Tinnitus
Conditions
Keywords
Manual acupuncture, Sham acupuncture, Usual care, Tinnitus
Brief summary
This multicenter clinical trial aims to investigate the efficacy and safety of manual acupuncture on acute primary tinnitus.
Detailed description
This is a multicenter randomized, single-blind, sham-controlled trial. The total trial period was 14 weeks, including two weeks of baseline assessment, four weeks of treatment after randomisation, and eight weeks of follow-up. Informed consent will be obtained from each patient before randomisation. After the baseline assessment, an independent investigator will randomise eligible patients in a 1:1:1 ratio to receive manual acupuncture, sham acupuncture, or usual care. All patients will receive 10 sessions of 30 minute acupuncture treatments or usual care over a four-week treatment period. They will be treated three times a week to fulfil a two-week of initial treatment course and then will be treated twice a week to fulfil a two-week of consolidation treatment course. In both the manual and sham acupuncture group, acupuncture treatment will begin after randomisation. In the usual care group, patients will receive acupuncture for free after waiting 12 weeks.
Interventions
OTHERManual acupuncture
After sterilisation, the fine needles will be inserted into the deep tissue layers of all acupoints and will be retained for 30 min. Acupuncturists will tried to elicit acupuncture de-qi sensation with light lifting, thrusting, and twirling every 10min during each session.
OTHERSham acupuncture
After sterilisation, Streitberger placebo needles with blunt tip will be used. It can be fixed on the surface of the sham points without piercing the skin. Within a 30-minute period, each point will undergo a simulated twisting motion of the needle for at least 10 seconds, and this will be repeated four times at 10-minute intervals.
BEHAVIORALUsaual care
Health education and standard evaluation related to tinnitus
Sponsors
Dan Bing
Hubei Xinhua Hospital
Wuhan No.1 Hospital
The Third People's Hospital of Hubei Province
Taihe Hospital
Qianjiang Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 65 years (either sex）; 2. The primary complaint is tinnitus; 3. Fulfilled diagnostic criteria for primary tinnitus; 4. Tinnitus should be bothersome, with a THI score ranging from 28 to 76, and lasting for ≥2 weeks; 5. Duration of tinnitus less than 6 months; 6. No acupuncture experience in the past 3 months; 7. No use of medication for tinnitus within 2 weeks before treatment, including intratympanic injections, postauricular injections, corticosteroids, Traditional Chinese Medicine (TCM) or proprietary Chinese medicines and so on; 8. Agree to sign the informed consent form.
Exclusion criteria
1. Objective tinnitus; 2. Pulsatile tinnitus; 3. Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians; 4. Combined conductive hearing loss (confirmed by abnormal otoscopy or abnormal tympanogram); 5. Had contraindications for acupuncture, including pregnant women, severe anemia, coagulation disorders, etc; 6. Having difficulties in expressing their symptoms clearly such as severe mental disorders or cognitive impairment; 7. Currently suffering from other serious acute or chronic organic diseases, such as cerebrovascular, cardiovascular, liver, kidney, hematological diseases, infectious diseases, or malignant tumors; 8. Participated in other clinical trials, particularly those closely related to tinnitus treatment, such as sound therapy; 9. have a strong desire for medication treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tinnitus handicap inventory (THI) compared with baseline | During the baseline period, and 2,4,6,8,10,12 weeks after randomization. | The THI scale covering 25 questions in three dimensions: function, emotion, and severity. |
| Changes in tinnitus functional index (TFI) compared with baseline | During the baseline period, and 2,4,6,8,10,12 weeks after randomization. | The TFI scale was used to comprehensively assess the impact of tinnitus on the multi-dimensional and various functions of patients' daily lives |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective response rate of THI | 2,4,6,8,10,12 weeks after randomization. | The proportion of patients with a THI score decrease of ≥7 points. |
| Effective response rate of TFI | 2,4,6,8,10,12 weeks after randomization. | The proportion of patients with a TFI score decrease of ≥13 points. |
| Visual Analogue Scale (VAS) for aural fullness | Baseline, and at weeks 2, 4, 6, 8 ,10 and 12 after randomization. | We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness. |
| Visual Analogue Scale (VAS) for tinnitus | Baseline, and at weeks 2, 4, 6, 8 ,10 and 12 after randomization. | The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness". |
| Pittsburgh sleep quality index (PSQI) | Baseline, and at weeks 4, 8 ,12 after randomization. | PSQI is a self-rated questionnaire which evaluate sleep quality and disturbances over a 1-month time interval. |
| Depression | Baseline, and at weeks 4, 8 ,12 after randomization. | The Zung Self-Rating Depression Scale(SDS) will be adopted. |
| Anxiety | Baseline, and at weeks 4, 8 ,12 after randomization. | The Zung Self-Rating Anxiety Scale(SAS) will be adopted |
| Short Form-36 Health Survey (SF-36) | Baseline, and at weeks 4, 8 ,12 after randomization. | The SF-36 consists of 36 items and is used to assess eight health areas: physiological function, body role, somatic pain, overall health, vitality, social function, emotional role and mental health |
| Patient-Doctor Relationship Questionnaire (PDRQ-9) | Baseline, and at weeks 4, 8 ,12 after randomization. | — |
Countries
China
Contacts
CONTACTDan Bing, PhD
PRINCIPAL_INVESTIGATORDan Bing, PhD
Tongji Hospital
Outcome results
None listed