Background
Summary of Council decision:
Four issues were investigated and all were Upheld.
Ad description
A website which offered kinesio taping services, www.kinesiotaping.co.uk, made a number of claims about the treatment.
On a page headed "How does Kinesio Taping® Work?", text stated "Kinesio Taping's key differentiator is its ability to aid the lymphatic and muscle systems. For many, the Kinesio Taping® applications are a major breakthrough which substantially reduce recovery times and improve fitness levels. Applications can also encourage lymphatic fluid to move from areas of high pressure to low pressure and towards working lymph nodes. For example, it might be necessary to clear areas where the lymph will be draining towards. Kinesio taping can also help to facilitate the stretch response of the angions, with movement or muscle contraction. To ensure that the muscles have free range of motion, elastic tapes with an elasticity of 130-140% of its original length are recommended for Kinesio Taping. This specific elasticity also will not allow an over stretch of the muscles themselves. It may look like conventional athletic tape, but tape and Kinesio Taping is [sic] fundamentally different. Kinesio Taping is based on a different philosophy that aims to give free range of motion in order to allow the body's muscular system to heal itself bio-mechanically. Without KT there is pain and pressure on the receptors. Blood and Lymph is trapped under the skin. With KT the top layer of tape causes convolutions and lifts the skin. Pain and pressure is reduced. Blood and Lymph fluid is dispersed. Physiological Effects of Kinesio Tex Taping: Relieves pain; Supports muscles in movement; Removes lymphatic fluid congestion; Corrects joint mis-alignment; Assists in positioning a muscle or joint into proper position for rehabilitation; Assists a weak muscle by placing it in a normal position; Improves kinesthetic awareness of posture and alignment..."
On another webpage headed "A Brief History of Kinesio Tex Taping®", text stated "Kinesio® Tex can assist many conditions including: TMJ Dysfunction; Headaches (tension), Whiplash, Torticollis, Shoulder Impingement/Subluxation, Rotator Cuff Tear, Biciptal Tendonitis, Tennis/Golfers Elbow, Compartment Syndrome, Trigger Finger, Forward Shoulder, Thoracic Outlet Syndrome, Shin Splits, Foot Drop, Herniated Disk, Sciatica, De Quervains, Low Back Sprain/Strain, Sacroiliac Sprain/Strain, Piriformis Syndrome, Quadriceps Strain, Toe Cramps, Sprained Ankle, Meniscus Tear (minor), Osteoarthritis of Knee, Calf Cramps, Plantar Fascitis, Bunions, Post Operative/Traumatic Oedema, Hamstring Strain, Bells Palsy, Headaches (Migraine), Tinnitis (SCM cause), Frozen Shoulder".
On another page headed "Lymphoedema", text stated "Kenesio Taping For Lymphoedema. Reduce Swelling, Alleviate Pain and Manage Oedema. Kinesio Tex Taping® is a new and effective treatment for Lymphoedema. The taping method can substantially aid sufferers of Lymphoedema by increasing the body's ability to drain lymphatic fluid to healthy lymph nodes. This is achieved using Kinesio Taping® techniques which have been designed specifically to aid lymphatic drainage".
On another page headed "Patients", text stated "Kinesio Taping® can be used for a wide range of treatments including: Lymphoedema treatment; Sports Injuries, Hand Therapy, Paediatrics, Scar Taping...".
Issue
The complainant challenged whether the following claims were misleading and could be substantiated:
1. the description of the therapy under the heading "How does Kinesio Taping Work?";
2. the efficacy claim that the therapy could be used for "Lymphoedema treatment, Sports Injuries, Hand Therapy, Paediatrics, Scar Taping";
3. the claim "Kinesio Tex® can assist many conditions including …" followed by the list of conditions; and
4. the claims that the therapy could "Reduce Swelling, Alleviate Pain and Manage Oedema" and subsequent description "The taping method can substantially aid sufferers of Lymphoedema by increasing the body's ability to drain lymphatic fluid to healthy lymph nodes. This is achieved using Kinesio Taping® techniques which have been designed specifically to aid lymphatic drainage".
Response
1. Limb Volume Ltd (LV) said the description on the website represented the view of the founder of the Kinesio Taping method and its governing body. They explained that Kinesio Taping was regulated and maintained by the Kinesio Taping Association International (KTAI) and that KTAI trained healthcare professionals in the method of Kinesio tape application. They further explained that the tape used (Kinesio Tex Tape) was a registered Class 1 medical device and that the method of applying the tape was based on a scientific theory. They said the description outlined the current scientific understanding of, and theories behind, Kinesio Taping, based on 25 years of research, although they accepted that more research was needed. They did not believe the description of how the therapy worked was misleading. They said the theory of the method could be broken down into five key areas: the method encourages lymphatic fluid to move from areas of high pressure to low pressure and towards working lymph nodes; increases range of motion; relieves pain; corrects joint misalignment; and assists recovery of weak muscles. They provided 47 case studies, articles and clinical trials of which 23 they believed substantiated the claim.
2. LV believed Kinesio Taping was a well-recognised therapy used to assist in the treatment of lymphoedema, a wide range of common sports injuries, 'hand therapy' which covered a range of conditions relating to the upper limb including lymphatic swelling, muscle disorders within paediatrics and repetitive strain injuries, and scar treatment. Of the 47 case studies, articles and clinical trials provided, they believed 22 of them substantiated the claim.
3. LV explained that they had taken care to restrict the wording on the website to "assisting" in the treatment of the conditions listed, rather than suggesting that Kinesio Taping was a "cure". They said that with so many combinations of muscles within the body, it would take many years of research to gain clinical evidence for each muscle combination and condition. They believed that because skin, fascia, muscle and bone being of a similar composition throughout the body, the effects of external biochemical input for one part of the body were transferrable to other parts. For example, the taping principles to support a muscle in the shoulder would be the same for supporting a muscle in the leg.
4. LV maintained that Kinesio Taping was a well-recognised therapy used to assist in the treatment of lymphoedema by many nurses working in the field. They said photographic evidence was available to show the benefits of Kinesio Taping on lymphoedema. Of the 47 papers provided, they believed that six of them substantiated the claims.
Assessment
1. Upheld
The ASA understood that Kinesio Tape (KT) was different to conventional therapeutic tape and that there was a specific technique involved in applying it. We noted that LV stated that the theory of the method could be broken down into five key areas: the method encourages lymphatic fluid to move from areas of high pressure to low pressure and towards working lymph nodes; increases range of motion; relieves pain; corrects joint misalignment; and assists recovery of weak muscles.
We considered the evidence provided. We noted that of the 23 reports provided in relation to this issue, one referred to a different type of tape rather than KT, another was a dissertation for a Master's Degree which had not been signed or approved by the university and a third related to the effect of taping in animals using a different kind of tape. One of the reports was a summary of a clinical trial but we had not been provided with the full study.
Ten of the reports were case studies involving small numbers of subjects (between one and six) which were not clinically-controlled trials. Five of these reported the effects of KT used in conjunction with other therapies such as physical therapy so it was difficult to ascertain whether the observed effects were due to KT or the other therapies. In relation to the other five case studies, one reported the effects of KT on an adult with work-related lower back pain. The study reported lower self-reported pain scores and disability scores, and an increase in trunk range of motion, following the application of KT around the trunk for three days. However, we noted that the study did not assess or measure how the therapy worked but reported the observed effects of the therapy on the patient.
Another observational study measured the effect of KT on calf injuries prevention in six male triathletes during competition. The study measured self-reported pain, soreness and cramps in the calf muscles of the participants after they had completed a triathlon with KT applied to their lower legs. Although the study reported positive effects, we noted that it did not assess or measure how the therapy worked.
We noted that the description of how the therapy worked included references to its effects on lymphatic fluid and on relieving pain and we considered three case studies which looked at these areas. One study reported the effect of KT on a 20-year-old female patient with acute myofascial shoulder pain. In the introduction to the study, the author noted that the KT technique claimed to have four effects: to normalise muscular function; to increase lymphatic and vascular flow; to diminish pain; and aid in the correction of possible articular malalignment. The study itself reported that after wearing the tape for two days, the patient's self-reported pain scores (as measured on a Visual Analog Scale) had reduced, although it was not known whether the reduction was statistically significant. We noted that this was a single case study involving one patient who had experienced shoulder pain for two days prior to the study. We considered that because the study was not clinically-controlled and involved only one patient with acute shoulder pain, it was not clear whether the reduction in self-reported pain was due to KT or natural healing processes.
Another case study evaluated the effects of KT on an amateur badminton player with chronic Achilles tendon pain following injury. The study reported a decrease in self-reported pain scores and tenderness as well as an increase in ankle joint range of motion following the application of KT over a five-week period. However, we noted that this was a single case study which was not controlled or blinded and therefore cause and effect could not be ascertained. We also noted that the author of the study reported that the mechanism of the effect of KT was not known but that proposed hypotheses included protecting and supporting joints, improving blood and lymph circulation and decreasing pain.
Another case study considered the effects of KT on lymphoedema in a patient with advanced cancer. After wearing the KT on her lower legs for three days, the patient reported that the oedema, pain and feeling of heaviness associated with lymphoedema had decreased. However, we noted that this was a single case study which was not controlled or blinded and relied on a subjective assessment of symptoms by the patient.
We considered the ten clinical trials provided in relation to this issue.
One study compared the short-term efficacy of KT and physical therapy in the treatment of shoulder impingement syndrome (SIS). Of 55 patients with SIS, 30 were treated with KT and 25 were given physical therapy; the response to treatment was evaluated using disability and pain questionnaires. After one week, pain scores in the KT group were statistically significantly lower than pain scores in the physical therapy group. However, after two weeks, there were no significant differences in pain scores between the two groups, although disability scores for the KT group were significantly lower. However, the author noted several limitations with the study, including the absence of a sham taping control group, the lack of randomisation of patients, and the relatively small number of patients and short testing period. We also noted that the study did not look at how the KT treatment worked, but rather measured the efficacy of the treatment. Furthermore, the author of the study noted that there was no clear evidence regarding potential mechanisms underlying the treatment.
Another study was a randomised, double-blinded and controlled clinical trial, which reported the short-term effects of KT when applied to the cervical spine, on neck pain and cervical range of motion in patients with acute whiplash injury. Forty-one patients were randomly assigned either to a KT group or to a control group who received sham taping. Self-reported neck pain scores, and range of motion data (using a cervical range of motion device) were collected at baseline, immediately after tape application, and after 24 hours by an assessor who was blinded to the treatment allocated to the patients. Although positive results were reported, we noted the author expressed several limitations of the study. In particular, only short-term effects were measured, a wash-out period of 72 hours may not have been enough time to remove the effects of pain medications, the sample size was relatively small and consisted of patients from the same clinic and the author noted that the improvements were small and may not be clinically meaningful. We also noted that the outcome measures did not show how the treatment worked and the author of the study commented that the mechanisms by which the treatment worked were hypothetical.
Another study was a two-phase design to measure the effect of KT on pain, disability and lumbar muscle function in patients with chronic lower back pain. The second phase consisted of a randomised and single-blinded clinical trial. Thirty-nine patients with chronic lower back pain were randomly assigned to one of three groups: KT only; KT and exercise; and exercise only. Self-reported pain and disability and lumbar muscle function (measured using a surface electromyographic (EMG) device) were evaluated before and after a four-week treatment period. Although positive results were reported for each of the treatment groups in relation to pain scores and muscle function, and a reduction in disability scores in the exercise only group, we noted that there was no sham tape group to control for placebo bias and the author noted certain limitations such as the small sample size and the fact that participants were recruited from a particular clinical sub-group (i.e. patients with chronic lower back pain who could not achieve flexion-relaxation of the lumbar muscles). We also noted that the study measured the effects of KT rather than how it worked.
Another study was a randomised, double-blinded clinical trial which measured the short-term clinical efficacy of KT when applied to college students with shoulder pain due to rotator cuff tendonitis/impingement. Forty-two patients, all college students at a United States Military Academy aged between 18 and 24, were randomly assigned to either a therapeutic KT group or a sham tape group and wore the tape for two consecutive three-day intervals. Self-reported pain and disability scores and pain-free active range of motion (ROM) were measured at multiple intervals. Positive results were limited. The KT group showed immediate improvement in pain-free shoulder abduction (i.e. lifting the arms to shoulder level) after tape application although no other differences were observed between the groups in terms of pain and disability scores, or ROM, at any other time. The author noted that the study was limited by the small sample size and the fact that the subjects were of a particular age group (18 to 24). The author noted that subjects in this age category were more likely to have shoulder instability which had not been assessed in the study. The author also noted that only short-term effects were measured and stated that further studies were needed. He also noted that the physiological mechanisms by which KT was presumed to work remained hypothetical.
A further study measured the effect of KT application on the flexor muscles on dominant hand grip strength in 40 healthy participants using a cross-over design. Hand grip strength was measured using a dynamometer in each of three conditions: with the head rotated (no KT); with the head in a neutral position (no KT); and KT. Results showed that the application of KT to the flexor muscles of the dominant hand significantly increased grip strength compared to that measured in the neutral (no KT) condition. However, we noted that there were limitations to the study, for example, the small sample size, there was no sham tape control condition, the study was not blinded and it was not clear the order in which the measurements were taken (although we noted that there was a five-minute rest period between each measurement). We also noted that the study measured the effects of KT rather than how it worked.
Another study measured the effects of KT on EMG muscle activity and proprioception feedback in the shoulders of 12 healthy subjects. Outcomes were measured in each of two conditions: no tape (control); and KT. Results showed significant changes in the EMG activity in the scapular muscles with the application of KT. Proprioceptive feedback was also enhanced with the application of KT. However, there was no change in muscle activity in the Lower Trapezius (LT) muscles with the application of KT and the author recommended further research in relation to the LT muscles. We also noted significant limitations with the study design, such as the small number of subjects and the fact that it was not blinded.
A further study examined the clinical efficacy of KT in reducing oedema in the lower limbs of patients who had limb-lengthening treatment using the Ilizarov Method. Twenty-four patients were randomly assigned to one of two experimental groups: KT plus physiotherapy; and standard lymphatic drainage plus physiotherapy. Patients in both groups experienced a significant reduction in limb circumference measurements following ten days of treatment, although the reduction was greater in the KT group. We noted the following limitations with the study design. First, a small number of patients were sampled and they were a very distinct clinical sub-group (i.e. patients with oedema resulting from limb-lengthening treatment using the Ilizarov Method). Second, KT was combined with physiotherapy so it was not clear whether the positive results were attributed to the KT, the physiotherapy or both. Third, the trial was not blinded and there was no sham tape control group. For these reasons, we considered that the study was not sufficiently robust to prove that KT worked by encouraging the movement of lymphatic fluid.
Another study compared the efficacy of KT with compression bandage treatment in patients with unilateral breast-cancer-related lymphodoema. Forty-one patients diagnosed with breast-cancer-related lymphodoema for at least three months were randomly assigned to receive treatment with KT or compression bandage, in conjunction with regular lymphatic drainage and physical therapy over a four-week period. Outcome measures included limb circumference and volume measures, water composition of the upper extremity measured using a tactile-electrode impedance meter, self-reported lymphodoema-related symptoms using a Visual Analog Scale, and self-reported quality of life scores using a questionnaire. Although positive results were reported in both the KT and compression bandage groups, we considered that because KT was used in conjunction with other therapies, it was not clear whether the positive results were due to KT, the other therapies or both. We noted that the study had no sham tape control group, the sample size was small and there was a distinct clinical sub-group (i.e. patients with unilateral breast-cancer-related lymphodoema). We also noted that the study measured the effects of KT rather than assessed how it worked. Because of these limitations, we considered that the study did not prove that KT encouraged the movement of lymphatic fluid.
Another study, which post-dated the claims, assessed the effect of KT on self-reported pain levels and "effort tolerance" in patients who had undergone laparoscopic cholocystectomy (keyhole surgery to remove the gallbladder). The study involved 63 patients who were randomly assigned to either a test group or a control group. Both groups received complex physiotherapy and the test group also received KT 24 hours after surgery. Patients were assessed before surgery and on the first, second, third and eighth day after surgery for pain levels (measured using a Visual Analogue Scale and pain medication intake) and effort tolerance (measured using a 100-metre walk test).
Although it was reported that pain perception and effort tolerance scores for the test group were statistically significantly lower than in the control group, we noted that the study did not have a sham tape control group which would have measured any placebo effect from wearing the tape. Therefore, we considered that the positive results of the study, which indicated that KT could be used as a method complementing physiotherapy in patients after laparoscopic cholecystectomy, were limited because of the study's failure to control for placebo bias. We also noted that the author stated that the physiological mechanisms which were responsible for any analgesic effects of KT were hypothetical.
We considered that the body of evidence provided in relation to this issue was not sufficiently relevant or robust to substantiate the description of the therapy under the heading "How does Kinesio Taping Work?" and concluded it was misleading.
In relation to this point, the claims breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
2. Upheld
In relation to lymphoedema, we noted that LV had provided five reports. Four of these had already been considered in relation to issue 1 and discounted for the reasons specified above. The other report was an article from the Journal of Hand Surgery which summarised various case studies and clinical trials discussed at a physiotherapy conference, including some which referred to KT. However, we had not seen the full studies so could not take them into account.
In relation to sports injuries, LV referred to 13 studies, seven of which had been considered in relation to issue 1 and discounted for the reasons stated above. One study was a clinical trial with a cross-over repeated measures design, which measured the immediate effects of KT versus sham taping on muscle strength, muscle activity and scapular motion in amateur baseball players with shoulder impingement syndrome. The 17 subjects received both KT and placebo tape over the lower trapezius muscle and performed arm elevation exercises whilst measurements were taken. The results showed a significant increase in scapular motion and activity of the lower trapezius muscle with KT compared with placebo tape. However, the study was limited due to the small number of subjects. Furthermore, the study only reported the immediate effects of KT and the author noted that further studies were required to research the long-term effects of KT.
Two clinical trials reported the immediate effects of KT on forearm and grip strength in healthy athletes. We considered that because the trials did not consider the effect of KT on sports injuries, it was not relevant to this issue.
Three further studies did not use the KT method.
In relation to hand therapy, LV provided a journal article entitled "Therapy After Injury to the Hand" which mentioned KT as a potential therapy for hand injuries. They also provided a journal article which summarised various case studies and trials which were discussed at a physiotherapy conference. However, because we had not seen the full studies, we were unable to take into account these studies.
In relation to paediatrics, LV provided a pilot study which reported the use and effects of KT in an acute paediatric rehabilitation setting. Subjects were 15 patients (children aged between 4 and 16 years of age) who had muscle weakness and/or abnormal muscle tone due to brain disease or injury. Subjects were measured for upper-limb function using the Melbourne Assessment, an objective standardised measure evaluating the quality of upper-extremity function of reach, grasp, release and manipulation, both prior to taping, immediately after the application of KT and three days after wearing the tape. Although improvement was reported in upper-limb function pre- to post-taping, the author noted a number of significant limitations with the study methodology. For example, the study was not controlled or blinded, it measured only the immediate and short-term effects of the tape and the subjects were receiving other treatments and medication during the study period so it was not clear whether the positive results were attributable to KT. We also noted that the study sample was small.
In relation to scar treatment, LV provided a clinical trial which used a paper tape rather than KT, and we therefore discounted this study. They also provided a single case study which observed the effects of KT on a patient with a hypertrophic scar on his abdomen following surgery. Although positive results were reported, we considered that because this was an observational study involving a single patient, and was not a clinically controlled trial, it was not adequate substantiation to support the claim.
We considered that the body of evidence provided in relation to this issue was not sufficiently robust to substantiate the efficacy claim that the therapy could be used for "Lymphoedema treatment, Sports Injuries, Hand Therapy, Paediatrics, Scar Taping" and concluded that it was misleading.
In relation to this point, the claim breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
3. Upheld
We noted that LV considered that "assisting" was not the same as "curing" and that they had been careful to make that distinction in the claim. However, we considered that "assisting" implied that KT could improve the medical conditions listed and we needed to see evidence of this.
We considered the totality of the evidence provided. We noted that none of the studies and trials provided measured the efficacy of KT in treating the following medical conditions: TMJ Dysfunction, Headaches (tension), Torticollis, Rotator Cuff Tear, Biciptal Tendonitis, Tennis/Golfers Elbow, Compartment Syndrome, Trigger Finger, Forward Shoulder, Thoracic Outlet Syndrome, Shin Splits, Foot Drop, Herniated Disk, Sciatica, De Quervains, Low Back Sprain/Strain, Sacroiliac Sprain/Strain, Piriformis Syndrome, Quadriceps Strain, Toe Cramps, Sprained Ankle, Meniscus Tear (minor), Osteoarthritis of Knee, Calf Cramps, Plantar Fascitis, Bunions, Post Operative/Traumatic Oedema, Hamstring Strain, Bells Palsy, Headaches (Migraine), Tinnitis (SCM cause) and Frozen Shoulder.
Although one study provided measured the efficacy of KT on patients with acute whiplash injury, we considered that the study was not sufficiently robust to substantiate the claim that KT could assist with this condition for the reasons set out in point 1 above. Similarly, four studies measuring the efficacy of KT on patients with Shoulder Impingement/Subluxation had been considered in relation to issues 1 and 2, but not considered sufficiently robust to substantiate the claim that KT could assist with this medical condition. The same was considered of the studies relating to Low Back Sprain/Strain, Calf Cramps and Post Operative/Traumatic Oedema.
We therefore considered that the body of evidence did not substantiate the efficacy claims that KT could assist the medical conditions listed on the website, and concluded that the claims were misleading.
In relation to this point, the claims breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
4. Upheld
LV provided six studies in relation to this issue. However, we considered that they were not sufficiently robust to substantiate the claims that KT could "Reduce Swelling, Alleviate Pain and Manage Oedema" and "The taping method can substantially aid sufferers of Lymphoedema by increasing the body's ability to drain lymphatic fluid to healthy lymph nodes. This is achieved using Kinesio Taping® techniques which have been designed specifically to aid lymphatic drainage" for the reasons set out in issues 1 and 2 above. We therefore concluded that the claims were misleading.
In relation to this point, the claims breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
Action
The claims must not appear again in their current form. We told LimbVolume to ensure they hold adequate substantiation for the claims they make in future.
