Results of a multicenter, prospective, randomized, double-blind, placebo-controlled trial presented during the 2013 annual meeting of the American Orthopaedic Foot & Ankle Society (AOFAS) indicate that the use of high–molecular-weight hyaluronic acid (HA) injections may be effective in reducing pain and improving function in patients with plantar fasciopathy (PF).
According to presenter Tsukasa Kumai, MD, PhD, of Nara, Japan, PF is the most common cause of plantar heel pain. The diagnosis is fairly straightforward, based on a patient’s complaint of pain and tenderness on the medial plantar aspect of the calcaneus, and several conservative treatment options are available, including the following:
- stretching exercises
- night splints
- shoe insoles
- nonsteroidal anti-inflammatory drugs
- corticosteroid injections
With all these treatments, however, “complete resolution of pain often takes a long time and the drug treatments may be associated with side effects,” said Dr. Kumai. Because HA is naturally present in the body and its efficacy in treating other conditions (including osteoarthritis of the knee, frozen shoulder, lateral epicondylitis, and patellar tendinopathy) has been established, Dr. Kumai and his colleagues conducted a prospective, randomized controlled study to investigate the dose response for efficacy and the safety of using high–molecular-weight HA (Suvenyl®) in patients with PF.
The multicenter trial included 168 patients who had experienced persistent pain for at least 12 weeks. Patients were randomized to receive five weekly injections of one of the following solutions:
- 2.5 mL of 1 percent HA (high-dose HA)
- 0.8 mL of 1 percent HA (low-dose HA)
- 2.5 mL of a saline placebo without local anesthetic
Efficacy was assessed in several ways. A visual analogue scale (VAS) score was used for pain, a 4-point patient assessment (Roles and Maudsley score) for pain and activity limitations, and a physician assessment of local symptoms and activities of daily living (ADL). Scores were recorded at baseline and during each of the 5 weeks of treatment. To maintain blinding, the injections and the physician assessment were performed by different investigators.
A significant improvement
All three groups had similar VAS scores at baseline (6.557 ± 0.219 cm for high-dose HA; 6.592 ± 0.239 cm for low-dose HA; 6.736 ± 0.217 cm for placebo). The VAS score decreased gradually in each group after treatment was initiated.
At 5 weeks, the VAS score for the high-dose HA group was 3.329 ± 0.296 cm, compared to 4.042 ± 0.322 cm for the low-dose HA group and 4.247 ± 0.294 cm for the placebo group. Compared to placebo, the group that received the higher dose injections had a significant improvement (P = 0.0292). In addition, patients in the high-dose HA injection group had higher Roles and Maudsley scores, fewer local symptoms, and improved ADL.
Dr. Kumai reported that no serious adverse events were reported during the study period, nor was there any difference in the revelation rate of side effects among groups.
An alternative treatment
“High–molecular-weight HA injections in patients with plantar fasciopathy significantly reduced pain and improved function,” concluded Dr. Kumai. “They can be used as an alternative treatment for plantar fasciopathy without any serious adverse effects.”
Dr. Kumai’s coauthors of “High–Molecular-Weight Hyaluronic Acid Injection Is Effective for Plantar Fasciopathy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study” are Norihiro Samoto, MD, PhD; Atsushi Hasegawa, MD, PhD; Hideo Noguchi, MD; Astushi Shiranita, MD, PhD; Masaharu Shiraishi, MD, PhD; Satoshi Ikeda, MD, PhD; Kazuya Sugimoto, MD, PhD; Yasuhito Tanaka, MD, PhD; and Yoshinori Takakura, MD, PhD.
Disclosures: Drs. Kumai, Samoto, Shiraishi, and Sugimoto—Chugai Pharm; Drs. Hasegawa, Noguchi, Shiranita, Ikeda, Tanaka, and Takakura—no conflicts.
Mary Ann Porucznik is managing editor, AAOS Now. She can be reached at email@example.com
- Plantar fasciopathy is the most common cause of plantar heel pain, with multiple nonsurgical treatment options
- A multicenter randomized, double-blind, placebo-controlled trial conducted in Japan measured the dose response and efficacy of a course of 5 weekly high–molecular-weight hyaluronic acid injections to treat PF.
- Compared to placebo, the group that received 2.5 mL of 1 percent HA had a significant improvement in pain scores, as well as fewer local symptoms, increased activities of daily living, and no adverse events.