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Trial registered on ANZCTR


Registration number
ACTRN12615000494538
Ethics application status
Approved
Date submitted
5/02/2015
Date registered
19/05/2015
Date last updated
19/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kinesio Tape Application and Non-Specific Low Back Pain
Scientific title
Effect of Different Kinesio Tape Application Techniques on Pain and Function in Patient With Non-Specific Low Back Pain
Secondary ID [1] 286108 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Specific Low Back Pain 294107 0
Condition category
Condition code
Musculoskeletal 294420 294420 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294421 294421 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Erector Spine KT group (ES-KT Group) Technique:
In this group KT was applied according to the Kenzo Kaser Kinesio taping manual. The participants assumed sating position on chair without back support to allow forward bending, while the therapist standing behind the participants. The Kinesio Cure tape was applied as the following; Two I-Tapes (width 5cm, and 0.5mm thickness) were applied on the paravertebral muscles (bilaterally) parallel to the spinous processes of the lumbar spine, from the origin of the lumbar erector spine (iliocostalis lumborum) to its insertion (level of T12). The initial anchor point of tape (4 to 5cm) was carefully removed from its paper backing and applied to the posterior superior iliac crest without stretch. After that, the participant was asked to perform maximum trunk flexion and the tape was removed from the backing paper the tape was applied in the shape of an “I” over the skin in the paravertebral region up to the extremity of the T12 vertebra at 10-15% stretch. The final anchor point of tape (4 to 5cm) was fixed directly above the transvers process of T12 vertebra without a stretch. The same procedure was then applied to the other side. The tape was rubbed by hand several times to warm the adhesive film to achieve adhesion. Ask subjects to stand, and observe the wrinkles in tape that indicate right application.

Star KT Group (S-KT Group) technique. The subjects in this group were taped according to the Kenzo Kaser KT manual. Tape application was done in the sitting position and the measure was taken with subject flexion. Four I-strips were placed at 60-100% stretch overlapping in a star shape in the lumbar area. The first strip was applied horizontally with full stretch in center of tape and the end of tape without stretching. The second strip was applied at 90 degrees angle (vertical across the spinous process) with full stretch in center of tape and the end of tape without stretching. The third and fourth strip was applied diagonal (45degrees angle) across the other tape with full stretch in center of tape and the end of tape without stretching. The tape was rubbed by hand several times to warm the adhesive film to achieve good adhesion. The subject was asked to stand to show the wrinkles in tape that indicate right application.

Lumbar Package KT Group (LP-KT Group) Technique: the patient in this group received the following Lumber package tape (Sacrum tape , Quadratus lumborum, Lumber interspinal
and Iliac crest tape (PSIS up to ASIS) simultaneously as following;

Sacrum tape: Tape application was done in the sitting position. Three I-strips cover sacrum areas to support this joint. The measures of 3 strips is different, the measure of longest one between posterior superior iliac spine (PSIS) and the others smaller than the longest with overlapping one third each other. The proximal strip (longest strip) was applied with maximum stretch on the center of the tape to cover the 1/3 sacrum horizontally, and the end of tape without stretch. Then apply the second strip with maximum stretch on the center of the tape to cover middle 2/3 of sacrum, and the end of tape without stretch. Finally apply distal strip (smallest strip) was applied with maximum stretch on the center of the tape to cover the 3/3 of sacrum, and the end of tape without stretch. The tape was rubbed by hand several times to warm the adhesive film to achieve good adhesion.

Quadratus lumborum: Tape application was done in the sitting position. Two I-tapes were measure with lumber spine side bending and flexion. The tapes were applied on the Quadratus lumborum muscles (bilaterally) from origin (iliac crest) to insertion (12 ribs). The initial anchor point of tape (4 to 5cm) was carefully removed from its paper backing and applied to the iliac crest without stretch. After that, the participant was asked to do flexion and side bending to opposite side of applied tape of the trunk to stretch the skin and the tape was removed from the backing paper and applied in the shape of an “I” over the skin to 12th rib at 10-15% stretch (stretch from the backing paper). The final anchor point of tape (4 to 5cm) was fixed without stretch. The tape was rubbed by hand several times to warm the adhesive film to achieve good adhesion. Ask the subject to stand, the wrinkles in tape that indicate right application.

Lumber interspinal: Tape application was done in the sitting position. One I-tape was positioned longitudinal on the spinous process of lumbar vertebrae (L1-L5). The initial anchor point of tape (4 to 5cm) was carefully removed from its paper backing and applied below the L5 without stretch. Then, there is full stretch on the center of tape was applied in the shape of an “I” over the lumber spine with stretch skin. The final anchor point of tape was fixed without stretch. The tape was rubbed by hand several times to warm the adhesive film to achieve good adhesion.

Iliac crest tape [posterior superior iliac spine (PSIS) to anterior superior iliac spine ASIS)]: Tape application was done in the sitting position. Two I-tapes was positioned from posterior superior iliac spine (PSIS) to anterior superior iliac spine ASIS (bilaterally) with stretch skin through ask subject to do side bending. The initial anchor point of tape (4 to 5cm) was carefully removed from its paper backing and applied on PSIS without stretch (0%). After that, the participant was asked to do side bending of the trunk to opposite side of applied tape to stretch the skin and the tape will be applied in the curve shape over the skin to ASIS (stretch from the backing paper). The final anchor point of tape was fixed to ASIS without stretch. The tape was rubbed by hand several times to warm the adhesive film to achieve good adhesion.


The therapist who was certified as Kinesio-Tape therapist applied the KT twice per week for two weeks. Therefore, a total of four tape applications have been performed for each patients and instructed to wear the KT for 48hours.


The researcher taught the subjects how to perform relaxation position for back at home. First, ask patient to lie down on back with pillows under head and with hip and knee bent 90 degree. They were instructed to assume this position for 10 minutes, three times daily at home. All participants were instructed to maintain their regular physical activities during the study.
Intervention code [1] 291104 0
Rehabilitation
Intervention code [2] 291819 0
Treatment: Other
Comparator / control treatment
Placebo KT group (P-KT Group) technique:
Tape application was done in the standing position. Two I-strip of the same tape applied without stretch. The first anchored of tape was applied to the posterior superior iliac crest without stretch (0% tension). Then the patient was asked to remain in the standing position and tape was applied over each erector spinae muscle to the level of the T8 vertebra. Than completely removed the backing paper of the tape in order to remove the tension from the tape.
Control group
Placebo

Outcomes
Primary outcome [1] 294219 0
Pain Intensity using the visual analogue scale
Timepoint [1] 294219 0
Baseline (before )application of kinesio-taping
2weeks after application of kinesio-taping
follow-up after four weeks of application of kinesio taping
Secondary outcome [1] 312811 0
Functional Disability using oswestry disability index Arabic version
Timepoint [1] 312811 0
Baseline (before )application of kinesio-taping
2weeks after application of kinesio-taping
follow-up after four weeks of application of kinesio taping
Secondary outcome [2] 312812 0
Lumbar spine flexibility (Flexion range of Motion)
The researcher evaluated the pain-free active trunk flexion ROM for the all subjects using modified Schober’s test (MST)
Timepoint [2] 312812 0
Baseline (before )application of kinesio-taping
2weeks after application of kinesio-taping
follow-up after four weeks of application of kinesio taping

Eligibility
Key inclusion criteria
Inclusion Criteria: The subjects were considered for inclusion in this study if they were:
1- Males and females.
2-Aged between 25 and 55 years.
3-Had history of chronic NSCLBP more than 3 months,
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: Exclusion criteria attempted to eliminate confounding variables. Therefore, subjects were excluded from the study if they had one of the following;
1-Acute or sub-acute NSLBP.
2-BMI more than 35 kg/m2.
3-Past history of spinal surgery and/ or fracture.
4-Diagnosis of inflammatory joint disease (e.g. Ankylosing spondylitis), systemic metabolic disorder, rheumatic disease or chronic pain syndrome.
5-Evidence of neurological disorder, neuropathic pain or acute inflammatory process
6-Systemic/painful disease such as renal/urologic diseases, gynecologic diseases, and gastrointestinal diseases.
6-Debilitating/terminal diseases such as malignancy or serious cardio-respiratory diseases.
7-Pregnancy.
8-Using any medication that could alter the study results, i.e. analgesics, muscle relaxants, non-steroidal anti-inflammatory drugs or corticosteroids in last 2 weeks.
9-Previous physiotherapy treatment and / or KT during the last 6 weeks for the same problem.
10-Had contraindications (e.g. skin sensitivity and/or intolerance to tape, dermatitis, or pre-existing skin lesion and infection) on the taping area.

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 the initial assessment, eligible subjects were randomly allocated to; erector spinal taping (ES-KT-group) ; star taping group (S-KT group), lumbar packaged group ( LB-KT group) and placebo group (P-KT group). Allocation was performed using a computer-generated randomized table of numbers, collection by a researcher who was involved in participant recruitment, but not in assessment or treatment. Participant allocation was concealed using a random numerical sequence in sealed opaque envelopes. Before beginning the treatment, the researcher overseeing treatment was open the envelope in front of the patient and disclose the treatment technique that corresponds to the number in the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data were analyzed with Statistical Package of Social Science (SPSS) version 22.0 (Chicago USA). Kolmogorov-Smirnov test was used to determine the normality of data distribution. Normally distributed data (Kolmogorov-Smirnov test, p > 0.05) were described as mean and standard deviation; otherwise the data were presented as frequency, median and range and analyzed non-parametrically.

Participant’s characteristics and demographic data such as age, height, weight and BMI, as well as durations of low back pain and numbers of episodes were compared between groups prior to the treatment intervention with one-way ANOVA, and Chi-Square respectively.

Repeated measures ANOVA was used to test differences between groups and within groups (within each treatment group over time) for the pain, Oswestry disability index and lumbar spine flexion ROM. Variables showing significant differences were retained for further post hoc using Scheff-test . All analysis was performed at alpha (P <0.05), as statistical significant, with two -tailed test.

The minimal clinically important difference was used to measure the effectiveness of treatment for an individual. The proportion of participants between the two groups that attained the minimal clinically important difference in pain and function in the primary outcome measures in each group was compared. A 20 mm reduction on a 100 mm visual analogue scale and a 10% change on a 0–100% scale of back pain disability on the Oswestry Disability Index was considered to be the minimal clinically important difference. In addition differences of 1cm on MST would be considered as the minimally important difference.


Out of the results of previous studies, and the sample size is estimated to be 80 participants in all group. This sample will be increased to 96 to a potential dropout rate of 20%. Sample size was calculated to detect the difference in pain intensity between the treatment and control groups was 20 mm with a standard deviation of 20 mm on the VAS, with the statistical power of 80%, and was due to the possibility of .05 level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2014
Actual
6/07/2014
Date of last participant enrolment
Anticipated
18/01/2015
Actual
31/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 6628 0
Saudi Arabia
State/province [1] 6628 0
riyadh

Funding & Sponsors
Funding source category [1] 290686 0
Other
Name [1] 290686 0
King Abdul-Aziz City for Science and Technology
Country [1] 290686 0
Saudi Arabia
Primary sponsor type
University
Name
King Saud University
Address
King Abdullah Road, Riyadh, Saudi Arabia
P.O Box 10219, Riyadh 11433, Saudi Arabia
college of Applied Medical Science, rehabilitation Health Science Department
Country
Saudi Arabia
Secondary sponsor category [1] 289380 0
None
Name [1] 289380 0
Address [1] 289380 0
Country [1] 289380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292318 0
Research Ethics Committes
Ethics committee address [1] 292318 0
Ethics committee country [1] 292318 0
Saudi Arabia
Date submitted for ethics approval [1] 292318 0
23/04/2014
Approval date [1] 292318 0
04/05/2014
Ethics approval number [1] 292318 0
CAMS 23-34/35

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 299 299 0 0
/AnzctrAttachments/367903-11-3-2014.doc

Contacts
Principal investigator
Name 54670 0
Miss Amal Al-Shareef
Address 54670 0
Rehabilitation Health Science, College of Applied Medical Science, King Saud University, Riyadh, Saudi Arabia
king Abdullah Road, Riyadh
P.O Box 10219, Riyadh 11433, Saudi Arabia
Country 54670 0
Saudi Arabia
Phone 54670 0
+966-012- 6493597
Fax 54670 0
Email 54670 0
momarar@cu.edu.eg
Contact person for public queries
Name 54671 0
Mohammed Taher Ahmed Omar
Address 54671 0
Rehabilitation Health Science, College of Applied Medical Science, King Saud University, Riyadh, Saudi Arabia
king Abdullah Road, Riyadh
P.O Box 10219, Riyadh 11433, Saudi Arabia
Country 54671 0
Saudi Arabia
Phone 54671 0
+966-012-4693597
Fax 54671 0
Email 54671 0
momarar@cu.edu.eg
Contact person for scientific queries
Name 54672 0
Mohammed Taher Ahmed Omar
Address 54672 0
Rehabilitation Health Science, College of Applied Medical Science, King Saud University, Riyadh, Saudi Arabia
king Abdullah Road, Riyadh
P.O Box 10219, Riyadh 11433, Saudi Arabia
Country 54672 0
Saudi Arabia
Phone 54672 0
+966-012-4693597
Fax 54672 0
Email 54672 0
momarar@cu.edu.eg

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
SourceTitleYear of PublicationDOI
EmbaseEffect of Kinesio taping on pain and functional disability in chronic nonspecific low back pain: A randomized clinical trial.2016https://dx.doi.org/10.1097/BRS.0000000000001447
N.B. These documents automatically identified may not have been verified by the study sponsor.