Efficacy of a Vibratory Stimulus for the Relief of Hiv-Associated Neuropathic Pain

Ja, Paice; Shott, S; Oldenburg, Fp; Zeller, J; Swanson, B.

doi:10.1046/j.1529-8027.2000.00022-2.x

Cited by 4 publications

(5 citation statements)

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“…For example, in a study of the effects of VS on neuropathic foot pain, patients assigned shams might have experienced unappreciated therapeutic counterstimulation effects. 44 In this study a vibrating foot pad that also produced light and an audible hum was compared to a sham foot pad that produced light and the hum. The authors assumed that the light and sound could have no possible therapeutic effect on foot pain.…”

Section: Discussionmentioning

confidence: 99%

Sleep improvement for restless legs syndrome patients. Part III: effect of treatment assignment belief on sleep improvement in restless legs syndrome patients. A mediation analysis

Burbank¹

2013

JPRLS

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Two parallel-design, randomized, sham-controlled clinical trials were conducted to study the safety and efficacy of vibratory stimulation (VS) on restless legs syndrome (RLS) patients (Part I of this series of articles). Pooled data from the two studies was retroactively analyzed to compare the relative effects of actual pad assignment with therapeutic pad assignment belief on sleep improvement for patients with RLS. Patients and methods: One hundred fifty-eight patients with at least moderately severe RLS, as measured by a score of 15 points or greater on the International Restless Legs Syndrome Study Group rating scale (IRLS), were enrolled in the study. Patients were randomly assigned to treatment (patient-controlled vibration) or sham (patient-controlled sound or light-emitting) pads. Patients and clinicians were blinded to pad assignment. The pad was placed under the patient's legs while in bed at night and activated during an RLS episode. Improvements in Medical Outcomes Study Sleep Problems Index II (MOS-II) scores from baseline to week 4 were examined as a function of pad assignment (independent variable) and therapeutic pad assignment belief held by each patient (mediator variable) through mediation analysis. Results: Therapeutic pad assignment belief influenced change in MOS-II scores more than actual pad assignment. Patients who believed they had been assigned a therapeutic pad had substantially greater sleep improvement than those who concluded the opposite. When a patient believed that a therapeutic pad had been assigned, sleep improvement was comparable in magnitude, independent of the type of pad assigned (vibrating or sham). Patients assigned vibrating pads believed that they had been assigned a therapeutic pad 2.6 times more frequently than patients assigned sham pads. Consequently, vibrating pads were more efficient at improving sleep than sham pads. Similarity of sleep improvement for those who believed that they had been assigned a therapeutic pad among vibrating, sound, and light pad patients suggests a common counterstimulation therapeutic mechanism of action within the brain. Conclusion: Therapeutic pad assignment belief influenced improvement in MOS-II scores more strongly than actual pad assignment. Therapeutic pad assignment belief was more commonly associated with vibrating pads than sham pads. These results may have implications for the type of shams used in future device studies.

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Section: Discussionmentioning

confidence: 99%

Sleep improvement for restless legs syndrome patients. Part III: effect of treatment assignment belief on sleep improvement in restless legs syndrome patients. A mediation analysis

Burbank¹

2013

JPRLS

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“…The WHO pain ladder [ 33 ] outlines the need for non-opioid and opioid analgesics until pain has been controlled. Neuropathic pain, which is particularly common in HIV [ 34 ] is caused by damage to nerves and does not respond to traditional pain medication.…”

Section: Methodsmentioning

confidence: 99%

Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

et al. 2010

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BackgroundA public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government.Methods/DesignThis paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis.Aim 1) To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2) To determine patient health outcomes over time and principle cost drivers [Study Phase 2].The study objectives are as follows. 1) To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1) in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2) To conduct patient focus group discussions at each of these (Phase 1) to determine care received. 3) To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2). 4) To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2). 5) To undertake document analysis to appraise the clinical care procedures at each facility (Phase 2). 6) To determine principle cost drivers including staff, overhead and laboratory costs (Phase 2).DiscussionThis novel mixed methods protocol will permit transparent presentation of subsequent dataset results publication, and offers a substantive model of protocol design to measure and integrate key activities and outcomes that underpin a public health approach to disease management in a low-income setting.

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“…During the eligibility assessment 520 articles were excluded. Ultimately, a total of 18 completed studies published between 2000 and 2020 were included in the present review [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40]. The selection process is illustrated in Fig.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Paice et al investigated the efficacy of a 45-min vibration at a frequency of 60 Hz as a monotherapy in a double-blind sham-controlled RCT of 40 patients with moderate to severe HIV-associated polyneuropathy [37]. Statistically significant reduction of pain intensity was achieved in both treatment arms.…”

Section: Vibration Stimulationmentioning

confidence: 99%

Non-Pharmacological Management of Painful Peripheral Neuropathies: A Systematic Review

et al. 2020

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Efficacy of a Vibratory Stimulus for the Relief of Hiv-Associated Neuropathic Pain

Cited by 4 publications

References 0 publications

Sleep improvement for restless legs syndrome patients. Part III: effect of treatment assignment belief on sleep improvement in restless legs syndrome patients. A mediation analysis

Sleep improvement for restless legs syndrome patients. Part III: effect of treatment assignment belief on sleep improvement in restless legs syndrome patients. A mediation analysis

Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

Non-Pharmacological Management of Painful Peripheral Neuropathies: A Systematic Review

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