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MARCO AURÉLIO NEMITALLA ADDED, PT, MSc¹ • LEONARDO OLIVEIRA PENA COSTA, PT, PhD1,2 • DIEGO GALACE DE FREITAS, PT, PhD3
THIAGO YUKIO FUKUDA, PT, PhD3 • RENAN LIMA MONTEIRO, PT, MSc3 • EVELYN CASSIA SALOMÃO, PT, MSc¹
FLÁVIA CORDEIRO DE MEDEIROS, PT¹ • LUCÍOLA DA CUNHA MENEZES COSTA, PT, PhD¹
L
Copyright © 2016 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
ow back pain is a significant public health problem2,8,30 in order to summarize the best
that affects approximately 39% of individuals worldwide evidence for the care of these pa-
at some point in their lifetime.13,16 Because of this high pre tients.2,12,24 Several interventions
commonly used by physical ther-
valence, clinical practice guidelines have been developed
apists, such as manual therapy
techniques and exercises, are endorsed
TTSTUDY DESIGN: Randomized controlled trial. with care (5 weeks after treatment). Data were in most guidelines as effective treatments
TTBACKGROUND: Many clinical practice guide- collected by a blinded assessor. for patients with low back pain2,12,24; how-
lines endorse both manual therapy and exercise TTRESULTS: No between-group differences were ever, the effect of these techniques is, at
Journal of Orthopaedic & Sports Physical Therapy®
as effective treatment options for patients with low observed in the primary outcomes of pain intensity best, moderate.10,12,15 Therefore, new in-
back pain. To optimize the effects of the treatments (mean difference, –0.01 points; 95% confidence
terventions have been tested in order to
recommended by the guidelines, a new interven- interval [CI]: –0.88, 0.85) or disability (mean
tion known as Kinesio Taping is being widely used difference, 1.14 points; 95% CI: –0.85, 3.13) at 5
enhance the effects of existing treatments.
in these patients. weeks’ follow-up. In addition, no between-group One method that has long been used
TTOBJECTIVES: To determine the effectiveness of differences were observed for any of the other to treat patients, from those in rehabilita-
Kinesio Taping in patients with chronic nonspecific outcomes evaluated, except for disability 6 months tion clinics to Olympic athletes, is Kinesio
low back pain when added to a physical therapy after randomization (mean difference, 2.01 points; Taping. The Kinesio Taping method was
program consisting of exercise and manual therapy. 95% CI: 0.03, 4.00) in favor of the control group. introduced at the Olympic Games in Ath-
TTMETHODS: One hundred forty-eight patients TTCONCLUSION: Patients who received a physi- ens and has since gained in popularity.19
with chronic nonspecific low back pain were cal therapy program consisting of exercise and One of the main objectives of the method,
randomly allocated to receive 10 (twice weekly) manual therapy did not get additional benefit from
according to its creators, is to reduce pain
sessions of physical therapy, consisting of exercise the use of Kinesio Taping.
by inhibiting the nociceptive stimuli with
TTLEVEL OF EVIDENCE: Therapy, level 1b.
and manual therapy, or the same treatment with
the addition of Kinesio Taping applied to the lower elastic tape.18,19
Prospectively registered May 28, 2013 at www.
back. The primary outcomes were pain intensity The evidence of the benefits that Kine-
ClinicalTrials.gov (NCT01866332). J Orthop Sports
and disability (5 weeks after randomization) and sio Taping can provide for patients with
Phys Ther 2016;46(7):506-513. Epub 6 Jun 2016.
the secondary outcomes were pain intensity, dis-
doi:10.2519/jospt.2016.6590 chronic low back pain is still scarce. To
ability (3 months and 6 months after randomiza-
tion), global perceived effect, and satisfaction TTKEY WORDS: exercise, manual therapy, tape date, 4 randomized controlled trials have
been published,5,20,27,29 2 of which did
1
Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil. 2Musculoskeletal Division, The George Institute for Global Health,
Sydney, Australia. 3Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil. This clinical trial was approved by the Research Ethics Committee of Universidade
Cidade de São Paulo (protocol 254.063) and prospectively registered at www.ClinicalTrials.gov (NCT01866332). This clinical trial received funding from the Fundação de Amparo
a Pesquisa do Estado de São Paulo (2013/02075-8), the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, and Conselho Nacional de Desenvolvimento Científico
e Tecnológico (474012/2013-1). The authors certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the
subject matter or materials discussed in the article. Address correspondence to Dr Lucíola da Cunha Menezes Costa, Universidade Cidade de São Paulo, Rua Cesário Galeno
448, Tatuapé, CEP 03071-100, São Paulo, SP, Brazil. E-mail: luciolamenezes@gmail.com t Copyright ©2016 Journal of Orthopaedic & Sports Physical Therapy®
506 | july 2016 | volume 46 | number 7 | journal of orthopaedic & sports physical therapy
GRADE system means that new studies Prior to randomization, a blinded asses- with care.
have the potential to modify the results sor collected the data at baseline using All scales and questionnaires have
of current evidence.14 All systematic re- an evaluation form with questions on been translated and cross-culturally
views published to date indicate the need clinical and sociodemographic charac- adapted to the Brazilian population, and
Copyright © 2016 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
for new randomized controlled trials with teristics, as well as the following outcome their respective measurement properties
medium- to long-term follow-up and low measures: have been assessed.9,11,25 These measures
risk of bias.3,22,23,28 Most important, no 1. Numeric pain-rating scale,9 which are recommended by an expert commit-
studies have investigated the addition of assesses pain intensity. This is an tee on low back pain as essential instru-
Kinesio Taping to a physical therapy pro- 11-point scale ranging from 0 (no ments for all clinical trials that include
gram consisting of exercise and manual pain) to 10 (the worst possible pain). patients with low back pain.6
therapy. The participants were instructed to The primary outcome measures were
Therefore, the objective of this ran- report the level of pain intensity in the pain intensity and disability measured
domized controlled trial was to compare last 7 days. at 5 weeks after randomization (imme-
Journal of Orthopaedic & Sports Physical Therapy®
the effectiveness of adding Kinesio Taping 2. Roland-Morris Disability Question- diately after treatment). The secondary
to a physical therapy program in patients naire,9,25 which evaluates the patient’s outcome measures were pain intensity
with chronic nonspecific low back pain. level of disability by assessing disabil- and disability at 3 and 6 months after
ity associated with low back pain. The randomization and global perceived ef-
METHODS instrument consists of 24 questions fect at 5 weeks, 3 months, and 6 months
that describe daily tasks that patients after randomization. Another secondary
Study Design have difficulty performing due to low outcome evaluated was satisfaction with
T
his is a 2-arm, randomized con- back pain, with scores ranging from 0 care at 5 weeks after randomization. All
trolled trial with a blinded assessor. to 24, higher scores indicating greater baseline assessments were conducted in
This clinical trial was approved by disability. person, but the vast majority of data col-
the Research Ethics Committee of Uni- 3. Global perceived effect scale,9 which lected during the follow-up assessments
versidade Cidade de São Paulo (protocol assesses the global impression of re- were collected over the phone.
254.063) and prospectively registered at covery after receiving the treatment All patients deemed eligible for the
www.ClinicalTrials.gov (NCT01866332). by measuring change in status from study were tested for allergic reaction
All methodological details of this trial the onset of symptoms to the last few to the Kinesio Tape (Kinesio Holding
were published before the start of the days. The instrument is an 11-point Corporation, Albuquerque, NM) prior
data collection.1 numeric scale ranging from –5 (abso- to randomization. The test consisted of
lutely worse) to 0 (no changes) to +5 applying a small piece of Kinesio Tape to
Participants (completely recovered). the thoracic spine of patients and leaving
The participants were recruited and 4. MedRisk Instrument for Measuring it for 24 hours. If the participants devel-
treated at the rehabilitation department Patient Satisfaction With Physical oped allergies or intolerance to the tape,
of Irmandade da Santa Casa de Mi- Therapy Care,4,11 which is a 13-item they were excluded from the study. If they
sericórdia de São Paulo (São Paulo, Bra- questionnaire that assesses satisfac- did not, they were allocated to one of the
zil) from June 2013 to November 2014. tion with physical therapy care. Each treatment groups.
journal of orthopaedic & sports physical therapy | volume 46 | number 7 | july 2016 | 507
FIGURE 1. Application of Kinesio Tape. The initial anchor point was applied to the S1 region (0% tension). Subsequently, the participant was asked to flex the trunk, and the
tape was applied over the skin of the T12 vertebra at 10% to 15% tension (paper-off tension). The final anchor point was fixed directly above T12 (0% tension), according to the
principles of the technique.18,19,29
Randomization and Interventions terventions were reducing pain intensity, to standardize the approach. All senior
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Immediately after the allergy test, the muscle strengthening, improving motor authors (L.O.P.C., L.C.M.C., D.G.F., and
therapist completed a checklist to deter- control, and promoting the independence T.Y.F.) audited the interventions over the
mine whether the eligibility criteria of of the participant. trial period.
patients were correct, then opened the The group that received physical
Copyright © 2016 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
randomization envelope prior to start- therapy plus Kinesio Taping had the Blinding
ing the first session of treatment. The elastic tape applied to the lower back at In this study, the assessor was blinded
randomization sequence was created the end of the sessions. Prior to applica- to the allocation of participants in their
using Microsoft Excel (Microsoft Corpo- tion, the area was shaved (if necessary) respective groups; however, given the na-
ration, Redmond, WA) and sealed in se- and cleansed to improve adherence. The ture of the interventions, it was not pos-
quentially numbered, opaque envelopes Kinesio Tape was positioned bilaterally sible to blind both the therapists and the
by a researcher who was not involved in on the erector spinal muscles parallel to patients.
the assessment or treatment of patients. the spinous processes of the lumbar ver-
Once the envelope was opened, the pa- tebrae (FIGURE 1). Sample-Size Calculation
Journal of Orthopaedic & Sports Physical Therapy®
tient was allocated to 1 of 2 groups: After that, the participant was in- The sample-size calculation was based
physical therapy or physical therapy plus structed to leave it on for 48 hours and on the detection of a 1-point difference
Kinesio Taping. return to normal activities, such as bath- between groups for the outcome of pain
Both groups received physical thera- ing, doing household chores, working, intensity, assessed by the numeric pain-
py treatment consisting of exercise and etc. If the participant developed any kind rating scale (estimated SD of 1.84), and a
manual therapy. The therapists could ap- of skin reaction, he or she was instructed 4-point difference for the outcome of dis-
ply the manual therapy techniques that to remove the tape. ability, measured by the Roland-Morris
were appropriate to the patient (includ- The sessions were 30 to 60 minutes Disability Questionnaire (estimated SD
ing joint mobilization and myofascial long, twice a week for 5 weeks. All partici- of 4.9),10 with a statistical power of 80%,
release), as well as general exercise (eg, pants were instructed to do the muscle- alpha of 5%, and possible sample loss
aerobic exercise and strengthening of the strengthening exercises at home, once of up to 15%. Therefore, 74 participants
large muscle groups such as rectus ab- a day (3 sets of 10 repetitions for each were needed per group (148 in total).
dominis and gluteus maximus) and spe- exercise); however, these home exercises
cific exercises to strengthen the lumbar were not monitored. A total of 3 physi- Statistical Analysis
spine (eg, strengthening of transversus cal therapists with an average of 6 years All statistical procedures were performed
abdominis and lumbar multifidus). The of clinical experience participated in this according to the principles of intention
decision to use 1 or more resources was trial. All were trained in manual therapy to treat. First, we conducted descriptive
pragmatic; that is, the therapist would (Maitland’s approach). The correspond- analyses and histogram inspections to
decide what procedures to use at each ing author (L.C.M.C.) is certified by the determine data normality (or lack there-
session based on clinical reasoning. Kinesio Taping Association International of ). The between-group comparisons to
These techniques were applied ac- (levels KT1 and KT2) and provided train- obtain the mean effects were conducted
cording to the clinical presentation of ing to the therapists on how to apply the by means of interaction terms (group ver-
each patient, as routinely assessed by Kinesio Tape. All therapists were formal- sus time interactions) using linear mixed
the therapist. The objectives of the in- ly trained for a period of 1 week in order models. The statistical analysis was
508 | july 2016 | volume 46 | number 7 | journal of orthopaedic & sports physical therapy
Excluded, n = 50
Randomized, n = 148
Participant
Physical therapy group, n = 74 Physical therapy plus Kinesio Taping group, n = 74
Allocation
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conducted by a researcher who was not transplant during the treatment period (n a participant in the group that received
involved in any of the phases of data col- = 1), multiple myeloma in the spine (n = physical therapy plus Kinesio Taping
lection and received data in coded form. 1), chemotherapy (n = 1), anxiety (n = 1), declined to answer the questionnaires
Journal of Orthopaedic & Sports Physical Therapy®
The differences were considered statisti- already receiving physical therapy treat- due to high pain intensity and because
cally significant at P<.05. The software ment (n = 1), and hepatomegaly (n = 1). he wanted to receive more sessions than
package SPSS 19 (IBM Corporation, Ar- Regarding the number of sessions, of the protocol allowed. There were only 3
monk, NY) was used for these analyses. the 1480 predicted sessions (n = 148 × 10 losses to follow-up, which reflects an ex-
sessions), only 47 absences were recorded cellent follow-up rate (FIGURE 2).
RESULTS (3.17%). On average, each patient attend- TABLE 1 shows the demographic char-
ed 9.70 1.00 sessions for the physical acteristics of the participants in their
A
total of 198 potential partici- therapy group and 9.66 1.17 sessions respective groups. The study included
pants sought treatment for back for the physical therapy plus Kinesio Tap- mainly single women who had completed
pain over the course of the study. Of ing group, which represents an excellent primary education. The groups had simi-
this total, 50 were considered ineligible adherence to treatment. The groups did lar baseline characteristics.
(FIGURE 2). The reasons for exclusion were not differ in their adherence (P = .82). In TABLE 2 shows the mean SD pain
back pain due to nerve root compromise 5 cases (6.7%), some type of skin irrita- intensity, disability, and global perceived
(n = 17), decompensated heart disease (n tion occurred due to the application of effect for all time points. The results in-
= 6), withdrawal prior to the start of the the Kinesio Tape; however, this irritation dicate that symptoms improved with the
study (n = 5), age above 60 years (n = 3), subsided before the following session and interventions and that this improvement
vertebral fracture (n = 3), previous surgery did not prevent the participants from was maintained over time. TABLE 3 shows
to the lumbar spine (n = 2), knee surgery completing the study. One participant the within- and between-group differ-
scheduled for the study period (n = 2), no from the physical therapy group was mis- ences for all outcomes. The within-group
telephone number for follow-up (n = 2), takenly treated with Kinesio Tape starting analysis found that the treatments re-
lower-limb tumor (n = 1), acute low back in the fifth session, but was analyzed in duced pain and disability and increased
pain (n = 1), contraindications to the use his original group following the recom- the participant’s perceived improvement
of Kinesio Taping (n = 1), pain in the tho- mendations of intention-to-treat analysis. (about 35% improvement, which can be
racic spine (n = 1), scheduled bone marrow During the 3-month reassessment, considered as clinically important).26 In
journal of orthopaedic & sports physical therapy | volume 46 | number 7 | july 2016 | 509
T
his randomized controlled tri- Height, m 1.64 0.9 1.64 0.9 1.64 0.9
al aimed to compare the effective-
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Body mass index, kg/m2 26.6 4.7 26.1 4.4 27.1 5.0
ness of adding Kinesio Taping to a Marital status, n (%)
physical therapy program consisting of
Single 62 (41.9) 31 (41.9) 31 (41.9)
exercise and manual therapy in patients
Married 60 (40.5) 31 (41.9) 29 (39.2)
with chronic nonspecific low back pain
Copyright © 2016 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
physical therapy did not enhance treat- Masters degree 0 (0) 0 (0) 0 (0.0)
ment outcomes at any point in time. An- PhD 1 (0.7) 0 (0) 1 (1.4)
other outcome measured was the level Use of medication, n (%) 73 (49.3) 39 (52.7) 34 (45.9)
of satisfaction with care, which was very
Recent episode of low back pain, 37 (25.0) 20 (27.0) 17 (23.0)
high in both groups. Similarly, there were n (%)‡
no between-group differences in satisfac-
Regular exercise, n (%)§ 39 (26.4) 18 (24.3) 21 (28.4)
tion levels.
Smoking, n (%) 20 (13.5) 12 (16.2) 8 (10.8)
Currently, there is 1 meta-analysis
related to prevention and treatment of Medical leave, n (%) 10 (6.8) 7 (9.5) 3 (4.1)
sports injuries,31 and there are 5 system- Paid medical leave, n (%) 4 (2.7) 3 (4.1) 1 (1.4)
atic reviews, including 217,22 with different Pain intensity (0-10) 7.5 1.72 7.4 1.69 7.5 1.76
clinical conditions and 33,23,28 that assess Global perceived effect (–5 to +5)‖ –1.57 2.97 –1.3 2.88 –1.8 1.76
musculoskeletal conditions, of the effects
Disability (0-24) 13.5 5.77 14.1 5.95 13.0 5.57
of Kinesio Taping. None of the studies cit-
Abbreviations: KT, Kinesio Taping; PT, physical therapy.
ed above provide favorable results for the *Values are mean SD unless otherwise indicated.
use of this method. The randomized con- †
Values are median (interquartile range).
trolled trials that evaluated the musculo- ‡
Did you have an episode of back pain recently? (yes/no).
§
Do you practice any physical activity? (yes/ no).
skeletal conditions published to date have ‖
Compared to when the episode started, how would you describe your back these days?
moderate methodological quality22,23,28
and, for the most part, small samples (ie,
42 patients per trial).28,31 Furthermore, of the present study, not only for the sci- tients in order to better understand the
the quality of the evidence against the entific community but also for clinicians, effects of adding Kinesio Taping to the
use of Kinesio Taping28 varies from low to because it aims to minimize the risk of treatment of patients with chronic low
very low. This reinforces the importance bias and use an appropriate sample of pa- back pain. Another strength of this study
510 | july 2016 | volume 46 | number 7 | journal of orthopaedic & sports physical therapy
Baseline 5 wk 3 mo 6 mo
PT Plus KT PT Plus KT PT Plus KT PT Plus KT
Outcome PT (n = 74) (n = 74) PT (n = 74) (n = 74) PT (n = 73) (n = 73) PT (n = 73) (n = 72)
Pain intensity (0-10) 7.40 1.69 7.55 1.76 4.70 2.77 4.86 3.00 5.91 2.84 5.59 2.76 5.67 2.98 5.74 3.10
Disability (0-24) 14.07 5.95 12.97 5.57 9.03 7.51 9.07 7.56 9.70 7.63 9.46 7.96 8.61 8.20 9.51 7.67
Global perceived effect –1.28 2.88 –1.85 3.05 2.74 2.34 2.30 3.00 1.60 3.17 1.68 3.18 1.15 3.15 0.83 3.58
(–5 to +5)†
Satisfaction with care (1-5)
Interpersonal ... ... 4.7 0.38 4.7 0.37 ... ... ... ...
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Efficiency/convenience ... ... 4.8 0.59 4.7 0.64 ... ... ... ...
Patient education ... ... 4.6 0.81 4.5 0.93 ... ... ... ...
Abbreviations: KT, Kinesio Taping; PT, physical therapy.
*Values are mean SD.
Copyright © 2016 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
†
Compared to when the episode started, how would you describe your back these days?
that do not support the application of Pain Intensity (0-10) Disability (0-24) (–5 to +5)
Kinesio Taping in patients with chronic Within-group differences
nonspecific low back pain. The study by Week 5 – baseline
Paoloni et al27 aimed to evaluate pain in-
PT 2.70 (2.03, 3.38) 5.04 (3.48, 6.60) –4.03 (–4.83, –3.23)
tensity and disability in 39 patients with
PT plus KT 2.69 (2.03, 3.35) 3.89 (2.48, 5.30) –4.15 (–5.12, –3.18)
chronic low back pain after 4 weeks of
treatment. The patients were allocated Month 3 – baseline
into 3 different groups: Kinesio Taping PT 1.50 (0.85, 2.17) 4.31 (2.91, 5.72) –2.93 (–3.81, –2.05)
alone, muscle strengthening and relax- PT plus KT 1.99 (1.30, 2.67) 3.49 (2.02, 4.97) –3.60 (–4.42, –2.78)
ation techniques, and a combination of Month 6 – baseline
the 2 interventions. As in the present
PT 1.75 (1.03, 2.47) 5.41 (3.60, 7.22) –2.48 (–3.39, –1.57)
study, the analysis of the results showed
PT plus KT 1.89 (1.18, 2.59) 3.61 (2.20, 5.02) –2.83 (–3.79, –1.87)
no statistically significant difference
between groups. Castro-Sánchez et al5 Between-group differences
journal of orthopaedic & sports physical therapy | volume 46 | number 7 | july 2016 | 511
T
One of the differences between the he literature suggests that the trials in non-specific low back pain. Eur Spine
J. 2015;24:2097. http://dx.doi.org/10.1007/
existing clinical trials is in relation to use of Kinesio Taping in isolation
s00586-015-3984-0
patient follow-up periods. Paoloni et provides no benefit to patients with 7. Costa LC, Koes BW, Pransky G, Borkan J,
al27 and Castro-Sánchez et al5 included chronic low back pain.20,29 Similarly, its use Maher CG, Smeets RJ. Primary care research
a short-term follow-up period, while as an additional method in a treatment priorities in low back pain: an update. Spine
(Phila Pa 1976). 2013;38:148-156. http://dx.doi.
the present study conducted follow-ups program based on exercise and manual
org/10.1097/BRS.0b013e318267a92f
for up to 6 months from randomization. therapy did not alter the outcomes, as 8. Costa LC, Maher CG, Hancock MJ, McAuley JH,
The 3 clinical trials published to date5,27,29 shown by the results of our study. t Herbert RD, Costa LO. The prognosis of acute
evaluated the effect of Kinesio Taping and persistent low-back pain: a meta-analysis.
CMAJ. 2012;184:E613-E624. http://dx.doi.
with different objectives: isolated, com- KEY POINTS org/10.1503/cmaj.111271
bined with global strengthening exercis- FINDINGS: In patients with back pain who 9. Costa LO, Maher CG, Latimer J, et al. Clini-
es, and the form of application. Our study received physical therapy consisting of metric testing of three self-report outcome
aimed to replicate clinical practice and exercises and manual therapy, this study measures for low back pain patients in Brazil:
Downloaded from www.jospt.org at on July 2, 2016. For personal use only. No other uses without permission.
512 | july 2016 | volume 46 | number 7 | journal of orthopaedic & sports physical therapy
@ MORE INFORMATION
http://dx.doi.org/10.3109/09593985.2012.731675 in chronic low back pain patients. Eur J Phys
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journal of orthopaedic & sports physical therapy | volume 46 | number 7 | july 2016 | 513