for measurement of lumbopelvic angels. It is used in health care to measure spinopelvic angles after taking photos of them from their x-rays on mobile.
After taking lumbopelvic x-ray from lateral view for all subjects from standing position . Put each X ray on lighting unit and take a photo by mobile camera. Put all soft copies of X ray pictures on a computer and measure the spinopelvic angels (sacral slope, lumber lordosis, pelvic incidence and pelvic tilt) by using CorelDraw graphic suits.
treatment tools and procedures :
muscle energy technique : In this study post isometric relaxation on gluteus maximus will be used:-
- Patient position: side lying with lower most leg extended and upper most leg flexed at hip and knee joint and held by therapist hand and his pelvis.
- Therapist position: stand in front of the patient with wide base of support one hand on PSIS and other hand hold the femur of the patient.
- Order: ask the patient to push his femur toward the therapist hand ( hip extension for glutes maximus muscle ) and hold for five to seven seconds, then relax and the therapist will get a new barrier and repeat this method for three to five times
Posterior innominate mobilization
- Patient position: side lying with lower most leg extended and upper most leg flexed at hip and knee joints.
- Therapist position: stand in front of the patient one hand on anterior superior iliac spine( ASIS) and his another forearm on the buttock.
- Procedure: pull ASIS backward (grade 3 mobilization). Frequency of mobilization: 30 oscillations , 3 sets per session ( every set has 30 oscillations )
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haytham M Elhafez, PhD
- Phone Number: +201001909630
- Email: elhafez@yahoo.com
Study Locations
-
-
Giza
-
Dokki, Giza, Egypt, 12612
- Recruiting
- Faculty of physical therapy
-
Contact:
- Haytham M Elhafez, PhD
- Phone Number: +201001909630
- Email: elhafez@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Internal torsion of ilium on sacrum in sacroiliac joint dysfunction patients
- Normal weight - BMI greater than or equal to 18.5 to 24.9 kg/m^2
- Patients with age from 25 to 45
- Patients with VAS more than 3
- Pain around SIJ and groin area
- Patients testing positive at least 3 of six SIJ pain provocation tests (Ganesen's test, Distraction test, Compression test, Thigh thrust test, Sacral thrust test, Patrick and fabric test)
Exclusion Criteria:
- Underlying neuro defects in leg
- Sacroiliitis
- Spondylolisthesis
- Pre diagnosed disease of central or peripheral nervous system
- Current pregnancy
- Rheumatological disease
- History of major surgery of lower extremity or spine
- Osteoporosis
- Recent injection of corticosteroids in SIJ
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: muscle energy technique arm
this arm will receive muscle energy technique
|
in muscle energy technique, the target is gluteus maximus muscle ( hip extension ) and repeat the method from three to five times .
|
Experimental: posterior innominate mobilization arm
this arm will receive posterior innominate mobilization
|
in posterior innominate mobilization ( grade 3 mobilization ) , frequency of mobilizations is 30 oscillations , 3 sets per session ( every set has 30 oscillations )
|
Placebo Comparator: control arm
this arm will receive conventional treatment
|
conventional treatment include
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lumbopelvic angles
Time Frame: 2 days
|
measurement of lumbopelvic angle ( pelvic incidence , sacral slope , lumbar lordosis and pelvic tilt
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: about 2 days
|
measurement of pain intensity by visual analogue scale It will be used to assess current level of sacroiliac joint pain.
Once subjects reported a pain level more than 3 on the visual analog scale [VAS], it will be included in the study
|
about 2 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Haytham M Elhafez, Faculty of physical therapy
Publications and helpful links
General Publications
- Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
- Nejati P, Safarcherati A, Karimi F. Effectiveness of Exercise Therapy and Manipulation on Sacroiliac Joint Dysfunction: A Randomized Controlled Trial. Pain Physician. 2019 Jan;22(1):53-61.
- Dydyk AM, Forro SD, Hanna A. Sacroiliac Joint Injury. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557881/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/005532
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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