A Call to Action by the Italian Mesotherapy Society on Scientific Research.

Mesotherapy (local intradermal therapy, LIT) is a technique used to slowly spread drugs in tissues underlying the site of injection to prolong the pharmacological effect with respect to intramuscular injection. Recommendations for proper medical use of this technique have been made for pain medicine and rehabilitation, chronic venous disease, sport medicine, musculoskeletal disorders, several dermatological conditions, skin ageing, and immune-prophylaxis. Although mesotherapy is considered a valid technique, unresolved questions remain, which should be answered to standardize methodology and dosing regimen as well as to define the right indications in clinical practice. New randomized controlled trials are needed to test single products (dose, frequency of administration, efficacy and safety). Even infiltration of substances for dermo-cosmetic purposes must be guided by safety and efficacy tests before being proposed by mesotherapy. In this article, we put forth a preclinical and clinical research plan and a health technology assessment as a call to action by doctors, researchers and scientific societies to aid national health authorities in considering mesotherapy for prevention, treatment and rehabilitation paths.

Mesotherapy: From Historical Notes to Scientific Evidence and Future Prospects.

Intradermal therapy, known as mesotherapy, is a technique used to inject a drug into the surface layer of the skin. In particular, it involves the use of a short needle to deposit the drug in the dermis. The intradermal microdeposit modulates the drug's kinetics, slowing absorption and prolonging the local mechanism of action. It is successfully applied in the treatment of some forms of localized pain syndromes and other local clinical conditions. It could be suggested when a systemic drug-sparing effect is useful, when other therapies have failed (or cannot be used), and when it can synergize with other pharmacological or nonpharmacological therapies. Despite the lack of randomized clinical trials in some fields of application, a general consensus is also reached in nonpharmacological mechanism of action, the technique execution modalities, the scientific rationale to apply it in some indications, and the usefulness of the informed consent. The Italian Mesotherapy Society proposes this position paper to apply intradermal therapy based on scientific evidence and no longer on personal bias.

Current statement about Dry Needling practice in Italy after the opinion of the Italian Superior Health Council: practical implications for the safeguard of the patients in a case of malpractice.

In an our previous article, we described a case of a professional swimmer who presented a pneumothorax after treatment with dry needling (DN), performed by a physiotherapist. Although only few cases of serious adverse events after this treatment are reported in literature, the description of this case seemed to us of considerable interest to underline and discuss the medical-legal and ethical aspects regarding the skills and responsibilities of medical doctors and physiotherapists performing the procedure. The doctor-patient relationship, in this case, has failed because the patient has not received a correct diagnosis and adequate rehabilitation treatment according to international guidelines. In Italy a specialist medical doctor's prescription is required as a guide in the rehabilitation program performed by the physiotherapist after a clear and official diagnosis. The Italian Council of Health in the session of 13 June 2017, established that the practice of DN is a doctor's exclusive competence due to the invasive characteristics and potential complications of this technique.

Efficacy of intradermal administration of diclofenac for the treatment of nonspecific chronic low back pain: results from a retrospective observational study.

BACKGROUND: Intradermal administration of analgesic drugs with mesotherapy is effective for the local treatment of musculoskeletal pain. Few studies analyzed the effects of different drugs administrated with this technique. AIM: The aim of this study was to compare the efficacy of diclofenac versus lysine acetylsalicylate-based mesotherapy in relieving pain (primary outcome), and disability (secondary outcome) in patients with nonspecific chronic low back pain. DESIGN: Retrospective observational study. SETTING: Outpatient rehabilitation medicine center. POPULATION: Records of 101 patients with nonspecific chronic low back pain. METHODS: Data were extracted from the outpatients records of patients affected by nonspecific chronic low back pain since 12 weeks before, treated with 5 sessions of mesotherapy with diclofenac mixtures (group A) or aspirin-lysine acetylsalicylate mixture (group B). Assessments recorded were taken before the first treatment (T0), at the end of the 5-week treatment (T1), and at 4 (T2) and 12 weeks (T3) of follow-up after the last treatment, using a pain visual analogue scale (VAS) primary outcome, Oswestry Disability Index (ODI) secondary outcome, and the Short-Form McGill Pain Questionnaire (SF-MPQ) Comparisons within and between groups were performed using the t-test, the χ2 test, and analysis of variance (ANOVA) models, as appropriate. RESULTS: Records from 101 patients consecutively were analyzed, 51 in group A (mean age and standard deviation [SD]=62.8±10.7; F/M=33/18) and 50 in group B (mean age±SD=64.1±15.8; F/M=30/20). At baseline VAS, SF-MPQ, ODI scores were respectively 7.6±1.3, 22.49±9.96, 44.80±15.55 (mean and SD) in group A; VAS, SF-MPQ, ODI scores were respectively 6.7±1.6, 18.66±9.65, 39.04±16.06 (mean and SD) in group B. Mean differences between group A and group B in the changes of scores from baseline (T0) to end of study (T3) were -1.3 (VAS), -5.81 (SF-MPQ) and -17.05 (ODI). Mesotherapy induced significant reductions in pain severity and disability in both groups with better results in diclofenac-based treatment. CONCLUSIONS: This retrospective pilot study suggests the efficacy and safety of diclofenac mesotherapy for relieving pain and disability in patients affected by chronic nonspecific low back pain in a convenient sample but further studies will confirm these results. CLINICAL REHABILITATION IMPACT: Diclofenac mesotherapy appears to be a viable treatment. to reduce pain and improve function in patients affected by chronic moderate-to-severe nonspecific low back pain.

[Mesotherapy as a treatment of pain and disability in patients affected by neck pain in spondylartrosis]. / La mesoterapia come trattamento del dolore e della disabilità in pazienti affetti da cervicalgia in spondilartrosi.

Mesotherapy is a technique that treats locoregional pain with intradermal injection of a drug in the affected area. Its short-term efficacy was observed in patients with low back pain using both normal saline solution, if there were contraindications to drugs' use, or a cocktail of drugs (normal saline solution, lidocaine hydrochloride, and lysine acetylsalicylate), whereas only the latter provided benefit for up to three months after treatment. The aim of this study was to measure the effects of mesotherapy in patients affected by neck pain in spondylarthrosis, a common pathology in rehabilitation, associated with significant disability and increased health expenditure. One hundred patients participated in the study, of whom 50 (mean age 66.9 years) were treated with mesotherapy with a cocktail of drugs and 50 (mean age 64.7 years) with normal saline solution. Pain and disability were measured at different times (i.e. before treatment, at the end of five weeks of treatment, four weeks and 12 weeks after treatment), by using different pain scales, including a visual analogue scale, the short-form McGill pain questionnaire, the Present Pain Intensity scale and the Neck Disability Index. Mesotherapy with either normal saline solution or with a cocktail of drugs were both found to be effective in the short term in reducing pain and disability. However, only patients treated with a cocktail of drugs showed improvement at three months following treatment.

[Short-term and medium-term efficacy of mesotherapy in patients with lower back pain due to spondyloarthrosis]. / Efficacia della mesoterapia a breve e medio termine in pazienti affetti da lombalgia muscolotensiva da spondilartrosi.

Mesotherapy is an intradermal treatment for patients with local pain. The literature describes the efficacy of mesotherapy in the treatment of musculoskeletal disorders measuring a reduction of analgesic drug intake and of healthcare spending. The aim of this study was to measure the effects of mesotherapy on pain and disability in patients with low back pain due to spondyloarthrosis.

Efficacy of mesotherapy using drugs versus normal saline solution in chronic spinal pain: a retrospective study.

Mesotherapy, or intradermal therapy, is a therapeutic approach that is gaining popularity, but there is still a significant lack of information on its mechanisms of action or the pharmacokinetics of the therapeutic regimens. This retrospective study on 220 records compared the short-term and long-term effects of mesotherapy using a mixture of drugs versus normal saline solution in the treatment of patients with chronic spinal pain (CSP). At the end of treatment, outcome measures showed a significant improvement (P<0.003) in both groups, which persisted at the follow-up assessments. At 12 weeks of follow-up, the improvement was significantly greater in patients treated with the drug cocktail than with the saline solution (P<0.05). Mesotherapy was effective in patients affected by CSP, with high patient satisfaction reported irrespective of the agent used. Considering the risks and costs of drugs, normal saline solution appears to be the best agent in cost-benefit terms for treating localized pain by mesotherapy in CSP.

[Pneumothorax following dry needling treatment: legal and ethical aspects]. / Pneumotorace successivo a trattamento riabilitativo con tecnica "dry needling": aspetti medico legali e etico-deontologici.

Trigger point "dry needling" is a technique used to treat myofascial pain. It involves using filiform needles which are inserted into muscles to give local pain relief. Few cases of serious adverse events following this treatment have been reported in the literature. In this paper we describe the case of a professional swimmer who developed pneumothorax after dry needling treatment and discuss the medicolegal and ethical aspects related to competencies and responsibilities of medical doctors and physiotherapists performing the procedure.

Immediate effects of kinesiotaping on quadriceps muscle strength: a single-blind, placebo-controlled crossover trial.

OBJECTIVE: To investigate the immediate effects on maximal muscle strength of kinesiotaping (KT) applied to the dominant quadriceps of healthy subjects. DESIGN: Single-blind, placebo-controlled crossover trial. SETTING: "Salvatore Maugeri" Foundation. PARTICIPANTS: With ethical approval and informed consent, a convenience sample of 36 healthy volunteers were recruited. Two subjects did not complete the sessions and were excluded from the analysis. INTERVENTIONS: Subjects were tested across 3 different sessions, randomly receiving 2 experimental KT conditions applied with the aim of enhancing and inhibiting muscle strength and a sham KT application. MAIN OUTCOME MEASURES: Quadriceps muscle strength was measured by means of an isokinetic maximal test performed at 60 and 180 degrees per second. Two secondary outcome measures were performed: the single-leg triple hop for distance to measure limb performance and the Global Rating of Change Scale (GRCS) to calculate agreement between KT application and subjective perception of strength. RESULTS: Compared with baseline, none of the 3 taping conditions showed a significant change in muscle strength and performance (all P > 0.05). Effect size was very low under all conditions (≤0.08). Very few subjects showed an individual change greater than the minimal detectable change. Global Rating of Change Scale scores demonstrated low to moderate agreement with the type of KT applied, but some placebo effects were reported independently of condition. CONCLUSIONS: Our findings indicated no significant effect in the maximal quadriceps strength immediately after the application of inhibition, facilitation, or sham KT. These results do not support the use of KT applied in this way to change maximal muscle strength in healthy people.

Short-term effects of local microwave hyperthermia on pain and function in patients with mild to moderate carpal tunnel syndrome: a double blind randomized sham-controlled trial.

OBJECTIVE: To determine the short-term effects of local microwave hyperthermia on pain and function in patients with mild to moderate idiopathic carpal tunnel syndrome. DESIGN: Double-blind randomized sham-controlled trial. SETTING: Outpatient clinic of the Department of Physical Medicine and Rehabilitation, University Hospital. PARTICIPANTS: Twenty-two patients with idiopathic carpal tunnel syndrome, 12 of whom had bilateral involvement, for a total of 34 wrists, divided into two groups: a hyperthermia active treatment group (number of wrists = 17) and a sham-controlled group (number of wrists = 17). INTERVENTION: Six sessions, two per week, of either hyperthermia or sham treatment were provided over a period of three weeks. MAIN MEASURES: Visual analogue scale, Levine-Boston Self-Assessment Questionnaire (part I: evaluation of pain intensity; part II: evaluation of functional status) and neurophysiological assessments, were determined at baseline and at the end of the treatment. RESULTS: The hyperthermia group experienced a significant improvement in pain (visual analogue scale: P = 0.002; Levine-Boston part I: P < 0.0001) and functional status (Levine-Boston part II: P = 0.002) relative to baseline. No improvements in pain intensity or functionality were observed in the sham-treated group. Changes in pain severity between baseline and the end of treatment were larger in the hyperthermia group than in the sham-controlled group (Δ visual analogue scale P = 0.004; Δ Levine-Boston part I: P = 0.009). No differences either intra or between groups were observed for median nerve conduction velocity. CONCLUSION: Hyperthermia provides short-term improvements in pain and function in patients with mild to moderate carpal tunnel syndrome.