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Trial registered on ANZCTR


Registration number
ACTRN12616000076471
Ethics application status
Approved
Date submitted
2/10/2015
Date registered
22/01/2016
Date last updated
23/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of lumbar Kinesio taping on low back pain, disability and range of motion
Scientific title
Effects of lumbar kinesio taping in addition to habitual multimodal treatment versus only the multimodal treatment on low back pain, disability and range of motion in patients with chronic non-specific low back pain: a randomized controlled trial
Secondary ID [1] 287589 0
None
Universal Trial Number (UTN)
U1111-1164-6288
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific low back pain 296381 0
Condition category
Condition code
Musculoskeletal 296654 296654 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 296655 296655 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will include both interventions (habitual multimodal treatment plus kinesio tape) which will commence at the same time.
The whole treatment will be administered by a physiotherapist. It will be perfomed during 15 sessions: once a day, from Monday to Friday, for three weeks. The neuromuscular bandage must be changed every three days.

A: Habitual multimodal treatment. 65 minutes each session, comprising thermotherapy, TENS and stretching as follows:
a) Thermotherapy: continuous microwave at 80Hz, on the lumbar area for 15 minutes.
b) TENS for pulsed asymmetrical biphasic rectangular current, pulse rate 2Hz, pulse width 150 micros, intensity of the current between 40 and 100 mA according to the patient´s perception. The current will be applied by means of two channels, putting four adhesive silicone quadrangular electrodes (two on each channel) of 5 cm2 on paravertebral lumbar muscles for 30 minutes.
c) Passive stretchings of paravertebral lumbar muscles, psoas-iliac, square lumbar and pyramidal muscles. Each exercise will be performed from 3 to 5 times per session keeping the stretching position from 10 to 20 seconds. The total time for stretchings will be of 20 minutes.

B: Kinesio tape
Use of neuromuscular bandage on the lumbar area using the muscular technique: three strips of 5 cms of width (two in vertical position on the paravertebral zone and one across on the point of maximum pain) will be placed in the following way:
a) With the patient seated in neutral position, the bases of the neuromuscular bandage in the sacrum are fixed.
b) The patient flexes and rotates the trunk to one side and the strip of the bandage on the paravertebral lumbar muscles to the contrary side of the rotation is also placed.
c) The same operation is performed in the contralateral side.
With the patient in neutral position
d) The upright moorings are finally fixed exceeding the lumbar curvature.
e) A strip of bandage in horizontal direction with a certain tension in the vertebra with maximum pain is placed.
f) Finally, the moorings of this last one are fixed but without any tension.
Intervention code [1] 292985 0
Treatment: Other
Intervention code [2] 292986 0
Rehabilitation
Comparator / control treatment
The control group will include only habitual multimodal treatment.
The whole treatment will be administered by a physiotherapist. It will be perfomed during 15 sessions: once a day, from Monday to Friday, for three weeks.
Each session will last 65 minutes, comprising thermotherapy, TENS and stretching as follows:
a) Thermotherapy: continuous microwave at 80Hz, on the lumbar area for 15 minutes.
b) TENS for pulsed asymmetrical biphasic rectangular current, pulse rate 2Hz, pulse width 150 micros, intensity of the current between 40 and 100 mA according to the patient´s perception. The current will be applied by means of two channels, putting four adhesive silicone quadrangular electrodes (two on each channel) of 5 cm2 on paravertebral lumbar muscles for 30 minutes.
c) Passive stretchings of paravertebral lumbar muscles, psoas-iliac, square lumbar and pyramidal muscles. Each exercise will be performed from 3 to 5 times per session keeping the stretching position from 10 to 20 seconds. The total time for stretchings will be of 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 296265 0
Low back pain severity self-perceived, assessed by a Visual Analogue Scale (VAS)
Timepoint [1] 296265 0
At baseline, after the fifteen-sessions intervention (three weeks) and a month after the intervention
Primary outcome [2] 296266 0
Disability, assessed using the Oswestry Low Back Disability Questionnaire
Timepoint [2] 296266 0
At baseline, after the fifteen-sessions intervention (three weeks) and a month after the intervention
Secondary outcome [1] 318013 0
Pain-free active lumbar range of motion. Flexion and extension evaluated using modified Schober’s test. Lateral bending assessed using Melling´s test.
Timepoint [1] 318013 0
At baseline, after the fifteen-sessions intervention (three weeks) and a month after the intervention

Eligibility
Key inclusion criteria
Patients of both gender diagnosed with chronic non-specific low back pain, with pain, disability and limitation of the range of motion, between the age of 30 to 65.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lumbar pain associated to a systemic illness.
Clear evidences of spinal canal stenosis.
Low back pain related to surgery that affects the lumbar spine, the pelvis of the hip.
To suffer from a psychological or psychiatric process.
To endure some oncological process.
To have suffered from vertebral fractures.
To endure vertebral anterolisthesis or retrolisthesis
To suffer dermatological alteration on the back.
A pregnant or having possibilities of being pregnant patient.

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)
Patients diagnosed with chronic non-specific low back pain who arrive at The Physiotherapy Unit of “Hospital La Merced” in Osuna, will be received by a researcher assistant who will confirm his or her eligibility and will be invited to participate in the research. After the signature of the informed consent and the initial evaluation, a researcher not involved in assessment or treatment of patients, will perform the allocation of subjects to the groups of study at random with stratification by sex, asking to each participant that according to his/her gender, takes out a ticket from an opaque container. Both containers for men and women will have 40 tickets or ballots with 20 with the text “Group A” for the experimental group and other 20 with the text “Group B” that will be the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects will be assigned at random with the stratification of genders. The allocation is hidden by means of opaque containers, one for men and the other for women. The subjects will take out a ticket which indicates the group assigned.
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
Efficacy
Statistical methods / analysis
We have estimated the sample size using GPower 3.1.6 programme, considering as principal variable the pain assessed by the visual analogue scale, including the following information: effect size 0.64 (obtained from a preliminary study); hypothesis at one-tailed; an error probability of 0.05, a power (1-beta) of 0.80, and proportion between the groups 1. The initial sample size was 60 participants. Considering a loss of 20% it reaches 74 subjects (37 in each group). Finally, we decide to include 80 people in case the loss is higher.
To check the normality of the variables we will use the Shapiro-Wilk test. To determine the differences within each group the test ANOVA of repeated measures completed with Helmert contrasts and simple type, and Friedman ANOVA completed with the Dunn test will be used, taking into account the normality of the variables.To determine differences between both groups we will use the Student's t-test or Mann-Whitney U test according to the normality of the variables. We will calculate the effect size applying the formula suggested by Grissom.

We will performed intention-to-treat analyses. For all statistical tests, a 95 % confidence intervals will be considerate (P value < 0,05)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/10/2015
Date of last participant enrolment
Anticipated
8/02/2016
Actual
4/04/2016
Date of last data collection
Anticipated
Actual
23/05/2016
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 7201 0
Spain
State/province [1] 7201 0
Seville

Funding & Sponsors
Funding source category [1] 292151 0
Hospital
Name [1] 292151 0
Hospital La Merced
Country [1] 292151 0
Spain
Primary sponsor type
University
Name
Universidad de Sevilla. Grupo de Investigacion Area de Fisioterapia CTS-305
Address
Facultad de Enfermeria, Fisioterapia y Podologia (edificio de Fisioterapia)
C/ Avicena S/N
41009 - SEVILLA
Country
Spain
Secondary sponsor category [1] 290824 0
University
Name [1] 290824 0
Escuela Universitaria Francisco Maldonado
Address [1] 290824 0
Edificio Antigua Universidad
Los Cipreses,1
41640 OSUNA (Sevilla)
Country [1] 290824 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293626 0
Comite etico de experimentacion de la Universidad de Sevilla
Ethics committee address [1] 293626 0
Ethics committee country [1] 293626 0
Spain
Date submitted for ethics approval [1] 293626 0
Approval date [1] 293626 0
13/01/2012
Ethics approval number [1] 293626 0
Ethics committee name [2] 293627 0
Comite de etica de la investigacion de centro Hospital Universitario Virgen del Rocio
Ethics committee address [2] 293627 0
Ethics committee country [2] 293627 0
Spain
Date submitted for ethics approval [2] 293627 0
Approval date [2] 293627 0
28/03/2012
Ethics approval number [2] 293627 0
2012PI/095

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 570 570 0 0
/AnzctrAttachments/369430-Ethics approval University of Seville.pdf
Attachments [2] 571 571 0 0
/AnzctrAttachments/369430-Ethics approval Virgen del Rocio Hospital.pdf

Contacts
Principal investigator
Name 60778 0
Dr Maria Francisca Navarro Perez
Address 60778 0
E.U. Francisco Maldonado
Edificio Antigua Universidad
los Cipreses,1
41640 Osuna (Sevilla)
Country 60778 0
Spain
Phone 60778 0
+34 955820289
Fax 60778 0
+34 954811282
Email 60778 0
franciscanp@euosuna.org
Contact person for public queries
Name 60779 0
Jesus Rebollo Roldan
Address 60779 0
Facultad de Enfermeria, Fisioterapia y Podologia
Edificio de Fisioterapia
C/ Avicena S/N
41009 - SEVILLA
Country 60779 0
Spain
Phone 60779 0
+34 954486517
Fax 60779 0
+34 954486527
Email 60779 0
jesusrebollo@us.es
Contact person for scientific queries
Name 60780 0
Jesus Rebollo Roldan
Address 60780 0
Departamento de Fisioterapia.
C/ Avicena S/N
41009 - Sevilla
Country 60780 0
Spain
Phone 60780 0
+34 954486517
Fax 60780 0
+34 954486527
Email 60780 0
jesusrebollo@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

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