Chronic Low Back PainNCT03586882
Effect of Spinal Cord Stimulation on Gait and Balance in Chronic Low Back Pain Patients
A study testing Spinal Cord Stimulation in people with Chronic Low Back Pain and Pain in Leg, Unspecified, run by Texas Back Institute at 1 site in United States.
Trial summary
Spinal Cord Stimulation (SCS) uses electrical signals to disrupt noxious signals arising from painful areas, thereby reducing pain perception. Successful SCS implants lead to a broad range of positive outcomes: 1) long-term pain can be expected to be reduced by at least by 50%; 2) quality of life as assessed by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain, Pain in Leg, Unspecified
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Considered to be a candidate for SCS
- Leg pain and/or LBP lasting than 6 months.
- Therapy consists of a short trial with a percutaneous implantation of neurostimulator electrode(s) in the epidural space for assessing a candidate's suitability for ongoing treatment with a permanent surgically implanted SCS. Performance and documentation of an effective trial is required for consideration of permanent SCS.
- The implantation of the stimulator is used only as a late or last resort for patients with chronic intractable pain.
- Other treatment modalities (pharmacologic, surgical, physical/and psychological therapies) have been tried and did not prove satisfactory; were judged unsuitable, or were contraindicated for the patient.
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- Patient has undergone appropriate psychological screening, including psychometric testing using the Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF), and diagnosis by a multidisciplinary team before implantation; to include patient education, discussion and disclosure including an extensive discussion of the risk and benefits of therapy.
- All the facilities, equipment, and professional support personnel required for the proper diagnosis, treatment, training, and follow-up of the patient are available.
- All trials which proceed to permanent implantation should demonstrate adequate documentation to support the decision. A successful trial should be associated with at least 50% reduction of target pain, a reduction of analgesic medications and show some element of functional improvement (i.e. sitting, standing and walking tolerances).
- Able to ambulate without assistance and stand without assistance with eyes open for a minimum of 10 seconds
- Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up
Who cannot join
- Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
- BMI higher than 35
- Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
- Major trauma to the pelvis
- Pregnant or wishing to become pregnant during the study
- Previous spinal surgery that would preclude the safe percutaneous or permanent implantation of the SCS leads
- Previous history of spinal infection either iatrogenic or denovo
- Previous SCS attempts either successful or not
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Spinal Cord Stimulation on Gait and Balance in Chronic Low Back Pain Patients With or Without Leg Pain
Spinal Cord Stimulation (SCS) uses electrical signals to disrupt noxious signals arising from painful areas, thereby reducing pain perception. Successful SCS implants lead to a broad range of positive outcomes: 1) long-term pain can be expected to be reduced by at least by 50%; 2) quality of life as assessed by subjective measurements improves substantially; 3) patients can significantly reduce opioid medication intake.1 However, the impacts of SCS intervention on neuromuscular and biomechanical outcomes including gait and balance have not been fully explored. Fifty subjects with symptomatic leg pain and/or low back pain (LBP) who are deemed appropriate SCS candidates and are scheduled for surgery will undergo gait and balance analyses preoperatively as well as 6 weeks and 3 months post operatively. In addition, 50 control subjects having no pain will undergo 1 session of gait and balance assessment. Objective spine and lower extremity motion and neuromuscular control will be evaluated using dynamic surface EMG and a video motion capture system during functional evaluation. Also, explored will be the relationship of changes in gait and balance to psychosocial factors that have previously been shown to be correlated with SCS outcomes.
Read the detailed description
Low back pain is reported in 75-80% of the population and can significantly influence patients' quality of life. Fortunately, 80-90% of individuals recover from their back pain, whether they receive treatment or not. However, the small percentage of people who do not recover quickly present a costly problem to society and a great challenge to health care providers. Low back pain is the second leading cause for missed days at work, potentially having disability and major socioeconomic consequences. Chronic LBP can also limit flexibility and/or range of motion, which may contribute to an overall decrease in functional capacity, and may ultimately heighten the risk for additional lower extremity injury. Many chronic LBP patients have conditions not amenable to spine surgery, or they have failed to achieve successful outcome with previous spine surgery. For these patients, SCS can be an effective alternative. For example, in a recent demonstration, randomized 100 failed back surgery syndrome (FBSS) patients to either SCS or conventional medical management. At 6 months post-implant, 64% of patients had achieved the 50% reduction in leg pain criterion (vs. 18% of conventional medical management patients). Similarly, North et al. found 52% of patients had achieved at least the 50% reduction in pain when they investigated 171 patients treated with SCS.
SCS uses electrical signals to decrease nociception of impulses arising from painful areas in the spine and or leg. In order to accomplish this goal, SCS involves implantation of a small electrical pulse generator, along with thin leads strategically placed into the epidural space. Stimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception. Occasionally, some patients feel a mild paresthesia as a result of the stimulation.
While the effectiveness of SCS on reduction of subjective pain complaints is now well-established, such improvement may not translate into improved functional ability. Previous research found that, for FBSS patients treated with SCS, patients' scores on Oswestry Disability index did not correlate significantly with improvements in function as measured by an accelerometer contained within the stimulator device. Very few studies have examined the effect of SCS on objectively-measured functional abilities, including gait and balance. Those studies suffer from a small sample size and lack of electromyography (EMG) and full body kinematics analyses. Despite that, those studies did find improvement in the spatiotemporal variables (i.e. gait speed, step length and width) while other variables (ground reaction force and trunk motion) were not significantly different using the SCS.
Therefore, the purpose of this study is to evaluate the effect of SCS, on the biomechanics of the lower extremities and spine, using dynamic EMG, video motion capture, and force plate analysis, during gait and static balance testing, in patients with chronic low back and/or leg pain, before and after intervention. In addition this study will compare these same biomechanical parameters found in the chronic low back pain and /or leg pain patients to an asymptomatic control group.
- Conditions
- Chronic Low Back Pain, Pain in Leg, Unspecified
- Being tested
- Spinal Cord Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Stimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation Group | Experimental | Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery Receives: Device: Spinal Cord Stimulation |
| Control Group | No intervention | Gait and balance testing to be administered once in healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic Variables Change assessed with human motion capture system
3-Dimensional Range of Motion (ROM) during the stance and swing phase of the spine, pelvis, hip, knee, ankle, shoulder, and elbow joint angles along with center of mass and head sway and displacement
Measured: Baseline; 6 and 12 weeks after surgery
Secondary outcomes (4)
Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS)
VAS for lower back pain, neck and arm pain, and leg pain. Scale range from 0 (no pain) - 10 (most pain)
Measured: Baseline; 6 and 12 weeks after surgery
Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).
Scale range from 0 (no pain) - 10 (most pain)
Measured: Baseline; 6 and 12 weeks after surgery
Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK).
TSK is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement.
Measured: Baseline; 6 and 12 weeks after surgery
Patient Self-Reported Outcome Assessments Change - Minnesota Multiphasic Personality Inventory - 2 - Restructured Form (MMPI-2-RF).
The MMPI-2-RF is a 338-item, self-report inventory that assesses personality and psychopathology across 42 substantive scales.
Measured: Baseline; 6 and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start15 Jun 2018
- Primary completionFeb 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Back Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Ram Haddas, PhD, Principal investigator, Texas Back Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586882
- Sponsor's protocol ID
- TBIRF-Medt
- Status last verified
- Jun 2018
- First submitted
- 2 Jul 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gee L, Smith HC, Ghulam-Jelani Z, Khan H, Prusik J, Feustel PJ, McCallum SE, Pilitsis JG. Spinal Cord Stimulation for the Treatment of Chronic Pain Reduces Opioid Use and Results in Superior Clinical Outcomes When Used Without Opioids. Neurosurgery. 2019 Jan 1;84(1):217-226. doi: 10.1093/neuros/nyy065.
PubMed 29538696Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. doi: 10.1097/00007632-198709000-00002.
PubMed 2961080Block AR, Gatchel RJ, Deardorff WW, et al. The Psychology of Spine Surgeryed. Washington, D.C.: American Psychological Association, 2003.
Frey ME, Manchikanti L, Benyamin RM, Schultz DM, Smith HS, Cohen SP. Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review. Pain Physician. 2009 Mar-Apr;12(2):379-97.
PubMed 19305486Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011 Mar-Apr;11(2):148-53. doi: 10.1111/j.1533-2500.2010.00407.x. Epub 2010 Sep 8.
PubMed 21371254Eldabe S, Kumar K, Buchser E, Taylor RS. An analysis of the components of pain, function, and health-related quality of life in patients with failed back surgery syndrome treated with spinal cord stimulation or conventional medical management. Neuromodulation. 2010 Jul;13(3):201-9. doi: 10.1111/j.1525-1403.2009.00271.x. Epub 2010 Feb 22.
PubMed 21992833Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
PubMed 22850494Turner JA, Hollingworth W, Comstock BA, Deyo RA. Spinal cord stimulation for failed back surgery syndrome: outcomes in a workers' compensation setting. Pain. 2010 Jan;148(1):14-25. doi: 10.1016/j.pain.2009.08.014. Epub 2009 Oct 28.
PubMed 19875232de Andrade DC, Bendib B, Hattou M, Keravel Y, Nguyen JP, Lefaucheur JP. Neurophysiological assessment of spinal cord stimulation in failed back surgery syndrome. Pain. 2010 Sep;150(3):485-491. doi: 10.1016/j.pain.2010.06.001. Epub 2010 Jun 29.
PubMed 20591571North RB, Kidd DH, Zahurak M, James CS, Long DM. Spinal cord stimulation for chronic, intractable pain: experience over two decades. Neurosurgery. 1993 Mar;32(3):384-94; discussion 394-5. doi: 10.1227/00006123-199303000-00008.
PubMed 8455763Geurts JW, Joosten EA, van Kleef M. Current status and future perspectives of spinal cord stimulation in treatment of chronic pain. Pain. 2017 May;158(5):771-774. doi: 10.1097/j.pain.0000000000000847. No abstract available.
PubMed 28106667Goudman L, Smet I, Marien P, De Jaeger M, De Groote S, Huysmans E, Putman K, Van Buyten JP, Buyl R, Moens M. Is the Self-Reporting of Failed Back Surgery Syndrome Patients Treated With Spinal Cord Stimulation in Line With Objective Measurements? Neuromodulation. 2018 Jan;21(1):93-100. doi: 10.1111/ner.12719. Epub 2017 Nov 3.
PubMed 29105225Rijken NH, Vonhogen LH, Duysens J, Keijsers NL. The effect of spinal cord stimulation (SCS) on static balance and gait. Neuromodulation. 2013 May-Jun;16(3):244-50; discussion 249-50. doi: 10.1111/j.1525-1403.2012.00512.x. Epub 2012 Sep 25.
PubMed 23009103Brugliera L, De Luca A, Corna S, Bertolotto M, Checchia GA, Cioni M, Capodaglio P, Lentino C. Spinal Cord Stimulation in Failed Back Surgery Syndrome: Effects on Posture and Gait-A Preliminary 3D Biomechanical Study. Pain Res Manag. 2017;2017:3059891. doi: 10.1155/2017/3059891. Epub 2017 Sep 25.
PubMed 29147083Al-Kaisy A, Palmisani S, Smith TE, Pang D, Lam K, Burgoyne W, Houghton R, Hudson E, Lucas J. 10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study. Neuromodulation. 2017 Jan;20(1):63-70. doi: 10.1111/ner.12563. Epub 2016 Dec 26.
PubMed 28025843
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spinal Cord Stimulation on Gait and Balance in Chronic Low Back Pain Patients With or Without Leg Pain
- ClinicalTrials.gov ID
- NCT03586882
- Acronym / sponsor ID
- TBIRF-Medt
- Conditions
- Chronic Low Back Pain, Pain in Leg, Unspecified
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Texas Back InstituteUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 16 Jul 2018 (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.
Spinal Cord Stimulation (SCS) uses electrical signals to disrupt noxious signals arising from painful areas, thereby reducing pain perception. Successful SCS implants lead to a broad range of positive outcomes: 1) long-term pain can be expected to be reduced by at least by 50%; 2) quality of life as assessed by subjective measurements improves substantially; 3) patients can significantly reduce opioid medication intake.1 However, the impacts of SCS intervention on neuromuscular and biomechanical outcomes including gait and balance have not been fully explored. Fifty subjects with symptomatic leg pain and/or low back pain (LBP) who are deemed appropriate SCS candidates and are scheduled for surgery will undergo gait and balance analyses preoperatively as well as 6 weeks and 3 months post operatively. In addition, 50 control subjects having no pain will undergo 1 session of gait and balance assessment. Objective spine and lower extremity motion and neuromuscular control will be evaluated using dynamic surface EMG and a video motion capture system during functional evaluation. Also, explored will be the relationship of changes in gait and balance to psychosocial factors that have previously been shown to be correlated with SCS outcomes.
Detailed description
Low back pain is reported in 75-80% of the population and can significantly influence patients' quality of life. Fortunately, 80-90% of individuals recover from their back pain, whether they receive treatment or not. However, the small percentage of people who do not recover quickly present a costly problem to society and a great challenge to health care providers. Low back pain is the second leading cause for missed days at work, potentially having disability and major socioeconomic consequences. Chronic LBP can also limit flexibility and/or range of motion, which may contribute to an overall decrease in functional capacity, and may ultimately heighten the risk for additional lower extremity injury. Many chronic LBP patients have conditions not amenable to spine surgery, or they have failed to achieve successful outcome with previous spine surgery. For these patients, SCS can be an effective alternative. For example, in a recent demonstration, randomized 100 failed back surgery syndrome (FBSS) patients to either SCS or conventional medical management. At 6 months post-implant, 64% of patients had achieved the 50% reduction in leg pain criterion (vs. 18% of conventional medical management patients). Similarly, North et al. found 52% of patients had achieved at least the 50% reduction in pain when they investigated 171 patients treated with SCS.
SCS uses electrical signals to decrease nociception of impulses arising from painful areas in the spine and or leg. In order to accomplish this goal, SCS involves implantation of a small electrical pulse generator, along with thin leads strategically placed into the epidural space. Stimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception. Occasionally, some patients feel a mild paresthesia as a result of the stimulation.
While the effectiveness of SCS on reduction of subjective pain complaints is now well-established, such improvement may not translate into improved functional ability. Previous research found that, for FBSS patients treated with SCS, patients' scores on Oswestry Disability index did not correlate significantly with improvements in function as measured by an accelerometer contained within the stimulator device. Very few studies have examined the effect of SCS on objectively-measured functional abilities, including gait and balance. Those studies suffer from a small sample size and lack of electromyography (EMG) and full body kinematics analyses. Despite that, those studies did find improvement in the spatiotemporal variables (i.e. gait speed, step length and width) while other variables (ground reaction force and trunk motion) were not significantly different using the SCS.
Therefore, the purpose of this study is to evaluate the effect of SCS, on the biomechanics of the lower extremities and spine, using dynamic EMG, video motion capture, and force plate analysis, during gait and static balance testing, in patients with chronic low back and/or leg pain, before and after intervention. In addition this study will compare these same biomechanical parameters found in the chronic low back pain and /or leg pain patients to an asymptomatic control group.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation Group | Experimental | Device: Spinal Cord StimulationGait and balance testing as well as self-reported outcome assessments to be administered before and after surgery |
| Control Group | No intervention | –Gait and balance testing to be administered once in healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years and older
- Considered to be a candidate for SCS
- Able to ambulate without assistance and stand without assistance with eyes open for a minimum of 10 seconds
- Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up
Key exclusion criteria (8 listed)
- Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
- BMI higher than 35
- Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
- Major trauma to the pelvis
- Pregnant or wishing to become pregnant during the study
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 |
|---|---|---|
| Spinal Cord StimulationStimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception. | Device | Spinal Cord Stimulation Group |
Primary outcome
Kinematic Variables Change assessed with human motion capture system
Time frame: Baseline; 6 and 12 weeks after surgery
3-Dimensional Range of Motion (ROM) during the stance and swing phase of the spine, pelvis, hip, knee, ankle, shoulder, and elbow joint angles along with center of mass and head sway and displacement
4 secondary outcomes
Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS)
Time frame: Baseline; 6 and 12 weeks after surgery
Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).
Time frame: Baseline; 6 and 12 weeks after surgery
Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK).
Time frame: Baseline; 6 and 12 weeks after surgery
Patient Self-Reported Outcome Assessments Change - Minnesota Multiphasic Personality Inventory - 2 - Restructured Form (MMPI-2-RF).
Time frame: Baseline; 6 and 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Background: PubMed 29538696Gee L, Smith HC, Ghulam-Jelani Z, Khan H, Prusik J, Feustel PJ, McCallum SE, Pilitsis JG. Spinal Cord Stimulation for the Treatment of Chronic Pain Reduces Opioid Use and Results in Superior Clinical Outcomes When Used Without Opioids. Neurosurgery. 2019 Jan 1;84(1):217-226. doi: 10.1093/neuros/nyy065.
- Background: PubMed 2961080Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. doi: 10.1097/00007632-198709000-00002.
- BackgroundBlock AR, Gatchel RJ, Deardorff WW, et al. The Psychology of Spine Surgeryed. Washington, D.C.: American Psychological Association, 2003.
- Background: PubMed 19305486Frey ME, Manchikanti L, Benyamin RM, Schultz DM, Smith HS, Cohen SP. Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review. Pain Physician. 2009 Mar-Apr;12(2):379-97.
- Background: PubMed 21371254Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011 Mar-Apr;11(2):148-53. doi: 10.1111/j.1533-2500.2010.00407.x. Epub 2010 Sep 8.
- Background: PubMed 21992833Eldabe S, Kumar K, Buchser E, Taylor RS. An analysis of the components of pain, function, and health-related quality of life in patients with failed back surgery syndrome treated with spinal cord stimulation or conventional medical management. Neuromodulation. 2010 Jul;13(3):201-9. doi: 10.1111/j.1525-1403.2009.00271.x. Epub 2010 Feb 22.
- Background: PubMed 22850494Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
- Background: PubMed 19875232Turner JA, Hollingworth W, Comstock BA, Deyo RA. Spinal cord stimulation for failed back surgery syndrome: outcomes in a workers' compensation setting. Pain. 2010 Jan;148(1):14-25. doi: 10.1016/j.pain.2009.08.014. Epub 2009 Oct 28.
- Background: PubMed 20591571de Andrade DC, Bendib B, Hattou M, Keravel Y, Nguyen JP, Lefaucheur JP. Neurophysiological assessment of spinal cord stimulation in failed back surgery syndrome. Pain. 2010 Sep;150(3):485-491. doi: 10.1016/j.pain.2010.06.001. Epub 2010 Jun 29.
- Background: PubMed 8455763North RB, Kidd DH, Zahurak M, James CS, Long DM. Spinal cord stimulation for chronic, intractable pain: experience over two decades. Neurosurgery. 1993 Mar;32(3):384-94; discussion 394-5. doi: 10.1227/00006123-199303000-00008.
- Background: PubMed 28106667Geurts JW, Joosten EA, van Kleef M. Current status and future perspectives of spinal cord stimulation in treatment of chronic pain. Pain. 2017 May;158(5):771-774. doi: 10.1097/j.pain.0000000000000847. No abstract available.
- Background: PubMed 29105225Goudman L, Smet I, Marien P, De Jaeger M, De Groote S, Huysmans E, Putman K, Van Buyten JP, Buyl R, Moens M. Is the Self-Reporting of Failed Back Surgery Syndrome Patients Treated With Spinal Cord Stimulation in Line With Objective Measurements? Neuromodulation. 2018 Jan;21(1):93-100. doi: 10.1111/ner.12719. Epub 2017 Nov 3.
- 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.
Ram Haddas, PhD principal investigator
Texas Back Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation in people with Chronic Low Back Pain and Pain in Leg, Unspecified, run by Texas Back Institute 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 11 inclusion and 8 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 Jul 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.
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?
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?
Kinematic Variables Change assessed with human motion capture system (time frame: Baseline; 6 and 12 weeks after surgery). 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 NCT03586882, which also lists 30 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 16 Jul 2018.