{"groups":[{"description":"The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5-10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \\[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261\\]","id":"FG000","title":"Active Acupuncture"},{"description":"The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \\[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005; 86:2248-2255\\]","id":"FG001","title":"Sham Acupuncture"},{"description":"Participants approached in the screening process but ultimately not randomized.","id":"FG002","title":"Screened Non-Randomized"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"}],"type":"Not meet inclusion criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"24"}],"type":"Excluded due to time constraints"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"123"}],"type":"Refused to Participate"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"154"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Evaluable for quality of life assessment.","type":"Evaluable at Baseline"},{"achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Evaluable for quality of life assessment.","type":"Evaluable at 20 Weeks"},{"achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Evaluable for quality of life assessment.","type":"Evaluable at 12 Months"},{"achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"154"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Since one primary aim was to assess feasibility as measured by recruitment the screening non-randomized count is included in the participant flow.","recruitmentDetails":"Patients were screened for potential enrollment from January 2009 through December 2011."}