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- Braz J Phys Ther
- v.19(6); Nov-Dec 2015
- PMC4668342
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Braz J Phys Ther. 2015 Nov-Dec; 19(6): 482–490.
Published online 2015 Oct 9. doi:10.1590/bjpt-rbf.2014.0128
PMCID: PMC4668342
PMID: 26647750
Maurício A. Luz, Júnior,1,2 Manoel V. Sousa,2 Luciana A. F. S. Neves,2 Aline A. C. Cezar,2 and Leonardo O. P. Costa3,4
Author information Article notes Copyright and License information PMC Disclaimer
Abstract
Background:
Kinesio Taping® has been widely used in clinical practice. However, it is unknownwhether this type of tape is more effective than placebo taping in patients withchronic lower back pain.
Objective:
To compare the effectiveness of Kinesio Taping® in patients with chronic non-specific low back pain against a placebotape and a control group.
Method:
This is a 3-arm, randomized controlled trial with a blinded assessor. Sixtypatients with chronic non-specific low back pain were randomized into one of thethree groups: Kinesio Taping® group (n=20), Micropore® (placebo) group (n=20) andcontrol group (n=20). Patients allocated to both the KinesioTaping® group and the placebo group used the different types of tape for aperiod of 48 hours. The control group did not receive any intervention. Theoutcomes measured were pain intensity (measured by an 11-point numerical ratingscale) and disability (measured by the 24-item Roland Morris DisabilityQuestionnaire). A blinded assessor measured the outcomes at baseline, 48 hours and7 days after randomization.
Results:
After 48 hours, there was a statistically significant difference between theKinesio Taping® group versus the control group (mean between-group difference = -3.1points, 95% CI=-5.2 to -1.1, p=0.003), but no difference when compared to theplacebo group (mean between-group difference= 1.9 points, 95% CI=-0.2 to 3.9,p=0.08). For the other outcomes no differences were observed.
Conclusions:
The Kinesio Taping® is not better than placebo (Micropore®) in patients withchronic low back pain.
Keywords: physical therapy, kinesio taping, tape, lower back pain, rehabilitation
Introduction
Low back pain is a serious worldwide health problem1,2 and has been quoted as the major cause ofdisability around the world3,4. In Brazil, spinal pain (cervical, thoracic andlumbar) was considered the second most prevalent complaint, affecting approximately13.5% of the population5. It is estimated thatglobally 39% of the population will have at least one episode of back pain throughouttheir lives6. In episodes of pain greater than 12weeks (classified as chronic lower back pain2),the prognosis is unfavorable2 and is highlyassociated with high treatment costs and work absenteeism7.
A technique widely used today to assist in the treatment of various musculoskeletalconditions is an elastic tape, called Kinesio Taping®2,8,9. The technique was developed in the 1970s in Japan by Kase et al.10 and consists of tape applied to the skin. Thistape has elasticity in the longitudinal direction with an elongation of 40% to 60% fromits resting length10. The effects of theKinesio Taping® described by its creators included: changes in muscle activation, reductionof pain, joint repositioning and reduction of abnormal muscular tension10,11. The use of this technique is widespread inthe sports area12,13 and is also common in clinical practice14. In the 2008 Olympics, kilometers ofKinesio Taping® tapes were donated to the delegations of 58 countries, increasing itsexposure and curiosity in the use of the tape13,15. At the 2012 Olympics, it was noted that thetechnique had been used by more than 80 delegations12.
In recent years, an increasing number of studies using Kinesio Taping® for pain relief have been conducted16-20; however only three of them used theKinesio Taping® in the treatment of non-specific chronic lower back pain16,17,19. Parreira et al.16 compared two forms of application of this tape. One group ofpatients received the tape as described in the official manual of KinesioTaping® Association International21, withtension between 10-15%, generating circumvolutions which are winding movements of thetape around a body part, and in a second group, the tape was applied without any tensionto avoid circumvolutions. The authors found no significant difference between groups,which raises the question about the need of circumvolutions when applying the tape.Castro Sánchez et al.17compared theKinesio Taping® with a placebo group and the results showed that, although statisticallysignificant for the pain and disability outcomes, the effects were so small that authorsdid not considered clinically important in relation to the placebo application results.Paoloni et al.19used the KinesioTaping® combined with therapeutic exercises. Although the authors observed adecrease in the EMG activity in the paraspinal muscles in patients who underwent theKinesio Taping® methods, the results were not statistically significant for the pain whencompared to patients who only underwent therapeutic exercises. Studies have beencompiled in systematic reviews8,13,22-24 and meta analysis25, and concluded, based on recommendations of the Grading ofRecommendations, Assessment, Development, and Evaluation (GRADE) from the CochraneCollaboration26, that there is low qualityevidence for the application of Kinesio Taping® in patients with lower back pain. The term "low quality evidence" meansthat further studies may or may not eventually alter the conclusions of thesereviews26. Therefore, new randomizedcontrolled trials with high methodological quality trials need to be conducted.
To date, there is no information on the effects of Kinesio Taping® due to the lack of studies that compared a group of patients receiving tothis intervention versus a control group that did not receive the intervention.Furthermore, in the presence of some beneficial effect, it was unclear whether thiseffect was due to the intervention or simply due to a placebo effect. Therefore, the aimof this study was to compare the effectiveness of applying KinesioTaping®, Micropore® taping (placebo therapy) and a control group with notaping on the outcomes of pain and disability in patients with chronic non-specific lowback pain. The observed results were obtained 48 hours and seven days following theapplication of the different taping methods to the 2 groups for 48 hours. Our hypothesiswas that patients who received Kinesio Taping® would demonstrate greater clinical improvements when compared to patientsallocated to the placebo and control groups.
Method
Study design
A three-arm, randomized controlled trial with a blinded assessor was conducted. Thisstudy was approved by the Research Ethics Committee of UniversidadePaulista (UNIP), São Paulo, SP, Brazil (number 304 408) and prospectivelyregistered at ClinicalTrials.gov (NCT0200766). All patients signed a consent formbefore the inception of the study.
Study location
The present study was conducted at the Physical Therapy Clinic of UNIP, CampusJundiaí, SP, Brazil and at private physical therapy clinics in Campo Limpo PaulistaCity, SP, Brazil, from August to December of 2013.
Subjects
Subjects of both sexes and between 18 and 80 years of age were included. They werereferred to physical therapy service by a physician for treatment of chronicnon-specific low back pain (back pain of mechanical origin, apparently without adefined cause, for at least 12 weeks duration)27. In addition, participants had not had any physical therapy treatmentin the past six months and had never used Kinesio Taping®. Exclusion criteria were: presence of skin diseases; contraindicationdue to the use of the tape, serious spinal pathologies such as a tumor, aninflammatory disease or fracture; nerve root compromise; pregnancy; subjects who hadphysical therapy treatment in the past six months, and subjects who had used or hadprior knowledge of the Kinesio Taping® method. Nerve root compromise was tested through clinical examinationinvolving tests of strength, sensitivity and reflexes following the recommendationsof the European Guidelines for the Management of Patients with BackPain1.
Randomization and interventions
After the baseline assessment, participants were referred to the physical therapistresponsible for the interventions. An independent researcher, who was not involved inthe recruitment of the participants, executed a randomization program on a computerto assign each individual to a specific test group. Each participant received asealed, opaque envelope that revealed their assigned group. The groups were:
Kinesio Taping® Group: the Kinesio® Tex Classic beige tape was used and applied over the erectorspinae muscle with 10-15% of tension in the stretched position, as describedin the official manual of Kinesio Taping® Association International21.
Micropore® Group: the Micropore® 3M®tapebeige tape was used and applied over the erector spinae muscle in thestretched position.
Control Group: this group did not receive any tape intervention.
The participants allocated to the Kinesio Taping® and Micropore® intervention groups received the tapeapplication once and the tape remained in place for 48 hours, following theinstructions of the Kinesio Taping® Association International to minimize the risk of allergies or skindamage. After the application, the subjects were instructed to remove the tape ifthey had any allergic reaction due to the tape, and in cases where the tapes becameloose and began to fall off, the subjects were instructed to report when the tapefell off or was removed to the evaluators at the next evaluation which was when thetape was supposed to be removed (then the tape was re-applied). The application wasperformed by a physical therapist who had over nine years of clinical experience intreating patients with lower back pain and had formal training in the application ofKinesio Taping® (level KT3) of the Kinesio Taping® Association International). After randomization, instructions about thecharacteristics and expected effects of the Kinesio Taping®, such as pain relief, were given to the Kinesio Taping® and Micropore® groups. During the application of the tapes tothe groups receiving intervention, subjects were positioned backwards to the physicaltherapist applying the tape and the distal part of the tape was attached to theposterior superior iliac spine; subjects were then asked to bend the trunk forwarduntil they were in a comfortable flexed position. The tapes were applied over theerector spinae muscles bilaterally moving upward to the 8ththoracicvertebrae. The therapists took about 1-2 minutes to apply the tapes. The controlgroup did not receive any intervention. All subjects were scheduled to begin thephysical therapy treatment at the end of the test period (i.e. 7 days afterrandomization).
Evaluation and instruments
The evaluations were performed at baseline, 48 hours and seven days afterrandomization, by a blinded evaluator who was unaware of which group the subjectswere allocated to. The initial assessment occurred in the clinic and the 48-hourevaluation was conducted by telephone. The evaluation at seven days, in most cases,was carried out in the clinic when the patient returned to start the conventionalphysical therapy treatment. If the patient missed the day to start the conventionaltreatment, the evaluation was also conducted by telephone. It was impossible to blindthe therapist to the different tapes applied. Furthermore, due to the presence of agroup with no taping, the subjects were not blinded to the treatment theyreceived.
The outcomes measured were pain intensity and disability. Pain intensity wasevaluated using a pain numeric rating scale28,consisting of 11 items, with 0 being "no pain" and 10 the "worst possible pain".Disability was assessed using the Brazilian version of the Roland Morris DisabilityQuestionnaire (RMDQ)29, which contains 24items related to daily activities that might be impaired due to low back pain whereeach affirmative answer corresponds to a point on the scale. The final score of theRMDQ was determined by summation of the values obtained: the higher the score, thegreater the disability. These scales were cross culturally adapted and tested for theBrazilian Portuguese language30,31.
Statistical analysis
The study was designed to detect a clinically important difference for the outcomesof pain and disability32. For pain intensity,a difference of two points was calculated, as measured by the Portuguese version ofthe Numerical Pain Rating Scale (with a standard deviation estimated at 2.05 points),and three points for disability assessed by Roland Morris DisabilityQuestionnaire29 (with a standard deviationestimated at 5.1 points). A α=0.05, a statistical power of 80% and a sample loss of15% were considered. The sample size calculation resulted in a sample of 20participants per group, totaling 60 subjects.
A double entry of data was performed, and the analysis followed the principles ofintention to treat. Data normality was tested by visual inspection of the histograms,and all data were normally distributed. The confidence interval was set to 95% forall analyses. Estimates of average effects (i.e. between-group differences) for alloutcomes were calculated using linear mixed models. These longitudinal models ofanalyses incorporate terms for treatment groups (Kinesio Taping®, placebo and control), time (baseline, 48 hours, and seven dayspost-randomization), and interactions terms of group versus time. The regressioncoefficients from the interaction group versus time were equivalent to the estimatesof the between group differences of the effects of interventions. The post-hocanalyses for multiple comparisons were performed. Data were analyzed using the SPSS19 for Windows software.
Results
The recruitment of the subjects from the physical therapy clinics was conducted betweenAugust and December of 2013. Eighty-three patients with chronic low back pain wereenrolled; of these, 23 were excluded because they did not meet the eligibility criteria.Eight patients declined to participate, nine had previously undergone back surgery, fivewere excluded because of nerve root compromise and one was excluded due to the presenceof psoriasis (Figure 1).
Figure 1
Flow diagram of participants throughout the study.
This study included 60 participants with chronic non-specific low back pain, randomlyallocated into three groups; a Kinesio Taping® group (11 women and nine men, mean age of 44.3 years, SD=15.0); aMicropore® group (13 women and seven men, mean age of 50.1 years,SD=17.5); and a control group (17 women and three men, mean age of 48.1 years, SD=13.4).The demographic characteristics of the sample are shown in Table 1.
Table 1.
Baseline characteristics of subjects with chronic low back pain whor*ceived Kinesio Taping, micropore taping or had no intervention.
| Variable | Participants | ||
|---|---|---|---|
| Kinesio Taping® (n=20) | Micropore® Taping (n=20) | Control (n=20) | |
| Age (y) | 44.3 (15.0) | 50.1 (17.5) | 48.1 (13.4) |
| Gender | |||
| Male | 9 (45) | 7 (35) | 3 (15) |
| Female | 11 (55) | 13 (65) | 17 (85) |
| Duration of low back pain(mo)* | 76.4 (61.6) | 49.6 (42.4) | 82.2 (63.4) |
| Weight (kg) | 72.5 (7.1) | 74.9 (15.7) | 79.7 (20.9) |
| Height (m) | 1.67 (0.1) | 1.66 (0.1) | 1.65 (0.1) |
| Body mass index (kg/m2) | 26.0 (3.0) | 27.1 (4.7) | 30.3 (7.4) |
| Marital status | |||
| Single | 2 (10) | 3 (15) | 1 (5) |
| Married | 16 (80) | 13 (65) | 18 (90) |
| Divorced | 2 (10) | 1 (5) | 1 (5) |
| Widower | 0 (0) | 3 (15) | 0 (0) |
| Academic level | |||
| Primary education | 10 (50) | 10 (50) | 13 (65) |
| Secondary education | 6 (30) | 6 (30) | 4 (20) |
| Academic education | 3 (15) | 4 (20) | 3 (15) |
| MBA | 1 (5) | 0 (0) | 0 (0) |
| Income (in minimum wages) | 3.3 (2.4) | 3.6 (3.1) | 3.1 (2.2) |
| Physical therapy treatment | |||
| Yes | 11 (55) | 11 (55) | 9 (45) |
| Use of medication | |||
| Yes | 9 (45) | 6 (30) | 5 (25) |
| Pain intensity (0-10) | 6.6 (1.2) | 6.7 (1.6) | 6.1 (2.1) |
| Disability (0-24) | 12.9 (5.6) | 12.2 (6.5) | 11.8 (6.5) |
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The categorical variables are expressed as n (%), and the continuousvariables are expressed as mean (SD). *Expressed as median (IQR).
Regarding the use of medications, in the Kinesio Taping® group nine patients were taking medication as follows: four were takingpainkillers, three were taking muscle relaxants and two were taking anti inflammatorydrugs. In the Micropore® group, six patients were using medication asfollows: one patient was taking analgesics, three were taking muscle relaxants and twowere taking anti-inflammatory drugs. In the control group, five patients were usingmedication as follows: two were taking painkillers, one was taking a muscle relaxant andtwo were taking anti-inflammatory drugs.
From the Kinesio Taping® group, two participants (10%) abandoned the study and missed the evaluationphases of 48 hours and seven days. From the Micropore® group, one participant(5%) abandoned the study and missed the 48-hour and seven days evaluation. From thecontrol group, none of the participants abandoned the study.
Table 2 shows the mean and standard deviation ofthe pain intensity28 and disability29. Table 3shows the between-group analysis for all comparisons. A statistically significantdifference was observed between the Kinesio Taping® group and control group for the disability outcome (mean difference of -3.1points; 95% CI=-5.2 to -1.1) at the 48-hour follow up. No differences were detectedbetween the Kinesio Taping® and placebo groups for all the outcomes analyzed.
Table 2.
Means (SD) at baseline and 48 hours and seven-day follow-ups for subjectswith chronic low back pain who received Kinesio Taping, Micropore taping or hadno intervention.
| Outcome | Interventions | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Follow-up 48 hours | Follow-up 7 days | ||||||||||
| Kinesio Taping® Group | Micropore® Taping Group | Control Group | Kinesio Taping® | Micropore® Taping Group | Control Group | Kinesio Taping® | Micropore® Taping Group | Control Group | ||||
| Pain | 6.6 | 6.7 | 6.1 | 4.9 | 5.1 | 5.4 | 5.8 | 6.3 | 5.5 | |||
| (0-10) | (1.2) | (1.6) | (2.1) | (2.6) | (2.7) | (2.6) | (1.3) | (2.0) | (1.9) | |||
| Disability | 12.8 | 12.2 | 11.8 | 8.6 | 9.4 | 10.6 | 9.6 | 10.2 | 10.3 | |||
| (0-24) | (5.6) | (6.5) | (6.5) | (5.6) | (6.7) | (6.9) | (5.6) | (7.4) | (6.6) | |||
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Data expressed as mean and standard deviation (SD).
Table 3.
Between-group differences at 48 hours and 7-days after randomization forsubjects with chronic low back pain who received Kinesio Taping, Microporetaping or had no intervention.
| Outcome | Difference between interventions Adjusted Mean Difference (95%CI) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Follow-up at 48 hours (95% CI), p | Baseline to Follow-up at 7 days (95% CI), p | |||||||||||
| Kinesio vs Micropore | p | Kinesio vs Control | p | Micropore vs Control | p | Kinesio vs Micropore | p | Kinesio vs Control | p | Micropore vs Control | p | |
| Pain | 0.1 | 0.82 | -1.0 | 0.09 | -0.8 | 0.13 | 0.3 | 0.54 | -0.2 | 0.76 | 0.2 | 0.75 |
| (0-10) | (-1.0 to 1.2) | (-2.1 to 0.1) | (-1.9 to 0.3) | (-0.8 to 1.5) | (-1.3 to 0.9) | (-0-9 to 1.3) | ||||||
| Disability | 1.9 | 0.08 | -3.1* | 0.003 | -1.3 | 0.22 | 1.7 | 0.11 | -1.8 | 0.08 | -0.1 | 0.89 |
| (0-24) | (-0.2 to 3.9) | (-5.2 to -1.1) | (-3.3 to 0.8) | (-0.4 to 3.8) | (-3.9 to 0.2) | (-2.2 to 1.9) | ||||||
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*Significant difference (p<0.05).
Discussion
This study tested the effects of a single application of Kinesio Taping® compared with Micropore® (placebo group) taping and a controlgroup with no intervention in patients with chronic non-specific low back pain for theoutcomes of pain intensity and disability. This is the first study that compared theKinesio Taping® method with Micropore® taping as a form of placebo therapy. Theauthors observed that, although the Kinesio Taping® group showed an improved disability score 48 hours after the application ofthe tape, the observed difference is so small that it could not be considered clinicallyimportant. All other statistical comparisons between groups showed no statisticalsignificance. These findings raise a question regarding the use of KinesioTaping® in clinical practice for patients with chronic non-specific low back painsince the effects observed (small) appears to be due to the placebo effect, regressionto the mean, natural history and other possible confounders.
One of the strengths of this study is related to the recruitment of subjects. It hasbeen shown that studies which recruited subjects seeking treatment for low back pain getmore representative results than studies which recruited subjects from thecommunity33. The limitations of our studyincluded the fact that clinician were not blinded to the allocation of the participantsto the groups - this was impossible due to the therapist's experience with the use ofKinesio Taping® - and that some of the seven-day assessments were conducted at the clinicwhile others were conducted by phone. This criterion was adopted to avoid a sample lossabove 15%, which could interfere with the results due to attrition bias. Although thesubjects allocated in the Micropore® group were inclined to believe that theywere using the Kinesio Taping® tape, the authors cannot consider this as a blinded study since theparticipants allocated to the control group received no intervention for the seven days.Participants from the control group were asked to avoid telling the assessor, at thetime of the reassessment, whether they had or had not received taping. This allowed forthe evaluator to remain blinded during the study. Finally, the authors observed thatthere was a higher proportion of painkiller users in the Kinesio Taping® group, which may have influenced the study results.
Although all participants showed some improvement (as described in Table 2), these differences could not be consideredclinically important since none of these differences were greater than two points forthe pain outcome and five points for the disability outcome, which were the cutoffpoints considered clinically significant32.
When the pain outcome was analyzed between groups, no statistically significantdifference was observed. However, this result should be considered with caution, sincethe effect size was approximately one point when the two groups that receivedintervention were compared with the control group. When the authors analyzed theKinesio Taping® group versus the Micropore® group, this difference waspractically nil, which favors the hypothesis that the Kinesio Taping® is similar to the Micropore® taping in the treatment of patientswith chronic non-specific low back pain. In a study19 conducted using Kinesio Taping® associated with therapeutic exercises, where one group received the taping,a second group received the tape combined with therapeutic exercises, and a third groupreceived only the therapeutic exercises, the results showed no difference among thegroups. These results corroborate our study, since there was no statisticallysignificant difference between the groups that received a taping intervention16.
In relation to the disability outcome, the difference was only statistically significantdifferent when the Kinesio Taping® group was compared to the control group after 48 hours. However, theobserved difference was too small and could not be considered clinically important. Inaddition, these differences were not observed at seven days. In another study17 that compared the application of KinesioTaping® versus a placebo application the results were favorable for theKinesio Taping® group for the outcomes pain and disability. The hypothesis for thedifference observed might be related to how the taping was applied. For theKinesio Taping® group, four strips with 25% of tension were superimposed, in a star format,to the point of greatest pain, while the placebo group received a single strip withouttension in the transverse direction over the greatest point of pain. The difference inplacement may have been more comfortable for the subjects that used more strips. Theseresults showed the importance of studies focused on analyzing the different types oftape placement. Studies describing the electromyographic activity of muscles submittedto different tape and tension applications of Kinesio Taping® should also be encouraged.
Although systematic reviews8,13,22-24 do not recommend the use of KinesioTaping® in clinical practice, the results of this study suggest thatKinesio Taping® was superior to no treatment for the disability outcome 48 hours after theapplication of the tape. For the pain outcome, although no statistically significantdifferences were found, the effect size was slightly higher in the groups usingKinesio Taping® and Micropore® taping when compared to the control group. Theseresults raise the hypothesis that subjects who received Kinesio Taping® or Micropore® taping may remain more active and returned totheir normal activities earlier, as it is recommended for patients with back pain34,35, than patients who did not receive any form ofintervention. However these improvements are due to placebo effects only.
Conclusion
The results showed that Kinesio Taping® showed similar results to Micropore® taping in the outcomesinvestigated at 48 hours and at seven days after baseline testing. The KinesioTaping® intervention was superior only when compared to the control group for thedisability outcome at the 48-hour assessment. Therefore, the results of this studyconfirm that the therapeutic effects of the Kinesio Taping® are similar to the placebo effect. These results suggest that physicaltherapists should avoid this type of therapy.
Acknowledgements
To Luiz Carlos Hespanhol Junior, for helping editing the text.
Footnotes
BULLET POINTS
Kinesio Taping is a widely used intervention for patients with low backpain.
This study has shown that the effects of Kinesio Taping are the same as aplacebo.
Physical therapists should not use Kinesio Taping in patients with chroniclower back pain.
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Articles from Brazilian Journal of Physical Therapy are provided here courtesy of Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia
