Andrew A. Fischer

Tissue Compliance Meter is a More Reproducible Method of Measuring Radiation-Induced Fibrosis than Late Effects of Normal Tissue–Subjective Objective Management Analytical in Patients Treated with Intracavitary Brachytherapy Accelerated Partial Breast Irradiation: Results of a Prospective Trial

Identification of radiation‐induced fibrosis (RIF) remains a challenge with Late Effects of Normal Tissue–Subjective Objective Management Analytical (LENT‐SOMA). Tissue compliance meter (TCM), a non‐invasive applicator, may render a more reproducible tool for measuring RIF. In this study, we prospectively quantify RIF after intracavitary brachytherapy (IB) accelerated partial breast irradiation (APBI) with TCM and compare it with LENT‐SOMA. Thirty‐nine women with American Joint Committee on Cancer Stages 0‐I breast cancer, treated with lumpectomy and intracavitary brachytherapy delivered by accelerated partial breast irradiation (IBAPBI), were evaluated by two raters in a prospective manner pre‐IBAPBI and every 6 months post‐IBAPBI for development of RIF, using TCM and LENT‐SOMA. TCM classification scale grades RIF as 0 = none, 1 = mild, 2 = moderate, and 3 = severe, corresponding to a change in TCM (ΔTCM) between the IBAPBI and nonirradiated breasts of ≤2.9, 3.0–5.9, 6.0–8.9, ≥9.0 mm, respectively. LENT‐SOMA scale employs clinical palpation to grade RIF as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Correlation coefficients—Intraclass (ICC), Pearson (r), and Cohens kappa (κ)—were employed to assess reliability of TCM and LENT‐SOMA. Multivariate and univariate linear models explored the relationship between RIF and anatomical parameters [bra cup size], antihormonal therapy, and dosimetric factors [balloon diameter, skin‐to‐balloon distance (SBD), V150, and V200]. Median time to follow‐up from completion of IBAPBI is 3.6 years (range, 0.8–4.9 years). Median age is 69 years (range, 47–82 years). Median breast cup size is 39D (range, 34B–44DDD). Median balloon size is 41.2 cc (range, 37.6–50.0 cc), and median SBD is 1.4 cm (range, 0.2–5.5 cm). At pre‐IBAPBI, TCM measurements demonstrate high interobserver agreement between two raters in all four quadrants of both breasts ICC ≥ 0.997 (95% CI 0.994–1.000). After 36 months, RIF is graded by TCM scale as 0, 1, 2, and 3 in 10/39 (26%), 17/39 (43%), 9/39 (23%), and 3/39 (8%) of patients, respectively. ΔTCM ≥6 mm (moderate‐severe RIF) is statistically different from ΔTCM ≤3 mm (none‐mild RIF) (p < 0.05). At 36 months post‐IBAPBI, TCM measurements for two raters render ICC = 0.992 (95% CI 0.987–0.995) and r = 0.983 (p < 0.0001), whereas LENT‐SOMA demonstrates κ = 0.45 (95% CI 0.18–0.80). SBD and V150 are the only factors closest to 0.05 significance of contributing to RIF. This prospective study indicates that TCM is a more reproducible method than LENT‐SOMA in measuring RIF in patients treated with IBAPBI. This tool renders a promising future application in assessing RIF.

Prospective Study Validating Inter- and Intraobserver Variability of Tissue Compliance Meter in Breast Tissue of Healthy Volunteers: Potential Implications for Patients With Radiation-Induced Fibrosis of the Breast

PURPOSE Accurate detection of radiation-induced fibrosis (RIF) is crucial in management of breast cancer survivors. Tissue compliance meter (TCM) has been validated in musculature. We validate TCM in healthy breast tissue with respect to interobserver and intraobserver variability before applying it in RIF. METHODS AND MATERIALS Three medical professionals obtained three consecutive TCM measurements in each of the four quadrants of the right and left breasts of 40 women with no breast disease or surgical intervention. The intraclass correlation coefficient (ICC) assessed interobserver variability. The paired t test and Pearson correlation coefficient (r) were used to assess intraobserver variability within each rater. RESULTS The median age was 45 years (range, 24-68 years). The median bra size was 35C (range, 32A-40DD). Of the participants, 27 were white (67%), 4 black (10%), 5 Asian (13%), and 4 Hispanic (10%). ICCs indicated excellent interrater reliability (low interobserver variability) among the three raters, by breast and quadrant (all ICC ≥ 0.99). The paired t test and Pearson correlation coefficient both indicated low intraobserver variability within each rater (right vs. left breast), stratified by quadrant (all r ≥ 0.94, p < 0.0001). CONCLUSIONS The interobserver and intraobserver variability is small using TCM in healthy mammary tissue. We are now embarking on a prospective study using TCM in women with breast cancer at risk of developing RIF that may guide early detection, timely therapeutic intervention, and assessment of success of therapy for RIF.

Quantitative assessment of radiation-induced fibrosis of the breast with tissue compliance meter, palpation, and radiological imaging: preliminary results.

Abstract:  Quantification of radiation (RT)‐induced fibrosis (RIF) continues to present a challenge in breast cancer survivors. We compare assessment of RIF by palpation and tissue compliance meter (TCM) to the radiological findings in women treated with RT. Of 300 patients treated with adjuvant RT, 17 women had ≥2‐year follow‐up sufficient to document RIF. Palpation and TCM were employed by three radiation oncologists in a blinded fashion. Palpation grades 1, 2, and 3 denoted mild, moderate, and severe RIF. TCM measured degree of compliance (DC) of RIF in irradiated (RTB) and nonirradiated breasts (NRTB). Architectural distortions (AD) on mammograms, ultrasound (US), and MRI were assessed. Median time of follow up was 3.9 years (range 2.1–6.5 years). Palpation revealed RIF grades 1, 2, and 3 in four, 10, and three patients, respectively. Mean percent changes (PC) in DC between RTB and NRTB by TCM were 19.5%, 37.1%, and 57.5% for grades 1, 2, and 3 RIF, respectively (p < 0.0001). There was a strong linear correlation between palpation grade and PC of DC by TCM (spearman‐rank correlation=0.88, p < 0.0001). Interobserver variability (reliability) was computed using intraclass correlation coefficient (ICC) for TCM and kappa statistic for clinical palpation (ICC=0.99 [p < 0.0001] and kappa=0.70 [p < 0.0001], respectively). There was no correlation between average size of the AD as measured by the imaging modalities and RIF as assessed by palpation or TCM. Our preliminary data suggest that quantification of RIF is best with TCM. TCM results correlate better with palpation than with radiological imaging. The study with larger number of patients required to confirm our findings is underway.

Local Injections in Pain Management

Five main types of injections for soft-tissue pain management and treatment of soft-tissue damage are discussed. They are (1) trigger point injections, (2) needling and infiltration of damaged and tender areas, (3) somatic block, (4) needling and infiltration of ligament sprains and bursitis, and (5) preinjection nerve blocks. Two important aspects of injections must be emphasized. First, needling combined with infiltration is the most effective modality for immediate alleviation of pain and for complete removal of pathology causing pain. Second, the injection represents only the first step in management; special follow-up treatment after injections assures the best and fastest healing.

Assessment of pain as a sequela in patients treated with intracavitary brachytherapy accelerated partial breast irradiation (IBAPBI): preliminary results of a prospective study.

To assess pain rates and relationship to radiation‐induced fibrosis (RIF) in patients treated with intracavitary brachytherapy accelerated partial breast irradiation (IBAPBI). Thirty‐nine patients treated with IBAPBI were assessed prospectively for development of pain pretreatment, 1 month post‐IBAPBI, and every 6 months thereafter. A qualitative subjective Late Effects of Normal Tissue–Subjective Objective Management Analytical (LENT‐SOMA) questionnaire assessed pain. Use of pain medications was assessed as “no”, “sometimes”, or “regularly”. A quantitative objective validated pressure threshold (PTH) measured pain in the site of IBAPBI breast (index) and its mirror‐image in the nonirradiated breast (control). A validated tissue compliance meter (TCM) quantitatively assessed RIF in the index and control breasts at all time points. Mean ΔPTH(kg) and ΔTCM(mm) values reflected mean difference between the index and control breasts. Median follow‐up is 44 months (range 5–59 months). According to LENT‐SOMA, pain occurred in 89% at 1 and 24 months, 67% at 30 months, 30% at 36 months, 29% at 40 months, and 20% at 48 months. No patient used pain medication “regularly” but the use “sometimes” decreased over time: 61% at 1 month, 42% at 18 and 24 months, 13% at 36 months, and 10% at 40 months. Mean ΔPTH values, compared to Δ0 kg at baseline, peaked in absolute value by 1 month to −1.36 kg (p < 0.0001), persisted after 18 months at −0.99 kg (p < 0.0001) and 24 months at −0.73 kg (p < 0.0001), and returned to nearly baseline by 40 months at −0.11 kg (p < 0.57). Mean ΔPTH and ΔTCM correlated significantly with subjective patient reports of pain at each time point (p < 0.0001). To date, this is the first report to prospectively assess pain employing quantitative and qualitative inventories in patients treated with IBAPBI. Pain is experienced in the majority of patients experienced pain within the first 2 years, sometimes requiring a medication, and though subsides, it may persist 4 years after IBAPBI.

Poster 81: A novel injection technique for the treatment of myofascial trigger points at the subscapularis muscle and serratus anterior insertion1

Abstract Setting: Outpatient musculoskeletal pain and sports clinic. Patients: Persons with shoulder pain and dysfunction related to subscapularis muscle trigger points and serratus anterior weakness. Case Description: Patients are instructed to lie on the involved side, with the elbow directly underneath the ribs and in 90° of flexion. This position moves the medial scapula superficial and outward, opening access to the subscapularis muscle and serratus anterior insertion at the medial border of the scapula. Needling and infiltration of 1% lidocaine is performed from underneath the medial scapula, directing the needle away from the ribs to the entire taut band, introducing 0.2mL at each stop either where there is a twitch response, an increase in muscle tone, or a pain complaint on needle penetration. A total of 3 to 5mL can be introduced at the attachment of the muscles. Aspiration is done prior to each injection. On days 1, 2, and 3 postinjection, patients should receive sessions of physical therapy with superficial heat and electric stimulation, sinusoid surging, at the injection sites. Relaxation exercises are performed at hourly intervals by contraction of external rotator muscles. Main perpetuating factors such as biomechanical imbalances should also be addressed. Assessment/Results: This procedure has been performed routinely at our clinic without complications. Usually 1 or 2 sessions are necessary for complete relief of symptoms. Discussion: This is the first report of this novel injection technique, to our knowledge, of the treatment of myofascial trigger points in the subscapularis muscle and serratus anterior insertion in this fashion. Conclusion: Injections for treatment of myofascial pain at the subscapularis muscle and serratus anterior insertion can be performed in an easier and safer manner by the novel injection technique described here. No complications were reported.

Abstract 18: Plantar fasciitis: a new treatment approach.1

Abstract Objective: To evaluate the efficacy of a new approach that shortens the duration of plantar fasciitis treatment. Design: Randomized controlled study. Setting: Outpatient clinic. Participants: 64 patients were randomly assigned to intensive conventional physical therapy (PT) (n=34) or needling and infiltration of the myofascial trigger points at the proximal portion of the medial gastrocnemius muscle (n=30). Interventions: Patients in the PT group received ultrasound and electric stimulation at the origin of the plantar fascia followed by stretching exercises of the gastrocnemius muscle. The other group was treated by needling and infiltration (1% lidocaine) of the taut band at the proximal portion of the medial gastrocnemius muscle of the involved limb(s). Injections were performed at weekly intervals. PT was administered for 3 consecutive days after the injections. Patients were instructed to perform stretching of the gastrocnemius muscles and of the plantar fascia at home twice a day. Main Outcome Measures: Visual analog scale and hindfoot functional test (American Orthopaedic Foot and Ankle Society Hindfoot Questionnaire) were performed before and after treatment by an independent evaluator. Duration of treatment was compared between the 2 groups. Results: Statistically significant reduction of pain and improvement in function were observed in both groups, without any differences between them. The time required to achieve the same improvement was significantly less (80%) in the injected group than in the control group ( P P Conclusions: Although treatment in both groups was equally successful, needling and infiltration of the medial gastrocnemius muscle provided faster pain relief and functional recovery in patients with plantar fasciitis.