Peripheral Nervous System ProblemHIT-CIPNNCT03978585
Comparison of High Tone Therapy and TENS Therapy
A study testing high tone external muscle stimulation and transcutaneous electrical nerve stimulation (TENS) therapy in people with Peripheral Nervous System Problem, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
This study evaluates the efficacy of home-based high tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) in chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nervous System Problem
- What is being tested?
- high tone external muscle stimulation and transcutaneous electrical nerve stimulation (TENS) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteAustria
- Study dates
- 3 Sep 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Histologically proven cancer
- ECOG performance score 0-1(Eastern Cooperative Oncology Group)
- Completed neoadjuvant or adjuvant chemotherapy with taxane or platin
- Minimum time distance to neurotoxic agent 4 weeks, maximum 24 weeks
- Clinical diagnosis of CIPN ≥Grade 1 according to CTCAE during or after completion of chemotherapy
- Ability to complete questionnaires by themselves or with assistance
- Ability to understand the study regimen, its requirements, risks, and discomforts, and ability and willingness to sign an informed consent form
Who cannot join
- Ongoing treatment with antitumor treatments with potential neurotoxic side effects (e.g. platins, taxanes, vinca alkaloids, bortezomib or thalidomide)
- Completed chemotherapy with neurotoxic side effects other than taxane or platin
- Pre-existing clinically manifest peripheral neuropathy prior to start of chemotherapy (e.g. caused by radiation or malignant plexopathy, lumbar or cervical radiculopathy, carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.)
- Peripheral arterial occlusive disease > Grade 1
- Skin conditions such as open sores preventing proper application of the electrodes
- Patients with implantable medical electronic devices (e.g. pace maker, Implantable Cardioverter Defibrillator - ICD, catheter, etc.)
Show all 10Show fewer
- Patients with myocard damages or cardiac arrhythmia
- Patients with epilepsy
- Patients with febrile illnesses or acute infectious diseases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Paracelsus Medical University Salzburger Landeskliniken
Salzburg, 5020
About this study
Official title: Comparison of High Tone Therapy and TENS Therapy in Chemotherapy-induced Polyneuropathy
This study evaluates the efficacy of home-based high tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) in chemotherapy-induced peripheral neuropathy (CIPN). One half of the participants will receive TENS therapy, the other half will receive High tone external muscle Stimulation. It is expected that HTEMS improves symptoms of CIPN.
Read the detailed description
One of the most common adverse side effects of chemotherapeutic agents especially in taxanes, platins or vinca alkaloids is chemotherapy-induced peripheral neuropathy (CIPN). Prevalence of CIPN was reported in 30% to 40% of patients treated with neurotoxic chemotherapy and may be transient or permanent. It appears predominantly as sensory neuropathy and affects the peripheral parts of the extremities in a "stocking and glove"-distribution. CIPN often presents with symptoms like paresthesia, pain, numbness or tingling, but motor symptoms can occur as well. Symptoms of CIPN may lead to dose reduction or even early cessation of chemotherapy and therefore may affect overall survival in cancer patients. Currently, no evidence-based treatment (drug or non-drug therapy) is available for CIPN. Several approaches to manage peripheral neuropathy have been proposed, but evidence showing a benefit of these procedures regarding clinically relevant endpoints is scarce. One promising approach to ease CIPN symptoms is the application of electrotherapy. Different types of electrical sensory interventions have been explored in the literature e.g. transcutaneous electrical nerve stimulation (TENS) and high-tone external muscle stimulation (HTEMS).TENS is used in medical settings and in self-administration of patients at home. In TENS only the frequency is modulated. The device sends electrical impulses through conductive rubber electrodes to the skin of the impaired region. The applied frequencies range from 2 to 120 Hertz. The pain region must be in the middle of the two electrodes, which have a maximum distance of 20cm. In contrast to the TENS therapy, the HTEMS operates in-depth directly on the muscle and produces pleasant, but intense and thus effective contractions. Additionally in HTEMS, the amplitude and the frequency are modulated simultaneously. The applied frequencies range continuously from 4096 to 32768 Hertz. Different frequencies activate structures of different size. For this reason, it is important to offer a broad spectrum of frequencies. The electrical stimulation is applied by using conductive rubber electrodes. On the upper limbs as well as on the lower limbs the electrodes are positioned as far as possible proximal and distal. During the treatment the muscle is stimulated to contraction through intervals. One interval consists of three seconds ramp-up time (intensity rises), three seconds holding time (intensity maintains on maximum) and three seconds pause (no stimulation).
The application of HTEMS has been shown to be more effective than TENS in the therapy of diabetic peripheral neuropathy. Furthermore, HTEMS demonstrated improvement in pain, discomfort, sleep disturbance and quality of life in patients with end-stage renal disease due to uremic peripheral neuropathy. So far, little research on HTEMS or TENS in CIPN has been carried out, even if this approach is used in clinical practice. The aim of this study is to evaluate the effect and feasibility of home-based HTEMS in patients with chemotherapy-induced peripheral neuropathy.
This pilot study will be based on a single blinded randomised controlled trial study design with an observation time of eight weeks. Patients with cancer receiving a taxan-or platin-based chemotherapy and symptoms of CIPN will be included. Subjects will be stratified by treatment delivery, taxan and platin. The therapy will start after completed adjuvant chemotherapy after a time period of 4 weeks minimum to exclude patients with spontaneous remission of CIPN and in order to reduce the effect of any known or unknown biases related to the treatment regime. Potential study participants will receive information about the study as soon as symptoms occurred to plan inclusion, randomisation and allocation of appointments. Patients will receive a TENS or HTEMS device after randomisation. Participants who are allocated to the control intervention group will receive TENS therapy. The participant is educated for home-based therapy and the treatment should be used daily for 30 minutes for 8 weeks. Additionally, participants' compliance will be checked by reading out the tool box. Participants are asked to fill out the EORTC CIPN 20 (chemotherapy-induced) and EORTC QLQ-C30 (quality of life) questionnaire at baseline and after 8 weeks. Clinical examination encompassing vibration sensibility, tendon reflexes, temperature sensibility perception of touch and muscel strength will be conducted at the same time points.
The investigators would prefer not to constrain patients to specific daily time points and disturb their individual rhythm. Therefore, the investigators recommend performing the intervention at a regular daily time point adapted to the individual daily routine. The primary endpoint is a change in the EORTC-QLQ-CIPN20 score during the eight weeks of intervention. For our primary endpoint the investigators will use an intention-to-treat analysis according to the CONSORT statement. Furthermore, the investigators will analyse the intensity of intervention (compliance) and the effect on the primary endpoint (for example comparison of infrequently and frequently use of device). A minimum use on 5 of 7days per week is required.
- Conditions
- Peripheral Nervous System Problem
- Being tested
- high tone external muscle stimulation, transcutaneous electrical nerve stimulation (TENS) therapy
- Keywords
- HTEMS, peripheral neuropathy, chemotherapy, TENS therapy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tone external muscle stimulationDevice
Also called HiTOP 191 therapy device (gbo Medizintechnik, Rimbach, Germany)
Participants receive self-administered home based high tone therapy for 8 weeks for 30 minutes daily after device instruction
transcutaneous electrical nerve stimulation (TENS) therapyDevice
Also called DoloBravo therapy device 10-05 (MTR GmbH, Scheideggweg 7, 12277 Berlin),CE 0123
Participants receive self-administered home based TENS therapy for 8 weeks for 30 minutes daily after device instruction
| Study group | Role | What they receive |
|---|---|---|
| HTEMS Arm | Experimental | High tone therapy (home based) daily for 30 minutes on at least 5 of 7 days per week Receives: Device: high tone external muscle stimulation; Device: transcutaneous electrical nerve stimulation (TENS) therapy |
| TENS Arm | Active comparator | TENS therapy (home based) daily for 30 minutes on at least 5 of 7 days per week Receives: Device: high tone external muscle stimulation; Device: transcutaneous electrical nerve stimulation (TENS) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of CIPN associated symptoms
Improvement of CIPN associated Symptoms will be assessed according to the EORTC CIPN 20 questionnaire.The EORTC QLQ-CIPN 20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items), using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"). All scale scores are linearly converted to a 0-100 scale (0=no sensory impairment, 100=worst sensory impairment)
Measured: 8 weeks
Secondary outcomes (6)
Assessment of Quality of life
The QLQ-C30 Version 3.0 is composed of multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. The functional scales and the symptom scales have four-point scales. These are coded with "Not at all", "A little", "Quite a bit" and "Very much." The global health status includes 2 items and an item range of 6 from "Very bad" to "Excellent". All of the scales and single-item measures range in score from 0 to 100. The principle for scoring is the same in all cases: Estimate the average of the items that contribute to the scale; this is the Raw Score. Use a linear transformation to standardise the Raw Score, so that scores range from 0 to 100. For all scales, the Raw Score is the mean of the component items calculated with a formula included in the manual.
Measured: 8 weeks
Vibration sensibility
Vibration sensibility: is evaluated by the use of a graduated Rydel-Seiffer tuning fork (128Hz) with a scale from 0 to 8. Due to age related neural deconditioning, values ≤4 are considered pathological for patients ≥60 years old, for patients under 60 years old, a score≤5 is regarded as pathological
Measured: 8 weeks
Tendon reflex
Achilles tendon, biceps and patellar tendon reflexes are assessed with a reflex hammer and graded on a 5 point scale of 0 to 4+ with 0 being no response, 1+ being diminished/low normal, 2+ being average/normal, 3+ being brisker than average/possibly indicative of disease, and 4+ being very brisk, hyperactive, with clonus.
Measured: 8 weeks
Temperature sensibility
Is assessed by TipTherm (tip therm Gesellschaft mit beschränkter Haftung, Düsseldorf, Germany). The examiner places the two circular end faces of the instrument alternately and in an irregular sequence on the back of the patient's foot and asks for the sensory impression: cold or less cold? Only correct answers suggest an intact temperature discrimination capability. Incorrect answers or uncertainties are to be understood as temperature sense - disturbance at the investigation site
Measured: 8 weeks
Perception of touch
is evaluated by stroking patients´ upper and lower legs and feet in order to detect reduced or altered sensation due to demyelinisation or axonal degeneration
Measured: 8 weeks
Assessment of muscle strength
Strength of the lower muscles is assessed by asking the patient to perform toe standing/walking and heel standing/walking on both feet (possible, not possible)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start3 Sep 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nervous System ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The random allocation sequence will be generated using the random number generator available online (www.randomization.com). The unit of randomization will be the individual participant, such that each patient will be randomised to either have use of the HTEMS device (intervention), or TENS device (control intervention). To ensure balance in the sample size across groups, we will perform a stratified block randomisation (ratio 1:1, block size 4). Subjects will be stratified by treatment delivery, taxan and oxaliplatin. To assure concealment of allocation, physicians of the Institute of Physical Medicine and Rehabilitation will report to the Institute of General Practice, Family Medicine and Preventive Medicine as soon as patient recruitment has been completed and then randomisation by computerised sequence generation will be performed.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Responsible party
- Principal investigator, Robert Sassmann, Paracelsus Medical University
- Investigators
- Maria Flamm, Prof, Study director, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978585
- Sponsor's protocol ID
- 415-E/2376/7-2018
- Acronym
- HIT-CIPN
- Status last verified
- Sep 2022
- First submitted
- 27 May 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Briani C, Argyriou AA, Izquierdo C, Velasco R, Campagnolo M, Alberti P, Frigeni B, Cacciavillani M, Bergamo F, Cortinovis D, Cazzaniga M, Bruna J, Cavaletti G, Kalofonos HP. Long-term course of oxaliplatin-induced polyneuropathy: a prospective 2-year follow-up study. J Peripher Nerv Syst. 2014 Dec;19(4):299-306. doi: 10.1111/jns.12097.
PubMed 25582667Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PubMed 25261162Gibson W, Wand BM, Meads C, Catley MJ, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for chronic pain - an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2019 Apr 3;4(4):CD011890. doi: 10.1002/14651858.CD011890.pub3.
PubMed 30941745Humpert PM, Morcos M, Oikonomou D, Schaefer K, Hamann A, Bierhaus A, Schilling T, Nawroth PP. External electric muscle stimulation improves burning sensations and sleeping disturbances in patients with type 2 diabetes and symptomatic neuropathy. Pain Med. 2009 Mar;10(2):413-9. doi: 10.1111/j.1526-4637.2008.00557.x. Epub 2009 Jan 16.
PubMed 19207234Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
PubMed 15911236Rieder F, Sassmann R, Kienberger YT, Castagnaviz V, Schaffler-Schaden D, Johansson T, Rinnerthaler G, Flamm M, Greil R, Schulze C, Gampenrieder SP. Different types of electrostimulation target specific impaired sensory and motor functions in chemotherapy-induced peripheral neuropathy: a secondary analysis of a controlled trial. Front Neurol. 2026 Mar 4;17:1653161. doi: 10.3389/fneur.2026.1653161. eCollection 2026.
PubMed 41859404Sassmann R, Gampenrieder SP, Rieder F, Johansson T, Rinnerthaler G, Castagnaviz V, Lampl K, Herfert J, Kienberger YT, Flamm M, Schaffler-Schaden D, Greil R. Electrotherapy as treatment for chemotherapy-induced peripheral neuropathy - a randomized controlled trial. Front Neurol. 2024 Dec 24;15:1451456. doi: 10.3389/fneur.2024.1451456. eCollection 2024.
PubMed 39777312
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Tone Therapy and TENS Therapy in Chemotherapy-induced Polyneuropathy
- ClinicalTrials.gov ID
- NCT03978585
- Acronym / sponsor ID
- HIT-CIPN / 415-E/2376/7-2018
- Conditions
- Peripheral Nervous System Problem
- Keywords
- HTEMS, peripheral neuropathy, chemotherapy, TENS therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of home-based high tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) in chemotherapy-induced peripheral neuropathy (CIPN). One half of the participants will receive TENS therapy, the other half will receive High tone external muscle Stimulation. It is expected that HTEMS improves symptoms of CIPN.
Detailed description
One of the most common adverse side effects of chemotherapeutic agents especially in taxanes, platins or vinca alkaloids is chemotherapy-induced peripheral neuropathy (CIPN). Prevalence of CIPN was reported in 30% to 40% of patients treated with neurotoxic chemotherapy and may be transient or permanent. It appears predominantly as sensory neuropathy and affects the peripheral parts of the extremities in a "stocking and glove"-distribution. CIPN often presents with symptoms like paresthesia, pain, numbness or tingling, but motor symptoms can occur as well. Symptoms of CIPN may lead to dose reduction or even early cessation of chemotherapy and therefore may affect overall survival in cancer patients. Currently, no evidence-based treatment (drug or non-drug therapy) is available for CIPN. Several approaches to manage peripheral neuropathy have been proposed, but evidence showing a benefit of these procedures regarding clinically relevant endpoints is scarce. One promising approach to ease CIPN symptoms is the application of electrotherapy. Different types of electrical sensory interventions have been explored in the literature e.g. transcutaneous electrical nerve stimulation (TENS) and high-tone external muscle stimulation (HTEMS).TENS is used in medical settings and in self-administration of patients at home. In TENS only the frequency is modulated. The device sends electrical impulses through conductive rubber electrodes to the skin of the impaired region. The applied frequencies range from 2 to 120 Hertz. The pain region must be in the middle of the two electrodes, which have a maximum distance of 20cm. In contrast to the TENS therapy, the HTEMS operates in-depth directly on the muscle and produces pleasant, but intense and thus effective contractions. Additionally in HTEMS, the amplitude and the frequency are modulated simultaneously. The applied frequencies range continuously from 4096 to 32768 Hertz. Different frequencies activate structures of different size. For this reason, it is important to offer a broad spectrum of frequencies. The electrical stimulation is applied by using conductive rubber electrodes. On the upper limbs as well as on the lower limbs the electrodes are positioned as far as possible proximal and distal. During the treatment the muscle is stimulated to contraction through intervals. One interval consists of three seconds ramp-up time (intensity rises), three seconds holding time (intensity maintains on maximum) and three seconds pause (no stimulation).
The application of HTEMS has been shown to be more effective than TENS in the therapy of diabetic peripheral neuropathy. Furthermore, HTEMS demonstrated improvement in pain, discomfort, sleep disturbance and quality of life in patients with end-stage renal disease due to uremic peripheral neuropathy. So far, little research on HTEMS or TENS in CIPN has been carried out, even if this approach is used in clinical practice. The aim of this study is to evaluate the effect and feasibility of home-based HTEMS in patients with chemotherapy-induced peripheral neuropathy.
This pilot study will be based on a single blinded randomised controlled trial study design with an observation time of eight weeks. Patients with cancer receiving a taxan-or platin-based chemotherapy and symptoms of CIPN will be included. Subjects will be stratified by treatment delivery, taxan and platin. The therapy will start after completed adjuvant chemotherapy after a time period of 4 weeks minimum to exclude patients with spontaneous remission of CIPN and in order to reduce the effect of any known or unknown biases related to the treatment regime. Potential study participants will receive information about the study as soon as symptoms occurred to plan inclusion, randomisation and allocation of appointments. Patients will receive a TENS or HTEMS device after randomisation. Participants who are allocated to the control intervention group will receive TENS therapy. The participant is educated for home-based therapy and the treatment should be used daily for 30 minutes for 8 weeks. Additionally, participants' compliance will be checked by reading out the tool box. Participants are asked to fill out the EORTC CIPN 20 (chemotherapy-induced) and EORTC QLQ-C30 (quality of life) questionnaire at baseline and after 8 weeks. Clinical examination encompassing vibration sensibility, tendon reflexes, temperature sensibility perception of touch and muscel strength will be conducted at the same time points.
The investigators would prefer not to constrain patients to specific daily time points and disturb their individual rhythm. Therefore, the investigators recommend performing the intervention at a regular daily time point adapted to the individual daily routine. The primary endpoint is a change in the EORTC-QLQ-CIPN20 score during the eight weeks of intervention. For our primary endpoint the investigators will use an intention-to-treat analysis according to the CONSORT statement. Furthermore, the investigators will analyse the intensity of intervention (compliance) and the effect on the primary endpoint (for example comparison of infrequently and frequently use of device). A minimum use on 5 of 7days per week is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The random allocation sequence will be generated using the random number generator available online (www.randomization.com). The unit of randomization will be the individual participant, such that each patient will be randomised to either have use of the HTEMS device (intervention), or TENS device (control intervention). To ensure balance in the sample size across groups, we will perform a stratified block randomisation (ratio 1:1, block size 4). Subjects will be stratified by treatment delivery, taxan and oxaliplatin. To assure concealment of allocation, physicians of the Institute of Physical Medicine and Rehabilitation will report to the Institute of General Practice, Family Medicine and Preventive Medicine as soon as patient recruitment has been completed and then randomisation by computerised sequence generation will be performed.
| Arm | Type | Receives |
|---|---|---|
| HTEMS Arm | Experimental | Device: high tone external muscle stimulation, Device: transcutaneous electrical nerve stimulation (TENS) therapyHigh tone therapy (home based) daily for 30 minutes on at least 5 of 7 days per week |
| TENS Arm | Active comparator | Device: high tone external muscle stimulation, Device: transcutaneous electrical nerve stimulation (TENS) therapyTENS therapy (home based) daily for 30 minutes on at least 5 of 7 days per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (10 listed)
- Ongoing treatment with antitumor treatments with potential neurotoxic side effects (e.g. platins, taxanes, vinca alkaloids, bortezomib or thalidomide)
- Completed chemotherapy with neurotoxic side effects other than taxane or platin
- Pre-existing clinically manifest peripheral neuropathy prior to start of chemotherapy (e.g. caused by radiation or malignant plexopathy, lumbar or cervical radiculopathy, carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.)
- Peripheral arterial occlusive disease > Grade 1
- Skin conditions such as open sores preventing proper application of the electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high tone external muscle stimulationAlso: HiTOP 191 therapy device (gbo Medizintechnik, Rimbach, Germany)Participants receive self-administered home based high tone therapy for 8 weeks for 30 minutes daily after device instruction | Device | HTEMS Arm, TENS Arm |
| transcutaneous electrical nerve stimulation (TENS) therapyAlso: DoloBravo therapy device 10-05 (MTR GmbH, Scheideggweg 7, 12277 Berlin),CE 0123Participants receive self-administered home based TENS therapy for 8 weeks for 30 minutes daily after device instruction | Device | HTEMS Arm, TENS Arm |
Primary outcome
Improvement of CIPN associated symptoms
Time frame: 8 weeks
Improvement of CIPN associated Symptoms will be assessed according to the EORTC CIPN 20 questionnaire.The EORTC QLQ-CIPN 20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items), using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"). All scale scores are linearly converted to a 0-100 scale (0=no sensory impairment, 100=worst sensory impairment)
6 secondary outcomes
Assessment of Quality of life
Time frame: 8 weeks
Vibration sensibility
Time frame: 8 weeks
Tendon reflex
Time frame: 8 weeks
Temperature sensibility
Time frame: 8 weeks
Perception of touch
Time frame: 8 weeks
Assessment of muscle strength
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Background: PubMed 25582667Briani C, Argyriou AA, Izquierdo C, Velasco R, Campagnolo M, Alberti P, Frigeni B, Cacciavillani M, Bergamo F, Cortinovis D, Cazzaniga M, Bruna J, Cavaletti G, Kalofonos HP. Long-term course of oxaliplatin-induced polyneuropathy: a prospective 2-year follow-up study. J Peripher Nerv Syst. 2014 Dec;19(4):299-306. doi: 10.1111/jns.12097.
- Background: PubMed 25261162Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Background: PubMed 30941745Gibson W, Wand BM, Meads C, Catley MJ, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for chronic pain - an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2019 Apr 3;4(4):CD011890. doi: 10.1002/14651858.CD011890.pub3.
- Background: PubMed 19207234Humpert PM, Morcos M, Oikonomou D, Schaefer K, Hamann A, Bierhaus A, Schilling T, Nawroth PP. External electric muscle stimulation improves burning sensations and sleeping disturbances in patients with type 2 diabetes and symptomatic neuropathy. Pain Med. 2009 Mar;10(2):413-9. doi: 10.1111/j.1526-4637.2008.00557.x. Epub 2009 Jan 16.
- Background: PubMed 15911236Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
- Derived from this study: PubMed 41859404Rieder F, Sassmann R, Kienberger YT, Castagnaviz V, Schaffler-Schaden D, Johansson T, Rinnerthaler G, Flamm M, Greil R, Schulze C, Gampenrieder SP. Different types of electrostimulation target specific impaired sensory and motor functions in chemotherapy-induced peripheral neuropathy: a secondary analysis of a controlled trial. Front Neurol. 2026 Mar 4;17:1653161. doi: 10.3389/fneur.2026.1653161. eCollection 2026.
- Derived from this study: PubMed 39777312Sassmann R, Gampenrieder SP, Rieder F, Johansson T, Rinnerthaler G, Castagnaviz V, Lampl K, Herfert J, Kienberger YT, Flamm M, Schaffler-Schaden D, Greil R. Electrotherapy as treatment for chemotherapy-induced peripheral neuropathy - a randomized controlled trial. Front Neurol. 2024 Dec 24;15:1451456. doi: 10.3389/fneur.2024.1451456. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Flamm, Prof study director
Paracelsus Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tone external muscle stimulation and transcutaneous electrical nerve stimulation (TENS) therapy in people with Peripheral Nervous System Problem, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of CIPN associated symptoms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978585, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.