Sacroiliac Joint PainNCT05306236
Efficacy of Adding LLL Therapy to Postural Correction Exercises on Postnatal SIJ Pain
A study testing LLL therapy , postural correction ex in people with Sacroiliac Joint Pain, run by Cairo University at 1 site in Egypt.
Trial summary
the purpose of the study will be to to examine the effect of low level laser therapy on pain and function disability in postnatal women with sacroiliac joint pain. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- LLL therapy , postural correction ex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2022to 28 Jul 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post natal women suffering from sacroiliac joint pain for at least 3 months.
- They should have moderate to severe pain in the sacroiliac joint region (visual analogue scale ≥ 4).
- They should have positive findings in at least three of five provocation sacroiliac joint tests (i.e., Patrick's sign, Gaenslen test, compression test, thigh thrust test and distraction test).
- Their age will range from 25 to 40 years old.
- Their Body mass index (BMI) will be ranged from 25 to 30 Kg /m2.
- They should not have any musculoskeletal disorders.
Who cannot join
- Lumber or hip joint pathology.
- Acute pelvic bacterial or viral infections or tumour.
- Taking nonsteroidal anti-inflammatory drugs, or hormonal treatments.
- Having positive straight leg raising test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adding Low Level Laser Therapy to Postural Correction Exercises on Postnatal Sacroiliac Joint Pain
the purpose of the study will be to to examine the effect of low level laser therapy on pain and function disability in postnatal women with sacroiliac joint pain.
Read the detailed description
Women are more susceptible to sacroiliac joint pain than men because the physiological changes associated with childbearing (e.g. pregnancy associated with weight gain, exaggerated lumber lordosis, hormone-induced ligamentous laxity and the mechanical trauma associated with childbirth) may result in sacroiliac joint pathology .
Low level laser is effective for treatment of various musculoskeletal pain disorders. It releases local neurotransmitters such as serotonin and endorphins. Additionally, the analgesic effect of LLLT is thought to be related to its anti-inflammatory action. Laser irradiations also relieve pain by alleviating and removing swelling and by increasing oxygenation of the tissues, thus results in reduction of the pain .
- Conditions
- Sacroiliac Joint Pain
- Being tested
- LLL therapy , postural correction ex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLL therapy , postural correction exOther
study group: will receive low level laser therapy 2 sessions per week for 6 weeks in addition to posture correction exercises.
control group: will be treated by posture correction ex only.
| Study group | Role | What they receive |
|---|---|---|
| LLL therapy and postural correction ex (study group) | Experimental | study group will be treated by low level laser therapy and postural correction exercises Receives: Other: LLL therapy , postural correction ex |
| postural correction ex (control group) | Experimental | control group will be treated by postural correction exercises only Receives: Other: LLL therapy , postural correction ex |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The pain intensity will be assessed through visual analogue scale (VAS) for both groups before and after the end of treatment program. Each woman will be asked to mark a point on the line between the extremes that related to her pain intensity.
Measured: up to 2 months
pain pressure threshold
pressure algometer will be used to assess pain pressure threshold for both groups before and at the end of the study
Measured: up to 2 months
Secondary outcomes (1)
functional disability
oswestery disability index will be used to assess level of functional disability for both groups before and at the end of the study
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start30 Apr 2022
- Primary completion30 Jun 2022
- Study completion28 Jul 2022
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 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manal ahmed el-shafei mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306236
- Sponsor's protocol ID
- P.T.REC/012/003492
- Status last verified
- Jul 2023
- First submitted
- 23 Mar 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Low Level Laser Therapy to Postural Correction Exercises on Postnatal Sacroiliac Joint Pain
- ClinicalTrials.gov ID
- NCT05306236
- Acronym / sponsor ID
- P.T.REC/012/003492
- Conditions
- Sacroiliac Joint Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 1 Apr 2022 (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.
the purpose of the study will be to to examine the effect of low level laser therapy on pain and function disability in postnatal women with sacroiliac joint pain.
Detailed description
Women are more susceptible to sacroiliac joint pain than men because the physiological changes associated with childbearing (e.g. pregnancy associated with weight gain, exaggerated lumber lordosis, hormone-induced ligamentous laxity and the mechanical trauma associated with childbirth) may result in sacroiliac joint pathology .
Low level laser is effective for treatment of various musculoskeletal pain disorders. It releases local neurotransmitters such as serotonin and endorphins. Additionally, the analgesic effect of LLLT is thought to be related to its anti-inflammatory action. Laser irradiations also relieve pain by alleviating and removing swelling and by increasing oxygenation of the tissues, thus results in reduction of the pain .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLL therapy and postural correction ex (study group) | Experimental | Other: LLL therapy , postural correction exstudy group will be treated by low level laser therapy and postural correction exercises |
| postural correction ex (control group) | Experimental | Other: LLL therapy , postural correction excontrol group will be treated by postural correction exercises only |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Post natal women suffering from sacroiliac joint pain for at least 3 months.
- They should have moderate to severe pain in the sacroiliac joint region (visual analogue scale ≥ 4).
- They should have positive findings in at least three of five provocation sacroiliac joint tests (i.e., Patrick's sign, Gaenslen test, compression test, thigh thrust test and distraction test).
- Their age will range from 25 to 40 years old.
- Their Body mass index (BMI) will be ranged from 25 to 30 Kg /m2.
Key exclusion criteria (4 listed)
- Lumber or hip joint pathology.
- Acute pelvic bacterial or viral infections or tumour.
- Taking nonsteroidal anti-inflammatory drugs, or hormonal treatments.
- Having positive straight leg raising test.
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 |
|---|---|---|
| LLL therapy , postural correction exstudy group: will receive low level laser therapy 2 sessions per week for 6 weeks in addition to posture correction exercises. control group: will be treated by posture correction ex only. | Other | LLL therapy and postural correction ex (study group), postural correction ex (control group) |
Primary outcome
pain intensity
Time frame: up to 2 months
The pain intensity will be assessed through visual analogue scale (VAS) for both groups before and after the end of treatment program. Each woman will be asked to mark a point on the line between the extremes that related to her pain intensity.
pain pressure threshold
Time frame: up to 2 months
pressure algometer will be used to assess pain pressure threshold for both groups before and at the end of the study
1 secondary outcome
functional disability
Time frame: up to 2 months
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 14 Jul 2023.
- Individual participant dataSharing planned: Yes
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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 LLL therapy , postural correction ex in people with Sacroiliac Joint Pain, 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 6 inclusion and 4 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 14 Jul 2023. 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?
pain intensity (time frame: up to 2 months). The study lists 2 primary outcomes in all. 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 14 Jul 2023.