Effect of a mixed solution of sodium hyaluronate and carboxymethyl cellulose on upper limb dysfunction after total mastectomy: a double-blind, randomized clinical trial

Restricted shoulder mobility is a major upper limb dysfunction related to lower quality of life and disability 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 controlled 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.