Integrative medicine for significant dysfunction from tinnitus: Treatment rationale and protocol for a randomized clinical pilot trial

Objectives: Following the British Medical Research Council recommendations for pilot trials, this study aims to increase experience with a complex integrative medicine (IM) intervention in a randomized controlled design to assess the feasibility for studying this intervention in a larger trial. Specific objectives are to: 1) assess the feasibility of implementing this IM approach to improve dysfunction from tinnitus in a large clinical trial; 2) evaluate patient satisfaction with this complex intervention; and 3) obtain preliminary clinical efficacy data using the planned procedures and measures. Design & methods: This NIDCD-funded pilot study targets retention of 40 participants with significant tinnitus-related dysfunction, recruited from a conventional otolaryngology clinic. To maximize experience with the intervention, enrolled participants are randomized in a 3:1 ratio to IM + a commonly applied sound-based and educational therapy (SBE) or to SBE alone. The 6-month IM treatment includes the same SBE, modeled after the Veteran's Affairs Progressive Tinnitus Management approach, as well as 3 cognitive behavioral psychotherapy sessions, an 8-week Mindfulness Based Stress Reduction course, 5 acupuncture sessions, and 9 telephonic health coaching sessions. Enrollment, retention, patient satisfaction and lessons learned by the trial team will determine the feasibility of using this complex IM intervention in a large trial. Baseline, post-treatment, and 3-months follow-up measures and trial procedures planned for the larger trial are also piloted, with change in tinnitus-dysfunction over the intervention slated to provide preliminary clinical efficacy data. Discussion: This pilot protocol will inform decisions regarding the feasibility of using this complex IM intervention in a large clinical trial. The larger trial would potentially offer patients an IM treatment to amplify conventional SBE for those who are unable to habituate to tinnitus.

Duke Scholars

Author Debara Lyn Tucci Head and Neck Surgery & Communication Sciences