Faculty Opinions recommendation of Mirror therapy for phantom limb and stump pain: a randomized controlled clinical trial in landmine amputees in Cambodia.

2019 ◽  
Author(s):  
Joel Katz
Keyword(s):  
Clinical Trial ◽  
Phantom Limb ◽  
Controlled Clinical Trial ◽  
Mirror Therapy ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Stump Pain

scholarly journals Mirror therapy for phantom limb and stump pain: a randomized controlled clinical trial in landmine amputees in Cambodia

2018 ◽  
Vol 18 (4) ◽  
pp. 603-610 ◽  
Author(s):  
Ha Sam Ol ◽  
Yang Van Heng ◽  
Lena Danielsson ◽  
Hans Husum
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Phantom Limb Pain ◽  
Phantom Limb ◽  
Controlled Clinical Trial ◽  
Mirror Therapy ◽  
Randomized Controlled ◽  
Stump Pain ◽  
The Difference ◽  
Therapy Interventions

Abstract Background and aims The aim of the study was to examine the effect of mirror and tactile therapy on phantom and stump pain in patients with traumatic amputations, with particular reference to amputees in low-income communities. Methods The study was conducted with an open, randomized, semi-crossover case-control design in rural Cambodia. A study sample of 45 landmine victims with trans-tibial amputations was allocated to three treatment arms; mirror therapy, tactile therapy, and combined mirror-and-tactile therapy. Non-responders from the mono-therapy interventions were crossed over to the alternative intervention. The intervention consisted of 5 min of treatment every morning and evening for 4 weeks. Endpoint estimates of phantom limb pain (PLP), stump pain, and physical function were registered 3 months after the treatment. Results All three interventions were associated with more that 50% reduction in visual analogue scale (VAS)-rated PLP and stump pain. Combined mirror-tactile treatment had a significantly better effect on PLP and stump pain than mirror or tactile therapy alone. The difference between the three treatment arms were however slight, and hardly of clinical relevance. After treatment, the reduction of pain remained unchanged for an observation period of 3 months. Conclusions The study documents that a 4-week treatment period with mirror and/or tactile therapy significantly reduces PLP and stump pain after trans-tibial amputations. Implications The article reports for the first time a randomized controlled trial of mirror therapy in a homogenous sample of persons with traumatic amputations. The findings are of special relevance to amputees in low-resource communities.

scholarly journals Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain.

2021 ◽  
Author(s):  
Eva Lendaro
Keyword(s):  
Clinical Trial ◽  
Phantom Limb Pain ◽  
Statistical Analysis Plan ◽  
Phantom Limb ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Motor Execution ◽  
Limb Pain ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Purposeful control over the phantom limb activates of the affected neural circuitry and leads to dissolution of the pathological relationship linking sensorimotor and pain processing (which gives rise to PLP). An international, double-blind, randomized controlled clinical trial (RCT) on the use of phantom motor execution (PME) as a treatment for PLP is currently undertaken, where PME is compared to active placebo. Methods and design Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned in 2:1 ratio to PME or phantom motor imagery (PMI) interventions respectively. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are performed (PME) or just imagined (PMI). Results The primary outcome of the study is to examine whether 15 sessions of PME can induce a greater PLP relief, compared to PMI. The secondary objectives are to examine whether 15 sessions of PME provide a greater improvement on different aspects related to PLP compared to PMI, such as pain duration, pain intensity as measured by other metrics and the patient’s own impression about the effect of treatment. Long-term retention of treatment benefits will be assessed as change in all the variables (both primary and secondary) between baseline and follow-up timepoints (at one-, three- and six-months post treatment). Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain. The statistical analysis plan was completed on 3 August 2021. Trial registration number NCT03112928. SAP version Version: 1.0 Date: 2021/08/03 Protocol Version This document has been written based on information contained in the study protocol published in [1], in July 2018. SAP Revisions Not applicable

Comparision of two fluoride varnishes for controlling white spot lesions. Randomized clinical trial

2017 ◽  
Vol 16 (1) ◽  
Author(s):  
Jesús Alberto Luengo - Fereira
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
White Spot ◽  
Controlled Clinical Trial ◽  
White Spot Lesions ◽  
Randomized Controlled Clinical Trial ◽  
Chi Square ◽  
Randomized Controlled ◽  
Anterior Teeth ◽  
The Mean

Objective: To compare two fluorinated varnishes for the control of white spot lesions.Material and Methods: A randomized controlled clinical trial was conducted. A total of 103 active whitespot lesions on permanent upper anterior teeth from 24 patients, aged 7 to 9 years were randomly assigned totwo groups, G1: Duraphat® (n=52) and G2: DuraShield® (n=51). Weekly applications were perform for fourconsecutive weeks. Fifth week the dimension, regression and activity of the lesions were evaluated. Student’sT test, Wilcoxon Ranks and Chi square were used at 5% significance. Results: At the end of the study, the lesion reduction was observed in 69.7%, finding significant differences(p<0.05) in the mean of the initial and final dimensions in general (2.74 mm to 1.91 mm) and in each group, G1(2.84 mm to 2.03 mm), G2 (2.64 mm to 1.78 mm). In the activity of the lesions, it was found in the G1, 12 active and6 inactive lesions; while in G2, there were 14 active and 29 inactive; these differences were significant (p<0.05). Conclusions: The two evaluated products showed similar clinical efficacy in the remineralization of activewhite spot lesions after 4 weeks of therapy.

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