Low Back PainNCT02983747
Autologous Platelet Rich Plasma on Low Back Pain
A study testing PRP Treatment(P) and Medication Treatment(Loxoprofen Sodium tablets,M) in people with Low Back Pain, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce the pain feeling and benefit for restore of the intervertebral disk. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- PRP Treatment(P) and Medication Treatment(Loxoprofen Sodium tablets,M)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 30 Dec 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Chronic low back pain more than 2months
- Visual analog scale score more than 4
- Positive X-ray, MRI or CT scan findings
- Pfirrmann grading I-III
- Well understanding and communication ability
Who cannot join
- History of allergy
- Hemorrhagic trend or use of anticoagulant therapy
- Mental diseases
- Active infection or recent infectious diseases within 3 months
- Local skin infection near the puncture location
- Severe lumbar spinal stenosis, lumbar spondylolisthesis, ossification of posterior longitudinal
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- Ligament and lumbar disc herniation（more than 5mm）
- Immunologic diseases
- Tumors
- Metastatic disease
- Recent surgery less than 3 months)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, 200003
Xiaoguang Li, M.D., 86-21-81885045, Chzhhospital@163.com
About this study
Official title: Autologous Platelet Rich Plasma in Ultrasound Guided Intervertebral Disk Injection Therapy for Chronic Low Back Pain
The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce the pain feeling and benefit for restore of the intervertebral disk.
- Conditions
- Low Back Pain
- Being tested
- PRP Treatment(P), Medication Treatment(Loxoprofen Sodium tablets,M)
- Keywords
- Platelet Rich Plasma, Intervertebral Disk Injection Therapy, Low Back Pain, Ultrasound Guided, Degenerative Spinal Disease
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP Treatment(P)Other
Also called Platelet Rich Plasma
Ultrasound(Philips® iU22 ultrasound system) guided intra-disk injection using 2 ml of platelet rich plasma, containing 0.2 ml of calcium chloride(SINE®, SHANGHAI XINYI PHARMACEUTIAL Co . Ltd .) per treatment
Medication Treatment(Loxoprofen Sodium tablets,M)Drug
Also called LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
| Study group | Role | What they receive |
|---|---|---|
| PRP Treatment(P) | Experimental | PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets). Receives: Other: PRP Treatment(P); Drug: Medication Treatment(Loxoprofen Sodium tablets,M) |
| Medication Treatment(M) | Active comparator | NSAIDs medication(Loxoprofen Sodium tablets) therapy only. Receives: Drug: Medication Treatment(Loxoprofen Sodium tablets,M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS)
Pain relief evaluated using change from baseline in Visual Analog Scale (VAS):baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
Measured: 1 year
Secondary outcomes (5)
Oswestry Disability Index (ODI)
Pain relief and functions evaluated using change from baseline in Oswestry Disability Index (ODI): baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
Measured: 1 year
Functional Rating Index
Spinal functions evaluated using change from baseline by Functional Rating Index: baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
Measured: 1 year
Measuring the Quality of life using SF-36 questionnaire
Functions evaluated using change from baseline in SF-36:baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
Measured: 1 year
Imaging change
Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.
Measured: 1 year
Number of patients with side effect
Record how many patients had side effects after intervention (eg.aggravation of pain*(VAS change increased more than 3 from baseline),anaphylaxis,sensory/motion disturbances).
Measured: Within 1 year after injection therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start1 Nov 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuhua Lu, Shanghai Changzheng Hospital
- Investigators
- Xuhua Lu, M.D., Principal investigator, Shanghai Changzheng Hospotal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983747
- Sponsor's protocol ID
- 201540379
- Status last verified
- May 2022
- First submitted
- 21 Nov 2016
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet Rich Plasma in Ultrasound Guided Intervertebral Disk Injection Therapy for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02983747
- Acronym / sponsor ID
- 201540379
- Conditions
- Low Back Pain
- Keywords
- Platelet Rich Plasma, Intervertebral Disk Injection Therapy, Low Back Pain, Ultrasound Guided, Degenerative Spinal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 6 Dec 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.
The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce the pain feeling and benefit for restore of the intervertebral disk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Treatment(P) | Experimental | Other: PRP Treatment(P), Drug: Medication Treatment(Loxoprofen Sodium tablets,M)PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets). |
| Medication Treatment(M) | Active comparator | Drug: Medication Treatment(Loxoprofen Sodium tablets,M)NSAIDs medication(Loxoprofen Sodium tablets) therapy only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chronic low back pain more than 2months
- Visual analog scale score more than 4
- Positive X-ray, MRI or CT scan findings
- Pfirrmann grading I-III
- Well understanding and communication ability
Key exclusion criteria (12 listed)
- History of allergy
- Hemorrhagic trend or use of anticoagulant therapy
- Mental diseases
- Active infection or recent infectious diseases within 3 months
- Local skin infection near the puncture location
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 |
|---|---|---|
| PRP Treatment(P)Also: Platelet Rich PlasmaUltrasound(Philips® iU22 ultrasound system) guided intra-disk injection using 2 ml of platelet rich plasma, containing 0.2 ml of calcium chloride(SINE®, SHANGHAI XINYI PHARMACEUTIAL Co . Ltd .) per treatment | Other | PRP Treatment(P) |
| Medication Treatment(Loxoprofen Sodium tablets,M)Also: LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day | Drug | Medication Treatment(M), PRP Treatment(P) |
Primary outcome
Visual Analog Scale(VAS)
Time frame: 1 year
Pain relief evaluated using change from baseline in Visual Analog Scale (VAS):baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
5 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: 1 year
Functional Rating Index
Time frame: 1 year
Measuring the Quality of life using SF-36 questionnaire
Time frame: 1 year
Imaging change
Time frame: 1 year
Number of patients with side effect
Time frame: Within 1 year after injection therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Xuhua Lu, M.D. principal investigator
Shanghai Changzheng Hospotal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP Treatment(P) and Medication Treatment(Loxoprofen Sodium tablets,M) in people with Low Back Pain, run by Shanghai Changzheng Hospital at 1 site in China.
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 12 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 9 May 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Lu, M.D. (86-21-81885793, xuhualu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) (time frame: 1 year). 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 9 May 2022.