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Sacroiliac Joint DysfunctionMETNCT06280963

Posterior Innominate Mobilization Versus Muscle Energy Technique on Lumbopelvic Angles in Sacroiliac Joint Dysfunction

A study testing muscle energy technique, posterior innominate mobilization and conventional treatment in people with Sacroiliac Joint Dysfunction, run by Mahmoud Yousry Rashwan Hefny at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 1. Read more about this study

Who is it for?
Ages 25 to 45 years
Conditions the study is for
Sacroiliac Joint Dysfunction
What is being tested?
muscle energy technique, posterior innominate mobilization and conventional treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Feb 2024to 3 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • Underlying neuro defects in leg
  • Sacroiliitis
  • Spondylolisthesis
  • Pre diagnosed disease of central or peripheral nervous system
  • Current pregnancy
  • Rheumatological disease
Show all 9Show fewer
  • History of major surgery of lower extremity or spine
  • Osteoporosis
  • Recent injection of corticosteroids in SIJ

Trial locations and contacts

1 site in 1 country.

Haytham M Elhafez, PhD contact

+201001909630

elhafez@yahoo.com

Egypt1 site, 1 recruiting
  • Faculty of Physical Therapy

    Dokki, Giza Governorate, 12612

    Haytham M Elhafez, PhD, +201001909630, elhafez@yahoo.com

    Recruiting

Other trials in Egypt

About this study

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

Read more
  1. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on lumbopelvic angles in sacroiliac joint dysfunction patients ?
  2. 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
Read the 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:
  1. Gaenslen's test
  2. . Standing forward bending test
  3. . Sacroiliac distraction test
  4. . Sacroiliac compression test
  5. . Patrick and fabric test
  • Patients with visual analogue scale more than 3.\ lumbopelvic angles are four spinopelvic parameters which are
  1. 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
  2. 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
  3. 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
  4. 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 :
  1. 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
  2. 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.
  3. 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 :

  1. 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
  1. 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 )
Being tested
muscle energy technique, posterior innominate mobilization, conventional treatment
Keywords
lumbopelvic angles, muscle energy technique, sacroiliac joint dysfunction, posterior innominate mobilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • muscle energy techniqueBehavioural

    in muscle energy technique, the target is gluteus maximus muscle ( hip extension ) and repeat the method from three to five times .

  • posterior innominate mobilizationBehavioural

    in posterior innominate mobilization ( grade 3 mobilization ) , frequency of mobilizations is 30 oscillations , 3 sets per session ( every set has 30 oscillations )

  • conventional treatmentBehavioural

    Also called placebo treatment

    conventional treatment include

    • TENS ( 45 minutes of conventional TENS )
    • Ultrasound (pulsed mode 1:1 ,5 min .1.5W/cm2 )
    • Stretching exercises ( hamstrings ,hip flexors and hip adductors)
    • Strengthening exercises (lower abdomen and glutes muscles )
    • Lumpopelvic stabilization exercise
Study groups in NCT06280963
Study groupRoleWhat they receive
muscle energy technique armExperimentalthis arm will receive muscle energy technique
Receives: Behavioral: muscle energy technique
posterior innominate mobilization armExperimentalthis arm will receive posterior innominate mobilization
Receives: Behavioral: posterior innominate mobilization
control armPlacebo comparatorthis arm will receive conventional treatment
Receives: Behavioral: conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. lumbopelvic angles

    measurement of lumbopelvic angle ( pelvic incidence , sacral slope , lumbar lordosis and pelvic tilt

    Measured: 2 days

Secondary outcomes (1)
  1. pain intensity

    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

    Measured: about 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion3 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
group one will receive muscle energy technique group two will receive posterior innominate mobilization group three will receive conventional treatment ( TENS , US , stertching exercises and strenghening exercises )
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280963
Sponsor's protocol ID
012/005532
Acronym
MET
Status last verified
Feb 2024
First submitted
20 Feb 2024
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32123652
  • 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.

    PubMed 30700068
  • Dydyk, A. M., Forro, S. D., & Hanna, A. (2020). Sacroiliac joint injury. StatPearls Publishing, Treasure Island (FL), 04 Jun 2020 PMID: 32491804

Questions about this trial

What is this clinical trial studying?

A study testing muscle energy technique, posterior innominate mobilization and conventional treatment in people with Sacroiliac Joint Dysfunction, run by Mahmoud Yousry Rashwan Hefny at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haytham M Elhafez, PhD (+201001909630, elhafez@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lumbopelvic angles (time frame: 2 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06280963, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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