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Trial registered on ANZCTR


Registration number
ACTRN12616000964415
Ethics application status
Approved
Date submitted
27/05/2016
Date registered
21/07/2016
Date last updated
21/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electroanalgesia in the therapeutic approach of the inspecific chronic neck pain in Primary Care. Randomised controlled trial.
Scientific title
Electroanalgesia in the therapeutic approach of the inspecific chronic neck pain in Primary Care. Randomised controlled trial.
Secondary ID [1] 289321 0
NONE
Universal Trial Number (UTN)
U1111-1183-3243
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Neck Pain 298917 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298995 298995 0 0
Physiotherapy
Musculoskeletal 299086 299086 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IFC Definition:
Interferential current therapy is the application of alternating medium- frequency current (4,000 Hz) ampli- tude modulated at low frequency (0–250 Hz).(Fuentes 2010, Physiotherapy 2010 90-9 1219-1238)

IFC Adavntages:
A claimed advantage of IFC over low-frequency currents is its capacity to diminish the imped- ance offered by the skin.
Another advantage speculated for IFC is its ability to generate an amplitude- modulated frequency (AMF) parameter, which is a low-frequency current generated deep within the treatment area.(Fuentes 2010, Physiotherapy 2010 90-9 1219-1238)

IFC Effects:
Several theoretical physiological mechanisms such as the “gate control” theory, increased circulation, descending pain suppression, block of nerve conduction, and placebo have been proposed in the literature to support the analgesic effects of IFC.(Fuentes 2010, Physiotherapy 2010 90-9 1219-1238)


Our study is tries to get scientific evidence of the IF Currents effects over Chronic Neck Pain's Patients combined with a program of supervised therapeutic exercises.

The intervention will be provided by a physiotherapist with more than 10 years experience.
The duration of each session will be aproximately one hour and half.
The number of sessions administried to each participant will be 10.
The aplication of the IF currents will be one on one and the exercises will be provided in group sessions.


IFC Parameters:

Treatment with interferential currents, bipolar method 4000 Hz carrier frequency and 60 Hz AMF with a modulation frequency of 90 Hz, with electrodes 5x10 cm2 placed in opposition to the neck (C5-C6-C7), during 25 minutes.

The intensity (voltage) of the IFC will be adapated to the sensitivity of each patient.
The current intensity during the treatment time must be increased 3 to 5 times, within the limits of patients' perception without exceeding the threshold of excitability and pain. The increased intensity is intended to retard the aparition of accommodative phenomena .

Patients will receive 10 sesions from monday to friday during two weeks.
The Physiotherapist will register the attendance at sessions.

This group will receive also a supervised exercises program before the IFC treatment.

Patients undertake the supervised exercise group treatment early in the morning (8:30h) and receive treatment with interferential currents throughout the morning.

The minimum interval between the completion of the exercises will be one hour (The first patient of this experimental group will end exercises at 9:30 and will start IFC tratment at 10:30) and up to four (The last patient will end exercises at 9:30 and will start IFC tratment at 13:30)

SUPERVISED EXERCISES PARAMETERS:

The supervised exercises will include:
1) Ergonomic advice on reducing repetitive motion and / or maintained positions.
2) Program active physiotherapy for neck and shoulder muscles including:
a. Active stretching exercises
b. Isometric muscle strengthening exercises
c. Reeducation program oculo cervico kinetic
d. Homeworks

.The exercises will be practised in a very slow way. It will not increase significantly the heart rate. Our objective is to induce relaxation and pain relief at the same time that we improve the neck muscles' flexibility and strength

Patients will receive 10 sesions of supervised exercises in groups from monday to friday during two weeks. The duration of the sessions will be one hour
The Physiotherapist will register the attendance at sessions.

In order to encourage the adherence to the home exercises, the information provided by the physiotherapist will be clear, concise and they will ask patient after each session how do they feel after the realization of the exercises the day before and if they have any doubt about them. The physical therapist will also ask patients to write a daily in order to detect questions during the intersessional period and to encourage the daily practice during the next months.

The physical therapist will try to convey the difference between a bearable pain of analytical stretching (which disappears quickly after the execution of exercises) and persistent chronic pain characteristic of neck pain. It will also encourage them to take a pain diary to encourage them to see how the crisis periods will inter spacing for more time thanks to the implementation of the program of home exercises. The aim is to demonstrate or better manage their self care and self-efficacy

They will be asked to complete the same exercises at home at least over 30 to 45 minutes once a day , during the two weeks of treatment and at least during ten to twelve weeks after.
Intervention code [1] 294873 0
Treatment: Other
Intervention code [2] 294973 0
Treatment: Devices
Comparator / control treatment
Our control group will receive only a program of supervised therapeutic exercises.
The intervention will be provided by a physiotherapist with more than 10 years experience.

SUPERVISED EXERCISES PARAMETERS:

The supervised exercises will include:
1) Ergonomic advice on reducing repetitive motion and / or maintained positions.
2) Program active physiotherapy for neck and shoulder muscles including:
a. Active stretching exercises
b. Isometric muscle strengthening exercises
c. Reeducation program oculo cervico kinetic
d. Homeworks

.The exercises will be practised in a very slow way. It will not increase significantly the heart rate. Our objective is to induce relaxation and pain relief at the same time that we improve the neck muscles' flexibility and strength

Patients will receive 10 sesions of supervised exercises in groups from monday to friday during two weeks. The duration of the sessions will be one hour
The Physiotherapist will register the attendance at sessions.
Control group
Active

Outcomes
Primary outcome [1] 298462 0
Neck pain assessed by 100mm visual analogue scale
Timepoint [1] 298462 0
Two evaluations were performed by physiotherapists: before the intervention and when the intervention was finished (after 10 sesions).
Our objective is to study the effects on the short term.
Secondary outcome [1] 324217 0
Neck Disability Index (NDI)
Timepoint [1] 324217 0
Two evaluations were performed by physiotherapists: before the intervention and when the intervention was finished (after 10 sesions).
Our objective is to study the effects on the short term.

Eligibility
Key inclusion criteria
The key inclusion criteria are:
* Chronic Neck Pain
* Non Metallic Implants in the Vertebral Column.
* Non apprehension to electrotherapy
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The key exclusion criteria are:
* Metallic Implants in the Vertebral Column.
* Apprehension to electrotherapy
* Non Cervicogenic Headache.
* Non Cervicogenic Dizziness.
* Neck pain associated with neurological deficit.
* Unexplained Fever.
* Cervical Surgery associated to persistent pain.
* Specific diagnostics (cervical myelopathy, cervical stenosis, osteomyopathy).
* Other diagnostics (visceral pain referred to the neck or non cervical cause).

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 phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
* Student t-test.

* ANOVAS.

* D. of Cohen.

* Wilcoxon signed-rank test

* Mann-Whitney test


The target population for whom this protocol is made up of all patients diagnosed with chronic neck pain mechanical subacute or irradiation with or without upper limb pain or head of the Health District of La Rinconada, Sevilla.

This study is clinical trial randomized longitudinal, prospective with double-blind groups.

Randomization will be realized by a randomization table. Therefore, the total sample was subdividided in two groups of 21 subjects for the experimental group and 21 subjects in the control group.

The calculation of the sample was obtained using the statistical package GPower 3.1 for Windows. We have considered unknown but equal variances, a large effect Cohen (or clinical effect) (0.8) and a 1: 1 ratio between the size of both groups. We have taken an alpha error and 95% type I and type II error or beta 80%, with two-tailed hypothesis. The resulting sample size of 21 subjects for the experimental group and 21 individuals in the control group.

Therefore the sample of this study will consist of 50 subjects (N = 50) divided into two groups: experimental group (GE) of 25 patients and the control group (GC) of 25 individuals, holding consultations Physiotherapy Center Health of San Jose de la Rinconada, located on the street postmen of San Jose de la Rinconada (La Rinconada, Sevilla). The sample was randomly selected among patients who meet the inclusion criteria. The dropout rate we have considered is about the 15%, so we considered we will need a sample size of 50 subjects that is a higher number than the proposed in the calculation of the sample (42).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/06/2016
Date of last participant enrolment
Anticipated
30/09/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 7918 0
Spain
State/province [1] 7918 0
Seville

Funding & Sponsors
Funding source category [1] 293693 0
University
Name [1] 293693 0
University of Seville
Country [1] 293693 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Calle San Fernando, 4, 41004 Sevilla. Spain
Country
Spain
Secondary sponsor category [1] 292526 0
None
Name [1] 292526 0
Address [1] 292526 0
Country [1] 292526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295133 0
CEI de los Hospitales Universitarios Virgen Macarena-Virgen del Rocio
Ethics committee address [1] 295133 0
Ethics committee country [1] 295133 0
Spain
Date submitted for ethics approval [1] 295133 0
29/10/2014
Approval date [1] 295133 0
10/12/2014
Ethics approval number [1] 295133 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 910 910 0 0
/AnzctrAttachments/370784-peiba_DictamenFavorable20141210122747 (1).pdf

Contacts
Principal investigator
Name 66194 0
Mr Cristo Jesus Barrios Quinta
Address 66194 0
Cristo Jesus Barrios Quinta.
Physiotherapist of Los Carteros Primary Care Center
Servicio Andaluz de Salud.
Calle / Los Carteros Sin numero,
CP. 41300 San Jose de la Rinconada. La Rinconada. Sevilla, Espana
Country 66194 0
Spain
Phone 66194 0
+34669121747
Fax 66194 0
Email 66194 0
cristo.barrios@gmail.com
Contact person for public queries
Name 66195 0
Manuel Albornoz Cabello
Address 66195 0
Dr. Manuel Albornoz Cabello
Facultad De Enfemeria, Fisioterapia y Podologia
Universidad de Sevilla.
Direccion:
Calle AVICENA. Sin numero
C.P: 41009 (SEVILLA) ESPANA
Country 66195 0
Spain
Phone 66195 0
+34 954486502
Fax 66195 0
Email 66195 0
malbornoz@us.es
Contact person for scientific queries
Name 66196 0
Blanca de La Cruz Torres
Address 66196 0
Dra. Blanca de La Cruz Torres
Facultad De Enfemeria, Fisioterapia y Podologia
Universidad de Sevilla.
Direccion:
Calle AVICENA. Sin numero
C.P: 41009 (SEVILLA) ESPANA
Country 66196 0
Spain
Phone 66196 0
+34 954486502
Fax 66196 0
Email 66196 0
bcruz@us.es

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Synthesis of results: The scientific evidence rega... [More Details]
ThesisNo 370784-(Uploaded-27-05-2019-18-30-27)-Other results publication.pdf

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