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Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial.

Xie H, Li X, Lai J, Zhou Y, Wang C, Liang J - Trials (2014)

Bottom Line: Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase.The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS).Furthermore, adverse events are recorded and analyzed.

View Article: PubMed Central - PubMed

Affiliation: Department of Otorhinolaryngology, Head and Neck Surgery of the Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province 610072, PR China. wangxie-ctu@163.com.

ABSTRACT

Background: Acupuncture has been used in China to treat tinnitus for a long time. There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture. However, there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus. This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective, double-blind, randomized, sham-controlled trial.

Methods and design: This study compares two acupuncture groups (with or without manipulation) in 292 patients with a history of subjective tinnitus. The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment. Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase. The administration of acupuncture follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series Number 15, 1995), and is performed double-blind by physicians well-trained in acupuncture. The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). Furthermore, adverse events are recorded and analyzed. If any subjects are withdrawn from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed.

Discussion: The key features of this trial include the randomization procedures, large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus. The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized, double-blind, sham-controlled manner.

Trial registration: Chinese Clinical Trial Registry: ChiCTR-TRC-14004720 (6 May 2014).

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Related in: MedlinePlus

Tools used for outcome measurement: Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Tinnitus Severity Index Questionnaire, Tinnitus Loudness Questionnaire, and 10-cm VAS C-MMSAA: Chinese version of the ‘modified’ Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). A flowchart of the procedure of this clinical trial.
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Fig1: Tools used for outcome measurement: Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Tinnitus Severity Index Questionnaire, Tinnitus Loudness Questionnaire, and 10-cm VAS C-MMSAA: Chinese version of the ‘modified’ Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). A flowchart of the procedure of this clinical trial.

Mentions: The study population will be recruited at the Teaching Hospital of Chengdu University of Traditional Chinese Medicine (TCM), China. A total of 292 patients, aged 18 to 60, who complain of subjective tinnitus, will be initially enrolled in our study. The total study period will be 17 to 18 weeks, which includes the following time points: a run-in period of 1 week after screening, a treatment period of 4 weeks and a follow-up period of 12 weeks (Figure 1). The trial is to be executed from January 2014 to December 2014.Figure 1


Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial.

Xie H, Li X, Lai J, Zhou Y, Wang C, Liang J - Trials (2014)

Tools used for outcome measurement: Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Tinnitus Severity Index Questionnaire, Tinnitus Loudness Questionnaire, and 10-cm VAS C-MMSAA: Chinese version of the ‘modified’ Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). A flowchart of the procedure of this clinical trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4209070&req=5

Fig1: Tools used for outcome measurement: Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Tinnitus Severity Index Questionnaire, Tinnitus Loudness Questionnaire, and 10-cm VAS C-MMSAA: Chinese version of the ‘modified’ Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). A flowchart of the procedure of this clinical trial.
Mentions: The study population will be recruited at the Teaching Hospital of Chengdu University of Traditional Chinese Medicine (TCM), China. A total of 292 patients, aged 18 to 60, who complain of subjective tinnitus, will be initially enrolled in our study. The total study period will be 17 to 18 weeks, which includes the following time points: a run-in period of 1 week after screening, a treatment period of 4 weeks and a follow-up period of 12 weeks (Figure 1). The trial is to be executed from January 2014 to December 2014.Figure 1

Bottom Line: Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase.The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS).Furthermore, adverse events are recorded and analyzed.

View Article: PubMed Central - PubMed

Affiliation: Department of Otorhinolaryngology, Head and Neck Surgery of the Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province 610072, PR China. wangxie-ctu@163.com.

ABSTRACT

Background: Acupuncture has been used in China to treat tinnitus for a long time. There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture. However, there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus. This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective, double-blind, randomized, sham-controlled trial.

Methods and design: This study compares two acupuncture groups (with or without manipulation) in 292 patients with a history of subjective tinnitus. The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment. Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase. The administration of acupuncture follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series Number 15, 1995), and is performed double-blind by physicians well-trained in acupuncture. The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). Furthermore, adverse events are recorded and analyzed. If any subjects are withdrawn from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed.

Discussion: The key features of this trial include the randomization procedures, large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus. The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized, double-blind, sham-controlled manner.

Trial registration: Chinese Clinical Trial Registry: ChiCTR-TRC-14004720 (6 May 2014).

Show MeSH
Related in: MedlinePlus