Health TrialsbyHealthPanel

Manual Acupuncture for Acute Primary Tinnitus

ConditionTinnitus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDan Bing

About this trial

This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-65 years, male or female;

Primary complaint is persistent tinnitus (unilateral or bilateral);

Meet the diagnostic criteria for primary tinnitus according to the 2014 Clinical Practice Guideline developed by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF);

Had continuous tinnitus ≥2 weeks and <6 months;

Disqualifiers

Objective tinnitus;

Pulsatile tinnitus;

Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians(Menière's disease, temporomandibular joint disorder or other diseases);

Had evidence of conductive hearing loss (confirmed by abnormal otoscopy or tympanogram);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual acupuncture

    Other intervention

    Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the remaining weeks.

  • Sham acupuncture

    Other intervention

    Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the last 2 weeks.

  • Usaual care

    Behavioral

    Health education and standard evaluation related to tinnitus

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Manual acupuncture groupExperimental treatment 2 interventions
Group B: Sham acupunctureSham comparator 2 interventions
Group C: Usual careOther 1 intervention

Trial outcomes

Primary outcomes

1

Tinnitus Handicap Inventory (THI, 0-100)

25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap. In details, 0-16 points indicate no handicap; 18-36 points indicate mild handicap;38-56 points indicate moderate handicap; 58-76 points indicate severe handicap and \>76 points indicate catastrophic handicap.

Time frame
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
2

Tinnitus Functional Index (TFI, 0-100)

25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.

Time frame
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

Secondary outcomes

1

Effective response rate of THI

Effective response rate of THI is defined as the proportion of patients with a THI score decrease of ≥7 points.

Time frame
End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
2

Effective response rate of TFI.

Effective response rate of TFI is defined as the proportion of patients with a TFI score decrease of ≥13 points.

Time frame
End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
3

Visual Analogue Scale (VAS) for aural fullness

We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness.

Time frame
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
4

Visual Analogue Scale (VAS) for tinnitus

The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness".

Time frame
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

Other outcomes

1

10-item short version of the Big Five Inventory (BFI-10)

Personality is assessed by a10-item short version of the Big Five Inventory (BFI-10).

Time frame
Baseline visit(before randomization)
2

Pure-Tone Audiometry(PTA)

Pure tone audiometry is conducted under standard soundproof conditions using the Hughson-Westlake method to obtain the air conduction threshold (bone conduction threshold is only used for diagnosis, to determine whether there is conductive hearing loss, and to assist in the screening process; statistical analysis only uses the air conduction threshold). The standard test frequencies range from 0.25 to 8 kHz. If conditions permit, extended high frequencies (Extended High Frequency, EHF; ≥ 9-16 kHz) are added, and necessary masking is performed in accordance with the norms.

Time frame
Baseline visit(before randomization)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dan Bing

Lead sponsor

Tongji Hospital

Sponsor institution

Hubei Xinhua Hospital

Collaborator

Wuhan No.1 Hospital

Collaborator

The Third People's Hospital of Hubei Province

Collaborator

Taihe Hospital

Collaborator

Qianjiang Central Hospital

Collaborator

Source ClinicalTrials.gov

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