Sacroiliac Joint PainNCT05015413
Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women
A study testing Shockwave in people with Sacroiliac Joint Pain, run by Samar Mimi Mohamed Okby.
Trial summary
Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- Shockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2021to 29 Dec 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- postnatal women suffering from sacroiliac joint pain for at least 3 months.
- They should have moderate to severe pain .
- They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests
Who cannot join
- lumber or hip joint pathology
- Acute pelvic bacterial or viral infection .
- Receiving corticosteroid injections within the previous 6 weeks
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Shockwave Versus Low Level Laser Therapy on Sacroiliac Joint Pain in Postnatal Women
Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain
Read the detailed description
The study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women This study will be randomly distributed into two equal group Group A consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive shockwave therapy 2 session per week for 6 weeks Group B consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive low level laser therapy 2 session per week for 6 weeks
Evaluation procedures History taking recording in recording data sheet Weight and height measurement by calculate BMI Disability assessment by OWDI Pain assessment by VAS scale Assessment of pressure of pain threshold by pressure algometry
- Conditions
- Sacroiliac Joint Pain
- Being tested
- Shockwave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShockwaveDevice
Shock wave master 500 Germany
| Study group | Role | What they receive |
|---|---|---|
| shock wave group | Experimental | Group A will receive shockwave therapy 2 session per week for 6 weeks Receives: Device: Shockwave |
| low level laser group | Experimental | Group B will receive low level laser therapy 2 session per week for 6 weeks Receives: Device: Shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacroiliac joint pain
•Pain intensity: it will by measure by VAS it's presented as 10 cm horizontal line on which the patient pain intensity is point between no pain at zero score to extreme pain at 10 score .
Measured: About two months
Functional disability
•Functional disability :it will be measure by oswestry disability index it is 10 point Patient reported outcome questionnaire which the higher score mean its the worst and the low score mean its the better outcome.
Measured: About 2 month
Pain pressure threshold
•Pain pressure threshold : it will be measure by a device Called pressure algometry
Measured: About 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start25 Nov 2021 (estimated)
- Primary completion3 Dec 2021 (estimated)
- Study completion29 Dec 2021 (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.
- 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
- Group A will receive shock wave therapy Group B will receive low level laser therapy
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samar Mimi Mohamed Okby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samar Mimi Mohamed Okby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015413
- Sponsor's protocol ID
- 012/003237
- Status last verified
- Nov 2021
- First submitted
- 14 Jul 2021
- Last updated
- 23 Nov 2021
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shockwave Versus Low Level Laser Therapy on Sacroiliac Joint Pain in Postnatal Women
- ClinicalTrials.gov ID
- NCT05015413
- Acronym / sponsor ID
- 012/003237
- Conditions
- Sacroiliac Joint Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samar Mimi Mohamed OkbyUniversity, hospital or other
- Study start
- 25 Nov 2021 (estimated)
- Primary completion
- 3 Dec 2021 (estimated)
- Study completion
- 29 Dec 2021 (estimated)
- First posted
- 20 Aug 2021 (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.
Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain
Detailed description
The study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women This study will be randomly distributed into two equal group Group A consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive shockwave therapy 2 session per week for 6 weeks Group B consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive low level laser therapy 2 session per week for 6 weeks
Evaluation procedures History taking recording in recording data sheet Weight and height measurement by calculate BMI Disability assessment by OWDI Pain assessment by VAS scale Assessment of pressure of pain threshold by pressure algometry
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A will receive shock wave therapy Group B will receive low level laser therapy
| Arm | Type | Receives |
|---|---|---|
| shock wave group | Experimental | Device: ShockwaveGroup A will receive shockwave therapy 2 session per week for 6 weeks |
| low level laser group | Experimental | Device: ShockwaveGroup B will receive low level laser therapy 2 session per week for 6 weeks |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- postnatal women suffering from sacroiliac joint pain for at least 3 months.
- They should have moderate to severe pain .
- They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests
Key exclusion criteria (3 listed)
- lumber or hip joint pathology
- Acute pelvic bacterial or viral infection .
- Receiving corticosteroid injections within the previous 6 weeks
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 |
|---|---|---|
| ShockwaveShock wave master 500 Germany | Device | low level laser group, shock wave group |
Primary outcome
Sacroiliac joint pain
Time frame: About two months
•Pain intensity: it will by measure by VAS it's presented as 10 cm horizontal line on which the patient pain intensity is point between no pain at zero score to extreme pain at 10 score .
Functional disability
Time frame: About 2 month
•Functional disability :it will be measure by oswestry disability index it is 10 point Patient reported outcome questionnaire which the higher score mean its the worst and the low score mean its the better outcome.
Pain pressure threshold
Time frame: About 2 month
•Pain pressure threshold : it will be measure by a device Called pressure algometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave in people with Sacroiliac Joint Pain, run by Samar Mimi Mohamed Okby.
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 3 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Ahmed El shafei, Doctoral (201220664518, Manalpt1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sacroiliac joint pain (time frame: About two months). The study lists 3 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 23 Nov 2021.