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Trial registered on ANZCTR


Registration number
ACTRN12615001197527
Ethics application status
Approved
Date submitted
27/07/2015
Date registered
4/11/2015
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of medium and long-term effect of different therapeutic modalities in chronic hemiplegic shoulder pain
Scientific title
A comparison of short, medium and long-term effectiveness of electrical stimulation, postural treatment and Kinesiotape on pain perception and functionality in chronic hemiplegic shoulder pain:a randomized controlled trial
Secondary ID [1] 287156 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-perceived pain 295717 0
Functionality in daily life activities 295718 0
Hemiplegic shoulder pain 295890 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295997 295997 0 0
Physiotherapy
Musculoskeletal 295998 295998 0 0
Other muscular and skeletal disorders
Neurological 296142 296142 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292428 0
Rehabilitation
Intervention code [2] 292569 0
Treatment: Other
Comparator / control treatment
During the first week of hospitalization, a protocol of care exercises for the paretic shoulder will be administered. The physiotherapist will be also in charge of training the subject’s caregiver to perform the protocol during the rest of the study period. After the first week, the caregiver will perform the previously learned physiotherapy program daily, supervised by a physiotherapist during the first month.

Progressions in the exercises will be made depending on the course of each individual.

The treatment will undergo daily sessions (from Monday to Friday) for a whole month. The study period, one month, will start at the same time that the protocol of care exercises begin. Likewise, the study period will begin within 48 hours of hemiplegia diagnosis, after the baseline assessment.

There will be three treatment groups, the control group will receive only the conventional treatment, the KT group will undergo control treatment plus KT and the NMES group that will receive electrical stimualtion plus control treatment.

As an example, some of the postural and mobilisation exercises that will be administered to the participants are as follows.

1. Physiotherapist/caregiver will gently move the paretic upper limb in flexion/extension, abduction/adduction and internal/external rotation, during 15 minutes approximately.

2. Physiotherapist/caregiver will gently stretch shoulder adductor and internal rotator muscles. Three repetitions of approximately 30 seconds each one will be carried out

3. Participants will be taught to perform active-assisted movements with the help of the non-paretic arm. Especially, the participants will be taught to intertwine both hands and gently raise both arms up and down. This exercise will be repeated 10 times with a 5 seconds resting period between every repetition.

Each daily exercise session will be performed for aproximately 20 minutes
Control group
Active

Outcomes
Primary outcome [1] 295668 0
Shoulder pain perception as assessed by a Visual Analogue Scale (VAS)

The VAS allows us to know the intensity of pain perceived by the subject on a 100-mm horizontal or vertical line, where 0 is the total absence of pain and 100 is the worst pain imaginable. This is considered to be an effective, accurate, sensitive, easy to use, and reproducible method to assess acute and chronic pain. Its use does not require written or verbal skills and the possibility of misinterpreting the results is very low
Timepoint [1] 295668 0
The assessements will be made the first, second, third and fourth week after the beggining of the treatment protocol and also three and six months after the baseline measurements


Secondary outcome [1] 316165 0
Level of disability by means of the Modified Rankin Scale

The modified Rankin scale is used to quantify the disability of patients who have suffered a Cerebrovascular accident. It is derived from the original Rankin scale and its score ranges from 0 (asymptomatic) to 6 points (death). Although it has been concluded to have high validity and high correlations with other widely used functional scales, such as the Barthel scale (ICC = 0.79), in clinical studies it has shown a worse sensitivity to change in the subject’s status in the short-medium term.
Timepoint [1] 316165 0
The assessements will be made the first, second, third and fourth week after the beggining of the treatment protocol and also three and six months after the baseline measurements
Secondary outcome [2] 316166 0
Subject's level of independence by means of the Barthel Index

The Barthel Index has been described as valid, reliable, able to detect changes, easy to interpret and apply. It is useful in long-term evaluation of the prognosis and clinical course of stroke patients. It consists of 10 items where the respective disabilities in the proposed domains are assessed on a scale of 0-10 points or 0-15 points. The final score ranges from 0 to 100 points, establishing five possible levels (less than 20 points means total dependence, between 20 and 35 points is equal to severe dependence, between 40 and 55 points means moderate dependence, equal to 60 points and between 60 and 99 points means slight dependence and 100 points is total independence). In an adaptation of the Barthel index, the domains are scored from 0 to 2,and the total score therefore ranges from 0 to 20 points. The scale does not require linguistic adaptation since it is based on the observation of very specific activities. It is only necessary to use it in appropriate language version, or using a translation of the activities and score levels.

This index has shown a high interrater reliability (r=0.95) and test-retest reliability (r=0.87), as well as a high internal consistency . Over a total index of 20 points, the standard error of measurement based on test-retest agreement was established at 1.45 points.
Timepoint [2] 316166 0
The assessements will be made the first, second, third and fourth week after the beggining of the treatment protocol and also three and six months after the baseline measurements
Secondary outcome [3] 316167 0
Balance level of impairment by the Berg Balance Scale

The Berg Balance scale represents a quantitative measurement for identifying balance impairment in functional activities. Its validity, reliability and sensitivity to change have been demonstrated in hemiplegic patients. It consists of 14 items related to 14 tasks that the subject must complete while being evaluated by the examiner. Total scores range from 0 (severely impaired balance) to 56 (excellent balance).26 The scale has a high intraobserver and interobserver reliability.
Timepoint [3] 316167 0
The assessements will be made the first, second, third and fourth week after the beggining of the treatment protocol and also three and six months after the baseline measurements
Secondary outcome [4] 316168 0
Functional recovery of the upper limb trhough the Action Research Arm Test (ARAT)

The ARAT is composed of 19 items and determines functional recover of the upper extremity through evaluation of the ability to manipulate objects of different size, weight, and shape. Four basic movements are assessed: grasping, gripping, pinching and gross movements. Each element is scored from 0 to 3, where a higher score indicates better motor function. Its inter- and intrarater reliability is very high, as well as its test-retest reliability (0.99). The minimum clinically significant difference is established at 10% of the maximum value of the scale (5.7 points).
Timepoint [4] 316168 0
The assessements will be made the first, second, third and fourth week after the beggining of the treatment protocol and also three and six months after the baseline measurements
Secondary outcome [5] 316169 0
Quality of life (KATZ scale)

This scale consists of 6 items covering different activities of daily living in the personal sphere such as bathing, dressing, toileting, transferring, controlling sphincters, and feeding, and four in the social sphere (shopping, cleaning, cooking and transportation). Activities are assessed assigning one point to those tasks that are considered to be performed dependently by the evaluated subject or zero points when the subject is totally independent
Timepoint [5] 316169 0
The evaluations will be made the first, second, third and fourth week after the beggining of the treatment protocol and also three and six months after the baseline measurements

Eligibility
Key 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).
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed and numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence, based on a set of randomized numbers, was obtained using the Epidat 3.1 free software program (Conselleria de Sanidade, Xunta de Galicia, Spain, and Pan-American Health Organization).

An outside collaborator safeguarded the sequence from those participating in the study: study subjects, evaluators and the therapists responsible for the interventions
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/11/2015
Actual
16/11/2015
Date of last participant enrolment
Anticipated
11/01/2016
Actual
4/01/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
31
Recruitment outside Australia
Country [1] 7055 0
Spain
State/province [1] 7055 0
Sevilla

Funding & Sponsors
Funding source category [1] 291726 0
Hospital
Name [1] 291726 0
Hospital Universitario Virgen Macarena
Country [1] 291726 0
Spain
Primary sponsor type
Hospital
Name
Hospital Universitario Virgen Macarena
Address
Avd. Dr Fedriani, 3, 41071 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 290398 0
None
Name [1] 290398 0
Address [1] 290398 0
Country [1] 290398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293248 0
The Clinical Research Ethics Committee of Hospital Universitario Virgen Macarena (Sevilla, Spain
Ethics committee address [1] 293248 0
Avda. Dr. Fedriani, 3 41009 – Sevilla
Ethics committee country [1] 293248 0
Spain
Date submitted for ethics approval [1] 293248 0
Approval date [1] 293248 0
03/07/2014
Ethics approval number [1] 293248 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59074 0
A/Prof Anja Hochsprung
Address 59074 0
Hospital Universitario Virgen Macarena
Avd. Dr Fedriani, 3, 41071 Sevilla
Country 59074 0
Spain
Phone 59074 0
(+34) 671 562 074
Fax 59074 0
Email 59074 0
[email protected]
Contact person for public queries
Name 59075 0
Alberto Marcos Heredia Rizo
Address 59075 0
University of Sevilla (Spain). Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry.
C/ Avicena s/n 41009, Sevilla
Country 59075 0
Spain
Phone 59075 0
(+34) 95448 65 07
Fax 59075 0
(+34) 95448 65 27
Email 59075 0
[email protected]
Contact person for scientific queries
Name 59076 0
Alberto Marcos Heredia Rizo
Address 59076 0
University of Sevilla (Spain). Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry.
C/ Avicena s/n 41009, Sevilla
Country 59076 0
Spain
Phone 59076 0
(+34) 95448 65 07
Fax 59076 0
Email 59076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort- and medium-term effect of kinesio taping or electrical stimulation in hemiplegic shoulder pain prevention: A randomized controlled pilot trial.2017https://dx.doi.org/10.3233/NRE-172190
N.B. These documents automatically identified may not have been verified by the study sponsor.