Comparison of High Tone Therapy and TENS Therapy

NCT03978585 | Completed

• 1 other identifier: 415-E/2376/7-2018
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Peripheral Nervous System Problem

Keywords

HTEMS; peripheral neuropathy; chemotherapy; TENS therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks

Secondary Outcomes (6)

• Assessment of Quality of life

  8 weeks

• Vibration sensibility

  8 weeks

• Tendon reflex

  8 weeks

• Temperature sensibility

  8 weeks

• Perception of touch

  8 weeks

Study Arms (2)

HTEMS Arm

EXPERIMENTAL

High tone therapy (home based) daily for 30 minutes on at least 5 of 7 days per week

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

Device: high tone external muscle stimulation; Device: transcutaneous electrical nerve stimulation (TENS) therapy

Interventions

high tone external muscle stimulation DEVICE

Participants receive self-administered home based high tone therapy for 8 weeks for 30 minutes daily after device instruction

Also known as: HiTOP 191 therapy device (gbo Medizintechnik, Rimbach, Germany)

HTEMS Arm; TENS Arm

transcutaneous electrical nerve stimulation (TENS) therapy DEVICE

Participants receive self-administered home based TENS therapy for 8 weeks for 30 minutes daily after device instruction

Also known as: DoloBravo therapy device 10-05 (MTR GmbH, Scheideggweg 7, 12277 Berlin),CE 0123

HTEMS Arm; TENS Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Patients with myocard damages or cardiac arrhythmia
• Patients with epilepsy
• Patients with febrile illnesses or acute infectious diseases
• Pregnancy

Sponsors & Collaborators

• Paracelsus Medical University: lead
• Salzburger Landeskliniken: collaborator

Study Sites (1)

Paracelsus Medical University Salzburger Landeskliniken

Salzburg, 5020, Austria

Location

Related Publications (6)

• 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.

  PMID: 25582667 BACKGROUND

• Seretny 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.

  PMID: 25261162 BACKGROUND

• Gibson 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.

  PMID: 30941745 BACKGROUND

• Humpert 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.

  PMID: 19207234 BACKGROUND

• Postma 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.

  PMID: 15911236 BACKGROUND

• Sassmann 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.

  PMID: 39777312 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Transcutaneous Electric Nerve Stimulation; Therapeutics

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Maria Flamm, Prof

  Paracelsus Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After baseline data and outcome assessment participants will consecutively be randomly assigned to intervention or control group. Thus, neither patients nor the responsible physician will know about the allocation to the HTEMS or TENS group at the time of recruitment. Physicians responsible for the clinical examinations and outcome assessment will be blinded. Due to the technical design of the intervention patients cannot be blinded. The analyst and outcome assessors will be kept blind to patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Inverstigator

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 7, 2019
• Study Start: September 3, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)