None listed
Conditions
Brief summary
Even though many different therapeutic tools have been evaluated for their effectiveness in the management of hemiplegic shoulder pain (HSP), none of them have shown sufficient scientific evidence, probably because the pathological mechanisms still have not been clearly identified. The use of gentle mobilizations of the shoulder and electrostimulation, with their neuromodulatory effect on the central nervous system and action on the shoulder musculature in the flaccid stage, appears to reduce and prevent shoulder subluxation and pain. Likewise, proper postural hygiene can limit the development of spasticity and HSP, minimizing the risk of humeral subluxation. Finally, the use of neuromuscular bandages, specifically Kinesio(Registered Trademark) Tex tape (KT) has been suggested to be effective in reducing pain and improving upper extremity function in adults with hemiplegia. For all these reasons, we hypothesize that after applying a combined protocol witk KT and conventional postural treatment or electrical stimulation plus conventional treatment, this will have an effect on pain perception and upper limb functionality and general disability in subjects with hemiplegic shoulder pain in a medium and long-term fashion
Interventions
ELECTROSTIMULATION INTERVENTION
The protocol of exercises and conventional treatment that will be carried out in the control group will be complemented by neuromuscular electrical stimulation (NMES). The NMES is a handheld device which it is used to deliver a electrical stimulation to the paretic shoulder. Therefore, study subjects may feel a soft tingling sensation, but this sensation will never be painful
NMES will be applied at the end of each treatment session for 10 minutes using a neurom
ELECTROSTIMULATION INTERVENTION The protocol of exercises and conventional treatment that will be carried out in the control group will be complemented by neuromuscular electrical stimulation (NMES). The NMES is a handheld device which it is used to deliver a electrical stimulation to the paretic shoulder. Therefore, study subjects may feel a soft tingling sensation, but this sensation will never be painful NMES will be applied at the end of each treatment session for 10 minutes using a neuromuscular stimulator (NeurotracTM ETS CE 0120, Verity Medical LTD). This device uses muscle feedback to support motor skill and develop motor control. It has two channels of application with two electrodes for each. Electrodes will be placed on the anterior and posterior deltoid muscles. NMES is equipped with a biofeedback system and current intensity varied according to individual tolerance. The parameters that will be used are: (a) frequency of 30 hertz -50 Hertz; (b) pulse duration of 250 microseconds; (c) ramp up time (form of current input) of 0.6 (device has range of 0.1 - 9.9), also selecting synchronous current for both channels; and (d) contraction time of 5 seconds, with 7 seconds of rest to prevent muscle fatigue. The application of current was combined with active exercise. From a sitting position on a bench, the subject will be asked to intertwine both hands and raise them 90º, moving the body forward when the passage of current is felt. The objective is to reinforce the action of the NeurotracTM by active-assisted contraction of the deltoid muscle of the affected shoulder. The treatment will undergo daily sessions (from Monday to Friday) for a whole month KINESIOTAPE (KT) INTERVENTION PROTOCOL The protocol for the control group will be combined with the use of Kinesiotape in this group. KT has different characteristics than conventional tape, because it is slightly tighter than conventional tape. KT involves a thick tape that aims to provide mechanical support to the shoulder. Likewise, side effects associated with KT appear to be few, minor and transient. Therefore, participants may feel a slight pulling sensation when the KT is applied, but no pain should be felt. The general protocol for Kinesiotape placement is to be performed according to various principles: (a) increase tone of anterior deltoid muscle for which a tension of 0%-10% will be applied except for the bases and anchors which are with no tension; (b) increase tone of posterior deltoid muscle, applying the same tension as in the previous technique, and (c) increase tone of medial deltoid muscle. In this case the maximum tension will be applied to the KT, except for the bases and anchors which are with no tension. The subject will be told that the bandage should be kept on for 6 days. After this period, a day of rest will be left in between to prevent skin intolerance and the KT will be applied again. Therefore, during the month of intervention each subject will receive 4 applications of Kinesiotape. The treatment will undergo daily sessions (from Monday to Friday) for a whole month One physiotherapist will be responsible of the treatment protocol in each group. The adherence of participants to the treatment protocol will be monitored with a treatment diary, where a register of KT, NMES and conventional protocol use will be written down.
Sponsors
Hospital Universitario Virgen Macarena
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(a) age 35-80 years; (b) hospitalization for a cerebrovascular accident of the middle cerebral artery; (c) presence of hypertonic symptoms in the affected upper extremity within 24 hours poststroke, with a muscle assessment of 0 in deltoid muscles according to the Daniels scale; (d) score of 4 on item 5 of the NIH stroke scale (equivalent to absence of movement or motor activity) at 24 hours from the stroke episode, and (e) favorable family environment (subjects living in homes, supervised housing or destructured families were excluded).
Exclusion criteria
Subjects will be excluded from the study in any of the following circumstances: (a) prior disorders of the affected shoulder joint (fractures, surgical procedures); (b) skin alterations in the area to be treated; (c) presence of voluntary activity, even if minimal, in the affected shoulder within 24 hours poststroke; (d) cognitive impairment; (e) pacemaker user; (f) significant health problems or general deterioration impeding their adherence to the intervention protocol; (g) shoulder pain previous to stroke, and (h) previous physiotherapy treatment in the affected shoulder within two months prior to data collection.
Outcome results
None listed