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We studied the effect of botulinum toxin type A (BTX-A) injections to the scalene muscles on pain in subjects with thoracic outlet syndrome (TOS) in this double-blind, randomized, parallel group trial with follow-up at 6 weeks, 3 months, and 6 months. Thirty-eight patients referred to physiatrists for management of TOS with BTX-A injection were included. One subject was lost to follow-up and all other subjects completed the trial. A 75-unit dose of BTX-A reconstituted with 0.75 cc of normal saline was injected to the anterior scalene (37.5 units) and middle scalene (37.5 units) muscles using electromyographic guidance. The primary outcome measure was pain as measured on a horizontal visual analog scale (VAS) 6 weeks-post-injection. Secondary outcomes were paresthesias measured on a VAS and function measured with the Disabilities of the Arm, Shoulder and Hand (DASH) and Short-form 36 (SF-36) questionnaires. For the primary outcome measure of VAS scores for pain at 6 weeks, the difference in the means adjusted for baseline VAS scores between placebo and BTX-A was 5.03 mm in favor of BTX-A (95% confidence interval -15.7 to 5.7, P=.36). Changes in secondary outcome measures were also not statistically significant. We conclude that BTX-A injections to the scalene muscles did not result in clinically or statistically significant improvements in pain, paresthesias, or function in this population of subjects with TOS. [ABSTRACT FROM AUTHOR]

The concept of clinical trial feasibility is of great interest to the community of palliative care researchers, clinicians, and granting agencies. Significant allocation of resources is required in the form of funding, time, intellect, and motivation to carry out clinical research, and understandably, clinical investigators, institutions, and granting agencies are disappointed when funded trials are unsuccessfully conducted. We argue that for many trials conducted in palliative care, the feasibility of conducting the proposed trial should be formally explored before implementation. There is substantial information available within the literature on the topic of study feasibility but no singular guide on how one can pragmatically apply this advice in the palliative care setting. We suggest that a Formal Feasibility Study for palliative care trials should be commonly conducted before development of a larger pivotal trial, to prospectively identify barriers to research, develop strategies to address these barriers, and predict whether the larger study is feasible. If a Formal Feasibility Study is not required, elements of feasibility can be specifically tested before launching clinical trials. The purpose of this article is to offer a draft framework for the design and conduct of a Formal Feasibility Study that, if implemented, could concretely support successful completion of high-quality research in a timely fashion. Additionally, we hope to foster dialogue within the palliative care research community regarding the relevance of establishing feasibility before initiation of definitive trials in the palliative care population. [ABSTRACT FROM AUTHOR]

Partners of breast cancer patients are relied upon for support at a time when their own coping abilities are taxed by the challenge of cancer, yet few studies have investigated psychosocial interventions that include or target the patient's 'significant other'. Of the 118 consecutive patients approached, 36 patients and their partners participated in a randomized controlled trial of a brief psychoeducational group program for partners only. Psychometric instruments (including the Profile of Mood States (POMS), the Index of Marital Satisfaction (IMS) and DUKE-UNC Functional Social Support Scale (FSSS)) were administered pre-test, post-test and at 3 months follow-up. The Mental Adjustment to Cancer Scale (MAC) was also completed by patients. Three months after the intervention, partners had less mood disturbance than did controls. Patients whose partners received the intervention reported less mood disturbance, greater confidant support (CS) and greater marital satisfaction. [ABSTRACT FROM AUTHOR]