Efficiency of transcutaneous electrical nerve stimulation in the treatment of central and peripheral disorders
| ISRCTN | ISRCTN47534508 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47534508 |
| Secondary identifying numbers | 45453 |
- Submission date
- 27/11/2024
- Registration date
- 02/12/2024
- Last edited
- 02/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Transcutaneous electrical nerve stimulation (TENS) has long been used in the treatment of pain of any etiology. For a long time, studies were carried out in an attempt to find out the secret of the analgesic effect of this method. Experimental studies have proven that TENS has three levels of action: local, segmental, and suprasegmental. Local effect develops by improving microcirculation and releasing anti-inflammatory drugs, stimulating cell regeneration and suppressing peripheral sensitization. The segmental analgesic effect is due to an increase in afferentation along fast fibers, causing stimulation of the gelatinous substance, and inhibiting afferentation along nociceptive fibers. Due to its suprasegmental action, TENS has an analgesic and anti-anxiety effect due to the release of central endorphins. However, there is not enough clinical research studying the recovery effect of TENS. In addition, there is no specific data on algorithms for the use of TENS in the treatment of various pathologies of the peripheral and central nervous system.
Who can participate?
Patients over 25 years of age who had pain due to pathology of the central or peripheral nervous system for more than 3 months.
What does the study involve?
Patients will be examined in different nosological groups. Currently, studies are planned in the following groups:
- Tension headache
- Migraine
- Post-stroke headache
- Cervicalgia
- Thoracalgia
- Low back pain.
- Tunnel syndromes
- Meralgia paresthetica
Each group will be divided into 3 subgroups depending on the characteristics of the applied current: High-frequency low-amplitude TENS subgroup, Low-frequency high-amplitude TENS subgroup and Low-frequency low-amplitude TENS subgroup (Sham TENS).
What are the possible benefits and risks of participating?
The possible benefits of participating include relief from pain, improved motor and sensory function, and an overall improvement in quality of life. There are no known risks associated with participating in this study.
Where is the study run from?
Peoples' Friendship University of Russia (RUDN University), Medical Stomatology Institute
When is the study starting and how long is it expected to run for?
January 2023 to July 2029
Who is funding the study?
RUDN University
Who is the main contact?
Prof Al-Zamil Mustafa, mustafaalzamil33@gmail.com
Contact information
Public, Scientific, Principal Investigator
Peoples' Friendship University of Russia, Sherbinka, st. Rabochaya 2 - 42
Moscow-Sherbinka
108851
Russian Federation
 ORCID ID |
0000-0002-3643-982X |
|---|---|
| Phone | +7 89262893810 |
| alzamil@mail.ru |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Medical and other records |
| Study type | Other |
| Scientific title | Analgesic and recovery effect of transcutaneous electrical nerve stimulation in treatment of central and peripheral neurological disorders |
| Study acronym | TENS effect |
| Study objectives | To study the dynamics of pain, paresthesia, hypoesthesia and motor deficit after the use of transcutaneous electrical nerve stimulation in patients with pathology of the peripheral or central nervous system. |
| Ethics approval(s) |
Approved 05/04/2022, Local Medical Ethical Committee of Medical Dental Institute (Pskovskaya st. 7 - 1, Moscow, 127253, Russian Federation; +7 (499) 504-54-75; medinstmcu@inbox.ru), ref: 3111 |
| Health condition(s) or problem(s) studied | Pathology of the peripheral or central nervous system |
| Intervention | The treatment group receives effective transcutaneous electrical nerve stimulation. Each procedure lasts 20-30 minutes. The procedures are carried out 15 times every other day. In the control group, sham transcutaneous electrical nerve stimulation is carried out with electrical impulses of frequency 1 Hz, a duration - 50 μs, and an amplitude - mA. The randomization process will be conducted by program software: Statistica Version: 12.0.1133.15 (x86/x64) |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Transcutaneous electrical nerve stimulation |
| Primary outcome measure | Before treatment, a week after treatment, after 2 months and 4 months of observation: 1. Pain assessment by visual analogue scale and Mc Gill Pain questionnaire 2. Assessment of impaired sensation: temperature, tactile and vibratory sensation by 5-point scale 3. Assessment of neurogenic claudication by Zurich Claudication Questionnaire (ZCQ) 4. Step activity monitoring by a pedometer 5. Motor deficit by 5-point scale 6. Electroneuromyography (ENMG): 6.1. Amplitude of Compound Muscle Action Potential (CMAP): 6.2. Terminal Latency 6.3. Conduction Velocity 6.4. Amplitude of Evoked Potential of Sural Nerves 6.5. F-wave and A-wave Abnormalities 7. MRI will measure the narrowing of the spinal canal at the L4-S1 level before and after decompression surgery and at the end of the follow-up period. |
| Secondary outcome measures | Before treatment, a week after treatment, after 2 months and 4 months of observation: 1. Quality of life by SF-36 questionnaire 2. Quality of enjoyment by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) 3. Assessment of sexuality disorders by the Sexual Function Evaluation Questionnaire (SFEQ) |
| Overall study start date | 04/01/2023 |
| Completion date | 01/07/2029 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 115 |
| Key inclusion criteria | 1. European 2. Adults aged from 25 to 60 years old 3. Neurological disorder is older than 3 months but less than 2 years 4. The severity of pain by visual analogue scale (VAS) is 5 scores and higher 5. Changes in the neurophysiological examination of the nervous system: electromyography, electroencephalography, evoked potentials 6. Signed voluntary informed consent to participate in this study |
| Key exclusion criteria | 1. Presence of allergic reactions to any of the drugs used 2. Severe cognitive disorders 3. Epilepsy 4. Rheumatoid diseases 5. Atherosclerotic peripheral arterial disease of the lower extremities 6. Muscular dystrophies of the lower extremities 7. Diabetes mellitus 8. Pregnancy 9. Undergoing physiotherapy or acupuncture treatment |
| Date of first enrolment | 04/01/2023 |
| Date of final enrolment | 01/07/2029 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Mosvow
127253
Russian Federation
Moscow
117198
Russian Federation
Sponsor information
University/education
6 Miklukho-Maklaya Street
Moscow
108851
Russian Federation
| Phone | +7 (495) 787-38-03 |
|---|---|
| commercial.dept@rudn.ru | |
| Website | https://www.rudn.ru/ |
"ROR" |
https://ror.org/02dn9h927 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Российский университет дружбы народов, Rossiysky universitet druzhby narodov, Université RUDN, Universidad de Rusia de la Amistad de los Pueblos, 俄罗斯人民友谊大学, جامعة الصداقة بين الشعوب في روسي, Peoples' Friendship University of Russia
- Location
- Russian Federation
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository, RUDN Respiratory: https://repository.rudn.ru/ru/records/dissertations/. The type of data stored: Title of dissertations and scientific research. |
Editorial Notes
02/12/2024: Study's existence confirmed by The Brain and Spine Clinic, the clinical base of Peoples' Friendship University of Russia (RUDN) University and the Department of Restorative Medicine and Neurorehabilitation of Medical Dental Institute.
