Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000402842
Ethics application status
Approved
Date submitted
5/04/2012
Date registered
10/04/2012
Date last updated
12/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kinesio Taping in chronic non-specific low back pain: a randomised controlled trial
Scientific title
In adults with chronic non-specific low back pain, is Kinesio Taping better than sham taping to reduce disability and pain?
Secondary ID [1] 280283 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 286241 0
Condition category
Condition code
Musculoskeletal 286456 286456 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adhesive tape applied over the lumbar spine using a space saving technique, with four strips of Kinesio Tape applied in a star shape over the most painful point of the lumbar spine. The tape is left in situ for 7 days.
Intervention code [1] 284635 0
Treatment: Devices
Comparator / control treatment
Adhesive tape applied over the lumbar spine in a single horizontal strip of Kinesio Tape. This sham taping is left in situ for 7 days.
Control group
Placebo

Outcomes
Primary outcome [1] 286901 0
Disability assessed using the Oswestry Disability Index (ODI) questionnaire, which ranges from 0 to 100
Timepoint [1] 286901 0
at baseline and at 1 and 5 weeks after intervention commencement
Secondary outcome [1] 296946 0
Disability assessed using the Roland-Morris Disability (RMD) questionnaire, which ranges from 0 to 24 points
Timepoint [1] 296946 0
at baseline and at 1 and 5 weeks after intervention commencement
Secondary outcome [2] 296947 0
Low back pain severity, scored by the patient on a 10-cm visual analogue scale
Timepoint [2] 296947 0
at baseline and at 1 and 5 weeks after intervention commencement
Secondary outcome [3] 296948 0
Fear of movement assessed using the Tampa Scale for Kinesiophobia (TSK) questionnaire, which ranges from 17 to 64 points
Timepoint [3] 296948 0
at baseline and at 1 and 5 weeks after intervention commencement
Secondary outcome [4] 296949 0
Trunk flexion range of motion (in degrees), measured with the patient in the orthostatic position with their knees extended and arms crossed across the chest, with a fleximeter attached laterally to the thorax at breast height.
Timepoint [4] 296949 0
at baseline and at 1 and 5 weeks after intervention commencement
Secondary outcome [5] 296950 0
McQuade test of trunk muscle endurance (measured in seconds), in which the participant holds their trunk isometrically off the floor in a side-bridge position until fatigue
Timepoint [5] 296950 0
at baseline and at 1 and 5 weeks after intervention commencement

Eligibility
Key inclusion criteria
To be eligible for inclusion in the trial, participants are required to have low back pain for at least 3 months, to be aged between 18 and 65 years, to score of four or more on the Roland-Morris Low Back Pain and Disability Questionnaire at randomisation (UK Trial BEAM team 2004), and to not achieve flexion-relaxation in the lumbar muscles during trunk flexion (Neblett et al 2003).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are clinical signs of radiculopathy, lumbar stenosis, fibromyalgia, spondylolisthesis, previous spinal surgery or Kinesio Tape therapy, corticosteroid treatment in the previous two weeks, and central or peripheral nervous system disease.

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)
After eligibility is confirmed and baseline measures are recorded, participants are randomly assigned to experimental or control group. Allocation is concealed by using a computer-generated randomised table of numbers created before the data collection by an investigator not involved in the assessment or treatment of the participants. Individual sequentially numbered index cards with the random assignment were folded and placed in sealed opaque envelopes. On the day after the initial examination, the envelope allocated to the participant is opened by a second investigator. This investigator proceeds with the treatment according to the group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocations are generated using a computer-generated randomised table of numbers created before the data collection by an investigator not involved in the assessment or treatment of the participants.
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
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4243 0
Spain
State/province [1] 4243 0

Funding & Sponsors
Funding source category [1] 285051 0
Self funded/Unfunded
Name [1] 285051 0
Country [1] 285051 0
Primary sponsor type
Individual
Name
Adelaida Maria Castro Sanchez
Address
Department of Nursing and Physical Therapy,
Universidad de Almeria,
Universidad de Almeria Rd,
Sacramento s / n,
La Canada de San Urbano,
04120 Almeria
Country
Spain
Secondary sponsor category [1] 283915 0
None
Name [1] 283915 0
Address [1] 283915 0
Country [1] 283915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287056 0
Ethics and Research Committee of the University of Almeria
Ethics committee address [1] 287056 0
Ethics committee country [1] 287056 0
Spain
Date submitted for ethics approval [1] 287056 0
Approval date [1] 287056 0
Ethics approval number [1] 287056 0
12-368190

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

Contacts
Principal investigator
Name 34030 0
Address 34030 0
Country 34030 0
Phone 34030 0
Fax 34030 0
Email 34030 0
Contact person for public queries
Name 17277 0
Adelaida Maria Castro-Sanchez
Address 17277 0
Department of Nursing and Physical Therapy,
Universidad de Almeria,
Universidad de Almeria Rd,
Sacramento s / n,
La Canada de San Urbano,
04120 Almeria
Country 17277 0
Spain
Phone 17277 0
+34 950 214576
Fax 17277 0
+34 950 214384
Email 17277 0
[email protected]
Contact person for scientific queries
Name 8205 0
Adelaida Maria Castro-Sanchez
Address 8205 0
Department of Nursing and Physical Therapy,
Universidad de Almeria,
Universidad de Almeria Rd,
Sacramento s / n,
La Canada de San Urbano,
04120 Almeria
Country 8205 0
Spain
Phone 8205 0
+34 950 214576
Fax 8205 0
+34 950 214384
Email 8205 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.