Trial Outcomes & Findings for Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery (NCT NCT02416973)
NCT ID: NCT02416973
Last Updated: 2017-02-09
Results Overview
Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
60 days
Results posted on
2017-02-09
Participant Flow
Participant milestones
| Measure |
Sham of Provant
Sham of Provant
Provant
|
Active Treatment
Active Provant Treatment
Provant
|
Active Treatment With Alternative Settings
Active Provant Treatment with alternative settings
Provant
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery
Baseline characteristics by cohort
| Measure |
Sham of Provant
n=14 Participants
Sham of Provant
Provant
|
Active Treatment
n=13 Participants
Active Provant Treatment
Provant
|
Active Treatment With Alternative Settings
n=14 Participants
Active Provant Treatment with alternative settings
Provant
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.6 years
n=5 Participants
|
54.9 years
n=7 Participants
|
50.2 years
n=5 Participants
|
51.83 years
n=4 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
PainDETECT Questionnaire
|
16.6 units on a scale
n=5 Participants
|
14.5 units on a scale
n=7 Participants
|
16.1 units on a scale
n=5 Participants
|
15.8 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Per protocol population results displayed. This results in a discrepancy in the number of participants provided above. Baseline characteristics include the entire intent to treat population.
Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable).
Outcome measures
| Measure |
Sham of Provant
n=13 Participants
Sham of Provant
Provant
|
Active Treatment
n=9 Participants
Active Provant Treatment
Provant
|
Active Treatment With Alternative Settings
n=13 Participants
Active Provant Treatment with alternative settings
Provant
|
|---|---|---|---|
|
Percent Change From Baseline in Pain Scores
|
-25.6 Percent Difference
Standard Deviation 24.81
|
-40.2 Percent Difference
Standard Deviation 26.35
|
-18.6 Percent Difference
Standard Deviation 39.47
|
Adverse Events
Sham of Provant
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active Treatment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Active Treatment With Alternative Settings
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham of Provant
n=14 participants at risk
Sham of Provant
Provant
|
Active Treatment
n=13 participants at risk
Active Provant Treatment
Provant
|
Active Treatment With Alternative Settings
n=14 participants at risk
Active Provant Treatment with alternative settings
Provant
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/14
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/14
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/14
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/14
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/14
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/14
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
0.00%
0/14
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/14
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/14
|
0.00%
0/13
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication Rights. Independent analysis and/or publication of data generated is not permitted without the prior written consent of sponsor. Such consent may be contingent on sponsor review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
- Publication restrictions are in place
Restriction type: OTHER