**3. 'Customized' 'in‐patient' assessment of clinical effects**

The phantom contains at one end a bovine bone disk 2 (±1) mm thick inserted at 3 (±0.5) cm depth (simulating a 'deep joint') and at the other end a bovine bone disk 1 (±0.5) mm thick inserted at 1 (±0.5) cm (simulating a 'superficial joint') (see **Figure 1A** and **B**). The two disks were always fixed approximately in the centre of the phantom, and their diameter was always smaller than one‐half of the phantom diameter. Deep and superficial 'joints' were treated at 1 and 3 MHz, respectively, using the equipment Enraf Nonius SonoPlus. Thermal probes, inserted at different depth, perform temperature measurements before, during and after sonications lasting 5 min and performed using the most diffused clinical treatment modalities (e.g. selecting 'continuous' (CW) or 'pulsed' (PW) wave on the apparatus and keeping fixed or massaging the probe on the phantom surface). Such massaging is per‐ formed by small circular movements where the probe is freely and randomly moved on the phantom cross section. The temperature increases detected into the phantoms are different in superficial and deep joints, and mainly depends on the operating mode (CW or PW) and on the fixed or massage modality selected for the probe application. The (min‐max) tempera‐ ture increases detected at different positions (see **Figure 1**) and with different modalities are

**Figure 1.** Scheme of the phantoms mimicking a superficial (A) and a deep (B) joint indicating the position of the bone

given in **Table 1**.

T1 T2 T3

T1 T2 T3

**Table 1.** (Min‐max) temperature increase (in °C).

CW: (5–10) CW: (10–12.5) CW: (5–15) PW: (0–2.5) PW: (0–2.5) PW: (2.5–5)

CW: (5–7.5) CW: (5–7.5) CW: (2.5–5) PW: (0–2.5) PW: (0–2.5) PW: (0–2.5)

3 MHz

1 MHz

insert and of the temperature probes.

218 Clinical Physical Therapy

Very often physiotherapeutic US is applied by using 'protocols' which sets the same treat‐ ment parameters values (e.g. duration and treatment modalities) for all patients and all kind of diseases [22, 24]. In everyday clinical practice, it is uncommon to give a definite and quan‐ titative clinical evaluation of the therapeutic results. Whenever it is done, the effectiveness of the US treatment is often evaluated only by using clinical tests and pain scores such as VAS or NRS, which give a subjective rather than quantitative and objective measure. It is therefore necessary, in order to obtain an objective assessment of the US treatment effec‐ tiveness, a multimodal evaluation of patients, including clinical, functional and pain scores, and also including a sonographic quantitative investigation of the local phlogosis before and after the treatment and of the final edema resolution. In a pilotal study [23] performed at the Department of Physical Therapy and Rehabilitation Medicine at Turin University from May to September 2015, 10 patients with shoulder pain and functional limitation, due to biceps brachii long head muscle or rotator cuff tendonitis, bursitis, intra‐articular effusion, without indication for surgical treatment were enrolled. After a preliminary physiatric evaluation, each patient underwent the US and other successive rehabilitative treatments. The US thera‐ peutic protocol is based on 10 sessions in consecutive days for an overall period of 2 weeks. US treatments were then designed and performed by selecting the specific US parameters values and the treatment modalities for each patient in consideration of their specific clini‐ cal, functional and sonographic findings. A preliminary sonographic study was performed in order to quantify edema, phlogosis or effusion. Relevant images were saved and transferred on PC for further elaboration. As far as the other US parameter values are concerned, a care‐ ful evaluation of the estimated depth of the lesion suggested the choice of the frequency of 1 MHz for deep and of 3 MHz for more superficial treatment sites. Moreover, depending on the expected therapeutic increase in temperature at the lesion, the 'continuous' modality was selected to induce more heat deposition (for a shorter time) while the 'pulsed' modal‐ ity, with a Duty Cycle (i.e. the US emitting time related to the total time length of the cycle) selected at 25% was preferred for longer time (10 min) treatments. A multimodal assessment (clinical, functional and sonographic) of the actual pathology was performed before the US treatment, recording shoulder pain, ROM, strength, functional parameters and sonographic imaging. Pain was estimated using the Numeric Rating Scale (NRS), Constant Score and DASH scale were used for shoulder's function evaluation [25, 26]. The same procedure for result assessment was followed at the end of the US treatment. The sonographic examination was performed following a standardized procedure for the shoulder imaging named musku‐ loskeletal ultrasonographic exam (MSUS) which satisfactorily detects the main findings of the phlogosis process [27]. MSUS exam was performed before the US treatment session and at the end of the last US session by a rehabilitation medical specialist, using an Edge Ultrasound System (Sonosite, USA) connected to a 7.5 MHz frequency probe. To each alteration, a semi‐ quantitative score from 0 to 3 was given (0: no alterations; 1, 2, 3: low, mid and high inflam‐ matory alterations). Single scores were added to give a total value (total score), indicating the global index of phlogosis of the shoulder in each patient [28]. All patients enrolled in the study showed a significant reduction of shoulder pain and functional limitations with NRS and DASH scores significantly improved. Sonographic imaging supports clinical data, showing a considerable reduction of bursa or tendon's area of phlogosis. The previous expe‐ rience obtained in monitoring temperatures in a realistic model (phantom) heated with US with different modalities have been useful in defining more precisely which values of the US parameters and which treatment modalities would be optimal to induce the expected thermal effects for each specific patient.

#### **4. Conclusions**

Paying attention to the equipment efficiency, the '*in vitro*' and '*in vivo*' investigations of the thermal field induced by any specific US probe working at different modalities and to the specific characteristics of the joint to be treated, US physiotherapy may dramatically improve its quality and possibly show evidences of effectiveness which are nowadays lacking.
