Ad description
An advertorial for Judy Lewis' Training Station, which appeared in March 2011 stated, "... 'Restrictions in the connective tissues cause so many people to suffer from symptoms such as pelvic and lower back pain, fibromyalgia, poor posture, tight muscles, frozen shoulder, carpal tunnel syndrome, infertility, headaches, restricted movement in the body and joint pain and many more health issues,' explains Judy. 'The treatment strategy follows a whole body approach to identify why someone is experiencing such symptoms and looks at finding the cause.' Judy explains that experiencing pain and restriction maybe [sic] due to some kind of repetitive strain or trauma that may have happened many years ago. 'Once we have assessed a client, then we devise a treatment plan that involves working gently into the connective tissues to release the fascial restrictions within the body. Clients who have been treated in this way [with myofascial release] find that their pain has drastically diminished or disappears altogether,' adds Judy".
Issue
A reader challenged whether the claims that myofascial release could help with the conditions set out in the advertorial were misleading and could be substantiated.
Response
Ms Lewis did not believe that the advertorial stated or implied that myofascial release (MFR) treated any of the conditions mentioned. She said that the advertorial explained that MFR worked on the connective tissue to release fascial restrictions and highlighted that it stated "those [people who are] treated in this way find their pain has drastically diminished or disappears altogether".
Ms Lewis provided five studies and two articles which she believed substantiated the claims made. She also provided 'before' and 'after' photographs of two clients who had visited her for poor posture. She believed that those photographs substantiated that claim.
Assessment
Upheld
The ASA considered that the advertorial implied that MFR could help treat the medical conditions referred to and we expected Ms Lewis to hold robust, scientific substantiation to support those claims.
We considered the evidence provided but noted that none of it looked at how MFR could help with frozen shoulder, carpal tunnel syndrome, infertility or headaches. We therefore considered that the efficacy claims for those conditions were unsubstantiated and misleading.
We noted that one study considered the effect of MFR on fibromyalgia, which we had previously considered in a separate investigation. We understood from the study that subjects in the intervention group received 20, 90-minute sessions of MFR massage from a specialist physiotherapist to the 18 painful sensitive points on the body described by the American College of Rheumatology. We understood that subjects in the placebo group received 20, 30-minute sessions of sham magnotherapy to the lumbar and cervical areas. We therefore understood that the trial was only single-blinded and that the intervention group had received three times as much treatment time, pro rata, as the placebo group. Notwithstanding that, we had concerns about whether magnotherapy to only two areas was an appropriate method with which to control against an intervention group who were receiving, hands-on manual therapy to 18 points on the body. We considered that the control group should have received a 'sham' MFR therapy which reflected, as near as possible, the therapy given to those in the experimental group. For that reason, we concluded that the study did not support the claim that MFR could treat fibromyalgia.
We noted that one study looked at the influence of the temporomandibular joint (TMJ), which connected the lower jaw to the skull, on the range of motion in the hip joint in patients with complex regional pain syndrome (CRPS). The study compared patients with CRPS to healthy participants and both groups underwent the same testing. Prior to receiving the MFR, participants were asked to complete questionnaires in which they were asked to rate their perceived level of pain and rate their average pain intensity during the previous four weeks. We understood from the study that the dominant pain complaint reported by those with CRPS was the hand or foot, but pain in other parts of the body was also frequently encountered.
During the study, the range of motion in the hip was measured at three time points: at the start of the study, after MFR on the TMJ and after jaw clenching for 90 seconds. We understood the study showed that myofascial release in the jaw improved hip movement but that it did not show how long that improvement lasted. The study suggested that TMJ dysfunction played an important role in the restriction of hip motion experienced by patients with CPRS. Whilst we noted the positive outcome of the study – that CPRS patients experienced improved range of motion – we noted that it was a small study (there were 20 participants in each group). We noted further that similar studies looking at range of motion in CPRS patients were lacking, and that the study noted it was important that further studies be carried out.
We further noted that the study only considered specifically whether MFR could improve range of motion in the hip and not any other joints, which may experience restricted movement. We considered that the study was insufficient to substantiate the general claims made in the advertorial about MFR helping with joint pain in the body.
Another study looked at how neck mobility was affected following a cervical myofascial induction. The examiner in the experimental group applied a slight cranial traction to the occipital bone and held that position for five minutes. We noted that the control group received a 'sham' MFR which involved the examiner placing their hands in the same position for the experimental group but without applying any tension or performing traction on the control group participants.
We understood that the experimental group experienced greater neck mobility immediately after receiving MFR. Whilst the study noted the improvement was statistically significant, it noted that that improvement did not exceed the minimal detectable change for the measurement. The study stated that the improvement could be attributed to measurement error, rather than a true difference. We noted that the study had been carried on asymptomatic patients and that it was unknown whether the same effects would have occurred in patients with pain. The study also believed that it was possible that manual contact experienced by participants may have caused patients to expect a change or may have created a placebo effect and that the study was small (the study was 35 people). We noted that the study only looked at one point in the body and not across all joints of the body. For that reason, we concluded that the study did not support the general claim made in the advertorial that MFR could help with restricted movement in the body.
One article provided an abstract about a case study on two patients, 75 and 83, with severe kyphoscoliosis deformity with pain which necessitated them walking with a rolling walker. We understood that both patients received two weeks of physical therapy which consisted of 45 minutes of MFR and 15 minutes exercise and that both patients reported improvements for two days following the completion of treatment. However, we noted that the article only considered two patients and was not in the form of a clinically controlled and blinded trial. For those reasons, we concluded that they did not support efficacy claims for MFR.
We considered a patient case study which looked at the effect of MFR in diffuse systemic sclerosis, a chronic inflammatory disease of the connective tissue. The case study looked at one patient who received 20 MFR sessions in 2002, and between sessions 19 and 20, there was a break of 110 days. We noted that the patient reported positive outcomes in a number of areas, however, we also noted that the case study was only for one patient and for this reason we concluded that the study did not support efficacy claims for MFR.
One study considered the effect of MFR on plantar fasciitis, inflammation of the plantar fascia which is the connective tissue on the sole of the foot. The control group was treated with ultrasound with the output of 1W/cm2 for five minutes using a pulsed mode 1:4 ratio with frequency of 1 Mhz for 10 sittings for 10 consecutive days, a contrast bath for 20 minutes for 10 days and exercises for intrinsic muscle strengthening. The experimental group received the same treatment along with myofascial release by using thumb, plantar cupping and fingers technique for 15 minutes. We noted that participants in both groups were advised to use soft heel footwear, not to stand for long periods of time and not to walk bare foot and not to do any stretching exercises at home. The outcome was assessed, at the end of the 10th day of intervention, based on Foot Function Index and pain of VAS (Visual Analog Scale). The study showed that the experimental group showed a greater improvement in the experimental group for both pain relief and functional ability. The study concluded that the improvement in the experimental group could be attributed to the myofascial release which the group received in addition. Although we noted the positive results of the study, we noted that neither those carrying out the treatments nor those assessing the results or the groups had been blinded. We also noted that it was a small study (there were 30 participants). For those reasons, we concluded that the study did not support efficacy claims for MFR.
Another study considered the effect of MFR and paradoxical relaxation training (PRT) in a six-day intensive treatment protocol for refractory prostatitis/chronic pelvic pain syndrome. The study conducted a six-day intensive (immersion) treatment protocol which included training of participants in self-treatment of intrapelvic and extrapelvic myofascial trigger point release therapy, and training in paradoxical relaxation including some cognitive behavioural methods. Patients reported their subjective sensations of pain in the general locations of the penis, perineum, rectum, suprapubic region, testes, groin and coccyx and sites of referred pain after manipulation of a trigger point. For five consecutive days, the same physical therapist performed myofascial trigger point release and trained patients in the self-administration of the method. The therapist treated individual muscle groups and released trigger points with applied pressure. The therapy was delivered in 30- to 60-minute sessions each day and patients were also instructed on how to stretch and enhance relief of muscle tension. During the treatment protocol, a pscychologist provided daily instruction in PRT which was intended to modify habitual tendency to tighten the pelvic muscles. Patients were also provided with a two-year recorded training programme as part of their home self-treatment.
Whilst we noted the positive results of the study, we also noted that there was no control group, that the study was not blinded and that participants referred themselves to the study and were asked to provide their subjective assessment on pain. The study noted that immersion protocol participants were highly motivated to try something new and that the intensive personal interaction with the therapists might have contributed to the positive response. For those reasons, we concluded that the study did not support efficacy claims for MFR.
We noted the 'before' and 'after' photographs of the two clients provided by Ms Lewis but also that we had not seen any other information about the MFR they had received. We considered that Ms Lewis needed to hold robust, scientific evidence to support her claim that MFR could help with poor posture. We considered that the photographs alone were insufficient to substantiate that claim.
When looking at the body of evidence provided, we concluded that it was not sufficiently robust to substantiate either efficacy claims for MFR on the specific conditions listed or for treating "...many more health issues". We concluded that the claims were misleading.
The advertorial 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 advertorial must not appear again in its current form. We told Ms Lewis not to make claims that MFR could treat pelvic and lower back pain, fibromyalgia, poor posture, tight muscles, frozen shoulder, carpal tunnel syndrome, infertility, headaches, restricted movement in the body and joint pain, unless she held evidence to substantiate them.
