ORIGINAL ARTICLE

Combination therapy of focused ultrasoundand radio-frequency for noninvasive body contouringin Asians with MRI photographic documentation

Shyue-Luen Chang & Yau-Li Huang & Mei-Ching Lee &

Chih-Hsiang Chang & Wen-Hung Chung & En-Haw Wu &

Sindy Hu

Received: 30 October 2012 /Accepted: 5 March 2013 /Published online: 24 March 2013# Springer-Verlag London 2013

Abstract Previous studies have shown that single or multipletreatments by focused ultrasound are effective and safe.However, most include focused ultrasound only and notradio-frequency treatment. There is paucity of magnetic reso-nance imaging (MRI) measurements and pictures in the liter-ature. This study aimed to assess the efficacy, safety, and painand satisfaction levels of the combination therapy of focusedultrasound and radio-frequency for improving body contours.Thirty-two Asian patients received 3 sequential treatmentsevery 2 weeks in the abdominal region. Safety parametersand adverse events were recorded. The subjects’ pain andsatisfaction levels were evaluated using a five-point Likertscale. Two patients underwent MRI study randomly. Therewas a mean reduction in circumference of 3.91±1.8 cm (p≤0.001). In MRI measurement, the average in fat thickness re-duction was 21.4 and 25 % on the upper and lower abdomen,

respectively. There were three mild and self-limited localizedadverse events. The satisfaction survey showed that 71.9 %was satisfied with the results, while pain level evaluationshowed that 90.5 % felt no pain. Combination therapy offocused ultrasound and radio-frequency for noninvasive bodycontouring is an effective, safe, and painless procedure inAsians. Although the change is minor compared to traditionalsurgical procedure, it is real, definite, and effective.

Keywords Asians . Body contouring . Focused ultrasound .

Magnetic resonance imaging . Radio-frequency . UltraShape

Wider social acceptance of cosmetic procedures has resultedin increased demands for procedures that will improve bodyimage and quality of life. One of the most frequent cosmeticproblems encountered by doctors is the patient’s desire toachieve a better body shape. Body contouring by liposuctionis one of the most popular and leading cosmetic surgicalprocedures in the USA, with an increasing number of casesestimated to be 176,863 in 1997 to 325,332 in 2011 [1]. Onthe other hand, with the advent of less invasive dermatologicprocedures, nonsurgical cosmetic procedures have increasedmuch more than surgical procedures, rising by 920 % than74 % from 1997 to 2011 [1]. Current available options forbody contouring do not necessarily satisfy all of the pa-tient’s needs. Liposuction may require general anesthesia,may be uncomfortable, may be expensive, and may havelong recovery periods. Even with newer and safer tech-niques, pain, bruising, and edema can occur after surgery[2–4]. Moreover, the invasive nature of certain procedurescontributes to patient’s hesitance [5]. Laser-assisted lipolysisis a recently developed alternative to liposuction whereby alaser probe is introduced into the subcutis and used to melt

S.-L. Chang :Y.-L. Huang :M.-C. Lee : C.-H. Chang :W.-H. Chung : S. HuDepartment of Dermatology, Chang Gung Memorial Hospital andChang Gung University College of Medicine, Taoyuan, Taiwan

E.-H. WuDepartment of Diagnostic Radiology, Chang Gung MemorialHospital and Chang Gung University College of Medicine,Linkou, Taiwan

S.-L. Chang :Y.-L. Huang :M.-C. Lee : C.-H. Chang :W.-H. Chung : S. HuDepartment of Cosmetic Science, Chang GungUniversity of Science and Technology, Linkou, Taiwan

S. Hu (*)Department of Dermatology, Chang Gung Memorial Hospitaland Chang Gung University College of Medicine,No. 199, Tung Hwa North Road,Taipei, Taiwane-mail: ellis@cgmh.org.tw

Lasers Med Sci (2014) 29:165–172DOI 10.1007/s10103-013-1301-x

fat. While this procedure has less risk and faster recoveryperiod, it is still an invasive procedure.

Alternative therapies to invasive procedure include diet,exercise, lifestyle change, and methotherapy. However, it ishard to maintain diet and exercise, and certain body areasare difficult to shape even with optimal dietary and workoutregimens, such as the abdomen, flanks, and thighs.Methotherapy, on the other hand, is not currently approvedby the US Food and Drug Administration. A noninvasivemethod for fat reduction and body contouring will, there-fore, be a welcome procedure for patients seeking treatmentwith lower risk, less pain, and no downtime.

A novel noninvasive therapeutic ultrasound system(Contour I Ver.3, UltraShape Ltd., Tel Aviv, Israel) that usesfocused ultrasound to reduce adipose tissue has been devel-oped to improve the removal of unwanted fat depositswithout the drawbacks of invasive techniques [6, 7]. Thefocused ultrasound system is designed to disrupt adiposecells using mechanical energy without thermal effect.According to experimental results in a porcine model, acluster of small holes is generated in subcutaneous adiposetissue by each shock, with no observable damage on con-nective tissue, blood vessels, and nerves due to differentsusceptibilities to ultrasonic mechanical stress [8]. Previousstudies have shown that single or multiple treatments by thisdevice are effective and safe [6–9]. Most involve focusedultrasound only but not radio-frequency treatment. Studieson Asian populations are also rare [10].

The aim of this study was to assess the efficacy, safety,and pain and satisfaction levels of combined focused ultra-sound and radio-frequency to improve body contours. Inaddition, due to the notoriously imperfect measuringmethods of circumference measurement, caliper assessment,and diagnostic ultrasound imaging and the lack of magneticresonance imaging (MRI) measurements and pictures inavailable literature, MRI measurements were performed intwo study patients randomly before and after treatment todetermine fat changes and provide more evidence.

Materials and methods

Patients

This prospective study was conducted on 32 healthy patientsin single center. The institutional review board and ethicscommittee approved the study protocol, which conformed tothe tenets of the Declaration of Helsinki for human research.All patients provided written informed consent. Thirty-twohealthy Asian subjects (25 females and 7 males) were enrolledand received three sequential treatments every 2 weeks in theabdominal region, with at least 2 cm fat thickness measured bycaliper. Healthy nonpregnant individuals aged ≥20 years old

and body mass index (BMI) ≤30 were included. Treatmentarea with tattoos, scars, dermatitis, or open wounds and pa-tients with a history of major diseases like uncontrolled hy-pertension, ischemic heart disease, cardiac pacemaker,abdominal aneurysm, deep vein thrombosis, diabetes mellitus,HIV infection, connective tissue disease, and malignant dis-ease were excluded. Those with recent (within 3 months) liverdisease, renal disease, coagulation disease, hyperlipidemia,abdominal hernia, and concurrent use of medication that coulddisrupt coagulation (e.g., aspirin, NSAIDs, warfarin) werealso excluded. The patients were instructed to maintain ahealthy lifestyle with balanced diet and regular exercise dur-ing treatment and follow-up.

Preparation and treatment

Before treatment, a thorough evaluation of the patient’smedical and psychosocial history was conducted togetherwith detailed examination of the treatment area and focusedbody physical examination. The entire procedure and po-tential interventions were also discussed with the patients.

Prior to each treatment, the treatment area was markedand fat thickness was assessed by caliper to ensure that theminimal thickness in the marked area was >2 cm and bonyareas were avoided. Circumference measurements prior toeach treatment were obtained by two independent well-trained personnel each time, and the average was recorded.A special measuring tape was used and a ratchet system wasdeveloped by UltraShape to allow application of a constantforce at a constant height to eliminate any bias due todifferent amounts of pressure applied by the operator whenmeasuring circumferences. Body weight and photographicdocumentation were also recorded before each session.

The patients were placed in a supine position with themarked area exposed. An adhesive band was used to makethe area more prominent and homogeneous. Three stepswere taken in each session. In step 1, tissues were pretreatedwith vacuum-assisted bipolar radio-frequency (RFVac™)for 5–10 min to increase local blood circulation that mayenhance the mechanical effects of focused ultrasound. Instep 2, focused ultrasound was performed for fat cell de-struction. After acquiring all the parameters, the systemdisplayed the treatment nodes and indicated the node to betreated. It allowed firing of a focused ultrasound pulse onlywhen there is accurate positioning of the transducer. Cooledcastor oil was used to ensure optimal acoustic contact forproper ultrasound energy delivery and to reduce pain sen-sation. The operator continued to move the transducer on thetreatment area according to the guidance system. Treatmentwas controlled by the tracking and guidance system until theend of treatment. In step3, radio-frequency was again usedfor 5–10 min immediately after focused ultrasound to in-crease lymphatic drainage and accelerate fat clearance. This

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also had added tightening effect for skin and tissue [11]. Thewhole process for the abdomen took about 1 h. The fre-quency mode of radio-frequency was 0.8 MHz and thepower level of radio-frequency started from level 4 (34.5 W) and adjusted according to the patient’s response, whilethe vacuum level started from level 2 (210 mmHg) andadjusted according to skin laxity. The frequency of focusedultrasound was 0.2 MHz and treatment acoustic outputpower was fixed at a high level (141 W) in single focusedmode.

During the entire procedure, topical anesthetics were notused for the patients. If the patient complained of discomfortduring treatment, additional cooled castor oil was used. Ifpain persisted, a small area of node was skipped.

Assessments and statistical analysis

All of the patients underwent three treatments in the abdom-inal region, at 2-week intervals, and were followed up1 month after the last treatment. No other body contouringprocedure was used during the study. Circumference mea-surements and photographic documentation of the treatedarea were recorded prior to each treatment and follow-upsession under the same controlled condition.

Efficacy was determined by circumference measure-ments, while safety was determined by clinical findings.Adverse events, including evaluation of patient’s responseand local skin reaction in the treatment area, wererecorded throughout the study. Weight change was moni-tored to assess whether the reduction in circumferencewas about weight loss. The study subject’s overall painand satisfaction levels were evaluated using a question-naire with a five-point Likert scale during follow-up after1 month. In scoring pain level, 1 stood for least painfuland 5 for most painful. Regarding satisfaction level scor-ing, 1 stood for very good, 2 for good, 3 for average, 4for poor, and 5 for very poor.

Because most of the measuring methods includingcircumference measurement, caliper assessment, and di-agnostic ultrasound imaging measurement may not beaccurate and consistent due to operator error. For addi-tional information about fat changes, MRI was alsodone randomly in two of our study group on the base-line and 1 month after last treatments [12].

Statistical data analysis was performed using the SPSSsoftware. All tests were two-tailed and p≤0.05 was consid-ered statistically significant. Due to the small sample sizeand non-normal data distribution, nonparametric tests wereused to determine the difference between baseline and1 month follow-up. The Wilcoxon signed-rank test wasused to compare two paired variables (pretreatment andposttreatment circumference measurement). Spearman’srho correlation coefficient was applied to test the strength

of relationships among study parameters, while Friedmantest was used to compare treatment shots among the threesessions.

Results

Thirty-two subjects completed the treatments and werefollowed up after 1 month. All subjects were Asians, com-posed of 7 males and 25 females, with a mean age of 38.6±10.8 years (range, 26–64 years) and mean BMI of 24.8±2.4.Body weight changes pretreatment and posttreatmentremained constant without significant change. The meannumbers of focused ultrasound shots in the three sessionswere 542.3, 500.7, and 487.5, respectively, and the decreasefollowing each treatment session was significant (p<0.01).

After three consecutive treatments, a statistically signifi-cant reduction in the treating area comparing to baseline wasmeasured, with a mean circumference reduction of 3.91±1.8 cm (p≤0.001) (Figs. 1 and 2). The responses of males andfemales were similar, with a mean circumference reductionof 3.89 cm in females and 4.0 cm in males. The result wasconsistent with that of a previous study [6, 7, 9].

The MRI studies were done in cases 23 and 24. The T1-weighted image of both patients on the upper abdomen(above the umbilicus and lower kidney level) and the lowerabdomen (below the umbilicus and upper pelvic bone level)showed a significant reduction in abdominal fat thickness(Figs. 3 and 4). In MRI measurements, the average fatthickness reduction in percentage of two patients was 21.4and 25 % on the upper and lower abdomen, respectively(Table 1).

The procedure was safe and well-tolerated. No severeadverse side effect was noted during and after treatment.Three localized adverse events were noted during the treat-ment and most were self-limited within several days. Onewas allergic contact dermatitis to adhesive band that im-proved by using hypoallergenic tape. Another was transientmild erythema that subsided spontaneously within 1 h. Thelast was a swelling erythema for 3 days that became mildpost-inflammatory hyperpigmentation and resolved within2 weeks.

The subject satisfaction survey 1 month after the lasttreatment showed that 71.9 % of subjects felt that the resultof treatment was good or very good, 18.8 % felt average,and 9.4 % felt poor or very poor (Fig. 5). In pain levelevaluation of the entire procedure, the results showed that90.5 % felt no sensation or some sensation but no pain(score 1 or 2), 6.3 % felt minimal pain, 3.1 % felt pain,and none felt very extreme pain (Fig. 6).

Spearman’s rho correlation coefficient was applied to testthe relation among parameters. There was correlation be-tween abdominal circumference reduction and body weight

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(0.446; p=0.010), BMI (0.574; p=0.001), overall satisfac-tion level (−0.767; p=0.000), and total shots (0.381; p=0.

031). The correlation between circumference reduction andage, although not significant, was −0.243 (p=0.18).

Fig. 1 The abdomen before(left) and after (right) treatmentof case 3 (upper two figures)and case 21 (lower two figures)

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Discussion

Most of the cosmetic treatments are for conditions that arenot pathologic, so an ideal procedure for body contouringshould be noninvasive, painless, without downtime, safe,and of course, effective.

The combination therapy of focused ultrasound andradio-frequency is a noninvasive procedure that is painlessbut with mild and tolerable discomfort reported in <9.5 % ofpatients in the present study. The pain sensation may beminimized by adding coupling oil and avoiding bony pro-trusion area like the iliac crest. Moreover, cooled castor oil

can be immediately used and added very frequently andcopiously. Before firing each shot in different regions, per-fect contact between the skin and transducer must beachieved and patients should be informed of every antici-pated pain point and in the peripheral ring of the treatmentarea.

There is no downtime after nonthermal focused ultra-sound treatment. Compared to liposuction, laser-assistedlipolysis, or other noninvasive body contouring procedures,this procedure allows patients to resume their normal activ-ities and exercises immediately after because there is noneed to wear compression garment, no puncture or operationwound, and no skin texture change, irregularity, discolor-ation, ecchymosis, bruising, edema, and paresthesia.Patients can wear summer clothes and swimsuits immedi-ately after treatment.

The safety and efficacy of focused ultrasound for fatdisruption and body contouring has been studied and provenwith extensive evaluations. A series of physics modelingsystem, animal experiments, histologic analysis, and humanclinical studies have been done and concluded that thisdevice targets adipose tissue within a defined treatment zoneat a depth without transducer–skin interface damage. Inuntreated areas, all tissue components remain intact without

Fig. 2 Abdominal circumference reduction in the study patients(n=32)

Fig. 3 Before (left) and after (right) treatment of case 23. Upper row lower abdomen, lower row upper abdomen

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observable damage to connective tissue, blood vessel, andnerve [8]. As regards laboratory testing and liver burden,especially serum lipid profile and liver chemistry and sono-gram, several previous studies show no significanttreatment-induced changes [6, 7, 10]. Adverse cutaneousevents are few and range from erythema and blister toerosion and PIH. Most are anticipated and told to patientsbefore the procedure in this study. Most resolve spontane-ously or with topical antibiotics treatment. In the presentstudy, there are only few cutaneous complications, whichare mild and self-limiting. Of note, the patient with swellingerythema is the second patient, which may be related totreatment skill due to poor contact or insufficiently addedoil.

In this study, there is a statistically significant reductionin mean abdomen circumference of 3.91 cm at 1 monthfollow-up after the last of three consecutive treatments with2-week intervals. The minimal and insignificant bodyweight change and the visible reduction only in treated areassupport the benefit of focused ultrasound procedure. Theresult is consistent with previous reports of an average of 3.51 cm loss after three successive treatments in the abdomenby Ascher [9], an average of 3.95 cm loss after three suc-cessive treatments at 1-month intervals by Moreno-Moragaet al. [7], and a 2.3-cm loss after single treatment byTeitelbaum et al. [6]. Of note, the combination therapy offocused ultrasound and radio-frequency was used in thisstudy instead of focused ultrasound only in previous studies.

Fig. 4 Before (left) and after (right) treatment of case 24. Upper row lower abdomen, lower row upper abdomen

Table 1 Fat thickness reduction on the upper and lower abdomen by MRI measurement

Age BMI Upper abdomen Lower abdomen

Before treatment(mm)

After treatment(mm)

Fat thicknessreduction (mm) (%)

Before treatment(mm)

After treatment(mm)

Fat thicknessreduction (mm) (%)

Case 23 30 28.5 38.4 31.3 7.1 (18.5) 33.6 26.6 7 (20.8)

Case 24 42 24.2 22.7 17.2 5.5 (24.2) 18.8 13.3 5.5 (29.2)

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Although a previous study does not show significant reduc-tion after treatment [10], different versions of machines(with different spatial peak pulse average intensities be-tween the latest and previous versions of the machine, useof digital ultrasound pulser in the latest version, amongothers), the low follow-up rate in a previous study (1 monthfollow-up in 18 of 53 patients), and the addition of radio-frequency treatment immediately before and after focusedultrasound treatment in this study may be the possibleexplanation for such difference.

Although circumference measurements may not be per-fectly precise due to difficulty in using consistent pressureand operator error, the other popular method, diagnosticultrasound, is also not a reliable tool for analyzing fatthickness. The MRI is a preferred measuring method forinformation concerning fat composition, quality, distribu-tion, and fat thickness with less human factors and moreconsistent results. However, availability and high costs limitits use. Going a step further on fat changes and providingmore evidence for this study, MRI studies and measurementwere done in two patients in the study group. The averagereduction in fat thickness in the abdomen by MRI measure-ment ranged from 18.5 to 29.2 %. This result may be

accurate and representative since measurements using diag-nostic ultrasound by previous studies vary greatly [6, 7, 10].

According to the measurement data in this study andclinical and MRI pictures, this treatment is real and definitebut not as dramatic compared to traditional surgery in bodycontouring. However, the noninvasive nature and painlessprocess may make this method popular for both patients andphysicians.

The correlation test shows a positive correlation betweencircumference reductions and body weight, BMI, overallsatisfaction level, and total shots. The positive correlationbetween circumference reduction and the satisfaction levelor total shots seems reasonable. Although there is positivecorrelation between circumference reduction and bodyweight and BMI, it cannot be inferred that heavier patientswill get better results only by extending limited knowninformation. On the other hand, the decrease in treatmentshots in each session may suggest smaller treatment areas inthe subsequent sessions due to fat thickness reduction afterthe previous treatment.

The subject satisfaction survey shows that 71.9 % ofpatients are satisfied with the therapy. Pretreatment assess-ment is a crucial component in the selection and manage-ment of the cosmetic patient. This includes understandingthe patient’s concerns and expectations for esthetic improve-ment of the procedure. Effort should be exerted to commu-nicate with the patients. After the initial assessment ofpatients, a wide variety of available options for bodycontouring, including invasive methods like liposuction,mildly invasive approaches like laser lipolysis, and nonin-vasive choices such as cryolipolysis and focused ultrasound,are provided. Pros and cons of each procedure are explainedto make patients understand the risks and benefits of differ-ent levels of intervention.

For patients included in this study, videos, photos, andpreliminary data on Taiwanese patients were used to explainthe entire procedure, possible side effects, and results. Cooloil was frequently added, with warning to patients beforefiring in possible pain areas. The physician did most of theprocedures during treatment, including focused ultrasoundfiring and radio-frequency. Proper patient selection andcommunication can lessen overexpectation and are para-mount to optimize treatment outcome and patient satisfac-tion. In addition, the same circumference reduction inpatients with smaller total circumference like Asians mayadd benefits on patient’s satisfaction.

In conclusion, combination therapy of focused ultrasoundand radio-frequency for noninvasive body contouring is aneffective, safe, and painless procedure in Asians. The MRIstudy and measurements provide additional evidence for fatthickness reduction with less operator errors and humanfactors compared to other measuring methods. The limita-tions of this study are small sample size and no control

Fig. 5 Satisfaction survey 1 month after treatment

Fig. 6 Pain level evaluation 1 month after treatment

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group. Although minor compared to that of traditional sur-gical procedures, change is real, definite, and effective. Thenoninvasive nature and painless process without downtimemake it an alternative choice for patients and physiciansseeking focal fat reduction without surgery.

Disclosures The authors have no conflict of interest to disclose.There are no funding sources for this work.

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