A randomized controlled trial of comparative effectiveness of elastic therapeutic tape,sham tape or eccentric exercises alone for lateral elbow tendinosis

Abstract

Introduction

Lateral elbow tendinosis is a condition that is well known to cause difficult challenges for hand therapists due to its long-term recovery and morbidity. Elastic therapeutic tape is commonly used as a treatment modality, despite limited evidence.

Methods

A randomized controlled trial was conducted to evaluate the effectiveness of elastic therapeutic tape, in conjunction with eccentric exercises, in the treatment of lateral elbow tendinosis. Forty participants with this condition (12 men, 28 women) were randomly allocated to three groups: (i) elastic therapeutic tape and eccentric exercises, (ii) sham tape and eccentric exercises, and (iii) eccentric exercises alone. All groups received education on activity modification techniques. Interventions were undertaken over a 12-week period (four weekly sessions and four fortnightly sessions) and outcome measures were recorded at baseline, three months and six months post randomisation.

Results

At three and six months, improvements were made in all three groups as assessed with the Patient-Rated Tennis Elbow Evaluation, the Short Form 36, pain-free grip strength, and the Occupational Self Assessment. However, there were no statistically significant differences between groups in any of these measures. There were no significant side effects or symptom exacerbation with using the elastic therapeutic tape.

Conclusions

Whilst all groups improved on key outcomes, it is possible that exercise alone and/or natural recovery were responsible for improvements. It is positive to note that the use of elastic therapeutic tape was well tolerated by participants and not associated with any significant side effects or symptom exacerbation.

Keywords

Elastic therapeutic tape Kinesiotape taping lateral elbow tendinosis tennis elbow lateral epicondylitis

Background

Lateral elbow pain is a condition that is well known to cause challenges due to its long-term recovery, considerable morbidity, and financial costs, including time off work and prolonged treatment.^1,2 Approximately 40% of people will experience lateral elbow pain at some point in their life with over 50% of these patients reporting not being fully recovered at 12 months post onset.^3–5 This has been shown to correlate with direct costs of approximately £5600 per person resulting in a significant economic burden to the individual, health care system, and society.^4,6

‘Lateral epicondylitis’ and ‘tennis elbow’ are common terms used by physicians and therapists when describing the clinical diagnosis related to pain experienced at or around the lateral epicondyle.³ However, new research reveals that these terms are misleading. The suffix ‘itis’ implies an inflammatory pathology, but extensive histological immunohistochemical and electron microscopy studies have shown that the condition is degenerative rather than inflammatory.⁷

It has been suggested that the more appropriate terms for this condition are either (i) lateral elbow tendinosis, or (ii) lateral elbow tendinopathy.^7,8 It is important to apply the correct diagnostic terminology since the previous labels for this condition have led to misunderstanding and inappropriate treatment.

Understanding the pathophysiology of lateral elbow tendinosis may enable better targeting of treatment and rehabilitation efforts.^9,10 It is not clear why tendinosis is painful, given the absence of inflammatory cells, nor is it known why collagen fails to mature. The true cause of pain may be mechanical discontinuity of collagen fibers or biochemical irritation that results from damaged tendon tissue that activates nociceptors.^11,12

There is consensus that the management of tendinosis is through conservative treatment.¹³ While many treatments for lateral elbow tendinosis have been researched, including friction massage, ultrasound acupuncture, orthotics, splinting, shock wave therapy, oral non-steroidal anti-inflammatory medications and surgery, many have small short-term effects and few have shown consistent effectiveness over other treatments.^14–17

From the available evidence, it would seem apparent that exercise is an important aspect of the management of lateral elbow tendinosis. Findings from systematic reviews^18,19 have shown that eccentric exercises have had some positive effect on clinical outcomes such as pain, function, patient satisfaction, and return to work amongst this population. It has been suggested that eccentric loading has been shown to assist with tendon rehabilitation by improving collagen alignment and stimulating collagen cross-linkage formation, both of which can improve tensile strength.⁷ Despite these reported benefits of exercises, a barrier to conservative management is often the pain reported by patients with lateral elbow tendinosis which directly impacts on their ability to effectively undertake a therapeutic exercise program.¹⁹

Kinesiotape (a form of elastic therapeutic tape) has been proposed to play a role in biomechanically unloading the affected tendon.²⁰ Traditional taping methods for elbow tendinopathy have been examined^21,22 with results demonstrating some short-term improvements in pain-free grip strength; however, no studies have explored the use of Kinesiotape for this condition with long term follow up.²³

Although unsupported by evidence, the proposed mechanisms of elastic therapeutic tape by its creator, Dr Kenzo Kase, include alleviating pain, correcting muscle function, restoring functional movement patterns, improving circulation, and relieving abnormal muscle tension. Through these mechanisms, it is hypothesised that elastic therapeutic tape can assist in reducing symptoms, thereby, allowing patients to undertake appropriate rehabilitative exercises.²⁴

The recommended tape application methods are outlined in ‘Clinical Therapeutic Applications of the Kinesio Taping Method’.²⁵ Elastic therapeutic tape has been designed to allow for a longitudinal stretch of up to 140% of its resting length and has been designed to approximate the elastic qualities of the human skin.^20,24–26 In particular, the application of the tape over stretched muscle to create convolutions in the skin has been hypothesised to reduce pressure in the mechanoreceptors below the dermis, thereby decreasing nociceptive stimuli.²⁷ There is, however, some conjecture in the literature regarding how and why tape may work, with one review finding insufficient evidence to support kinesiotape for musculoskeletal injury, but concluding that a perceived benefit cannot be discounted.²⁸

This article describes a randomized controlled trial (RCT) examining the effectiveness of using elastic therapeutic tape, in conjunction with a structured eccentric exercise program and activity modification, for the treatment of lateral elbow tendinosis. In order to eliminate the possibility of a placebo effect associated with taping, we compared the recommended tape application with sham taping in this research study.

Despite the popularity of elastic therapeutic tape and its reported benefits in clinical practice, there is still relatively little empirical evidence to support the effectiveness of elastic therapeutic tape for injuries, let alone specific musculoskeletal upper extremity disorders (such as lateral elbow tendinosis). The research questions of this RCT are:

Is the recommended application of elastic therapeutic tape²⁵ (applied with tension), in conjunction with an eccentric exercise program and advice on activity modification techniques, more effective than either (i) sham taping, or (ii) eccentric exercises alone, in patients with lateral elbow tendinosis?

Are the benefits of three months of treatment using elastic therapeutic tape sustained at six months post intervention?

Methods

This study was an RCT with no external funding. Outcome measures were recorded at baseline and at three and six months after randomisation to examine longer terms effects of treatment. Figure 1 illustrates participant flow throughout the trial. This study protocol received ethics approval from the Monash University Human Research Ethics Committee (protocol number: CF14/835 – 2014000325) and was registered with the Australian New Zealand Clinical Trials Registry.

Figure 1.

CONSORT Flow diagram of the study.

Participants and therapists

Participants with lateral elbow tendinosis, aged between 18 and 80 years, were recruited through three private hand therapy clinics in Australia (Toowoomba, Townsville, and Canberra) following referral from their general practitioner or orthopaedic/hand surgeon. Selection criteria were based on participants who had undergone medical investigations confirming lateral elbow tendinosis (e.g. MRI). If this had not been completed, inclusion was based on the presence of pain at the lateral epicondyle, tenderness, and positive pain provocative tests that have been well documented in other studies, such as pain with grip strength testing (elbow extended), reduced grip strength and pain with either resisted wrist extension or resisted middle finger extension.^3,29–31 Participants with any co-morbidities (such as fractures, pain syndromes or inflammatory diseases), patients with any contraindications to the use of taping (such as skin allergies to the tape material), patients who were unable to understand written material in English and those unable to give informed consent were excluded from the study. Patients fulfilling inclusion and exclusion criteria were invited to participate in the trial. Written, informed consent was obtained before participation in the study and verbal and written information outlining the details of the study was provided with the aim of promoting treatment adherence. All participants were encouraged not to seek additional treatments during the trial. Participants were treated by four hand therapists who were all trained in the application of elastic therapeutic tape.

Overall, a total of 40 participants were randomly allocated to receive three different approaches for the management of lateral elbow tendinosis. Randomisation was achieved via a computer-generated sequence, which was administered by the primary researcher. Due to the small number of therapists involved in this study, both assessors and therapists were un-blinded. The randomisation sequence was placed in sealed envelopes and kept in a locked secure location to ensure that allocation was concealed from those recruiting participants. Participants in all three groups received the same structured exercise program which was established from existing literature on the benefits of eccentric exercises for lateral elbow tendinosis.^7,18 Advice on activity modification techniques were also provided, including ergonomic modifications and how to avoid aggravating tasks. Exercises and the application of tape (for the intervention and control groups) were reviewed at each session to further enhance adherence to therapy.

Application of elastic therapeutic tape

Taping applications for lateral elbow tendinosis can include the ‘Y’ or ‘I’ techniques.^20,25 In this study, participants in the intervention and comparison group had the tape applied using the ‘I’ shape along the common extensor muscle. Prior to the application of tape in both groups, the skin was cleaned using alcohol wipes to improve the tape adherence and to ensure that the skin was free of oils and creams. Participants were advised that the tape should be worn continuously for four to seven days before needing to be reapplied and were shown how to apply the tape themselves to allow reapplication in between sessions if needed. This process was continued over the 12-week period; however, participants were able to cease the use of the tape during this time if they felt their symptoms had improved.

Intervention group (see Figure 2)

Figure 2.

Application of tape using ‘I’ technique.

Elastic therapeutic tape was applied to each participant with the elbow extended. The first strip of tape was applied with 25% tension (the distal 1–2″ of tape is ‘tapered off’ and applied with no tension). The second and third strips of tape are applied as a ‘space correction’ for the area of pain over or around the lateral epicondyle. With the elbow slightly flexed, ‘I’ strips are used with 25–50% tension with the end of the strip tapered off at no tension. Moderate to full tension was applied to the middle part of the tape to further reduce tissue movement if required. Participants were shown on how to apply the tape at the initial session and educated on how to monitor for side effects, such as skin irritation.

Sham group Participants in this group were taped the same way as the intervention group; however, the tape was applied with no tension. As per the intervention group, participants were shown how to apply the tape, monitor for side effects, and wearing regime was identical.

Control group Participants in this group received no taping and were provided with the structured exercise program and advice on activity modification only.

The same home exercise program was given to each group and is described in Appendix 1.

Outcome measures

A total of four outcome measures were used for this study. Primary outcomes were pain and level of disability/function as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE)³² and pain-free grip strength assessments using a calibrated Jamar dynamometer with a standardised technique.³³ Secondary outcome measures were overall health status as measured by the Short Form 36 (SF-36),³⁴ work status and scores on the Occupational Self Assessment (OSA v 2.2).³⁵ All outcome measures are standardised assessments that have been widely used for upper extremity conditions.

Sample size and data analysis

The sample size calculation for this study was based on a difference of at least 14 points on the final score of the primary outcome measure (PRTEE), with a standard deviation of 12, which has been deemed to be clinically important in previous research.³⁶ With a minimum of 13 participants per group, it was calculated that this research study would have 80% power with a two-sided p value of 0.05.

Data analysis was conducted by the unblinded primary researcher and independently checked by a statistician who was blinded to group allocation. All data were coded for analysis. Differences in primary and secondary outcomes between groups were compared using intention-to-treat analysis. Outcomes were compared over the follow-up period with one-way analysis of variance for all variables; however, linear mixed model analysis was also used for primary outcome variables (PRTEE and grip strength) due to missing data amongst these measures. The Statistical Package for Social Sciences (SPSS version 20) was used for all analyses.

Results

Forty participants, 12 men and 28 women, were enrolled into the study. The mean age was 49.63 years (SD = 8.6). Of the participants, 39 (97.5%) were right-handed and 16 (40%) had lateral elbow tendinosis in their dominant arm. Prior to the study, eight participants (20%) had sought treatment for their elbow pain and 34 people (85%) had symptoms for longer than three months. Twelve participants (30%) had Worker’s Compensation claims, 23 (57.5%) had private health cover and five (12.5%) did not have any health cover. There were no differences between the three groups for gender, age, handedness, involvement of the dominant extremity, previous treatment, and insurance cover. Complete demographic details are outlined in Table 1.

Table 1.

Baseline characteristics of participants.

	Intervention Group (N = 14)	Control Group (N = 13)	Sham Intervention Group (N = 13)
Age	47.38 (7.54)	52.85 (7.14)	48.45 (9.64)
Gender
• Male	3 (21.4%)	4 (30.8%)	5 (38.46%)
• Female	11 (78.6%)	9 (69.2%)	8 (61.54%)
Insurance
• Private Health Cover	7 (50%)	8 (61.54%)	8 (61.54%)
• Compensation	5 (35.72%)	2 (15.38%)	5 (38.46%)
• Nil	2 (14.28%)	3 (23.08%)	0 (0%)
Initial work status
• Full duties	11 (78.57%)	11 (84.62%)	8 (61.54%)
• Light duties	3 (21.43%)	1 (7.69%)	1 (7.69%)
• Off work	0 (0%)	1 (7.69%)	4 (30.77%)
End work status
• Full duties	14 (100%)	11 (84.62%)	9 (60.24%)
• Light duties	0 (0%)	0 (0%)	2 (15.38%)
• Off work	0 0%)	2 (15.38%)	2 (15.38%)
Duration of symptoms
• Acute (<3 months)	3 (21.43%)	1 (7.69%)	2 (15.38%)
• Chronic (>3 months)	11 (78.57%)	12 (92.31%)	11 (84.62%)

Data presented are mean (SD), median (IQR) or frequency (%); SD = Standard Deviation

All 40 participants (100%) completed the 12-week study with a six-month follow-up. There were missing data for grip strength measurements for six participants due to difficulty returning to the hand therapy practice at three and six months; however, other outcome measures were able to be completed via mail. At baseline, all three groups appear to be well balanced with regards to their clinical and demographic variables.

Discussion

Overall, the majority of all participants (95%) within the three treatment groups exhibited improvements in the primary outcome measure (PRTEE) over the six-month period of the study. General improvements were also seen in secondary outcomes measures (grip strength, SF-36 and OSA). Whilst improvements in PRTEE scores were of greater magnitude in the intervention group, there were no statistically significant differences between the three groups at three or six months post randomisation. This may be due to the relatively low sample size (n = 40).

The evidence shows that many people with lateral elbow tendinosis will make some improvements over time, thus making it difficult to detect the impact or effectiveness of individual interventions that are used.^3,30,37 Given the lack of a true control group (i.e. no active intervention), it cannot be certain that the observed improvements amongst any of the three participant groups were not due to the natural course of the condition regardless of treatment interventions utilised. For future research, a study that involves another control group who do not receive any form of direct intervention may be needed so as to be able to more definitively differentiate spontaneous healing from response to specific interventions.

Despite the intent of the sham application to be non-therapeutic, the findings of similar improvements in both taping groups indicate that how the tape was applied had minimal impact. Therefore, the physiological mechanisms by which elastic therapeutic tape is presumed to work on this population remain hypothetical and open to speculation. Our findings highlight the need for further exploration into the possible role of placebo in the clinical effects of taping.

Importantly, the use of elastic therapeutic tape had no significant side effects (except for one participant who developed itchiness from the adhesive tape backing). However, costs of purchasing the tape and training staff in its correct application need to be considered. Given these findings, it is likely that eccentric exercises and activity modification techniques are more appropriate, evidence-based, and cost-effective in the clinical management of lateral elbow tendinosis.

Limitations

As this trial was completed within time and budget constraints, we were unable to recruit large participant numbers, and it was not possible to include a group receiving no treatment, even though this would have been ideal. A geographical bias and gender imbalance must also be considered as the majority of patients were females and located within one state; therefore, results may not be transferrable to the general population. Additionally, the authors acknowledge that participants with varying durations of symptoms were included in this trial. Nevertheless, it is considered that this would not have impacted findings as all groups had similar profiles of condition chronicity.

As it was difficult to blind the assessor and therapists, the authors also acknowledge the potential bias which may have impacted on results and the interpretations of findings. It was not feasible to blind the participants, as they knew if they were receiving taping (recommended or sham application) or no taping. However, in an attempt to minimise any placebo effect, it was explained that taping could not be considered more or less effective than other treatments.

Another limitation of this RCT is that the outcome measures used (PRTEE, SF-36, OSA, and grip strength) may not be sensitive enough to detect clinical change at three- and six-month follow-up. Furthermore, more rigorous supervision of each participant’s home exercise program may have also been beneficial. As the taping and exercise program was not supervised at all times, there may have been non-adherence to the specified treatment regimen which was not reported by participants, incorrect exercise techniques or inconsistencies with application of the tape, despite these being reviewed at each hand therapy appointment. These would be important considerations for future studies.

Conclusions

This article has described a RCT examining outcomes using elastic therapeutic tape, in conjunction with a structured eccentric exercise program and advice on activity modifications, for the management of lateral elbow tendinosis. To our knowledge, this trial is the first to evaluate the use of elastic therapeutic tape amongst this patient group and the first to include a comparison group with a sham application and a control group consisting of exercises alone.

Whilst all groups improved on key outcomes, there were no statistically significant differences between groups and it is possible that exercise alone and/or natural recovery were responsible for improvements. It is positive to note that the use of elastic therapeutic tape was well tolerated by participants and not associated with any significant side effects or symptom exacerbation.

Table 2.

Comparison of outcome variables at baseline.

	Intervention Group (N = 14)	Control Group (N = 13)	Sham Intervention Group (N = 13)
PRTEE	47.90 (17.36)	48.30 (21.83)	47.53 (16.22)
Pain-Free Grip strength	23.14 (13.10)	24.54 (8.35)	21.69 (13.27)
SF-36
– Physical functioning	65.71 (23.84)	72.69 (19.43)	70.76 (20.19)
– Role limitations (physical)	21.43 (36.50)	32.69 (31.26)	26.92 (38.81)
– Role limitations (emotional)	59.52 (45.62)	66.67 (43.03)	56.41 (47.89)
– Energy	57.14 (23.59)	57.31 (18.78)	40.46 (20.32)
– Emotional well-being	72.00 (24.25)	74.15 (16.22)	51.69 (19.62)
– Social functioning	63.39 (31.18)	77.88 (25.08)	65.38 (26.09)
– Pain	43.39 (23.15)	53.46 (15.46)	41.73 (20.03)
– General health	71.78 (28.59)	75.38 (19.84)	66.92 (22.96)
OSA
– Competence score	53.21 (8.88)	57.92 (11.77)	56.69 (20.74)

Data presented are mean (SD); SD: standard deviation.

PRTEE: Patient Rated Tennis Elbow Evaluation; SF-36: Short Form 36; OSA: Occupational Self Assessment.

Table 3.

Comparison of outcome measures at three and six months post intervention.

	3 months				6 months				Change from 3 to 6 months
	Intervention (N = 14)	Control (N = 13)	Sham (N = 13)	p value	Intervention (N = 14)	Control (N = 13)	Sham (N = 13)	p value	coefficient (95 % CI) Linear Mixed Model
PRTEE	28.21 (16.96)	24.20 (19.19)	37.81 (22.96)	0.21	12.26 (13.87)	17.28 (15.79)	22.33 (24.82)	0.38	2.076 [−0.70; 30.27]
Pain-Free Grip Strength	30.69 (11.93)	29.36 (11.55)	24.58 (14.66)	0.47	32.77 (10.76)	29.42 (10.39)	29.08 (14.12)	0.69	−0.803 [−7.77; 3.29]
SF-36
– Physical functioning	75.36 (24.37)	73.08 (25.04)	79.23 (13.97)	0.77	79.64 (24.29)	82.69 (12.35)	87.31 (12.18)	0.53	–
– Role limitations (physical)	58.92 (45.58)	71.15 (35.13)	55.77 (41.02)	0.60	83.93 (36.17)	84.61 (24.02)	75.00 (36.79)	0.71	–
– Role limitations (emotional)	64.28 (46.16)	79.49 (28.99)	74.36 (38.86)	0.59	76.19 (40.15)	84.62 (29.23)	79.49 (39.76)	0.84	–
– Energy	55.36 (23.08)	55.00 (19.36)	45.38 (22.95)	0.42	65.00 (25.94)	59.62 (20.56)	52.31 (20.37)	0.35	–
– Emotional well-being	70.00 (24.84)	70.15 (17.48)	64.31 (18.65)	0.71	76.00 (25.78)	75.38 (17.19)	68.92 (15.85)	0.61	–
– Social functioning	69.64 (27.61)	78.85 (17.96)	68.27 (26.33)	0.49	77.68 (29.89)	77.88 (19.87)	76.92 (17.56)	0.99	–
– Pain	55.53 (26.24)	65.58 (14.97)	53.85 (17.28)	0.29	74.46 (24.59)	66.92 (18.06)	64.81 (21.97)	0.49	–
– General health	71.43 (25.07)	70.00 (16.96)	62.30 (24.21)	0.54	73.93 (24.43)	75.00 (17.08)	72.30 (18.67)	0.94	–
OSA
– Competence score	55.92 (15.65)	61.15 (14.37)	54.08 (16.50)	0.49	63.14 (22.36)	66.38 (11.48)	71.31 (23.29)	0.57	–

PRTEE: Patient Rated Tennis Elbow Evaluation; SF-36: Short Form 36; OSA: Occupational Self Assessment; SD: standard deviation.

Data presented are mean (SD).

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Appendix 1

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