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.
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Acknowledgements
We thank the study investigators, their staff, and their patients for participating in this clinical study. The following investigators participated in the study: Jun Tsujino, Keijinkai Teine Keijinkai Hospital; Satoru Nakajo, Nakajo Orthopaedic Clinic; Atsushi Kita, Japanese Red Cross Sendai Hospital; Masahito Hatori, Tohoku University School of Medicine; Kazuo Ohuchi, Fukushima Medical University; Satoru Ozeki, Koshigaya Hospital, Dokkyo University School of Medicine; Akihiro Tsuchiya, Funabashi Orthopaedic Sports Medicine Center; Masato Takao, Teikyo University School of Medicine; Michiyasu Kayaoka, Tokyo Rosai Hospital; Yasunori Tsukimura, Kitasato Institute Hospital; Hisateru Niki, St. Marianna University School of Medicine; Atsushi Kato, Ando Orthopaedics Hospital; Ikuo Wada, Nagoya City University Hospital; Tatsuya Koike, Osaka City University Graduate School of Medicine; Hiroshi Nakajima, Otemae Hospital; Mitsuo Kinoshita, Osaka Medical College; Yoshitaka Ishizaki, Higashiosaka City General Hospital; Ichiro Higashiyama, Matsukura Hospital; Masatoshi Naito, Fukuoka University Faculty of Medicine; Toshio Inoue, Hakujyuji Hospital; Hiroshi Tsurukami, Tsurukami Orthopaedic Clinic; Shunji Oba, Oba Orthopaedics. This study was funded by Chugai Pharmaceutical Co., Ltd. (Chugai). Investigational drugs were provided at no cost by Chugai. Publication of this article was not contingent upon approval by Chugai.
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Conflict of interest
Yoshinori Takakura has received consulting fees from Chugai. Tsukasa Kumai, Norihiro Samoto, Atsushi Hasegawa, Hideo Noguchi, Atsushi Shiranita, Masaharu Shiraishi, Satoshi Ikeda, and Kazuya Sugimoto received grants from Chugai as study investigators. Yasuhito Tanaka declares no conflict of interest.
Funding
This study was funded by Chugai Pharmaceutical Co., Ltd. (Chugai). Investigational drugs were provided at no cost by Chugai. Publication of this article was not contingent upon approval by Chugai.
Ethical approval
The study was performed in accordance with the ethics principles of the Declaration of Helsinki and was conducted with the approval of the institutional review boards at each of the centers where the study was performed.
Informed consent
Informed consent was obtained from all individual participants included in this study.
Appendix
Appendix
This study was conducted at the following institutions after receiving IRB approval: Teine Keijinkai Hospital (ID: TKH2010-06), Nakajo Orthopaedic Clinic (ID: NJ-20100324), Japanese Red Cross Sendai Hospital (ID: SD-20100420), Tohoku University School of Medicine (ID: 101004), Fukushima Medical University (ID: TI22002), Higashimaebashi Orthopaedic Clinic (ID: HM-20100319), Koshigaya Hospital, Dokkyo University School of Medicine (ID: 10-01), Ishii Orthopaedic and Rehabilitation Clinic (ID: IS-20100319), Funabashi Orthopaedic Sports Medicine Center (ID: FS-20100318), Teikyo University School of Medicine (ID: TK-20100401), Tokyo Rosai Hospital (ID: RS-20100721), Kitasato Institute Hospital (ID: KK-20100617), Shiraishi Orthopaedic Pain Clinic (ID: SS-20100311), St. Marianna University School of Medicine (ID: A2036-Unv.), Ando Orthopaedics Hospital (ID: AD-20100709), Nagoya City University Hospital (ID: 11-10-0006), Osaka City University Graduate School of Medicine (ID: OC-20100625), Otemae Hospital (ID: OT-20100319), Osaka Medical College (ID: 10-1-08-0260), Higashiosaka City General Hospital (ID: TS-20100326), Matsukura Hospital (ID: MK-20100421), Nara Prefecture General Medical Center (ID: NK-20100318), Nara Medical University (ID: 10-002), Kyushu Rosai Hospital (ID: KR-20100511), Fukuoka University Faculty of Medicine (ID: 10-003), Hakujyuji Hospital (ID: HJ-20100309), Ken-Ai Memorial Hospital (ID: KA-20100330), Tsurukami Orthopaedic Clinic (ID: TR-20100401), and Oba Orthopaedics (ID: OB-20100610).
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Kumai, T., Samoto, N., Hasegawa, A. et al. Short-term efficacy and safety of hyaluronic acid injection for plantar fasciopathy. Knee Surg Sports Traumatol Arthrosc 26, 903–911 (2018). https://doi.org/10.1007/s00167-017-4467-0
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DOI: https://doi.org/10.1007/s00167-017-4467-0