scholarly journals Gabapentin as an Adjuvant Therapy for Prevention of Acute Phantom-Limb Pain in Pediatric Patients Undergoing Amputation for Malignant Bone Tumors: A Prospective Double-Blind Randomized Controlled Trial

2018 ◽  
Vol 55 (3) ◽  
pp. 721-727 ◽  
Author(s):  
Xiandi Wang ◽  
Ying Yi ◽  
Dingbo Tang ◽  
Yi Chen ◽  
Yanhua Jiang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Bone Tumors ◽  
Pediatric Patients ◽  
Controlled Trial ◽  
Phantom Limb Pain ◽  
Phantom Limb ◽  
Limb Pain ◽  
Malignant Bone Tumors ◽  
Double Blind ◽  
Randomized Controlled

scholarly journals Traditional and augmented reality mirror therapy for patients with chronic phantom limb pain (PACT study): results of a three-group, multicentre single-blind randomized controlled trial

2018 ◽  
Vol 32 (12) ◽  
pp. 1591-1608 ◽  
Author(s):  
Andreas Rothgangel ◽  
Susy Braun ◽  
Bjorn Winkens ◽  
Anna Beurskens ◽  
Rob Smeets
Keyword(s):  
Randomized Controlled Trial ◽  
Augmented Reality ◽  
Controlled Trial ◽  
Phantom Limb Pain ◽  
Phantom Limb ◽  
Mirror Therapy ◽  
Limb Pain ◽  
Randomized Controlled ◽  
Study Results ◽  
Patient Reported

Objective: To compare the effects of traditional mirror therapy (MT), a patient-centred teletreatment (PACT) and sensomotor exercises without a mirror on phantom limb pain (PLP). Design: Three-arm multicentre randomized controlled trial. Setting: Rehabilitation centres, hospital and private practices. Subjects: Adult patients with unilateral lower limb amputation and average PLP intensity of at least 3 on the 0–10 Numeric Rating Scale (NRS). Interventions: Subjects randomly received either four weeks of traditional MT followed by a teletreatment using augmented reality MT, traditional MT followed by self-delivered MT or sensomotor exercises of the intact limb without a mirror followed by self-delivered exercises. Main measures: Intensity, frequency and duration of PLP and patient-reported outcomes assessing limitations in daily life at baseline, 4 weeks, 10 weeks and 6 months. Results: In total, 75 patients received traditional MT ( n = 25), teletreatment ( n = 26) or sensomotor exercises ( n = 24). Mean (SD) age was 61.1 (14.2) years and mean (SD) pain intensity was 5.7 (2.1) on the NRS. Effects of MT at four weeks on PLP were not significant. MT significantly reduced the duration of PLP at six months compared to the teletreatment ( P = 0.050) and control group ( P = 0.019). Subgroup analyses suggested significant effects on PLP in women, patients with telescoping and patients with a motor component in PLP. The teletreatment had no additional effects compared to self-delivered MT at 10 weeks and 6 months. Conclusion: Traditional MT over four weeks was not more effective than sensomotor exercises without a mirror in reducing PLP, although significant effects were suggested in some subgroups.

scholarly journals A Randomized, Controlled Trial of Mirror Therapy for Upper Extremity Phantom Limb Pain in Male Amputees

2017 ◽  
Vol 8 ◽  
Author(s):  
Sacha B. Finn ◽  
Briana N. Perry ◽  
Jay E. Clasing ◽  
Lisa S. Walters ◽  
Sandra L. Jarzombek ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Upper Extremity ◽  
Controlled Trial ◽  
Phantom Limb Pain ◽  
Phantom Limb ◽  
Mirror Therapy ◽  
Limb Pain ◽  
Randomized Controlled

scholarly journals Hydrocortisone as an Intervention for Dexamethasone-Induced Adverse Effects in Pediatric Patients With Acute Lymphoblastic Leukemia: Results of a Double-Blind, Randomized Controlled Trial

2016 ◽  
Vol 34 (19) ◽  
pp. 2287-2293 ◽  
Author(s):  
Lidewij T. Warris ◽  
Marry M. van den Heuvel-Eibrink ◽  
Femke K. Aarsen ◽  
Saskia M.F. Pluijm ◽  
Marc B. Bierings ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Acute Lymphoblastic Leukemia ◽  
Adverse Effects ◽  
Pediatric Patients ◽  
Lymphoblastic Leukemia ◽  
Controlled Trial ◽  
Metabolic Parameters ◽  
Dexamethasone Treatment ◽  
Double Blind ◽  
Randomized Controlled

Purpose Dexamethasone is a key component in the treatment of pediatric acute lymphoblastic leukemia (ALL), but can induce serious adverse effects. Recent studies have led to the hypothesis that neuropsychological adverse effects may be a result of cortisol depletion of the cerebral mineralocorticoid receptors. We examined whether including a physiologic dose of hydrocortisone in dexamethasone treatment can reduce neuropsychologic and metabolic adverse effects in children with ALL. Patients and Methods We performed a multicenter, double-blind, randomized controlled trial with a crossover design. Of 116 potentially eligible patients (age 3 to 16 years), 50 were enrolled and were treated with two consecutive courses of dexamethasone in accordance with Dutch Childhood Oncology Group ALL protocols. Patients were randomly assigned to receive either hydrocortisone or placebo in a circadian rhythm (10 mg/m2/d) during both dexamethasone courses. Primary outcome measure was parent-reported Strength and Difficulties Questionnaire in Dutch, which assesses psychosocial problems. Other end points included questionnaires, neuropsychological tests, and metabolic parameters. Results Of 48 patients who completed both courses, hydrocortisone had no significant effect on outcome; however, a more detailed analysis revealed that in 16 patients who developed clinically relevant psychosocial adverse effects, addition of hydrocortisone substantially reduced their Strength and Difficulties Questionnaire in Dutch scores in the following domains: total difficulties, emotional symptoms, conduct problems, and impact of difficulties. Moreover, in nine patients who developed clinically relevant, sleep-related difficulties, addition of hydrocortisone reduced total sleeping problems and disorders of initiating and maintaining sleep. In contrast, hydrocortisone had no effect on metabolic parameters. Conclusion Our results suggest that adding a physiologic dose of hydrocortisone to dexamethasone treatment can reduce the occurrence of serious neuropsychological adverse effects and sleep-related difficulties in pediatric patients with ALL.

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

Sign in / Sign up

Export Citation Format

Share Document