Sacroiliac DisorderNCT06141954
US vs Low Level Laser on Sacroiliac Postpartum
A study testing Ultrasound waves therapy and Low level laser therapy in people with Sacroiliac Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare between effect of therapeutic ultrasound and low-level laser therapy on sacroiliac joint pain after delivery. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Sacroiliac Disorder
- What is being tested?
- Ultrasound waves therapy and Low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 Jun 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- sacroiliac joint dysfunction
- severe pain in the sacroiliac joint
- Age will range from 25 to 35 years old.
- Body Mass Index: ≤30 kg/m2
- The type of delivery is a cesarean section.
- All patients will not receive any medical treatment to relieve pain or decrease inflammation.
- All patients are not pregnant.
Who cannot join
- Diabetic mellitus and hypertension
- Cardiovascular diseases
- heart diseases
- Rheumatoid arthritis
- Cervical spondylosis with radiculopathy or any spinal diseases
- leukemia. (6) Deformities in their hands (7) Burns, ulcers, open wounds, or any skin diseases in dominant hands (8) received medications or have been injected with steroids at a tender point.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Ultrasound Versus Low Level Laser Therapy on Postpartum Sacroiliac Joint Pain
This study will be conducted to compare between effect of therapeutic ultrasound and low-level laser therapy on sacroiliac joint pain after delivery.
Read the detailed description
Women are more prone to sacroiliac joint (SIJ) pain during pregnancy and after childbirth. The hormonal changes during pregnancy and lactation make all the ligaments of the woman's body more lax and more flexible. Also, these hormones increase mobility of SIJs that are usually pretty stable, this in turn can leave the SIJs too mobile and can cause inflammation and pain in SIJ. In general, women are 8 to 10 times likely to experience SIJ pain and dysfunction than men due to the differences in their anatomy and body chemistry. Also, some studies have shown that, the younger woman has a greater risk of developing SIJ pain than the older one.On the other hand, the incidence of SIJ pain after delivery is very high and is more than we might think, since about 15-30% of postpartum women have SIJ pain. The pain starts when the mother's SIJs get inflamed. The SIJ pain can increase risk of low back pain after delivery.
The main cause of SIJ pain after delivery is the hypermobility and instability of SIJs. Hypermobility of SIJs caused by the pregnancy hormones causes an alteration in the normal joint motion (too much movement) which in turn causes instability in SIJs. About 30% of SIJ patients have postpartum instability in their SIJs so, they experience SIJ pain after delivery.Core weakness or muscle imbalances and sacroiliac dysfunction can also be the main cause of SIJ pain and low back pain after delivery . Increasing body mass index during pregnancy and after child birth, pre existing back pain before pregnancy and carrying multiple babies are risk factors for SIJ pain during pregnancy and after delivery. There are other factors causing SIJ pain additionally to hypermobility of the joints caused by pregnancy hormones like falling down. The mother might also get this problem, from an activity that gives the area a regular pounding like jogging or if she has one leg longer than the other that could be a cause of SIJ pain. Arthritis can also lead to SIJ pain ( a type that affects the spine called ankylosing spondylitis can damage the SIJ). SIJ pain can also occur when the cartilage over the joint slowly wears away by aging. SIJ pain may occur at any time during pregnancy and becomes more intense as the pregnancy progresses. This pain usually spontaneously resolves within 3 months after delivery. But, in some cases it can become chronic and disabling . SIJ pain could be a dull or sharp. It starts at SIJ but it can move to buttocks, thighs, groin or upper back. Sometimes, standing up trigger the pain and a lot of times the mother feels it only on one side of her lower back. The mother may notice that, it bothers her more in the morning and gets better during the day.There are many choices for treating SIJ pain. The first step is simply to stop any activities that make the mother hurt. The doctor will tell her to lay off any movement or sports that inflame her joints. She may also prescribe some pain drugs. Oral anti-inflammatory medications are often effective in pain relief.
Physiotherapy and exercises that focus on core stability of the trunk and pelvic girdle are considered the main line of treatment for SIJ pain. Sometimes a sacroiliac belt is prescribed to complement the core stability exercises and to give quick pain relief . The core stability exercises are very necessary and will form a large part of the treatment, and in some cases, mobilization (a gentle form of manipulation) of hip, back or pelvis may be used to correct any underlying movement dysfunction Other manual techniques can also be used to treat SIJ pain like muscle energy technique,myofacial release and massage therapy.
- Conditions
- Sacroiliac Disorder
- Being tested
- Ultrasound waves therapy, Low level laser therapy
- Keywords
- Ultrasound therapy, Low level laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound waves therapyDevice
Therapeutic ultrasound is proposed to deliver energy to deep tissue sites through ultrasonic waves, to produce increases in tissue temperature or non- thermal physiologic changes. Low level laser therapy penetrates particularly light waves that increase cellular metabolism.
Low level laser therapyDevice
Low-level laser (light) therapy (LLLT) is a fast-growing technology used to treat a multitude of conditions that require stimulation of healing, relief of pain and inflammation, and restoration of function.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Active comparator | Effect of ultrasound therapy on sacroiliac joint pain in woman postpartum Receives: Device: Ultrasound waves therapy |
| Low level laser | Active comparator | Effect of low level laser therapy on sacroiliac joint pain in woman postpartum Receives: Device: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
This scale will be used by each patient before and after treatment course to estimate the intensity of pain. Visual analogue scale (VAS) is a graphic rating scale with numerical values ranging from 0 to 4, placed equidistantly on a line of 10 cm long drawn horizontally.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023
- Primary completion30 Jan 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- Comparison between effect of ultrasound and low level laser on sacroiliac joint pain in woman postpartum
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Seif Eldein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141954
- Sponsor's protocol ID
- US vs Low level laser
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fiani B, Sekhon M, Doan T, Bowers B, Covarrubias C, Barthelmass M, De Stefano F, Kondilis A. Sacroiliac Joint and Pelvic Dysfunction Due to Symphysiolysis in Postpartum Women. Cureus. 2021 Oct 9;13(10):e18619. doi: 10.7759/cureus.18619. eCollection 2021 Oct.
PubMed 34786225
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Ultrasound Versus Low Level Laser Therapy on Postpartum Sacroiliac Joint Pain
- ClinicalTrials.gov ID
- NCT06141954
- Acronym / sponsor ID
- US vs Low level laser
- Conditions
- Sacroiliac Disorder
- Keywords
- Ultrasound therapy, Low level laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to compare between effect of therapeutic ultrasound and low-level laser therapy on sacroiliac joint pain after delivery.
Detailed description
Women are more prone to sacroiliac joint (SIJ) pain during pregnancy and after childbirth. The hormonal changes during pregnancy and lactation make all the ligaments of the woman's body more lax and more flexible. Also, these hormones increase mobility of SIJs that are usually pretty stable, this in turn can leave the SIJs too mobile and can cause inflammation and pain in SIJ. In general, women are 8 to 10 times likely to experience SIJ pain and dysfunction than men due to the differences in their anatomy and body chemistry. Also, some studies have shown that, the younger woman has a greater risk of developing SIJ pain than the older one.On the other hand, the incidence of SIJ pain after delivery is very high and is more than we might think, since about 15-30% of postpartum women have SIJ pain. The pain starts when the mother's SIJs get inflamed. The SIJ pain can increase risk of low back pain after delivery.
The main cause of SIJ pain after delivery is the hypermobility and instability of SIJs. Hypermobility of SIJs caused by the pregnancy hormones causes an alteration in the normal joint motion (too much movement) which in turn causes instability in SIJs. About 30% of SIJ patients have postpartum instability in their SIJs so, they experience SIJ pain after delivery.Core weakness or muscle imbalances and sacroiliac dysfunction can also be the main cause of SIJ pain and low back pain after delivery . Increasing body mass index during pregnancy and after child birth, pre existing back pain before pregnancy and carrying multiple babies are risk factors for SIJ pain during pregnancy and after delivery. There are other factors causing SIJ pain additionally to hypermobility of the joints caused by pregnancy hormones like falling down. The mother might also get this problem, from an activity that gives the area a regular pounding like jogging or if she has one leg longer than the other that could be a cause of SIJ pain. Arthritis can also lead to SIJ pain ( a type that affects the spine called ankylosing spondylitis can damage the SIJ). SIJ pain can also occur when the cartilage over the joint slowly wears away by aging. SIJ pain may occur at any time during pregnancy and becomes more intense as the pregnancy progresses. This pain usually spontaneously resolves within 3 months after delivery. But, in some cases it can become chronic and disabling . SIJ pain could be a dull or sharp. It starts at SIJ but it can move to buttocks, thighs, groin or upper back. Sometimes, standing up trigger the pain and a lot of times the mother feels it only on one side of her lower back. The mother may notice that, it bothers her more in the morning and gets better during the day.There are many choices for treating SIJ pain. The first step is simply to stop any activities that make the mother hurt. The doctor will tell her to lay off any movement or sports that inflame her joints. She may also prescribe some pain drugs. Oral anti-inflammatory medications are often effective in pain relief.
Physiotherapy and exercises that focus on core stability of the trunk and pelvic girdle are considered the main line of treatment for SIJ pain. Sometimes a sacroiliac belt is prescribed to complement the core stability exercises and to give quick pain relief . The core stability exercises are very necessary and will form a large part of the treatment, and in some cases, mobilization (a gentle form of manipulation) of hip, back or pelvis may be used to correct any underlying movement dysfunction Other manual techniques can also be used to treat SIJ pain like muscle energy technique,myofacial release and massage therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparison between effect of ultrasound and low level laser on sacroiliac joint pain in woman postpartum
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Active comparator | Device: Ultrasound waves therapyEffect of ultrasound therapy on sacroiliac joint pain in woman postpartum |
| Low level laser | Active comparator | Device: Low level laser therapyEffect of low level laser therapy on sacroiliac joint pain in woman postpartum |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- sacroiliac joint dysfunction
- severe pain in the sacroiliac joint
- Age will range from 25 to 35 years old.
- Body Mass Index: ≤30 kg/m2
- The type of delivery is a cesarean section.
Key exclusion criteria (6 listed)
- Diabetic mellitus and hypertension
- Cardiovascular diseases
- heart diseases
- Rheumatoid arthritis
- Cervical spondylosis with radiculopathy or any spinal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound waves therapyTherapeutic ultrasound is proposed to deliver energy to deep tissue sites through ultrasonic waves, to produce increases in tissue temperature or non- thermal physiologic changes. Low level laser therapy penetrates particularly light waves that increase cellular metabolism. | Device | Ultrasound |
| Low level laser therapyLow-level laser (light) therapy (LLLT) is a fast-growing technology used to treat a multitude of conditions that require stimulation of healing, relief of pain and inflammation, and restoration of function. | Device | Low level laser |
Primary outcome
Visual analogue scale (VAS)
Time frame: 4 weeks
This scale will be used by each patient before and after treatment course to estimate the intensity of pain. Visual analogue scale (VAS) is a graphic rating scale with numerical values ranging from 0 to 4, placed equidistantly on a line of 10 cm long drawn horizontally.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 34786225Fiani B, Sekhon M, Doan T, Bowers B, Covarrubias C, Barthelmass M, De Stefano F, Kondilis A. Sacroiliac Joint and Pelvic Dysfunction Due to Symphysiolysis in Postpartum Women. Cureus. 2021 Oct 9;13(10):e18619. doi: 10.7759/cureus.18619. eCollection 2021 Oct.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound waves therapy and Low level laser therapy in people with Sacroiliac Disorder, run by Cairo University 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 23 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 4 weeks). 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 NCT06141954, which also lists 1 linked publication.
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 23 Aug 2024.