Efficacy of acupuncture in the treatment of acute idiopathic hearing loss with tinnitus: a randomized, double blind control pilot study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012664

Enrollment

Registered

2017-06-29

Start date

2017-07-01

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

H93.1 H91.2

Interventions

Group 1: 14 days therapy with Prednisolone in descending dosage according to guideline. Day 1-3: each 250mg Prednisolone Day 4: 100mg Prednisolone Day 5: 75mg Prednisolone Day 6: 50mg Prednisolone Day

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Acute idiopathic hearing loss with tinnitus - Written declaration of consent - Knowledge of the German language - Age at least 18 years - initial, planned or ongoing, therapy with cortisone according to the standard of the ENT clinic Heidelberg

Exclusion criteria

Exclusion criteria: - Chronic recurrent hearing loss - Chronic tinnitus - Known coagulopathy or anticoagulant therapy with bleeding time over 4 minutes, thrombocytes <50,000 / µl - Lack of compliance - Acute disease in the acupuncture area, which do not allow acupuncture - Acute neuropsychiatric disorders - analgesic, opioid or drug dependence - Inability to follow the instructions in the study (lack of language, dementia) - Participate in another clinical trial - Continuous pension-related compensation or opposition proceedings - Specific immunotherapy (in treatment) - pregnancy - Malignomas in the anamnesis - Cortisone therapy before the beginning of the study (due to other diseases) - nickel allergy - silicone allergy

Design outcomes

Primary

Measure	Time frame
Changes in the subjectively perceived overall impairment by the symptoms of tinnitus and hearing loss by means of the visual analogue scale (VAS). Test are performed: at initial presentation, after 14 days of therapy with Prednisolone (2 weeks after initial presentation), after acupuncture (4 weeks after initial presentation), at time of follow-up examination 8 weeks after initial presentation.	—

Secondary

Measure	Time frame
The hearing is to be examined in the secondary objective criterion as a change of the frequency-dependent hearing sensitivity based on the measurement by a sound auditory and the frequency of the ear noise by tinnitus masking. With the aid of the PHQ-9 questionnaire, the patients are examined for depression, and one of the nine DSM-IV criteria (classification system for the detection of mental disorders) is recorded with each question for the diagnosis of "major depression". Hearing loss and tinnitus are often associated with psychiatric comorbidity, so that the interrelationship or their change in the course of the study can be documented. The international Tinnitus Handycap Inventory Questionnaire (THI) in its German version also represents the impairment of the quality of life in the sense of a self-assessment instrument. In the Tinnitus questionnaire according to Goebel and Hiller (TF), the influencing of behaviors and attitudes by the complaints is depicted and he Is used to measure the subjective severity of tinnitus. Questionnaires will be completed: at initial presentation, after 14 days of therapy with Prednisolone (2 weeks after initial presentation), after acupuncture (4 weeks after initial presentation), at time of follow-up examination 8 weeks after initial presentation.	—

Measure

Time frame

The hearing is to be examined in the secondary objective criterion as a change of the frequency-dependent hearing sensitivity based on the measurement by a sound auditory and the frequency of the ear noise by tinnitus masking. With the aid of the PHQ-9 questionnaire, the patients are examined for depression, and one of the nine DSM-IV criteria (classification system for the detection of mental disorders) is recorded with each question for the diagnosis of "major depression". Hearing loss and tinnitus are often associated with psychiatric comorbidity, so that the interrelationship or their change in the course of the study can be documented. The international Tinnitus Handycap Inventory Questionnaire (THI) in its German version also represents the impairment of the quality of life in the sense of a self-assessment instrument. In the Tinnitus questionnaire according to Goebel and Hiller (TF), the influencing of behaviors and attitudes by the complaints is depicted and he Is used to measure the subjective severity of tinnitus. Questionnaires will be completed: at initial presentation, after 14 days of therapy with Prednisolone (2 weeks after initial presentation), after acupuncture (4 weeks after initial presentation), at time of follow-up examination 8 weeks after initial presentation.

—

Countries

Germany

Contacts

Public ContactSerkan Sertel

HNO Uniklinik Heidelberg

akupunkturstudie@gmx.de06221-560

Outcome results

None listed

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