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Trial registered on ANZCTR


Registration number
ACTRN12617001124325
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
31/07/2017
Date last updated
31/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of electro-massage with interferential current therapy on pain and function following acromioplasty surgery
Scientific title
The effect of electro-massage with interferential current therapy on pain and function levels in people who have undergone acromioplasty surgery - A randomized controlled trial.
Secondary ID [1] 292076 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain post acromioplasty 303496 0
Condition category
Condition code
Musculoskeletal 302915 302915 0 0
Other muscular and skeletal disorders
Surgery 302916 302916 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group: all subject received a conservatory treatment (1h and 40 min) and electro-massage (10min).
The treatment were applied six Physiotherapy sessions, two times a week for three weeks. The duration was 1 hour and 40 min for the conservatory treatment and 10 min for the electro-massage.
Description of the electro-massage that was performed by a specialist physiotherapist with more than 8 years of experience
We use ENDOMED 482 (Enraf Nonius, Spain) for the elecro-massage. the current parameters are: frequency shift at 4000 Hz IFC, 100 Hz AMF in CV mode. We will gradually raise the current intensity until reaching a high level, but not so high as to cause pain or discomfort, nor evident muscle contraction, although a gentle vibration is allowed. The electro-massage was performed on the musculature of the shoulder and neck.
Superficial rubbing: We place both electrodes in parallel, always keeping that one in our distal hand in distal position. We perform a smooth skating, with light compression, through the different structures in the cervical-scapulohumeral complex. Rubbing speed must be low, 2-3 cm per second. We perform this procedure both at the beginning and the end of the treatment. Treatment time: one minute (30 seconds at the beginning and 30 seconds at the end).
Deep rubbing: we perform a slipping of the electrodes, now placing a higher compression over them. We place the fixed proximal electrode in the initial belly area; at the same time, we slip the distal electrode along the muscular belly, until reaching its insertion. Slipping speed is higher than that in superficial rubbing, 5-6 cm per second. We perform this procedure over the following muscles: anterior deltoid, middle deltoid, posterior deltoid, biceps, triceps, upper trapezius, supraspinatus, infraspinatus and rhomboid muscle. Treatment time: two minutes.
Deep rubbing with gleno-humeral decoaptation: we perform the deep rubbing procedure, asking the patient to get the shoulder down. We keep the fixed proximal electrode placed on the upper trapezius. We perform the deep rubbing procedure using the distal electrode from the middle deltoid, through the arm lateral side to the epycondile. We ask the patient to get the shoulder down when we perform the slipping from proximal to distal, whereas he will not do so when we go back to proximal, establishing so a contraction-relax cycle. Treatment time: 1 minute and 30 seconds.
Kneading: we place both electrodes in parallel in the initial belly area, keeping the one in our distal hand in distal position at all times; then, in the distal direction, we perform kneading on the muscular belly, moving the electrodes alternatingly front-to-back. Speed and compression over the electrodes will be the same as in deep rubbing. We perform this procedure on the following muscles: upper trapezius, anterior deltoid, middle deltoid, posterior deltoid, biceps and triceps. Treatment time: 1minute and 30 seconds.
Stretching. First, we ask the patient to move the body segment undergoing stretching, placing it in pre-stretching position. We must take into account that we are working with patients with limited joint range motion, and therefore we should take care in not forcing stretching in any way. We will perform this previous step just over these muscles: superior trapezoidal, scapula elevator, supraspinatus and infraspinatus. Regarding the remaining muscles, the therapist will move the body segment while the stretching is being performed. We place both electrodes in parallel on the initial belly area, the one in our distal hand always in distal position, then, in distal direction, we will slip the distal electrode all along the muscular belly until reaching its insertion. Speed and compression over the electrodes will be the same as in deep rubbing. Besides, we will perform additional compression over the muscular origin all stretching long; this compression will equal that one in the distal electrode when this one reaches its insertion. We will then keep the stretching for 15-20 seconds, as if it were a manual passive stretching. We will perform this procedure over the following muscles: superior trapezoidal, scapula elevator, anterior deltoid, middle deltoid, posterior deltoid, supraspinatus, infraspinatus, biceps and triceps. Treatment time: 2 minutes and 30 seconds.
Articular procedure for humeral head: we place both electrodes in the same position as in the beginning of the treatment (distal electrode on the shoulder anterior side, longitudinally, following the anterior deltoid muscular fibres direction, proximal electrode on the shoulder posterior side, longitudinally, following the posterior deltoid muscular fibres direction). Then, we will perform traction and slipping towards the humeral head retropulsion using the distal electrode. Such slipping will be performed until reaching the proximal electrode; this one will remain fixed. Once reached, the distal electrode will be placed again on its initial position, thus completing a retropulsion-relax cycle. Speed and compression over the electrodes will be the same as in deep rubbing. Treatment time: 1minute and 30 seconds.
Intervention code [1] 298218 0
Rehabilitation
Comparator / control treatment
Control group: all subject received a conservatory treatment. The treatment were applied six Physiotherapy sessions, three times a week.
This conseratory treatment was performed by a specialist physiotherapist with more than 8 years of experience and consisted: thermotherapy, exercises, manual therapy, ultrasound and electrotherapy.
The duration of physiotherapy session in control group was 1 hour and 40 min
Control group
Active

Outcomes
Primary outcome [1] 302298 0
Pain level, assessed by Visual Analogue Scale
Timepoint [1] 302298 0
Baseline and three weeks after intervention commencement
Primary outcome [2] 302299 0
Functional evaluation, assessed by Constant Scale. This scale is the most accepted at European level. It calculates pain, activities of daily living, mobility and strength. It is a scale validated by the European Society of Shoulder and Elbow Surgery
Timepoint [2] 302299 0
Baseline and three weeks after intervention commencement
Secondary outcome [1] 335402 0
Range of shoulder´s motion (Flexion, extension, abduction, adduction, internal and external rotation) were measured by goniometer (iPhone app).
Timepoint [1] 335402 0
Baseline and three weeks after intervention commencement

Eligibility
Key inclusion criteria
patients having undergone acromioplasty surgery in the three months prior to the first day of Physiotherapy treatment
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Value equal to or less than 45 in Personal Psychological Apprehension Scale, showing any absolute contraindication for Physiotherapy or Electrotherapy treatment, fear or apprehension for Electrotherapy application, not signing informed consent, showing alterations in local level sensitivity (cervical-scapulohumeral complex), showing bone fracture associated with SCS, having been applied local infiltration with corticoids following surgery and having started Physiotherapy treatment before signing informed consent.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sample randomization was made for calculated sample size, using the randomization programme available in the website www.randomization.com
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/11/2012
Date of last participant enrolment
Anticipated
Actual
30/04/2013
Date of last data collection
Anticipated
Actual
30/04/2013
Sample size
Target
56
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 8932 0
Spain
State/province [1] 8932 0
Seville

Funding & Sponsors
Funding source category [1] 296608 0
Hospital
Name [1] 296608 0
Alta Resolución de Utrera Hospital
Country [1] 296608 0
Spain
Primary sponsor type
Hospital
Name
Alta Resolución de Utrera Hospital
Address
Brigadas Internacionales Avenue s/n, 41710.
Utrera, Seville, Spain
Country
Spain
Secondary sponsor category [1] 295566 0
None
Name [1] 295566 0
None
Address [1] 295566 0
None
Country [1] 295566 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297837 0
University Hospital Virgen del Rocio
Ethics committee address [1] 297837 0
Brigadas Internacionales, s/n Avenue
41710 Utrera (Sevilla)
Ethics committee country [1] 297837 0
Spain
Date submitted for ethics approval [1] 297837 0
10/07/2012
Approval date [1] 297837 0
28/09/2012
Ethics approval number [1] 297837 0

Summary
Brief summary
Objectives: Establishing and validating an electrotherapy procedure with interferential current (IFC) application using electro-massage on patients who have undergone acromioplasty surgery. Evaluating decrease in pain and degree of functionality following surgical intervention.
Design: Randomized, single blind clinical trial.
Subjects: 18-patient sample (aged 51.83±15.56), range 18 to 76, male (9) and female (9).
Methods: 10-patient experimental group, 8-patient control group. Both groups of patients were applied six Physiotherapy sessions, three times a week. The experimental group patients were also applied electro-massage with constant voltage (CV) IFC bipolar application, 4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes were used. Session length was ten minutes.
Results: VAS showed statistically significant differences following treatment between both groups (p=0.031 when p<0.05), analysed using Wilcoxon Signed Rank test. The experimental group evolved from a 7±1,72 pre- treatment VAS to a 2,75±1,31 post-treatment VAS, whereas the control group evolved from a 8±2,32 pre-treatment VAS to a 5±2,76 post- treatment VAS. There were statistically significant differences in Constant- Murley score following treatment between both groups (p=0.026 when p<0.05), analysed using Wilcoxon Signed Rank Test. It evolved from 28,9±13,37 pre-treatment to 53,8±11,32 post-treatment in the experimental group, whereas it evolved from 23,5± 13,28 pre-treatment to 35,5± 17,19 post-treatment in the control group. There were no statistically significant differences in range of motion between both groups. Conclusions: Electro-massage application is clinically significant for decrease in pain measured using VAS, with a 4.25-point decrease (p=0.031), as well as for increase in degree of functionality, with a 24.9- point increase (p=0.026) in Constant score. There were no statistically significant differences in range of motion between both groups.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 75230 0
Dr Jose Antonio Sanchez-Santos
Address 75230 0
Avda. Brigadas Internacionales, s/n
Alta Resolución de Utrera Hospital
41710 Utrera (Sevilla)
Country 75230 0
Spain
Phone 75230 0
+34 955839001
Fax 75230 0
Email 75230 0
[email protected]
Contact person for public queries
Name 75231 0
Blanca de la Cruz Torres
Address 75231 0
Avicena s/n street 41009
Department of Physiotherapy
University of Seville
Seville
Country 75231 0
Spain
Phone 75231 0
+34 666676870
Fax 75231 0
Email 75231 0
[email protected]
Contact person for scientific queries
Name 75232 0
Blanca de la Cruz Torres
Address 75232 0
Avicena s/n street 41009
Department of Physiotherapy
University of Seville
Seville
Country 75232 0
Spain
Phone 75232 0
+34 666676870
Fax 75232 0
Email 75232 0
[email protected]

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