Remote Post Marketing follow up observation of the efficacy and safety of electrostimulation with the Healy device in patients suffering from one of the following indications: chronical back pain, skeletal pain (e.g. knee, shoulder), fibromyalgia, migraine or depression, anxiety and associated sleep disorders

Remote Post Marketing follow up observation of the efficacy and safety of electrostimulation with the Healy device in patients suffering from one of the following indications: chronical back pain, skeletal pain (e.g. knee, shoulder), fibromyalgia, migraine or depression, anxiety and associated sleep disorders - PMCF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026011

Enrollment

250

Registered

2021-08-16

Start date

2021-07-05

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Migraine chronical back pain Fibromyalgia Depression Skeletal Pain Anxiety and sleep disorders

Interventions

Group 1: There are no study arms. The participants are already healy users and use the healy device in the daily routine without any interventions. Study period is 6 months.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: The following criteria must be met for inclusion in the study: • Patients must have voluntarily signed the informed consent form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed. • Patients must be males or females who are a minimum of 18 years and a maximum of 70 years of age. • Patients have been using the Healy for at least 2 months One of the following indications should be diagnosed by the therapist during the screening visit • chronical back pain • skeletal pain (e.g. knee, shoulder) • fibromyalgia • migraine • depression (depressive mood), anxiety and associated sleep disorders

Exclusion criteria

Exclusion criteria: Patients matching any contraindications as stated in the Instructions for Use (IfU) should be excluded: Relative contraindications • Microcurrent treatment must not be performed when metallic foreign bodies are in the area of treatment, pacemakers or implanted defibrillators are present, bleeding, risk of bleeding or embolism are present. Treatments must not be performed on areas of the skin which have been treated radio therapeutically or have a sensory disorder or if the user has a fever. • pregnant women • persons with epilepsy or heart disease General contraindications • serious internal medical problems • poor general state of health • uncooperative, unmotivated patient • drug or alcohol abuse • psychosis • prolonged therapy-resistant functional disorders • uncontrollable endocrine disorders

Design outcomes

Primary

Measure	Time frame
The primary objective of this PMCF study is to assess efficacy according to the five indications	—

Secondary

Measure	Time frame
The secondary objective of this PMCF study is to assess the incidence of Adverse Events (AEs) and Adverse Device Effects (ADEs) within the device’s lifetime	—

Countries

Germany

Contacts

Public ContactPeter Marmann

Healy World

peter.marmann@healy.world+491754755534

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026