Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH® system) in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial

Abstract

BackgroundLow back pain (LBP) is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for less than 7 days. Almost 10% of all patients are at risk of developing chronic pain and disability. Little clinical evidence is available for the majority of treatments used in LBP therapy. However, moderate evidence exists for interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation, and cognitive behavioral therapy for subacute and chronic LBP. The SMATH® system (system for automatic thermomechanic massage in health) is a new medical device (MD) that combines basic principles of mechanical massage, thermotherapy, acupressure, infrared therapy, and moxibustion. SMATH® is suitable for automatic multidisciplinary treatment on patients with non-specific sub-acute and chronic LBP.Methods/designThis paper describes the protocol for a double-blinded, sham-controlled, randomized, single-center short term clinical trial in patients with non-specific sub-acute and chronic LBP aged 18 to 70 years. The primary outcome will be the effectiveness of SMATH® versus sham therapy (medical device without active principles) determined by evaluating self perceived physical function with Roland Morris Disability Questionnaire (RMDQ) scores after 4 weeks of treatment (end of treatment). Major secondary outcome will be effectiveness of SMATH® determined by evaluating self perceived physical function comparing RMDQ scores between end of treatment and baseline. The trial part of the study will take 7 months while observational follow-up will take 11 months. The sample size will be 72 participants (36 for each arm). The project has been approved by the Ethical Committee of Cremona Hospital, Italy on 29 November 2010.DiscussionCompared to other medical specialties, physical and rehabilitation medicine (PRM) has not yet received the deserved recognition from clinicians and researchers in the scientific community, especially for medical devices. The best way to change this disadvantage is through well-conducted clinical research in sham-controlled randomized trials. Sham treatment groups are essential for improving the level of evidence-based practice in PRM. The present trial will counter the general lack of evidence concerning medical devices used in LBP therapy.Trial RegistrationISRCTN: ISRCTN08714168

Effectiveness of acupressure versus isometric exercise on pain, stiffness, and physical function in knee osteoarthritis female patients

“…On the other hand, the acupressure group of the present study showed more improvement in the pain component of the WOMAC scale. This is in congruence with previous studies that demonstrated the effectiveness of this treatment modality in the relief of various types of pain such as low back pain [44] , dysmenorrhea [45] , and pain in breast cancer [46] . The pain relief of acupressure has been attributed to its analgesic action, which has been considered by Litscher [21] as similar to general anesthesia.…”

Green exercise and mg-ca-SO4 thermal balneotherapy for the treatment of non-specific chronic low back pain: a randomized controlled clinical trial

“…Preference is given to conservative non-pharmacological treatments [9], with a wide range of recommendations. There are more than 50 different potential therapies promising pain relief or even healing, but only few have been thoroughly evaluated by evidence-based methods [10]. For patients already suffering from back pain, recurrences and chronification can be prevented best by multimodal programs, which means the combination of different sorts of therapy [11].…”

Massage Therapy of the Back Using a Real-Time Haptic-Enhanced Telerehabilitation System

“…Massage therapy has been shown to a ect both structure and function of the musculoskeletal system by promoting a relaxation response, decreasing muscle tension, and decreasing tonic muscle contractions [13][14][15][16]. In recent years, the integration of mechanical instruments to support the implementation of massage therapies such as massage chairs [5][6][7], automatic massage systems [6], or robotic systems [17][18][19][20][21] has bene ted therapists and their patients.…”

“…ere also exist automatic massage systems such as medical devices that combine basic principles of mechanical massage, thermotherapy, acupressure, infrared therapy, and moxibustion. For instance, the device described in [6] is capable of releasing modulated and controlled thermomechanical energy on the patient following a programmable and fully reproducible automatic treatment program selected by the operator. Another example of automatic massage systems is robotic systems that use massage patterns, for example, robots that provide maxillofacial massages [17], massage of the back [20,21,25], or feet massage [18].…”

“…A massage is de ned as "a mechanical manipulation of body tissues with rhythmical pressure and stroking for the purpose of promoting health and wellbeing" [4]. Despite the availability of novel mechanical support tools for back massage intervention, for example, [5][6][7], massage therapy is still provided in a traditional way, where both the patient and the therapist need to be in the same place [8].…”