Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ANZCTR |
Last refreshed on:
|
13 January 2020 |
Main ID: |
ACTRN12616000076471 |
Date of registration:
|
22/01/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
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 |
Date of first enrolment:
|
19/10/2015 |
Target sample size:
|
80 |
Recruitment status: |
Completed |
URL:
|
https://anzctr.org.au/ACTRN12616000076471.aspx |
Study type:
|
Interventional |
Study design:
|
Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Spain
| | | | | | | |
Contacts
|
Name:
|
Dr Jesus Rebollo Roldan
|
Address:
|
Facultad de Enfermeria, Fisioterapia y Podologia
Edificio de Fisioterapia
C/ Avicena S/N
41009 - SEVILLA
Spain |
Telephone:
|
+34 954486517 |
Email:
|
jesusrebollo@us.es |
Affiliation:
|
|
|
Name:
|
Dr Jesus Rebollo Roldan
|
Address:
|
Departamento de Fisioterapia.
C/ Avicena S/N
41009 - Sevilla
Spain |
Telephone:
|
+34 954486517 |
Email:
|
jesusrebollo@us.es |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
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.
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.
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
Both males and females
|
Health Condition(s) or Problem(s) studied
|
Chronic non-specific low back pain; Chronic non-specific low back pain
|
Physical Medicine / Rehabilitation - Physiotherapy
|
Musculoskeletal - Other muscular and skeletal disorders
|
Intervention(s)
|
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 p
|
Primary Outcome(s)
|
Low back pain severity self-perceived, assessed by a Visual Analogue Scale (VAS) [At baseline, after the fifteen-sessions intervention (three weeks) and a month after the intervention]
|
Disability, assessed using the Oswestry Low Back Disability Questionnaire[At baseline, after the fifteen-sessions intervention (three weeks) and a month after the intervention]
|
Secondary Outcome(s)
|
Pain-free active lumbar range of motion. Flexion and extension evaluated using modified Schober’s test. Lateral bending assessed using Melling´s test.[At baseline, after the fifteen-sessions intervention (three weeks) and a month after the intervention]
|
Source(s) of Monetary Support
|
Hospital La Merced
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Comite de etica de la investigacion de centro Hospital Universitario Virgen del Rocio
|
Status: Approved
Approval date:
Contact:
Comite etico de experimentacion de la Universidad de Sevilla
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|