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Short-term efficacy and safety of hyaluronic acid injection for plantar fasciopathy

  • Tsukasa Kumai
  • Norihiro Samoto
  • Atsushi Hasegawa
  • Hideo Noguchi
  • Atsushi Shiranita
  • Masaharu Shiraishi
  • Satoshi Ikeda
  • Kazuya Sugimoto
  • Yasuhito Tanaka
  • Yoshinori Takakura
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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.

Keywords

Plantar fascia Heel pain Enthesopathy Hyaluronic acid Double-blind Randomized controlled trial 

Notes

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.

Compliance with ethical standards

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.

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Copyright information

© European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2017

Authors and Affiliations

  • Tsukasa Kumai
    • 1
  • Norihiro Samoto
    • 1
  • Atsushi Hasegawa
    • 2
  • Hideo Noguchi
    • 3
  • Atsushi Shiranita
    • 4
  • Masaharu Shiraishi
    • 5
  • Satoshi Ikeda
    • 6
  • Kazuya Sugimoto
    • 1
  • Yasuhito Tanaka
    • 1
  • Yoshinori Takakura
    • 1
  1. 1.Department of Orthopaedic SurgeryNara Medical UniversityKashiharaJapan
  2. 2.Agatsuma Higashi Orthopaedic ClinicNakanojo-machi Agatsuma-gunJapan
  3. 3.Ishii Orthopaedic and Rehabilitation ClinicGyoda-shiJapan
  4. 4.Shiranita Orthopaedic ClinicFukuokaJapan
  5. 5.Shiraishi Orthopaedic Pain ClinicTokyoJapan
  6. 6.Department of Orthopaedic SurgeryKen-Ai Memorial HospitalFukuokaJapan

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