Tsukasa Kumai1, Norihiro Samoto2, Atsushi Hasegawa3, Hideo Noguchi4, Atsushi Shiranita5, Masaharu Shiraishi6, Satoshi Ikeda7, Kazuya Sugimoto2, Yasuhito Tanaka2, Yoshinori Takakura2. 1. Department of Orthopaedic Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan. kumakumat@aol.com. 2. Department of Orthopaedic Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan. 3. Agatsuma Higashi Orthopaedic Clinic, 756-1, Isemachi, Nakanojo-machi Agatsuma-gun, Gumma, 377-0423, Japan. 4. Ishii Orthopaedic and Rehabilitation Clinic, 1089-1, Shimo-Oshi, Gyoda-shi, Saitama, 361-0037, Japan. 5. Shiranita Orthopaedic Clinic, 1-6-13, Shiragane, Kokurakita-ku Kitakyushu-shi, Fukuoka, 802-0074, Japan. 6. Shiraishi Orthopaedic Pain Clinic, 5-41-16, Nakakasai, Edogawa-ku, Tokyo, 134-0083, Japan. 7. Department of Orthopaedic Surgery, Ken-Ai Memorial Hospital, 1191, Kimori, Onga-cho, Onga-gun, Fukuoka, 811-4313, Japan.
Abstract
PURPOSE:Plantar fasciopathy is the most common cause of plantar heel pain and is considered to be a type of enthesopathy. The short-term efficacy, safety, and dose-response relationship of high-molecular-weight hyaluronic acid (HA) was investigated in patients with plantar fasciopathy. METHODS: In this multicenter, prospective, randomized, double-blind, placebo-controlled trial, 168 patients with persistent pain from plantar fasciopathy for more than 12 weeks were randomly assigned to receive 2.5 mL of 1% HA (H-HA), 0.8 mL of 1% HA (L-HA), or 2.5 mL of 0.01% HA (control group) once a week for 5 weeks. The primary endpoint was improvement in visual analogue scale (VAS) score for pain from baseline to week 5. RESULTS: The VAS scores (least squares mean ± standard error) in each group decreased gradually after the start of treatment, a change of -3.3 ± 0.3 cm for the H-HA group, -2.6 ± 0.3 cm for the L-HA group, and -2.4 ± 0.3 cm for the control group, with the H-HA group improving significantly more than the control group (P = 0.029). No serious adverse events were reported. There was no difference between the groups in the incidence rates of adverse drug reactions. CONCLUSION: The administration of five injections of high-molecular-weight HA is an effective treatment with no serious adverse drug reactions and is a conservative treatment option for plantar fasciopathy. This treatment contributed to alleviation of pain in patients with plantar fasciopathy and improvement in their activities of daily living. LEVEL OF EVIDENCE: I.
RCT Entities:
PURPOSE:Plantar fasciopathy is the most common cause of plantar heel pain and is considered to be a type of enthesopathy. The short-term efficacy, safety, and dose-response relationship of high-molecular-weight hyaluronic acid (HA) was investigated in patients with plantar fasciopathy. METHODS: In this multicenter, prospective, randomized, double-blind, placebo-controlled trial, 168 patients with persistent pain from plantar fasciopathy for more than 12 weeks were randomly assigned to receive 2.5 mL of 1% HA (H-HA), 0.8 mL of 1% HA (L-HA), or 2.5 mL of 0.01% HA (control group) once a week for 5 weeks. The primary endpoint was improvement in visual analogue scale (VAS) score for pain from baseline to week 5. RESULTS: The VAS scores (least squares mean ± standard error) in each group decreased gradually after the start of treatment, a change of -3.3 ± 0.3 cm for the H-HA group, -2.6 ± 0.3 cm for the L-HA group, and -2.4 ± 0.3 cm for the control group, with the H-HA group improving significantly more than the control group (P = 0.029). No serious adverse events were reported. There was no difference between the groups in the incidence rates of adverse drug reactions. CONCLUSION: The administration of five injections of high-molecular-weight HA is an effective treatment with no serious adverse drug reactions and is a conservative treatment option for plantar fasciopathy. This treatment contributed to alleviation of pain in patients with plantar fasciopathy and improvement in their activities of daily living. LEVEL OF EVIDENCE: I.
Authors: Robert J de Vos; Adam Weir; Hans T M van Schie; Sita M A Bierma-Zeinstra; Jan A N Verhaar; Harrie Weinans; Johannes L Tol Journal: JAMA Date: 2010-01-13 Impact factor: 56.272