Trial Outcomes & Findings for Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty (NCT NCT00750191)

NCT ID: NCT00750191

Last Updated: 2014-01-08

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 64 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-01-08

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	27	30
Overall Study COMPLETED	22	20
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

Baseline characteristics by cohort

Measure	Intradiscal Biacuplasty n=27 Participants 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.	Sham n=30 Participants 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.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	30 Participants n=7 Participants	57 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 10 • n=5 Participants	39 years STANDARD_DEVIATION 10 • n=7 Participants	39 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	30 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Intradiscal Biacuplasty n=27 Participants 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.	Sham n=30 Participants 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.
Physical Function	62.04 units on a scale Standard Deviation 21.89	48.67 units on a scale Standard Deviation 22.97

SECONDARY outcome

Timeframe: 6 months

Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)

Outcome measures

Measure	Intradiscal Biacuplasty n=27 Participants 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.	Sham n=30 Participants 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.
Pain	4.94 units on a scale Standard Deviation 2.15	6.58 units on a scale Standard Deviation 2.11

SECONDARY outcome

Timeframe: 6 months

Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)

Outcome measures

Measure	Intradiscal Biacuplasty n=27 Participants 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.	Sham n=30 Participants 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.
Disability	32.94 units on a scale Standard Deviation 16.14	41.17 units on a scale Standard Deviation 13.94

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Patient reported Opioid usage (converted to morphine equivalents)

Outcome measures

Measure	Intradiscal Biacuplasty n=27 Participants 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.	Sham n=30 Participants 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.
Opioid Usage	36.87 mg Standard Deviation 40.56	49.48 mg Standard Deviation 91.70

Adverse Events

Intradiscal Biacuplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Leonard Kapural

The Center for Clinical Research

Phone: 1-336-765-6181

Email: LKapural@ccrpain.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60