Trial Outcomes & Findings for Effect of Peripheral Magnetic Stimulation in Patients With Chronic Lower Back Pain (NCT NCT07243548)
NCT ID: NCT07243548
Last Updated: 2026-02-25
Results Overview
Disease-specific questionnaire measuring functional disability (0=no disability, 100=complete disability)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline and immediately post-treatment (after 10 sessions over 2 weeks)
Results posted on
2026-02-25
Participant Flow
Individuals with chronic low back pain with a score between 40 and 80 on the Oswestry scale were selected for care at the Physiotherapy School Clinic of the Federal University of Alfenas - MG and Egas Moniz University Clinic - CUEM. Subjects were divided into 2 groups: the control group and the intervention group. Inclusion: Adults with chronic low back pain, no major spinal pathology, normal neuro exam. Exclusion: Trauma, prior surgery, neurological symptoms, systemic disease
Due to slower-than-expected recruitment rates despite extensive advertising and referral strategies, only 40 participants (20 per group) met all eligibility criteria. This adjusted sample size remained adequate for the pilot nature of the study, as it exceeded the minimum required per group (n=15) specified in the protocol for detecting meaningful effect sizes with acceptable power.
Participant milestones
| Measure |
rPMS Controle
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Pre Intervention
STARTED
|
20
|
20
|
|
Pre Intervention
COMPLETED
|
20
|
20
|
|
Pre Intervention
NOT COMPLETED
|
0
|
0
|
|
Post intevention
STARTED
|
20
|
20
|
|
Post intevention
COMPLETED
|
20
|
20
|
|
Post intevention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex/Gender data were not collected from any participant.
Baseline characteristics by cohort
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 years and older
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Sex/Gender data were not collected
|
0 Participants
Sex/Gender data were not collected from any participant.
|
0 Participants
Sex/Gender data were not collected from any participant.
|
0 Participants
Sex/Gender data were not collected from any participant.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Oswestry Disability Index (ODI)
|
15.1 Scores on a scale
STANDARD_DEVIATION 5.2 • n=20 Participants
|
15.0 Scores on a scale
STANDARD_DEVIATION 5.4 • n=20 Participants
|
15.05 Scores on a scale
STANDARD_DEVIATION 5.3 • n=40 Participants
|
|
Pain intensity at rest (VAS)
|
3.2 Scores on a scale
STANDARD_DEVIATION 2.3 • n=20 Participants
|
3.4 Scores on a scale
STANDARD_DEVIATION 2.4 • n=20 Participants
|
3.3 Scores on a scale
STANDARD_DEVIATION 2.35 • n=40 Participants
|
|
Pain intensity during activity (VAS)
|
5.3 Scores on a scale
STANDARD_DEVIATION 2.6 • n=20 Participants
|
5.4 Scores on a scale
STANDARD_DEVIATION 2.7 • n=20 Participants
|
5.35 Scores on a scale
STANDARD_DEVIATION 2.65 • n=40 Participants
|
|
Pressure pain threshold right lumbar region
|
5600 grams (g)
STANDARD_DEVIATION 2400 • n=20 Participants
|
5700 grams (g)
STANDARD_DEVIATION 2500 • n=20 Participants
|
5650 grams (g)
STANDARD_DEVIATION 2450 • n=40 Participants
|
|
Pressure pain threshold left lumbar region
|
5300 grams (g)
STANDARD_DEVIATION 2200 • n=20 Participants
|
5400 grams (g)
STANDARD_DEVIATION 2300 • n=20 Participants
|
5350 grams (g)
STANDARD_DEVIATION 2250 • n=40 Participants
|
|
Lumbar mobility (Schober test)
|
15.1 cm
STANDARD_DEVIATION 1 • n=20 Participants
|
15 cm
STANDARD_DEVIATION 1 • n=20 Participants
|
15.05 cm
STANDARD_DEVIATION 1 • n=40 Participants
|
|
Oswestry Disability Category
|
1.4 Scores on a scale
STANDARD_DEVIATION 0.6 • n=20 Participants
|
1.3 Scores on a scale
STANDARD_DEVIATION .06 • n=20 Participants
|
1.35 Scores on a scale
STANDARD_DEVIATION .6 • n=40 Participants
|
|
Physical activity level (IPAQ)
|
.5 Scores on a scale
STANDARD_DEVIATION .5 • n=20 Participants
|
.6 Scores on a scale
STANDARD_DEVIATION .5 • n=20 Participants
|
.55 Scores on a scale
STANDARD_DEVIATION .5 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)Disease-specific questionnaire measuring functional disability (0=no disability, 100=complete disability)
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Oswestry Disability Index (ODI)
Baseline
|
15.1 Scores on a scale
Standard Deviation 5.2
|
15.0 Scores on a scale
Standard Deviation 5.4
|
|
Oswestry Disability Index (ODI)
Post-treatment
|
13.7 Scores on a scale
Standard Deviation 5.0
|
4.6 Scores on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)Visual Analogue Scale for pain at rest (0=no pain, 10=worst pain)
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Pain Intensity at Rest (VAS)
Baseline
|
3.2 Scores on a scale
Standard Deviation 2.3 • Interval 0.0 to 10.0
|
3.4 Scores on a scale
Standard Deviation 2.4 • Interval 0.0 to 10.0
|
|
Pain Intensity at Rest (VAS)
Post-treatment
|
2.9 Scores on a scale
Standard Deviation 2.0
|
2.0 Scores on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)Population: The VAS analysis population includes all participants with baseline and post-baseline VAS assessments. Differences from the total assigned participants may occur due to missing data, withdrawals, or protocol deviations. Subsets by timepoint or subgroup are documented per the statistical analysis plan.
Visual Analogue Scale for pain during physical activity (0=no pain, 10=worst pain)
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Pain Intensity During Activity (VAS)
Baseline
|
5.3 Scores on a scale
Standard Deviation 2.6
|
5.4 Scores on a scale
Standard Deviation 2.7
|
|
Pain Intensity During Activity (VAS)
Post-treatment
|
4.7 Scores on a scale
Standard Deviation 2.5
|
2.8 Scores on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)Algometry (1 cm² tip) over lumbar spinous processes L1-L5 (right), minimum pressure for first pain sensation (mean of 2 trials)
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Pressure Pain Threshold Right Lumbar Region
Baseline
|
5600 grams (g)
Standard Deviation 2400
|
5700 grams (g)
Standard Deviation 2500
|
|
Pressure Pain Threshold Right Lumbar Region
Post-treatment
|
6100 grams (g)
Standard Deviation 2500
|
7500 grams (g)
Standard Deviation 3000
|
SECONDARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)Algometry (1 cm² tip) over lumbar spinous processes L1-L5 (right), minimum pressure for first pain sensation (mean of 2 trials)
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Pressure Pain Threshold Left Lumbar Region
Baseline
|
5300 grams (g)
Standard Deviation 2200
|
5400 grams (g)
Standard Deviation 2300
|
|
Pressure Pain Threshold Left Lumbar Region
Post-treatment
|
5900 grams (g)
Standard Deviation 2400
|
7300 grams (g)
Standard Deviation 2800
|
SECONDARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)Increase in skin distance (cm) during forward flexion
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Lumbar Mobility (Schober Test)
Baseline
|
15.1 cm
Standard Deviation 1.0
|
15.0 cm
Standard Deviation 1.0
|
|
Lumbar Mobility (Schober Test)
Post-treatment
|
15.7 cm
Standard Deviation 1.1
|
16.5 cm
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)Categorical score derived from ODI (0=no disability to 5=bedbound)
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Oswestry Disability Category
Baseline
|
1.4 Scores on a scale
Standard Deviation 0.6
|
1.3 Scores on a scale
Standard Deviation 0.6
|
|
Oswestry Disability Category
Post-treatment
|
1.2 Scores on a scale
Standard Deviation 0.6
|
0.5 Scores on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)International Physical Activity Questionnaire category (0=sedentary, 1=physically active)
Outcome measures
| Measure |
rPMS Control
n=20 Participants
For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.
|
rPMS Intervention
n=20 Participants
For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.
|
|---|---|---|
|
Physical Activity Level (IPAQ)
Baseline
|
0.5 Scores on a scale
Standard Deviation 0.5
|
0.6 Scores on a scale
Standard Deviation 0.5
|
|
Physical Activity Level (IPAQ)
Post-treatment
|
0.5 Scores on a scale
Standard Deviation 0.5
|
0.6 Scores on a scale
Standard Deviation 0.5
|
Adverse Events
rPMS Controle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
rPMS Intervention
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
Luciano Maia Alves Ferreira
Egas Moniz School of Health and Science
Phone: +351913548646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place