The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients with Angina and Non-Obstructive Coronary Arteries; a Pilot Study

The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients with Angina and Non-Obstructive Coronary Arteries; a Pilot Study - TENS ANOCA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56491

Enrollment

Registered

2023-07-27

Start date

2024-03-13

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular coronary artery disease. Angina with non-obstructive coronary arteries

Interventions

All patients who participate in this study will receive TENS for a duration of 4 weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Angina and no obstructive coronary artery disease (ANOCA) (CCS class III or IV) o Vasospastic angina (VSA): FFR > 0.8, CFR >= 2.0, IMR = 90% diameter reduction, Angina pectoris & Ischaemic ECG changes. - Persisting angina pectoris despite optimal medical therapy (OMT) defined as: o VSA: Calcium channel blocker, long-acting nitrate and/or nicorandil. In the maximum tolerated dose. If the patient is currently not using one of the medications due to side-effects, this should be clearly stated. - Age > 18 years

Exclusion criteria

Exclusion criteria: - Both endotypes (VSA and MVA) present based on CFT findings. - Inability to give informed consent - The presence of a cardiac implanted electronic device (CIED) o Pacemaker o Implantable Cardiac Defibrillator (ICD) Due to the risk of interference between TENS and CIED - Presence of a spinal cord stimulator for another indication such as complex regional pain syndrome, failed back surgery syndrome, etc.

Design outcomes

Primary

Measure	Time frame
Change in the summary score of the Seattle Angina Questionnaire (SS SAQ) after 1 month treatment with TENS, compared to baseline.	—

Secondary

Measure	Time frame
Effect of TENS treatment in patients with ANOCA on: - Individual domains of the Seattle Angina Questionnaire; o Physical Limitations; o Angina Frequency; o Angina Stability; o Treatment Satisfaction; o Quality of Life. - Grading of angina pectoris using the Canadian Cardiovascular Society (CCS) class. - Side effects of TENS use (such as skin irritation, tenderness and/or TENS discomfort). The secondary objectives will be evaluated after the patient has received one month of TENS treatment.	—

Measure

Time frame

Effect of TENS treatment in patients with ANOCA on: - Individual domains of the Seattle Angina Questionnaire; o Physical Limitations; o Angina Frequency; o Angina Stability; o Treatment Satisfaction; o Quality of Life. - Grading of angina pectoris using the Canadian Cardiovascular Society (CCS) class. - Side effects of TENS use (such as skin irritation, tenderness and/or TENS discomfort). The secondary objectives will be evaluated after the patient has received one month of TENS treatment.

—

Countries

Netherlands

Contacts

Public ContactFE Vervaat

Catharina Ziekenhuis

fabienne.vervaat@catharinaziekenhuis.nl0402397000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)