Trial Outcomes & Findings for Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients (NCT NCT00290238)
NCT ID: NCT00290238
Last Updated: 2009-06-01
Results Overview
Visual analog scale (VAS) for pain (100mm line with "0/No pain" on the left and "100/Worst pain imaginable" on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome timeframe
Time-averaged from the first available observation to the last available observation (12 months for completed subjects)
Results posted on
2009-06-01
Participant Flow
Participant milestones
| Measure |
Percutaneous Neuromodulation Therapy (PNT)
Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
65
|
|
Overall Study
COMPLETED
|
15
|
24
|
|
Overall Study
NOT COMPLETED
|
42
|
41
|
Reasons for withdrawal
| Measure |
Percutaneous Neuromodulation Therapy (PNT)
Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
|
|---|---|---|
|
Overall Study
Study terminated
|
27
|
27
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
13
|
Baseline Characteristics
Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients
Baseline characteristics by cohort
| Measure |
Percutaneous Neuromodulation Therapy (PNT)
n=57 Participants
Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=65 Participants
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age Categorical
Between 18 and 65 years
|
43 participants
n=99 Participants
|
54 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
Age Categorical
>=65 years
|
14 participants
n=99 Participants
|
10 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Age Continuous
|
53.7 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
55.9 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
54.8 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=99 Participants
|
65 participants
n=107 Participants
|
122 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time-averaged from the first available observation to the last available observation (12 months for completed subjects)Population: Analysis population was intention to treat (ITT), excluding subjects who had no follow-up (after the initial 10-week treatment phase) data available.
Visual analog scale (VAS) for pain (100mm line with "0/No pain" on the left and "100/Worst pain imaginable" on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits.
Outcome measures
| Measure |
Percutaneous Neuromodulation Therapy (PNT)
n=51 Participants
Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=64 Participants
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
|
|---|---|---|
|
Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
Back pain
|
-10.9 mm
Standard Error 3.1 • Interval 29.5 to 89.5
|
-11.7 mm
Standard Error 2.7 • Interval 35.5 to 88.5
|
|
Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
Radiating leg/buttock pain
|
-12.8 mm
Standard Error 3.2
|
-9.8 mm
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12Population: Analysis population was intention to treat (ITT).
Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers' Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.
Outcome measures
| Measure |
Percutaneous Neuromodulation Therapy (PNT)
n=57 Participants
Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=65 Participants
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
|
|---|---|---|
|
Total Expenditure Per Day on All Lower Back Pain Related Interventions
|
2.97 Dollars
Interval 0.0 to 77.2
|
5.30 Dollars
Interval 0.0 to 118.08
|
Adverse Events
Percutaneous Neuromodulation Therapy (PNT)
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Transcutaneous Electrical Nerve Stimulation (TENS)
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Percutaneous Neuromodulation Therapy (PNT)
Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bruise/abrasion/fracture/other injury
|
1.8%
1/57 • Number of events 1
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Surgery
|
1.8%
1/57 • Number of events 1
|
0.00%
0/65
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/57
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low back pain (serious events)
|
0.00%
0/57
|
3.1%
2/65 • Number of events 2
|
Other adverse events
| Measure |
Percutaneous Neuromodulation Therapy (PNT)
Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Low back pain (non-serious events)
|
29.8%
17/57 • Number of events 44
|
33.8%
22/65 • Number of events 57
|
|
Musculoskeletal and connective tissue disorders
Leg/buttock/hip or radiating pain
|
12.3%
7/57 • Number of events 9
|
13.8%
9/65 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.5%
2/57 • Number of events 2
|
10.8%
7/65 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Arm/shoulder pain
|
3.5%
2/57 • Number of events 2
|
7.7%
5/65 • Number of events 6
|
|
Injury, poisoning and procedural complications
Bruise/abrasion/fracture/other injury
|
5.3%
3/57 • Number of events 3
|
10.8%
7/65 • Number of events 8
|
|
General disorders
Headache
|
3.5%
2/57 • Number of events 3
|
6.2%
4/65 • Number of events 6
|
|
Injury, poisoning and procedural complications
Drug reaction
|
1.8%
1/57 • Number of events 3
|
6.2%
4/65 • Number of events 4
|
|
Infections and infestations
Virus
|
3.5%
2/57 • Number of events 3
|
4.6%
3/65 • Number of events 5
|
|
Infections and infestations
Urinary/bladder infection
|
7.0%
4/57 • Number of events 4
|
0.00%
0/65
|
Additional Information
Clinical Research Manager
RS Medical
Phone: 360-891-7299
Results disclosure agreements
- Principal investigator is a sponsor employee If the PI expects to participate in the publication or presentation of data generated in the performance of the study, any reports, abstracts, manuscripts, or other presentation materials shall be submitted to the sponsor for review prior to submission for publication or presentation. The sponsor shall have 30 calendar days to respond with any requested revisions in order to protect the sponsor's confidential information.
- Publication restrictions are in place
Restriction type: OTHER