CLINICAL TRIAL Effect of a mixed solution of sodium hyaluronate and carboxymethyl cellulose on upper limb dysfunction after total mastectomy: a double-blind, randomized clinical trial Eun Joo Yang • Eunyoung Kang • Jin Youn Jang • Dongwon Kim • Cha Kyong Yom • Jae-Young Lim • Sung-Won Kim Received: 5 June 2012 / Accepted: 20 September 2012 Ó Springer Science+Business Media New York 2012 Abstract Restricted shoulder mobility is a major upper limb dysfunction related to lower quality of life and dis- ability after breast cancer surgery. We hypothesized that sodium hyaluronate–carboxymethyl cellulose (HA–CMC) applied to the surface of the pectoralis major muscle after mastectomy would significantly reduce pain and improve range of motion (ROM) of the shoulder in breast cancer patients. We conducted a double-blind, randomized con- trolled study to evaluate the clinical efficacy and safety of HA–CMC in the prevention of upper limb dysfunction after total mastectomy (TM). A total of 99 women with breast cancer were randomly assigned to one of two groups. In the HA–CMC group (n = 50), a mixed HA–CMC was applied to the surface of the pectoralis major and serratus anterior muscle after TM. In the control group (n = 49), TM was performed without the use of HA–CMC. The primary outcomes were ROM of the shoulder and motion-related pain assessed using a numeric rating scale measured before surgery (T0) and 3 (T1) and 6 months (T2) after surgery. Secondary outcomes included disabilities of the arm, shoulder, and hand (DASH) and the pectoralis minor length test. Compared with the control group, the HA–CMC group showed greater reductions in postoperative restriction of total shoulder ROM (sum of flexion and horizontal abduction) at 3 months (10.20°, P = 0.004). Mean pain levels related to flexion and horizontal abduction were significantly lower in the HA–CMC group (-1.32 and -0.93, respectively, P \ 0.05). The DASH score was lower (-4.94; P = 0.057) in the HA–CMC group at T2. No adverse effect was observed in either group. These results provide evidence that HA–CMC may provide pain relief and improve ROM of the shoulder without causing adverse effects. The effect on pectoralis tightness should be investigated in further studies. Keywords Mastectomy Á Upper limb dysfunction Á Sodium hyaluronate–carboxymethyl cellulose Á Range of motion Introduction Earlier detection and advances in treatment have signifi- cantly increased the 5-year breast cancer survival rate [1]. Good survival prospects make quality of life (QOL) an important health issue that warrants research attention [2]. Upper limb dysfunction adversely influences QOL in breast cancer survivors [3]. Pectoralis tightness is the most com- mon form of upper limb dysfunction for up to 6 months after surgery among upper limb dysfunctions categorized based on symptoms and assessments of pain and disabili- ties [4–6]; moreover, pectoralis tightness is a clinically important complication because it can cause pain and limit motion, making activity and participation difficult [4, 7]. The anterior pectoralis muscle fascia is removed during a muscle-sparing mastectomy [8]. As a result of impaired muscle sheaths and pain-induced contraction after surgery, the pectoralis may become hypertonic and tightened [5]. Pectoralis tightness can alter scapular kinematics. Pecto- ralis muscle tightness causes the scapula to be pulled into a protracted and depressed position, with adduction con- tracture in the horizontal plane that may restrict daily living activities [9]. This is a potential mechanism of subacromial impingement or long-term morbidity [10]. Prevention or E. J. Yang Á E. Kang Á J. Y. Jang Á D. Kim Á C. K. Yom Á J.-Y. Lim Á S.-W. Kim (&) Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea e-mail: brcakorea@gmail.com 123 Breast Cancer Res Treat DOI 10.1007/s10549-012-2272-5