Trial Outcomes & Findings for Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain (NCT NCT01117870)

Results Overview

Expected recruitment is at least 4 patients per month. At least 80% of eligible patients fulfilling the selection criteria can be recruited. The final assessment was at the end of 15 months, at which time all the subjects were enrolled. Participants withdrawing within 4 weeks after the interventional shall not be included in the study. However participants withdrawing after 4 weeks of the intervention shall be included in the final analysis, on intention to treat principle.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

15 month point

Results posted on

2017-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment. Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.	PRF Treatment PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius
Overall Study STARTED	15	16
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment. Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.	PRF Treatment PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius
Overall Study Inability to place needle	1	0

Baseline Characteristics

Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=15 Participants The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment. Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.	PRF Treatment n=16 Participants PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius	Total n=31 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	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	57.8 years n=5 Participants	63.8 years n=7 Participants	59.5 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 month point

Population: Patients with suspected leg pain were initially approached by the research assistant. Further screening for eligibility was done in the presence of the physician. Suitable patients met with the research assistant (blind to intervention), who noted down the baseline parameters of the patient after obtaining an informed consent.

Expected recruitment is at least 4 patients per month. At least 80% of eligible patients fulfilling the selection criteria can be recruited. The final assessment was at the end of 15 months, at which time all the subjects were enrolled. Participants withdrawing within 4 weeks after the interventional shall not be included in the study. However participants withdrawing after 4 weeks of the intervention shall be included in the final analysis, on intention to treat principle.

Outcome measures

Outcome measures
Measure	Eligible Patients n=41 Participants Patients meeting eligibility criteria	PRF Treatment PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials.
Recruitment Rate	32 Participants	—

PRIMARY outcome

Timeframe: 3 months

Patients who were lost to follow-up at 3 months were recorded.

Outcome measures

Outcome measures
Measure	Eligible Patients n=32 Participants Patients meeting eligibility criteria	PRF Treatment PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials.
Number of Participants Lost to Follow-up at 3 Months	3 Participants	—

SECONDARY outcome

Timeframe: baseline (at recruitment) and at 4 Weeks

Population: Intent to treat analysis was used.

Secondary outcomes were considered as exploratory. Is PRF an effective treatment for patients with CLR pain? It will be measured by a change in VAS scores from baseline measurement at recruitment. Visual analog scale (VAS) - For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10) on a 10-cm scale.

Outcome measures

Outcome measures
Measure	Eligible Patients n=15 Participants Patients meeting eligibility criteria	PRF Treatment n=16 Participants PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials.
Change in Mean Visual Analogue Scale (VAS) Scores From Baseline to 4 Weeks	-5.43 units on a scale Standard Deviation 1.95	-5.07 units on a scale Standard Deviation 3.01

SECONDARY outcome

Timeframe: 1 week and up to 3 months

Population: Assessment of persisting side effects and percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment

Percentage of patients having side effects after PRF treatment assessed at 1 week compared to placebo group. Assessment of persisting side effects, percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment

Outcome measures

Outcome measures
Measure	Eligible Patients n=15 Participants Patients meeting eligibility criteria	PRF Treatment n=16 Participants PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials.
Assessment of Side Effects % of participants with short term side effects	0 percentage of participants	0 percentage of participants
Assessment of Side Effects % of participants with persisting side effects	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: baseline (at recruitment) and at 4 weeks

Population: Success defined as at least 50% improvement in Oswestry Disability Index (ODI) - measured at 4 weeks compared to placebo group.

ODI is an index derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to: care for oneself, walk, sit, sexual function, stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Outcome measures

Outcome measures
Measure	Eligible Patients n=15 Participants Patients meeting eligibility criteria	PRF Treatment n=16 Participants PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials.
Change in Oswestry Disability Index (ODI) From Baseline to 4 Week	-46 percentage change of ODI Standard Deviation 14	-44 percentage change of ODI Standard Deviation 17

SECONDARY outcome

Timeframe: 4 weeks

Population: Number of participants who discontinued analgesics after intervention

Number of PRF treatment patients with increase or decrease in medication use (either in dose, frequency, or no use), compared with the placebo group.

Outcome measures

Outcome measures
Measure	Eligible Patients n=15 Participants Patients meeting eligibility criteria	PRF Treatment n=16 Participants PRF will be applied for 120 seconds at 42 degrees celsius. Pulsed RadioFrequency: 120 seconds at 42 degrees celsius The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials.
Number of Participants Who Discontinued Analgesics After Intervention	1 Participants	2 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRF Treatment

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. Harsha Shanthanna

McMaster University/ St. Joseph's Healthcare Hamilton

Phone: 905-522-1155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place