Lower Back Pain
Conditions
Keywords
Lower Back Pain
Brief summary
Each patient was assigned to one of the two groups: IDB or Sham. On the day of the procedure, an IV was inserted in pre-procedural area and patient transported to the procedure room. The procedure will be completed under fluoroscopy in prone position. Patients were given 1-4 mg of midazolam for relaxation before the procedure and, if needed, 50-100 mcg of fentanyl IV during the procedure. The patients was randomly assigned to treatment or placebo using computer-generated codes maintained in sequentially numbered opaque envelopes. The physician performing procedure was informed of the assignment. In IDB group, guided by the fluoroscopic imaging, two transdiscal probes was positioned in the posterior annulus using a posterolateral, oblique approach. First, two electrically insulated 17G transdiscal introducers was used to gain an access to the disc space. Than, two radiofrequency probes will be positioned through each of the introducers bilaterally to create a bipolar configuration. Placement of the transdiscal probes within the disc annulus will be confirmed using oblique, lateral, and anterior-posterior fluoroscopic images. Sham group had their introducers and electrodes positioned just outside of the disc. This was also be documented using fluoroscopy. Investigator attached the electrodes to inactive heater control device that provide a similar auditory and visual experience for the patient. Patients were therefore remain blinded to actual treatment and physician performing procedure was not involved in patient's follow-up. Patients were awake and communicating with the physician conducting the procedure and if pain in legs were present and increased during the procedure, the heating protocol would be stopped. Following completion of procedure the patient was transferred to recovery and monitored for 45 minutes, then discharged home with instructions. The patients were followed over a period of 12 months.
Detailed description
Back Pain
Interventions
DEVICEThe Transdiscal Radiofrequency Annuloplasty
Adjustment in dosage form, frequency and or duration.
Sponsors
Baylis Medical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The inclusion criteria will be as follows: * Age 18 + years * History of chronic low back pain unresponsive to nonoperative care (including physical therapy and anti-inflammatory medication) for longer than 6 months of at least 5 on VAS * No surgical interventions within the last 3 months * Back pain more than leg pain which is commonly exacerbated by sitting * Pain reproduction present on provocative discography in degenerated disc but not in control discs * Disc height at least 50% of adjacent control disc * Evidence of single level degenerative disc disease or two level disease without evidence of additional degenerative changes in other disc spaces on MRI
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | 6 months | Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component. Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 6 months | Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome) |
| Disability | 6 months | Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opioid Usage | 6 months | Patient reported Opioid usage (converted to morphine equivalents) |
Countries
United States
Participant flow
Pre-assignment details
Among the 32 treatment subjects, 4 were removed from the study due to violation of eligibility criteria and 1 removed for withdrawing patient consent. Among the 32 sham subjects, 2 patients were removed from the study due to violation of eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| Intradiscal Biacuplasty Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure. | 27 |
| Sham The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB. | 30 |
| Total | 57 |
Baseline characteristics
| Characteristic | Sham | Intradiscal Biacuplasty | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 27 Participants | 57 Participants |
| Age, Continuous | 39 years STANDARD_DEVIATION 10 | 40 years STANDARD_DEVIATION 10 | 39 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 30 participants | 27 participants | 57 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 30 |
| serious Total, serious adverse events | 0 / 27 | 0 / 30 |
Outcome results
Primary
Physical Function
Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component. Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intradiscal Biacuplasty | Physical Function | 62.04 units on a scale | Standard Deviation 21.89 |
| Sham | Physical Function | 48.67 units on a scale | Standard Deviation 22.97 |
Secondary
Disability
Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intradiscal Biacuplasty | Disability | 32.94 units on a scale | Standard Deviation 16.14 |
| Sham | Disability | 41.17 units on a scale | Standard Deviation 13.94 |
Secondary
Pain
Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intradiscal Biacuplasty | Pain | 4.94 units on a scale | Standard Deviation 2.15 |
| Sham | Pain | 6.58 units on a scale | Standard Deviation 2.11 |
Other Pre-specified
Opioid Usage
Patient reported Opioid usage (converted to morphine equivalents)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intradiscal Biacuplasty | Opioid Usage | 36.87 mg | Standard Deviation 40.56 |
| Sham | Opioid Usage | 49.48 mg | Standard Deviation 91.7 |