Abstract
BackgroundShoulder pain is reported to be one of the major challenges faced in the functional recovery of patients in rehabilitation following a stroke. In such cases, transcranial direct current stimulation (tDCS) has been used as an additional therapeutic tool for improvements in central and peripheral pain. The aim of the proposed study is to evaluate the effect of tDCS when combined with upper limb physical therapy on pain intensity and functional improvement in stroke survivors with shoulder pain in the hemiplegic limb.MethodsA randomized, placebo-controlled, double-blind, clinical trial is proposed. The volunteers will be randomly allocated to receive passive movement on the upper limb, which will be performed by the therapist for 20 min followed by either active tDCS or sham tDCS (current stimulation for 30 s) during simultaneous physical activity of the upper limb (“mini-bike”) for 20 min, totaling 40 min of intervention performed in 10 consecutive sessions. The anode electrode will be positioned over the primary motor cortex with a current of 2 mA and the cathode electrode will be positioned in the supraorbital region contralateral to the anode. The primary outcome will be shoulder pain intensity, which will be measured using the visual analog scale (VAS) on three occasions: 1) pre-intervention; 2) after 10 interventions (5 weekly sessions, for 2 weeks); and 3) 30 days after the end of the interventions. The secondary outcomes will be motor performance, upper limb function, and quality of life.Trial registrationBrazilian Registry of Clinical Trials, RBR-8F5MNY. Registered on June 2, 2017.
Highlights
Shoulder pain is reported to be one of the major challenges faced in the functional recovery of patients in rehabilitation following a stroke
Shoulder pain is a frequent complication of a stroke, with an incidence ranging from 34% to 85% [3]
Some cases of poststroke shoulder pain disappear spontaneously throughout the rehabilitation process, 65% of stroke survivors report the persistence of this symptom, which may extend for 12 months or longer
Summary
Study design A randomized, placebo-controlled, double-blind, longitudinal, clinical trial is proposed. The assessments will be performed with the patient at rest (lying down) as well as during the active (performed by the subject) and passive movements (performed by the researcher) of the painful upper limb on three occasions: preintervention, postintervention, and 30-day follow-up. The American Society of Hand Therapists recommends the use of position II as a standard in clinical practice and research during grip strength tests involving the Jamar dynamometer The reliability of this device is high (ICC > 0.87) [60]. Data analysis Descriptive data and characteristics of the patients (gender, age, initial score on the VAS, ischemic or hemorrhagic stroke, right/left hemisphere lesion, time with pain, injury time, Fugl-Meyer upper limb score, BDI, use of controlled medications, and associated comorbidities) will be represented by mean and standard deviation or median and interquartile range.
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