Lumbar Spinal StenosisEarly Phase 1IPaRONCT03088306
Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients
A Early Phase 1 study testing Standard analgesia use [Oxygen], Standard analgesia use [Hydromorphone] and Standard analgesia use [Volatile Anesthesia] in people with Lumbar Spinal Stenosis and Lumbar Spinal Instability, run by Johns Hopkins University at 1 site in United States.
Trial summary
Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Spinal Instability, Lumbar Spine Degeneration
- What is being tested?
- Standard analgesia use [Oxygen], Standard analgesia use [Hydromorphone] and Standard analgesia use [Volatile Anesthesia]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 31 Aug 2018
- Phase
- Early Phase 1
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will be English-speaking adults who are presenting to a spine surgeon (orthopaedic or neurosurgeon) for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e. fusion).
Who cannot join
- A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy.
- Spinal deformity as the primary indication for surgery.
- Spine surgery secondary to pseudarthrosis, trauma, infection, or tumor.
- Back and/or lower extremity pain < 3 months indicating no history of sub-acute or chronic pain.
- History of neurological disorder or disease, resulting in moderate to severe movement dysfunction.
- Presence of schizophrenia or other psychotic disorder.
Show all 11Show fewer
- Patient refusal to participate.
- Known allergic reactions to any of the study medications
- Surgery under a workman's compensation claim.
- Not able to return to clinic for standard follow-up visits with surgeon.
- Unable to provide a stable address and access to a telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery
Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.
Read the detailed description
Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. Proper pain management is necessary to reduce pain-related and medication side effects and to promote rehabilitation. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies.
Multi-modal pain management strategies have been proposed to (1) control pre-operative pain related to spine pathology; (2) employ non-opioid medication peri-operatively to pre-empt post-operative surgical pain; and (3) monitor and control pain intensity before and after surgery. There is a demonstrated lack of evidence regarding optimal post-operative protocols and pathways. The investigators have planned a randomized clinical trial to compare the effectiveness of two methods of peri-operative pain management to reduce post-operative pain and opioid use among patients undergoing lumbar spine surgery.
Prior to submission to National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), or Patient Centered Outcomes Research Institute (PCORI), it is necessary to demonstrate the feasibility and acceptability of the trial protocol. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.
- Being tested
- Standard analgesia use [Oxygen], Standard analgesia use [Hydromorphone], Standard analgesia use [Volatile Anesthesia], Standard analgesia use [Fentanyl], Multi-modal pain management [Acetaminophen + Gabapentin]
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard analgesia use [Oxygen]Drug
A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
Standard analgesia use [Hydromorphone]Drug
A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
Standard analgesia use [Volatile Anesthesia]Drug
A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
Standard analgesia use [Fentanyl]Drug
A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
Multi-modal pain management [Acetaminophen + Gabapentin]Drug
Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
Multi-modal pain management [Fentanyl]Drug
Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
Multi-modal pain management [Intravenous Ketamine]Drug
Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
Multi-modal pain management [Valium + Gabapentin]Drug
Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
| Study group | Role | What they receive |
|---|---|---|
| Standard analgesia use | Active comparator | A strategy to manage pain in the peri-operative period that is in common clinical use. Receives: Drug: Standard analgesia use [Oxygen]; Drug: Standard analgesia use [Hydromorphone]; Drug: Standard analgesia use [Volatile Anesthesia]; Drug: Standard analgesia use [Fentanyl] |
| Multi-modal pain management | Active comparator | A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication. Receives: Drug: Multi-modal pain management [Acetaminophen + Gabapentin]; Drug: Multi-modal pain management [Fentanyl]; Drug: Multi-modal pain management [Intravenous Ketamine]; Drug: Multi-modal pain management [Valium + Gabapentin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants undergoing lumbar spine surgery with complete follow-up
Number of participants undergoing lumbar spine surgery with complete follow-up
Measured: 52 week
Secondary outcomes (11)
Patient controlled analgesia (PCA) pump use
Total morphine equivalent of opioids administered by the PCA pump
Measured: during surgical hospitalization, up to 12 weeks
Opioid medication use
How many patients were prescribed and using opioid medication over the 90 days after hospital discharge?
Measured: up to 90 days
Patient Reported Outcomes Measurement Information System (PROMIS) Pain
Measure of pain intensity; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
PROMIS Physical Function
Measure of physical function; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
PROMIS Fatigue
Measure of fatigue; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
PROMIS Anxiety
Measure of anxiety; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
PROMIS Depression
Measure of depression; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
PROMIS Sleep Disturbance
Measure of sleep disturbance; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
PROMIS Satisfaction with Social Roles
Measure of satisfaction with social roles; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
Health status (Medical Outcome Study Short Form 12, version 2)
Measure of physical and mental health; Range 0 - 100; Population mean 50, standard deviation 10
Measured: at 6 and 12 weeks
Oswestry Disability Index (ODI)
Measure of pain-related disability; Range 0% - 100%; Scores greater than 30% indicative of moderate pain-related disability
Measured: at 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Jul 2017
- Primary completion31 May 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- North American Spine Society
- Responsible party
- Sponsor
- Investigators
- Richard L Skolasky, ScD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088306
- Sponsor's protocol ID
- IRB00113816
- Acronym
- IPaRO
- Status last verified
- Oct 2018
- First submitted
- 22 Feb 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT03088306
- Acronym / sponsor ID
- IPaRO / IRB00113816
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- North American Spine Society
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Mar 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.
Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.
Detailed description
Patients presenting for lumbar spine surgery experience pain related to their spine condition. Following surgery, these patients also experience surgical pain resulting from disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. Proper pain management is necessary to reduce pain-related and medication side effects and to promote rehabilitation. This pain is often treated with opioid medications - with roughly 40% of patient experiencing sub-optimal pain management. Adequate pain control has become a top priority among professional societies, healthcare systems, and accrediting agencies.
Multi-modal pain management strategies have been proposed to (1) control pre-operative pain related to spine pathology; (2) employ non-opioid medication peri-operatively to pre-empt post-operative surgical pain; and (3) monitor and control pain intensity before and after surgery. There is a demonstrated lack of evidence regarding optimal post-operative protocols and pathways. The investigators have planned a randomized clinical trial to compare the effectiveness of two methods of peri-operative pain management to reduce post-operative pain and opioid use among patients undergoing lumbar spine surgery.
Prior to submission to National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), or Patient Centered Outcomes Research Institute (PCORI), it is necessary to demonstrate the feasibility and acceptability of the trial protocol. The current proposal will provide this critical evidence of feasibility and acceptability of a multi-modal pain management plan for patients undergoing lumbar spine surgery. Additionally, this study will provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal pain management to control post-operative pain, reduce opioid medication use, and improve physical activity, sleep, and health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard analgesia use | Active comparator | Drug: Standard analgesia use [Oxygen], Drug: Standard analgesia use [Hydromorphone], Drug: Standard analgesia use [Volatile Anesthesia], Drug: Standard analgesia use [Fentanyl]A strategy to manage pain in the peri-operative period that is in common clinical use. |
| Multi-modal pain management | Active comparator | Drug: Multi-modal pain management [Acetaminophen + Gabapentin], Drug: Multi-modal pain management [Fentanyl], Drug: Multi-modal pain management [Intravenous Ketamine], Drug: Multi-modal pain management [Valium + Gabapentin]A strategy to manage pain in the peri-operative period that is in common clinical use that is designed to reduce the need for post-operative opioid medication. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be English-speaking adults who are presenting to a spine surgeon (orthopaedic or neurosurgeon) for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e. fusion).
Key exclusion criteria (11 listed)
- A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy.
- Spinal deformity as the primary indication for surgery.
- Spine surgery secondary to pseudarthrosis, trauma, infection, or tumor.
- Back and/or lower extremity pain < 3 months indicating no history of sub-acute or chronic pain.
- History of neurological disorder or disease, resulting in moderate to severe movement dysfunction.
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 |
|---|---|---|
| Standard analgesia use [Oxygen]A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone. | Drug | Standard analgesia use |
| Standard analgesia use [Hydromorphone]A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone. | Drug | Standard analgesia use |
| Standard analgesia use [Volatile Anesthesia]A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone. | Drug | Standard analgesia use |
| Standard analgesia use [Fentanyl]A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone. | Drug | Standard analgesia use |
| Multi-modal pain management [Acetaminophen + Gabapentin]Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge. | Drug | Multi-modal pain management |
| Multi-modal pain management [Fentanyl]Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge. | Drug | Multi-modal pain management |
| Multi-modal pain management [Intravenous Ketamine]Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge. | Drug | Multi-modal pain management |
| Multi-modal pain management [Valium + Gabapentin]Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge. | Drug | Multi-modal pain management |
Primary outcome
Number of participants undergoing lumbar spine surgery with complete follow-up
Time frame: 52 week
Number of participants undergoing lumbar spine surgery with complete follow-up
11 secondary outcomes
Patient controlled analgesia (PCA) pump use
Time frame: during surgical hospitalization, up to 12 weeks
Opioid medication use
Time frame: up to 90 days
Patient Reported Outcomes Measurement Information System (PROMIS) Pain
Time frame: at 6 and 12 weeks
PROMIS Physical Function
Time frame: at 6 and 12 weeks
PROMIS Fatigue
Time frame: at 6 and 12 weeks
PROMIS Anxiety
Time frame: at 6 and 12 weeks
PROMIS Depression
Time frame: at 6 and 12 weeks
PROMIS Sleep Disturbance
Time frame: at 6 and 12 weeks
PROMIS Satisfaction with Social Roles
Time frame: at 6 and 12 weeks
Health status (Medical Outcome Study Short Form 12, version 2)
Time frame: at 6 and 12 weeks
Oswestry Disability Index (ODI)
Time frame: at 6 and 12 weeks
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 16 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Lumbar Spinal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
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.
Richard L Skolasky, ScD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Standard analgesia use [Oxygen], Standard analgesia use [Hydromorphone] and Standard analgesia use [Volatile Anesthesia] in people with Lumbar Spinal Stenosis and Lumbar Spinal Instability, run by Johns Hopkins University 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 1 inclusion and 11 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 16 Oct 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants undergoing lumbar spine surgery with complete follow-up (time frame: 52 week). 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 Oct 2018.