Discogenic PainNCT03340818
Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain
A study testing Bone Marrow Concentrate in people with Discogenic Pain, run by APM Spine and Sports Physicians at 1 site in United States.
Trial summary
A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Discogenic Pain
- What is being tested?
- Bone Marrow Concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 7 Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chronic low back pain for more than 6 months w/ low back component greater than leg pain.
- Average pain of at lest 40/100 on VAS pre-procedure.
- Inadequate response to at least 6 months of conservative care including medication, physical therapy and/or spinal injection
- Advanced imaging of MRI or CT demonstrating abnormal disc pathology
- Presumed lumbar disc pain based on either positive discogram or patient must have MRi findings of either high intensity zone and/or Type 1 or 2 Modic endplate changes, or exclusion of other sources of pain.
- Having provided informed consent
Who cannot join
- Active moderate to severe lumbar radiculopathy
- Negative discogram
- Very severe decrease in disc height at planned injection level (disc height of less than 1/3 expected)
- Active infection
- Moderate to severe anemia, thrombocytopenia or leukopenia
- Spinal fracture within the past 6 months
Show all 29Show fewer
- Severe psychological illness
- Inability to consent to the procedure due to cognitive issues
- Prior surgery at a level considered to be the source of pain
- Lumbar surgery within the past 6 months
- Women who are pregnant or breast feeding
- Prior intradiscal therapeutic injection or procedure
- Severe uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease or any medical condition which would make the subject unsuitable for this study.
- Inflammatory arthritis
- Any cancer within the past 5 years, except basal cell or squamous cell skin cancer
- Intradural disc herniation
- Coagulopathy preventing spinal injection
- Inability to stop anticoagulants other than aspirin due to other medical issues
- Exceeds 30 mg morphine equivalent per day of opioid use.
- A history of alcohol or drug abuse within the past 5 years.
- Use of any investigational drug within the past 30 days.
- Steroid injection in the spine within the past 30 days.
- Discography within the last 21 days
- A known allergy or sensitivity to heparin or citrate (used for processing BMC)
- Pending litigation involving the subject's back pain.
- Active worker's compensation claim
- Central stenosis at a level to be injected with an AP diameter less than or equal to 5 mm
- Severe anaphylactic/anaphylactoid reaction to any of the medications used. (If a patient does have a mild or moderate allergy to any of the medications used in the procedure or prior anaphylactic/anaphylactoid reaction to any food or drug, they will be given prednisone 50 mg PO 13, 7, and 1 hour prior to the procedure and diphenhydramine 50mg PO 1 hour prior to the procedure.)
- In order to mitigate any economic risk, a patient without adequate medical insurance coverage for any subsequent tests or procedures deemed clinically necessary will be excluded. BMC is an autologous blood product with multiple clinical uses. Intradiscal administration should not preclude insurance coverage for any subsequent medical issues that might develop pertaining to the intradiscal injection itself or the BMC
Trial locations and contacts
1 site in 1 country.
United States1 site
Jordan Young Institute
Virginia Beach, Virginia, 23462
About this study
Official title: Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial
A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.
Read the detailed description
A randomized, double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain. The treatment will be a single injection of autologous bone marrow concentrate into suspected painful disc(s) based upon either prior discography or combination of imaging and exclusion of other anatomic structural sources of pain. The placebo treatment will be an intramuscular injection of normal saline directly dorsal to the transverse process at each suspected level. Outcomes will be measured using VAS and ODI. The primary outcome will be the percentage of patients in the treatment group vs control group at 6 months post-procedure, categorized as a clinical success defined by at least 50% relief of pain. Secondary outcomes will be comparison of success rates at 3 and 12 months, percentage of patients in the two groups with greater than 30% improvement in ODI at 3, 6 and 12 months, Global perceived index at 3, 6, 12 months. Medication log and adjunctive treatments will be recorded and analyzed.
- Conditions
- Discogenic Pain
- Being tested
- Bone Marrow Concentrate, Placebo
- Keywords
- Low back pain, bone marrow concentrate, disc degeneration
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow ConcentrateOther
Bone marrow concentrate is bone marrow harvested from the iliac crest and minimally processed in a centrifuge. It is then injected into the suspected painful disc (s) using fluoroscopic guidance
PlaceboOther
Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Concentrate | Experimental | Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs. Receives: Other: Bone Marrow Concentrate |
| Placebo Group | Sham comparator | Patients in this group will receive an injection of normal saline dorsal to the transverse process. The bone marrow aspiration will be simulated for these patients. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief treatment vs placebo group 50%
Pain reduction of at least 50% at 6 months post-procedure using Visual Analog Scale (VAS) as indicators of pain relief. A reduction in the VAS of at least 50% from baseline is considered successful. VAS of 10 is considered "worst pain imaginable" and VAS of 0 is no pain at all.
Measured: 6 months
Functional improvement vs Placebo group 50%
Functional improvement of at least 50% at 6 months post-procedure using the Oswestry Disability Index (ODI). A reduction of at least 50% in the Oswestry Disability Index is considered successful. The lower the ODI score, the less impact the pain has on a patients daily functioning.
Measured: 6 months
Secondary outcomes (4)
Pain relief treatment vs placebo group 50%
Pain reduction of at least 50% will be assessed at 3 and 12 months post-procedure using the Visual Analog Scale (VAS). A reduction of VAS score at 3 and 12 months of at least 50% of baseline will be considered successful. A score of 10 is the "worst pain imaginable" and a score of 0 is no pain at all.
Measured: 3 months, 12 months
Pain relief treatment vs placebo 30%
Pain reduction of at least 30% at 3, 6, 12 months post-procedure using the Visual Analog Scale (VAS). A decrease in score of at least 30% will be considered successful. A score of 10 is "the worst pain imaginable" and a score of 0 is no pain at all.
Measured: 3, 6, 12 months
Functional improvement treatment vs placebo 50%
Improvement in daily functioning of at least 50% from baseline using the Oswestry Disability Index (ODI). A decrease in score of ODI of at least 50% will be considered successful.
Measured: 3 months, 12 months
Functional improvement treatment vs placebo 30%
Improvement in daily functioning of at least 30% from baseline using the Oswestry Disability Index (ODI). A reduction in score by 30% is considered successful
Measured: 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Aug 2018
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Discogenic 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
- Randomized, double-blind placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- APM Spine and Sports Physicians
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S Levi, MD, Principal investigator, Jordan Young InstituteScott I Horn, DO, Study chair, Jordan Young InstituteJosh Levin, MD, Study chair, Stanford UniversitySara A Tyszko, PA-C, Study chair, Jordan Young Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340818
- Sponsor's protocol ID
- BMC-1788
- Status last verified
- Jan 2020
- First submitted
- 2 Nov 2017
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwarzer AC, Aprill CN, Derby R, Fortin J, Kine G, Bogduk N. The prevalence and clinical features of internal disc disruption in patients with chronic low back pain. Spine (Phila Pa 1976). 1995 Sep 1;20(17):1878-83. doi: 10.1097/00007632-199509000-00007.
PubMed 8560335Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.
PubMed 11725230Hanley EN Jr, David SM. Lumbar arthrodesis for the treatment of back pain. J Bone Joint Surg Am. 1999 May;81(5):716-30. doi: 10.2106/00004623-199905000-00015. No abstract available.
PubMed 10360702Peng B, Wu W, Hou S, Li P, Zhang C, Yang Y. The pathogenesis of discogenic low back pain. J Bone Joint Surg Br. 2005 Jan;87(1):62-7.
PubMed 15686239Coppes MH, Marani E, Thomeer RT, Groen GJ. Innervation of "painful" lumbar discs. Spine (Phila Pa 1976). 1997 Oct 15;22(20):2342-9; discussion 2349-50. doi: 10.1097/00007632-199710150-00005.
PubMed 9355214Freeman BJ, Fraser RD, Cain CM, Hall DJ, Chapple DC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2369-77; discussion 2378. doi: 10.1097/01.brs.0000186587.43373.f2.
PubMed 16261111Barendse GA, van Den Berg SG, Kessels AH, Weber WE, van Kleef M. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-second 70 C lesion. Spine (Phila Pa 1976). 2001 Feb 1;26(3):287-92. doi: 10.1097/00007632-200102010-00014.
PubMed 11224865Peng B, Zhang Y, Hou S, Wu W, Fu X. Intradiscal methylene blue injection for the treatment of chronic discogenic low back pain. Eur Spine J. 2007 Jan;16(1):33-8. doi: 10.1007/s00586-006-0076-1. Epub 2006 Feb 22.
PubMed 16496191Peng B, Pang X, Wu Y, Zhao C, Song X. A randomized placebo-controlled trial of intradiscal methylene blue injection for the treatment of chronic discogenic low back pain. Pain. 2010 Apr;149(1):124-129. doi: 10.1016/j.pain.2010.01.021. Epub 2010 Feb 18.
PubMed 20167430Levi DS, Horn S, Walko E. Intradiskal methylene blue treatment for diskogenic low back pain. PM R. 2014 Nov;6(11):1030-7. doi: 10.1016/j.pmrj.2014.04.008. Epub 2014 Apr 26.
PubMed 24780850Nguyen RT, Borg-Stein J, McInnis K. Applications of platelet-rich plasma in musculoskeletal and sports medicine: an evidence-based approach. PM R. 2011 Mar;3(3):226-50. doi: 10.1016/j.pmrj.2010.11.007.
PubMed 21402369Levi D, Horn S, Tyszko S, Levin J, Hecht-Leavitt C, Walko E. Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain: Preliminary Results from a Prospective Trial. Pain Med. 2016 Jun;17(6):1010-22. doi: 10.1093/pm/pnv053. Epub 2015 Dec 26.
PubMed 26814283Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24.
PubMed 26314234Connolly JF, Guse R, Tiedeman J, Dehne R. Autologous marrow injection as a substitute for operative grafting of tibial nonunions. Clin Orthop Relat Res. 1991 May;(266):259-70.
PubMed 2019059Muschler GF, Nitto H, Matsukura Y, Boehm C, Valdevit A, Kambic H, Davros W, Powell K, Easley K. Spine fusion using cell matrix composites enriched in bone marrow-derived cells. Clin Orthop Relat Res. 2003 Feb;(407):102-18. doi: 10.1097/00003086-200302000-00018.
PubMed 12567137
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03340818
- Acronym / sponsor ID
- BMC-1788
- Conditions
- Discogenic Pain
- Keywords
- Low back pain, bone marrow concentrate, disc degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- APM Spine and Sports PhysiciansUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 14 Nov 2017 (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.
A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.
Detailed description
A randomized, double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain. The treatment will be a single injection of autologous bone marrow concentrate into suspected painful disc(s) based upon either prior discography or combination of imaging and exclusion of other anatomic structural sources of pain. The placebo treatment will be an intramuscular injection of normal saline directly dorsal to the transverse process at each suspected level. Outcomes will be measured using VAS and ODI. The primary outcome will be the percentage of patients in the treatment group vs control group at 6 months post-procedure, categorized as a clinical success defined by at least 50% relief of pain. Secondary outcomes will be comparison of success rates at 3 and 12 months, percentage of patients in the two groups with greater than 30% improvement in ODI at 3, 6 and 12 months, Global perceived index at 3, 6, 12 months. Medication log and adjunctive treatments will be recorded and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Concentrate | Experimental | Other: Bone Marrow ConcentratePatients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs. |
| Placebo Group | Sham comparator | Other: PlaceboPatients in this group will receive an injection of normal saline dorsal to the transverse process. The bone marrow aspiration will be simulated for these patients. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chronic low back pain for more than 6 months w/ low back component greater than leg pain.
- Average pain of at lest 40/100 on VAS pre-procedure.
- Inadequate response to at least 6 months of conservative care including medication, physical therapy and/or spinal injection
- Advanced imaging of MRI or CT demonstrating abnormal disc pathology
- Presumed lumbar disc pain based on either positive discogram or patient must have MRi findings of either high intensity zone and/or Type 1 or 2 Modic endplate changes, or exclusion of other sources of pain.
Key exclusion criteria (29 listed)
- Active moderate to severe lumbar radiculopathy
- Negative discogram
- Very severe decrease in disc height at planned injection level (disc height of less than 1/3 expected)
- Active infection
- Moderate to severe anemia, thrombocytopenia or leukopenia
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 |
|---|---|---|
| Bone Marrow ConcentrateBone marrow concentrate is bone marrow harvested from the iliac crest and minimally processed in a centrifuge. It is then injected into the suspected painful disc (s) using fluoroscopic guidance | Other | Bone Marrow Concentrate |
| PlaceboInjection of normal saline dorsal to the transverse process after sham bone marrow aspiration | Other | Placebo Group |
Primary outcome
Pain relief treatment vs placebo group 50%
Time frame: 6 months
Pain reduction of at least 50% at 6 months post-procedure using Visual Analog Scale (VAS) as indicators of pain relief. A reduction in the VAS of at least 50% from baseline is considered successful. VAS of 10 is considered "worst pain imaginable" and VAS of 0 is no pain at all.
Functional improvement vs Placebo group 50%
Time frame: 6 months
Functional improvement of at least 50% at 6 months post-procedure using the Oswestry Disability Index (ODI). A reduction of at least 50% in the Oswestry Disability Index is considered successful. The lower the ODI score, the less impact the pain has on a patients daily functioning.
4 secondary outcomes
Pain relief treatment vs placebo group 50%
Time frame: 3 months, 12 months
Pain relief treatment vs placebo 30%
Time frame: 3, 6, 12 months
Functional improvement treatment vs placebo 50%
Time frame: 3 months, 12 months
Functional improvement treatment vs placebo 30%
Time frame: 3 months, 12 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 7 Aug 2024.
- Background: PubMed 8560335Schwarzer AC, Aprill CN, Derby R, Fortin J, Kine G, Bogduk N. The prevalence and clinical features of internal disc disruption in patients with chronic low back pain. Spine (Phila Pa 1976). 1995 Sep 1;20(17):1878-83. doi: 10.1097/00007632-199509000-00007.
- Background: PubMed 11725230Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.
- Background: PubMed 10360702Hanley EN Jr, David SM. Lumbar arthrodesis for the treatment of back pain. J Bone Joint Surg Am. 1999 May;81(5):716-30. doi: 10.2106/00004623-199905000-00015. No abstract available.
- Background: PubMed 15686239Peng B, Wu W, Hou S, Li P, Zhang C, Yang Y. The pathogenesis of discogenic low back pain. J Bone Joint Surg Br. 2005 Jan;87(1):62-7.
- Background: PubMed 9355214Coppes MH, Marani E, Thomeer RT, Groen GJ. Innervation of "painful" lumbar discs. Spine (Phila Pa 1976). 1997 Oct 15;22(20):2342-9; discussion 2349-50. doi: 10.1097/00007632-199710150-00005.
- Background: PubMed 16261111Freeman BJ, Fraser RD, Cain CM, Hall DJ, Chapple DC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2369-77; discussion 2378. doi: 10.1097/01.brs.0000186587.43373.f2.
- Background: PubMed 11224865Barendse GA, van Den Berg SG, Kessels AH, Weber WE, van Kleef M. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-second 70 C lesion. Spine (Phila Pa 1976). 2001 Feb 1;26(3):287-92. doi: 10.1097/00007632-200102010-00014.
- Background: PubMed 16496191Peng B, Zhang Y, Hou S, Wu W, Fu X. Intradiscal methylene blue injection for the treatment of chronic discogenic low back pain. Eur Spine J. 2007 Jan;16(1):33-8. doi: 10.1007/s00586-006-0076-1. Epub 2006 Feb 22.
- Background: PubMed 20167430Peng B, Pang X, Wu Y, Zhao C, Song X. A randomized placebo-controlled trial of intradiscal methylene blue injection for the treatment of chronic discogenic low back pain. Pain. 2010 Apr;149(1):124-129. doi: 10.1016/j.pain.2010.01.021. Epub 2010 Feb 18.
- Background: PubMed 24780850Levi DS, Horn S, Walko E. Intradiskal methylene blue treatment for diskogenic low back pain. PM R. 2014 Nov;6(11):1030-7. doi: 10.1016/j.pmrj.2014.04.008. Epub 2014 Apr 26.
- Background: PubMed 21402369Nguyen RT, Borg-Stein J, McInnis K. Applications of platelet-rich plasma in musculoskeletal and sports medicine: an evidence-based approach. PM R. 2011 Mar;3(3):226-50. doi: 10.1016/j.pmrj.2010.11.007.
- Background: PubMed 26814283Levi D, Horn S, Tyszko S, Levin J, Hecht-Leavitt C, Walko E. Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain: Preliminary Results from a Prospective Trial. Pain Med. 2016 Jun;17(6):1010-22. doi: 10.1093/pm/pnv053. Epub 2015 Dec 26.
- Individual participant dataSharing planned: No
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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.
David S Levi, MD principal investigator
Jordan Young Institute
Scott I Horn, DO study chair
Jordan Young Institute
Josh Levin, MD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Concentrate in people with Discogenic Pain, run by APM Spine and Sports Physicians at 1 site in United States.
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 29 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 7 Aug 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 United States. 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?
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 relief treatment vs placebo group 50% (time frame: 6 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?
On the ClinicalTrials.gov record for NCT03340818, which also lists 41 linked publications.
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 7 Aug 2024.