Primary studies included in this systematic review

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Primary study

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Tremor's glove-an innovative electrical muscle stimulation therapy for intractable tremor in Parkinson's disease: A randomized sham-controlled trial.

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Journal Journal of the neurological sciences
Year 2017
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Medically refractory resting tremor is a debilitating symptom of Parkinson's disease (PD) patients. In our pilot study, modulation of peripheral reflex mechanism by electrical muscle stimulation (EMS) temporarily suppressed tremor. OBJECTIVES: To investigate the efficacy of EMS, delivered using Tremor's glove, as a treatment of resting hand tremor. PATIENTS AND METHODS: Thirty PD patients with medically refractory resting tremor were randomly allocated to a Tremor's glove group (n=15) or a sham glove group (n=15). Gloves were placed on the most tremulous hand for 30min per testing session. Demographics, clinical rating scales, and tremor parameters (RMS of angular velocity and angular displacement, peak magnitude, and frequency) were assessed before and during stimulation. Correlations with validated clinical rating scales were performed. RESULTS: There were no statistically significant differences between groups in demographics, rating scales, or tremor parameters. During stimulation, significant reduction in RMS angular velocity (as percentage) in every axis and peak magnitude in axis (x-, y-) and UPDRS tremor score, were found with Tremor's glove compared to the sham groups (p<0.05, each). Significant moderate correlations were observed between a percentage reduction of RMS angular velocity in every axis and UPDRS tremor scores. Mean duration of tremor reduction after stimulation was 107.78±104.15s. No serious adverse events were observed. CONCLUSION: In this study, EMS-based Tremor's glove was effective in suppressing resting hand tremor in PD patients. Tremor's glove is light-weight with a good safety profile, making it a future potential therapeutic option for PD patients with medically refractory tremor.

Primary study

Unclassified

Water-based vs. non-water-based physiotherapy for rehabilitation of postural deformities in Parkinson's disease: a randomized controlled pilot study.

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Journal Clinical rehabilitation
Year 2017
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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OBJECTIVE: To compare the efficacy of two physiotherapy protocols (water-based vs. non-water-based) on postural deformities of patients with Parkinson's disease. DESIGN: A single blind, randomized controlled pilot study. SETTING: Inpatient (Rehabilitative Department). PARTICIPANTS: A total of 30 patients with idiopathic Parkinson's disease. INTERVENTIONS: Participants were randomly assigned to one of two eight-week treatment groups: Water-based ( n = 15) or non-water-based physiotherapy exercises ( n = 15). OUTCOME MEASURES: Changes in the degree of cervical and dorsal flexion and in the angle of lateral inclination of the trunk (evaluated by means of a posturographic system) were used as primary outcomes. Unified Parkinson Disease Rating Scale section III, Time Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale and the Parkinson's disease quality of life questionnaire (39 items) were the secondary outcomes. All outcomes were assessed at baseline, at the end of training and eight weeks after treatment. Patients were always tested at the time of their optimal antiparkinsonian medication ('on' phase). RESULTS: After the treatment, only Parkinson's disease subjects randomized to water-based treatment showed a significant improvement of trunk posture with a significant reduction of cervical flexion (water-based group: -65.2°; non-water-based group: +1.7°) and dorsal flexion (water-based group: -22.5°; non-water-based group: -6.5°) and lateral inclination of the trunk (water-based group: -2.3°; non-water-based group: +0.3°). Both groups presented significant improvements in the secondary clinical outcomes without between-group differences. CONCLUSION: Our results show that water-based physiotherapy was effective for improving postural deformities in patients with Parkinson's disease.

Primary study

Unclassified

A Randomized Controlled Trial of Chinese Medicine on Nonmotor Symptoms in Parkinson's Disease

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Journal Parkinson's disease
Year 2017
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Nonmotor symptoms (NMS) of Parkinson's disease (PD) have devastating impacts on both patients and their caregivers. Jiawei-Liujunzi Tang (JLT) has been used to treat some NMS of PD based on the Chinese medicine theory since Qing dynasty. Here we report a double-blind, randomized, placebo-controlled, add-on clinical trial aiming at evaluating the efficacy and safety of the JLT in treating NMS in PD patients. We randomly assigned 111 patients with idiopathic PD to receive either JLT or placebo for 32 weeks. Outcome measures were baseline to week 32 changes in Movement Disorder Society-Sponsored Revision of Unified PD Rating Scale (MDS-UPDRS) Parts I-IV and in NMS assessment scale for PD (NMSS). We observed improvements in the NMSS total score (p=0.019), mood/cognition (p=0.005), and reduction in hallucinations (p=0.024). In addition, post hoc analysis showed a significant reduction in constipation (p<0.001). However, there was no evidence of improvement in MDS-UPDRS Part I total score (p=0.216) at week 32. Adverse events (AEs) were mild and comparable between the two groups. In conclusion, long-term administration of JLT is well tolerated and shows significant benefits in improving NMS including mood, cognition, and constipation.

Primary study

Unclassified

Effectiveness of aquatic therapy for the control of pain and increased functionality in people with Parkinson's disease: a randomized clinical trial.

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Authors Pérez de la Cruz S
Journal European journal of physical and rehabilitation medicine
Year 2017
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This article is included in 3 Systematic reviews Systematic reviews (3 references)

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BACKGROUND: Gait, balance disorders and pain associated with Parkinson's disease represent important therapeutic challenges, as they are related with an increased risk of falls, together with disability and physical decline. AIM: To compare the effects of an aquatic ai chi training program on the perception of pain, the maintenance of balance and the functional independence of patients with Parkinson's disease. DESIGN: A single-blind randomized controlled trial. SETTING: Parkinson's associations and municipal pools. POPULATION: Thirty individuals from two Parkinson's associations in Spain participated in the study. INCLUSION CRITERIA: individuals diagnosed with Parkinson's disease in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms. METHODS: The experimental group (N.=15 patients) participated in a program of aquatic ai chi. The control group (N.=15) received therapy on dry land. The intervention lasted 10 weeks with sessions held twice weekly. The pain VAS, Tinetti, Berg, Test Get Up and Go, Five Times Test and Unified Parkinson's Disease Rating Scale were used. RESULTS: Significant differences were found between the baseline and one-month follow up assessments in pain perception values (F=26.89, P<0.001), and the Tinetti Test (F=21.57, P<0.001) in the experimental group compared to the control group (P<0.05) with the exception of the FTSTS (P=0.006). In the control group, improvements were only seen on the VAS Pain Scale (F=8.3, P=0.004) and these were less significant than the changes found in the experimental group. Regarding the scores obtained on the UPDRS scale in the experimental group, there were significant differences in activities of daily living and motor examination, with the exception of mentation, behavior and mood. CONCLUSIONS: An aquatic ai chi program appears to be a valid treatment option for patients diagnosed with mild to moderate Parkinson's disease for the treatment of pain, balance and functional capacity. CLINICAL REHABILITATION IMPACT: Physical exercise performed in water has positive effects on some of the necessary elements that contribute towards improved biomechanical gait patterns in our patients with Parkinson's disease.

Primary study

Unclassified

Effects of Safinamide on Pain in Fluctuating Parkinson's Disease Patients: A Post-Hoc Analysis.

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Journal Journal of Parkinson's disease
Year 2017
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Pain, a frequent non-motor symptom in Parkinson's Disease (PD), significantly impacts on quality of life. Safinamide is a new drug with dopaminergic and non-dopaminergic properties, approved in Europe as adjunct therapy to levodopa for the treatment of fluctuating PD patients. Results from two 24-month, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients. OBJECTIVE: To investigate the effects of safinamide on pain management in PD patients with motor fluctuations using pooled data from studies 016 and SETTLE. METHODS: This post-hoc analysis evaluated the reduction of concomitant pain treatments and the changes in the scores of the items related to pain of the Parkinson's Disease Quality of Life Questionnaire (PDQ-39). A path analysis was performed in order to examine direct and indirect associations between safinamide and PDQ-39 pain-related items assessed after 6-months of treatment. RESULTS: The percentage of patients with no pain treatments at the end of the trials was significantly lower in the safinamide group compared to the placebo group. Safinamide 100 mg/day significantly reduced on average the individual use of pain treatments by ≈24% and significantly improved two out of three PDQ-39 pain-related items of the "Bodily discomfort" domain.Path analysis showed that the direct effect of safinamide on pain accounted for about 80% of the total effect. CONCLUSIONS: These results suggest that safinamide may have a positive effect on pain, one of the most underestimated non-motor symptoms. Prospective studies are warranted to investigate this potential benefit.

Primary study

Unclassified

A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain

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Journal Journal of clinical pharmacology
Year 2016
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-associated chronic pain (≥3 months, ≥4 points on 11-point Likert pain scale) were randomized to rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo and maintained for 12 weeks. Primary efficacy variable was change in pain severity (Likert pain scale) from baseline to end of maintenance. Secondary variables included percentage of responders (≥2-point Likert pain scale reduction), King's PD Pain Scale (KPPS) domains, and PD Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized patients, 60 (rotigotine, 30; placebo, 30) were evaluable for efficacy. A numerical improvement in pain was observed in favor of rotigotine (Likert pain scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) rotigotine vs 14/30 (47%) placebo. An ∼2-fold numerical improvement in KPPS domain "fluctuation-related pain" was observed with rotigotine vs placebo. Rotigotine improved PDQ-8 vs placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest rotigotine may improve PD-associated pain; a large-scale confirmatory study is needed.

Primary study

Unclassified

Controlled pilot study of the effects of power yoga in Parkinson's disease.

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Authors Ni M , Mooney K , Signorile JF
Journal Complementary therapies in medicine
Year 2016
Links Pubmed DOI www.epistemonikos.org

This article is included in 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVES: To evaluate the effects of a specially designed power yoga program (YOGA) on bradykinesia, rigidity, muscular performance and quality of life in older patients with PD. DESIGN: Randomized controlled trial. SETTING: University laboratory, US. INTERVENTION: Twenty-six patients with mild to moderate PD were randomly assigned to a YOGA or control group (CON). The YOGA program was three months, incorporating two sessions/wk of yoga classes. MAIN OUTCOME MEASURES: Upper and lower limb bradykinesia and rigidity scores from the Unified Parkinson's Disease Rating Scale, one repetition maximums (1RM) and peak powers on biceps curl, chest press, leg press, hip abduction and seated calf, and quality of life (PDQ-39). RESULTS: The YOGA group produced significant improvement in both upper and lower limbs bradykinesia scores, rigidity score, 1RM for all 5 machines and leg press power (p<.05). Significant improvements were seen in the PDQ-39 overall score, mobility and activities of daily living domain for the YOGA group. CONCLUSION: The 3-month YOGA program significantly reduced bradykinesia and rigidity, and increased muscle strength and power in older patients with PD. Power training is an effective training modality to improve physical function and quality of life for PD.

Primary study

Unclassified

A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors.

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Journal PloS one
Year 2016
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Gait disorder, a key contributor to fall and poor quality of life, represents a major therapeutic challenge in Parkinson's disease (PD). The efficacy of acupuncture for PD remains unclear, largely due to methodological flaws and lack of studies using objective outcome measures. OBJECTIVE: To objectively assess the efficacy of electroacupuncture (EA) for gait disorders using body-worn sensor technology in patients with PD. METHODS: In this randomized pilot study, both the patients and assessors were masked. Fifteen PD patients were randomly assigned to an experimental group (n = 10) or to a control group (n = 5). Outcomes were assessed at baseline and after completion of three weekly EA treatments. Measurements included gait analysis during single-task habitual walking (STHW), dual-task habitual walking (DTHW), single-task fast walking (STFW), dual-task fast walking (DTFW). In addition, Unified Parkinson's Disease Rating Scale (UPDRS), SF-12 health survey, short Falls Efficacy Scale-International (FES-I), and visual analog scale (VAS) for pain were utilized. RESULTS: All gait parameters were improved in the experimental group in response to EA treatment. After adjustment by age and BMI, the improvement achieved statistical significant level for gait speed under STHW, STFW, and DTFW (9%-19%, p<0.05) as well as stride length during DTFW (9%, p = 0.037) and midswing speed during STFW (6%, p = 0.033). No significant changes were observed in the control group (p>0.110). The highest correlation between gait parameters and UPRDS scores at baseline was observed between gait speed during STFW and UPDRS II (r = -0.888, p = 0.004). The change in this gait parameter in response to active intervention was positively correlated with baseline UPDRS (r = 0.595, p = 0.057). Finally, comparison of responses to treatment between groups showed significant improvement, prominently in gait speed (effect size 0.32-1.16, p = 0.001). CONCLUSIONS: This study provides the objective proof of concept for potential benefits of non-pharmaceutical based EA therapy on enhancing gait in patients with PD. TRIAL REGISTRATION: ClinicalTrials.gov NCT02556164.

Primary study

Unclassified

Mindfulness Training among Individuals with Parkinson's Disease: Neurobehavioral Effects

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Journal Parkinson's disease
Year 2015
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Objective. To investigate possible neurobehavioral changes secondary to a mindfulness based intervention (MBI) training for individuals living with Parkinson's disease (PD). Background. In the context of complementary medicine, MBIs are increasingly being used for stress reduction and in patient populations coping with chronic illness. The use of alternative and complementary medicine may be higher in patients with chronic conditions such as PD. However, behavioral effects of mindfulness training in PD have not yet been reported in the literature and this points to an unmet need and warrants further examination. Methods. A total of 27 out of 30 PD patients completed a randomized controlled longitudinal trial. Questionnaires and the UPDRS I-IV were obtained at baseline and 8-week follow-up. Results. Significant changes after the MBI were found including a 5.5 point decrease on the UPDRS motor score, an increase of 0.79 points on Parkinson's disease questionnaire (PDQ-39) pain item, and a 3.15 point increase in the Five Facet Mindfulness Questionnaire observe facet. Conclusions. To the best of our knowledge, this is the first quantitative analysis of neurobehavioral effects of MBI in PD.

Primary study

Unclassified

Prolonged-release oxycodone-naloxone for treatment of severe pain in patients with Parkinson's disease (PANDA): a double-blind, randomised, placebo-controlled trial.

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Journal The Lancet. Neurology
Year 2015
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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BACKGROUND: Pain is a common non-motor symptom of Parkinson's disease. We investigated the analgesic efficacy of prolonged-release oxycodone-naloxone (OXN PR) in patients with Parkinson's disease and chronic, severe pain. METHODS: We did this phase 2 study in 47 secondary care centres in the Czech Republic, Germany, Hungary, Poland, Romania, Spain, and the UK. We enrolled patients with Hoehn and Yahr Stage II-IV Parkinson's disease, at least one type of severe pain, and an average 24-h pain score of at least 6 (assessed on an 11-point rating scale from 0=no pain to 10=pain as bad as you can imagine). Participants were randomly assigned (1:1) with a validated automated system (block size four) to either oral OXN PR or placebo for 16 weeks (starting dose oxycodone 5 mg, naloxone 2·5 mg, twice daily). Patients and investigators were masked to treatment assignment. The primary endpoint was average 24-h pain score at 16 weeks in the full analysis population. This study is registered with EudraCT (2011-002901-31) and ClinicalTrials.gov (NCT01439100). FINDINGS: We enrolled 202 patients; 93 were assigned to OXN PR and 109 to placebo; the full analysis population consisted of 88 patients versus 106 patients. Least squares mean average 24-h pain score at 16 weeks in the full analysis population was 5·0 (95% CI 4·5 to 5·5) in the OXN PR group versus 5·6 (5·1 to 6·0) in the placebo group (difference -0·6, 95% CI -1·3 to 0·0; p=0·058). Similar proportions of patients in each group had adverse events (60/92 [65%] vs 76/109 [70%]), treatment-related adverse events (52/92 [57%] vs 62/109 [57%]), and serious adverse events (5/92 [5%] vs 7/109 [6%]). Treatment-related nausea was more common in the OXN PR group than in the placebo group (16/92 [17%] vs 10/109 [9%]), as was treatment-related constipation (16/92 [17%] vs 6/109 [6%]). INTERPRETATION: The primary endpoint, based on the full analysis population at week 16, was not significant. Nonetheless, the results of this study highlight the potential efficacy of OXN PR for patients with Parkinson's disease-related pain and might warrant further research on OXN PR in this setting. FUNDING: Mundipharma Research.