Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000267853
Ethics application status
Approved
Date submitted
1/03/2012
Date registered
6/03/2012
Date last updated
24/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Neuromuscular taping effect on lower trunk muscles, in subjects with nonspecific low back pain.
Scientific title
Effects of lumbar neuromuscular taping on pain, lumbar range of motion and lower trunk muscles flexibility, in subjects with nonspecific low back pain.
Secondary ID [1] 273446 0
NIL
Universal Trial Number (UTN)
U111-1125-9977
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 279237 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279438 279438 0 0
Physiotherapy
Musculoskeletal 279439 279439 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly assigned to one of three study groups. The study groups are composed of two intervention groups (1 and 2) and one control group (3).

Intervention group (1):
"I-strip" neuromuscular taping will be applied on lower trunk muscles, from sacral base to twelfth thoracic vertebra.
Subjects will bend forward during the applicaton and both sides will be taped.
The tape will be applied with paper-off tension.
The tape will be applied just on one accasion and it will remain in place for 24 hours.
Intervention group (2):
"I-strip" neuromuscular taping will be applied on lower trunk muscles, from sacral base to twelfth thoracic vertebra.
Subjects will bend forward during the applicaton and both sides will be taped.
The paper-off tension tape will be applied with approximately 50% stretch.
The tape will be applied just on one accasion and it will remain in place for 24 hours.
Intervention code [1] 284062 0
Rehabilitation
Intervention code [2] 284403 0
Treatment: Other
Comparator / control treatment
Control group (3):
"I-strip" neuromuscular taping will be applied on lower trunk muscles, from sacral base to twelfth thoracic vertebra.
Subjects will be placed in a neutral positionduring the applicaton and both sides will be taped.
The tape will be applied without tension.
Control group
Placebo

Outcomes
Primary outcome [1] 286313 0
To analyze the differences in muscle lengthening after applying the neuromuscular tape on the erector muscles of the spine in subjects with nonspecific low back pain.
The differences in muscle legthening were assessed using the standard sit and reach test.
Timepoint [1] 286313 0
The measurement will be performed before the placement of the neuromuscular taping, 5 minutes and 24 hours after the placement of the bandage, and 5 minutes after the removal of the tape. Three measurements will be recorded and the average will be calculated.
Primary outcome [2] 286314 0
To know the variation of lumbar range of motion, in subjects with nonspecific low back pain, after the application of the neuromuscular tape on the erector muscles of the spine.
Lumbar range of motion (flexion and lateral bending) was assessed using an inclinometer and the standard sit and reach test.
Timepoint [2] 286314 0
The measurement will be performed before the placement of the neuromuscular taping, 5 minutes and 24 hours after the placement of the bandage, and 5 minutes after the removal of the tape. Three measurements will be recorded with the sit and reach test and the average will be calculated.
Primary outcome [3] 286315 0
To determine Pressure pain threshold variation at the erector spinae and gluteus medius trigger points in subjects with nonspecific low back pain.
Pressure pain threshold will be measured using an analogue algometer.
Timepoint [3] 286315 0
The measurement will be performed before the placement of the neuromuscular taping, 5 minutes and 24 hours after the placement of the bandage, and 5 minutes after the removal of the tape.
Secondary outcome [1] 295592 0
Nil
Timepoint [1] 295592 0
Nil

Eligibility
Key inclusion criteria
Patients with a history of mechanical and nonspecific low back pain for more than 6 weeks before the study or with intermittent low back pain who have experienced at least 3 episodes of back pain, each lasting more than a week during the year preceding the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suffering acute low back pain at the time of the study.
Suffering referred pain to the lower extremities.
Have a history of spinal surgery, vertebral fracture, pelvis fracture or lower limb fracture.
Have a history of hospitalization for severe trauma or traffic accident
Suffering from arthritis or systemic diseases
Patients with any skin condition that prevents the application of the bandage for the study.
Pregnancy

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)
There will be a volunteer recruitment campaign, using posters in the University buildings as well as through an email distributed by the universiy information service.

Those interested in participate in the study will be scheduled for a first interview, which will consist of information about the study, check on compliance with the inclusion and exclusion criteria and signature of informed consent.
Once accepted participation in the study, the volunteer will be registered with a code.

There will be two interventional groups, one formed by patients who are going to receive a standardized therapeutic neuromuscular tape application as described by Kenzo Kase and the other formed by patients who are going to receive neuromuscular tape application with more tension than Kenzo Kase proposed
The control group will be formed by patients who are going to receive a placebo neuromuscular tape application.

Once registered, volunteers will be allocated to one of the three study groups. The allocation concealment will involve contacting the holder of the allocation schedule who will be "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of secuence generation will be by simple randomization using Epidat program application.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2012
Actual
26/11/2012
Date of last participant enrolment
Anticipated
Actual
4/02/2013
Date of last data collection
Anticipated
Actual
5/02/2013
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 3972 0
Spain
State/province [1] 3972 0
Islas Baleares

Funding & Sponsors
Funding source category [1] 284532 0
Self funded/Unfunded
Name [1] 284532 0
Main researcher
Country [1] 284532 0
Spain
Primary sponsor type
Individual
Name
Olga Velasco
Address
Universidad de las Islas Baleares.
Edificio Beatriu de Pinos.
Carretera de valldemossa Km 7,5.
07122 Palma de Mallorca
Islas Baleares.
Country
Spain
Secondary sponsor category [1] 283461 0
None
Name [1] 283461 0
Address [1] 283461 0
Country [1] 283461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286518 0
Comite etico de investigacion de las Islas Baleares
Ethics committee address [1] 286518 0
Ethics committee country [1] 286518 0
Spain
Date submitted for ethics approval [1] 286518 0
Approval date [1] 286518 0
27/04/2011
Ethics approval number [1] 286518 0
IB 1557/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33428 0
Dr Olga Velasco-Roldán
Address 33428 0
Universidad de las Islas Baleares. Edificio Beatriu de Pinos. Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca Islas Baleares.
Country 33428 0
Spain
Phone 33428 0
+34971172713
Fax 33428 0
Email 33428 0
[email protected]
Contact person for public queries
Name 16675 0
Olga Velasco
Address 16675 0
Universidad de las Islas Baleares.
Edificio Beatriu de Pinos.
Carretera de valldemossa Km 7,5.
07122 Palma de Mallorca
Islas Baleares.
Country 16675 0
Spain
Phone 16675 0
+34971172713
Fax 16675 0
Email 16675 0
[email protected]
Contact person for scientific queries
Name 7603 0
Olga Velasco
Address 7603 0
Universidad de las Islas Baleares.
Edificio Beatriu de Pinos.
Carretera de valldemossa Km 7,5.
07122 Palma de Mallorca
Islas Baleares.
Country 7603 0
Spain
Phone 7603 0
+34971172713
Fax 7603 0
Email 7603 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
No additional documents have been identified.