Study Appraised:: Gonzalez-Iglesias et al. Short-term effects of cervical kinesio-taping on pain and cervical ROM in patients with acute whiplash injuries: A RCT. J Orthop Sports Phys Ther. 2009; 39(7):515-521.
Level of Evidence: 1b
Purpose of the study
Whiplash is the result of forceful back and forth movement of the spine which may lead to a variety of clinical manifestations. Previous studies have found that the majority of patients with whiplash return to activities within one week of their injury, nearly 30% of patients, however, continue to experience symptoms beyond three months, resulting in significant financial burden and loss of quality of life. Forty percent of whiplash patients experience persistent pain and disability.
The sample was taken from consecutive patients reporting neck pain as a result of an MVA within 490 days of injury during June 2007 and October 2008. The eligibility criteria included: meeting the Quebec Task Force Classification of WADII; which included neck pain and musculoskeletal signs without the loss of conduction at neurological examination. The exclusion criteria included LOC, concussion, and head or upper quadrant injury during MVA. Patients were also excluded if they had a previous history of neck pain, whiplash, headaches, any psychological condition or somatic condition, or had a current claim for litigation.
The proposed theoretical benefits of K- taping include: (1) increasing local circulation, (2) decreasing local edema by decreasing exudative substances, (3) improving circulation of blood by facilitating the muscle, (4) providing a positional stimulus to the skin, muscle, or fascial structures, (5) providing proper afferent input to the CNS, or (6) limiting ROM of the affected structures. However, there is no high-level evidence to support the proposed benefits of K-Taping. Therefore, the purpose of this study was to compare the short-term effects of K- Taping to the cervical spine versus a placebo tape on neck pain and cervical range of motion in patients with acute whiplash disorder.
Forty-one subjects met the inclusion criteria and were randomized into the real k- Tape (n=21) or the sham k- Tape (n=20) intervention groups. After performing a pairwise comparison the subjects whom received the real k- Taping experienced greater reduction in neck pain immediately post-application and at the 24-hour follow-up. Subjects in the real k- Taping group presented with improved cervical AROM than those in the control group.
In conclusion, subjects who received K-Taping presented with statistically significant improvements in neck pain and cervical AROM immediately following application of the tape and at a 24-hour follow-up, versus the placebo group. However, the improvements were small and may not be clinically meaningful. The clinical bottom line is that the results of this study provide preliminary evidence for the application of k- Taping in the management of patients with acute whiplash disorder.
ARE THE RESULTS OF THE STUDY VALID?
1a. R- Was the assignment of patients to treatments randomised?
Yes, patients were randomized using a computer-generated randomized table of numbers. The study also utilized numbered index cards with random assignment.
The randomization was blinded and masked. The subjects were split into two groups, the experimental group that included subjects receiving k- Taping, and the control group receiving the placebo k- Taping. Both the subjects and physical therapists were blinded throughout the investigation.
1b. R- Were the groups similar at the start of the trial with respect to known prognostic factors?
Yes, the subjects were randomized efficiently throughout the study. Therefore, we can conclude that the subjects in the study group had similar prognostic factors.
2a. A – Aside from the allocated treatment, were groups treated equally?
Yes, subjects were treated the same throughout the investigation apart from intervention.
2b. A – Were all patients who entered the trial accounted for? – and were they analysed in the groups to which they were randomised?
Yes, subjects in the study groups had similar known prognostic factors. Therefore, the prognostic balance was maintained as the study progressed. The two groups maintained this balance throughout the study.
Follow-up was complete. The effects of treatment on pain and cervical range of motion were measured at baseline, immediately after treatment and 24 hours after treatment.
All participants took part throughout the study and all results were statistically analyzed within the group to which they were randomized
3. M – Were measures objective or were the patients and clinicians kept “blind” to which treatment was being received?
Subjects were blinded to treatment allocation and were randomly assigned to receive k- Taping to the cervical spine or a placebo k- Taping application. The researcher that collected data was not involved with the treatment or assessment of patients. The physical therapist that applied the k- taping was blinded to patient information.
Results: How large was the treatment effect?
The outcome was dichotomous. In relation to this article, the treatment effect was present, but minimal. Even though the article reports statistically significant decrease in pain and improvement in ROM immediately and over the first 24 hours after application, the fact is that the results did not surpass the minimal clinically important difference for pain-reported to be 2 points on the NPRS and the improvements in cervical ROM between groups did not exceed the minimally detectable change to exceed measurement error.
· How precise was the estimate of the treatment effect?
Although the study appeared to be a well-designed randomized trial, the amount of participants seems to be too low (41 participants). As pointed out in the Guyatt2 text-“the larger the sample size of a trial, the larger the number of outcome events and the greater our confidence that the true results are close to what we have observed.” Again, citing the results where the change in pain level did not exceed the 2 points on the NPRS and the ROM measurements did not exceed the minimal detectable change to measurement errors.
· What likelihood ratios were associated with the range of possible test results?
The group-by-time interaction for the 2-by-3 mixed-model ANOVAs was statistically significant for neck pain as the dependent variable (F = 64.8; P<.001). Comparisons indicated that patients receiving the real k- taping intervention experienced greater reduction in neck pain immediately post application and at 24-hour follow-up (both, P<.001). The group-by-time interaction for the 2-by-3 mixed-model ANOVA was also statistically significant for all directions of the cervical range of motion. Flexion (F = 50.8; P<.001), extension (F= 50.7; P<.001), right (F = 39.5; P<.001) and left (F = 3.8, P<.05) lateral flexion and right (F = 33.9, P<.001) and left (F= 39.5, P<.001) rotation. Planned pairwise comparisons showed that patients in the experimental group obtained a greater improvement in cervical range of motion than those in the control group (all, P<.001).
Discussion: Will the results help me in caring for my patient? (ExternalValidity/Applicability)
Yes. The result that k- taping shows statistically significant reduction of pain and increased ROM of the cervical spine in WAD patients immediately after application and for 24 hour period afterward has clinical significance regarding treatment options for this disorder. Patient satisfaction seems to be high with this treatment. The information presented in this report is easily interpreted and can be applied to our patient care. Whiplash injuries are commonly seen from motor vehicle accidents and sports related injuries.
· Were all patient clinically important outcomes considered?
Yes, the clinically important outcomes were considered as pain reduction using the NPRS established at baseline and following application of the k- Tape. The study found improved AROM and functional capacity. Although, the results showed significant statistical improvements in pain reduction and motion they did not surpass the minimal clinically important difference for pain or the minimal detectable change of motion to overcome possibility of error in measurements. The study did eliminate a large cross-section of patients including those with associated concussions and ones that were involved in legal cases due to their injuries which would have provided a large sample and provided improved data of outcomes. Also, the study was conducted evaluating the affect alone of applying k- Tape in the experimental group with tension versus no tension in the control group. There was no use of further therapeutic procedures which could have influenced outcomes. The study involved only one application of k- Tape with a follow-up of 24-hours only provided immediate and short-term data versus. The study would have more reliable results if the long-term affect would have included repeated use.
· Are the likely treatment benefits worth the potential harm and costs?
Yes, the potential harm and costs are minimal and especially when measured in relation to the potential benefits shown in the study. There are no major side effects from use of the tape. The data provided by the study had reliable and valuable outcomes regarding the immediate decrease of pain and increase of ROM of the cervical spine. The study points out that physical therapists often use a wide variety of interventions in the treatment of post-whiplash disorder. k- Taping does appear to be a viable and affordable addition to the overall treatment plan based on the data. Incorporating it into any practice that has a large demographic of cervical spine flexion/extension injuries is very wise.
1. Sterling et al. Physical and psychological factors maintain long-term predictive capacity post-whiplash injury. Pain. 2006;122:102-108.
2. Guyatt G, Rennie D, Meade M, and Cook D. Users’ Guide to the Medical Literature Essentials of Evidence-Based Clinical Practice 2nd edition. 2008