Platelet-rich Plasma in Low Back PainNCT02970058
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
A study testing Platelet-rich Plasma in people with Platelet-rich Plasma in Low Back Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Platelet-rich Plasma in Low Back Pain
- What is being tested?
- Platelet-rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2018to 15 Jul 2020
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective gynecological surgery.
Who cannot join
- Spinal Pathology
Trial locations and contacts
1 site in 1 country.
About this study
Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.
- Conditions
- Platelet-rich Plasma in Low Back Pain
- Being tested
- Platelet-rich Plasma, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich PlasmaOther
The active group will receive Platelet-rich Plasma following spinal injection
ControlOther
The control group will receive saline as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich Plasma | Active comparator | 30 patients will receive platelet-rich plasma post-spinal anesthesia Receives: Other: Platelet-rich Plasma |
| Control | Placebo comparator | 30 patients will receive sterile saline post-spinal anesthesia Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start7 Mar 2018
- Primary completionJul 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-rich Plasma in Low Back PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman A. Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970058
- Sponsor's protocol ID
- 01003060392
- Status last verified
- Mar 2019
- First submitted
- 17 Nov 2016
- Last updated
- 16 Mar 2020
- 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 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
- ClinicalTrials.gov ID
- NCT02970058
- Acronym / sponsor ID
- 01003060392
- Conditions
- Platelet-rich Plasma in Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- 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.
Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich Plasma | Active comparator | Other: Platelet-rich Plasma30 patients will receive platelet-rich plasma post-spinal anesthesia |
| Control | Placebo comparator | Other: Control30 patients will receive sterile saline post-spinal anesthesia |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elective gynecological surgery.
Key exclusion criteria (1 listed)
- Spinal Pathology
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 |
|---|---|---|
| Platelet-rich PlasmaThe active group will receive Platelet-rich Plasma following spinal injection | Other | Platelet-rich Plasma |
| ControlThe control group will receive saline as a placebo | Other | Control |
Primary outcome
Visual Analogue Scale
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich Plasma in people with Platelet-rich Plasma in Low Back Pain, run by Assiut 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 1 inclusion and 1 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 Mar 2020. 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 mohmed Bakri, prof (+20882413201, mhbakri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 7 days). 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 Mar 2020.