Sacroiliac Joint PainGirlsNCT06262763
High-intensity Laser Therapy for Sacroiliac Joint Pain
A study testing Laser Therapy and Traditional exercises in people with Sacroiliac Joint Pain, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Effect of high intensity laser on sacroiliac joint pain Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- Laser Therapy and Traditional exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2023to 28 Mar 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The presence of Pain over the sacroiliac joint with no surgical history.
- Unmarried.
- Tender SIJ on palpation.
- Workers with an average age of 18-30 years.
- Body mass index did not exceed 30 kg/m2.
Who cannot join
- If they have Infections. .Fracture in and around the SIJ Complex.
- Arthritis of joint.
- Pregnancy. .Smoking girls. .Patient not willing to participate in the study. .Any history of surgery. Lumbar spine disc herniation or back injury. Tumor around the joint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Intensity Laser on Sacroiliac Joint Pain In Adult Women
Effect of high intensity laser on sacroiliac joint pain
Read the detailed description
Effect of high laser in reduction of pain and improve functional disability in adult women
- Conditions
- Sacroiliac Joint Pain
- Being tested
- Laser Therapy, Traditional exercises, Placebo laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyDevice
Also called High power
High-intensity
Traditional exercisesOther
Hamstring and piriformis stretch, plank exercises and bird dog exercise
Placebo laserOther
Not directed radiation to participant
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Laser with traditional exercises Receives: Device: Laser Therapy; Other: Traditional exercises |
| Group (B) | Placebo comparator | Placebo LASER with traditional exercises Receives: Other: Traditional exercises; Other: Placebo laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
By Visual Analogue Sclae (VAS)
Measured: At the beginning and at after 12 session (1 month)
Secondary outcomes (1)
Pressure pain threshold
By pressure algometer
Measured: At the beginning and at after 12 session (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start3 Jan 2023
- Primary completion28 Apr 2023
- Study completion28 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint PainStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takwa Mohamed Saied Gado, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262763
- Sponsor's protocol ID
- HILT for SIJP
- Acronym
- Girls
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Laser on Sacroiliac Joint Pain In Adult Women
- ClinicalTrials.gov ID
- NCT06262763
- Acronym / sponsor ID
- Girls / HILT for SIJP
- Conditions
- Sacroiliac Joint Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Mar 2024 (estimated)
- First posted
- 16 Feb 2024 (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.
Effect of high intensity laser on sacroiliac joint pain
Detailed description
Effect of high laser in reduction of pain and improve functional disability in adult women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Device: Laser Therapy, Other: Traditional exercisesLaser with traditional exercises |
| Group (B) | Placebo comparator | Other: Traditional exercises, Other: Placebo laserPlacebo LASER with traditional exercises |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The presence of Pain over the sacroiliac joint with no surgical history.
- Unmarried.
- Tender SIJ on palpation.
- Workers with an average age of 18-30 years.
- Body mass index did not exceed 30 kg/m2.
Key exclusion criteria (3 listed)
- If they have Infections. .Fracture in and around the SIJ Complex.
- Arthritis of joint.
- Pregnancy. .Smoking girls. .Patient not willing to participate in the study. .Any history of surgery. Lumbar spine disc herniation or back injury. Tumor around the joint.
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 |
|---|---|---|
| Laser TherapyAlso: High powerHigh-intensity | Device | Group (A) |
| Traditional exercisesHamstring and piriformis stretch, plank exercises and bird dog exercise | Other | Group (A), Group (B) |
| Placebo laserNot directed radiation to participant | Other | Group (B) |
Primary outcome
Pain intensity
Time frame: At the beginning and at after 12 session (1 month)
By Visual Analogue Sclae (VAS)
1 secondary outcome
Pressure pain threshold
Time frame: At the beginning and at after 12 session (1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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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 Laser Therapy and Traditional exercises in people with Sacroiliac Joint Pain, run by Kafrelsheikh 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 5 inclusion and 3 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 16 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?
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?
Pain intensity (time frame: At the beginning and at after 12 session (1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.