N/A
N=38
Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02320838 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Mechanical Pain Threshold During Treatment — 57.5; 63.2; 53.8 N — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 5 KHz (Device); TENS (Device); Sham stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Castilla-La Mancha
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mechanical Pain Threshold During Treatment |
57.5; 63.2; 53.8 | <0.001 sig |
| PRIMARY Thermal Pain Threshold During Treatment |
57.48; 63.16; 53.82 | 0.04 sig |
| PRIMARY Nerve Conduction Latency Immediately After Treatment |
3.71; 3.68; 3.63 | 0.9 |
| PRIMARY Tactile Threshold During Treatment |
18.3; 74.5; 1.1 | 0.001 sig |
| SECONDARY Habituation to Electrical Stimulation |
7.7; 5.5 | 0.003 sig |
| SECONDARY Perception Current Comfortability |
26; 12 | 0.023 sig |
| SECONDARY Change Current Density (mA/cm2) |
0.62; 0.44 | 0.003 sig |
| SECONDARY Change From Baseline in Nerve Conduction Amplitude ( µV) |
-0.09; 0.03; -0.4 | 0.8 |
| SECONDARY Baseline Mechanical Pain Threshold |
48.4; 48.3; 54.0 | 0.02 sig |
| SECONDARY Mechanical Pain Threshold Post-treatment 20 Min. |
53.8; 55.2; 51.5 | 0.4 |
| SECONDARY Mechanical Pain Threshold Post-treatment 40 Min. |
52.0; 52.6; 51.0 | 0.8 |
| SECONDARY Baseline Thermal Pain Threshold |
44.9; 45.0; 44.8 | 1.0 |
| SECONDARY Thermal Pain Threshold Post-treatment 20 Min. |
45.1; 45.4; 45.0 | 0.4 |
| SECONDARY Thermal Pain Threshold Post-treatment 40 Min. |
45.2; 45.7; 45.2 | 0.1 |
| SECONDARY Baseline Nerve Conduction Latency |
3.6; 3.6; 3.6 | 0.9 |
| SECONDARY Nerve Conduction Latency Post-treatment 20 Min. |
3.7; 3.7; 3.7 | 0.9 |
| SECONDARY Nerve Conduction Latency Post-treatment 40 Min. |
3.7; 3.7; 3.6 | 0.5 |
| SECONDARY Baseline Tactile Threshold |
1.1; 1.0; 1.0 | 0.6 |
| SECONDARY Tactile Threshold Post-treatment 20 Min. |
1.4; 1.5; 1.0 | 0.1 |
| SECONDARY Tactile Threshold Post-treatment 40 Min. |
1.3; 1.1; 1.0 | 0.2 |
Summary
The purpose of this study is to determine whether the transcutaneous application of unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover evidence whether the effect and comfort of this current is greater than Conventional TENS (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical pain.
Eligibility Criteria
Inclusion Criteria
- Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
Exclusion Criteria
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
- Cardiovascular disease.
- Pacemaker or other implanted electrical device.
- Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
- Presence of tattoos or other external agent introduced into the treatment or assessment area.
- Pregnancy.
- Sensitivity disturbance in upper limb.
Data sourced from ClinicalTrials.gov (NCT02320838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.