Custom-made foot orthoses for the treatment of foot pain
Editorial Group: Cochrane Musculoskeletal Group
Published Online: 16 JUL 2008
Assessed as up-to-date: 10 MAY 2008
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
How to Cite
Hawke F, Burns J, Radford JA, du Toit V. Custom-made foot orthoses for the treatment of foot pain. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD006801. DOI: 10.1002/14651858.CD006801.pub2.
- Publication Status: New
- Published Online: 16 JUL 2008
Custom foot orthoses are commonly recommended for the treatment of foot pain.
To evaluate the effectiveness of custom foot orthoses for different types of foot pain.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2), MEDLINE (from January 1966), EMBASE (from January 1980), CINAHL (from January 1982) and the Physiotherapy Evidence Database (PEDro) (to June 2007). We also contacted authors of included trials and known researchers in the field and checked the reference lists of included trials to identify trials. No language or publication restrictions were applied.
Randomised controlled trials and controlled clinical trials evaluating custom-made foot orthoses for any type of foot pain. Outcomes included quantifiable levels of foot pain, function, disability, health-related quality of life, participant satisfaction, adverse effects and compliance.
Data collection and analysis
Two authors independently selected trials, rated methodological quality and cross checked data extraction. Data were analysed separately for different diagnoses of foot pain and follow-up time points.
Eleven trials involving 1332 participants were included: five trials evaluated custom-made foot orthoses for plantar fasciitis (691 participants); three for foot pain in rheumatoid arthritis (231 participants); and one each for foot pain in pes cavus (154 participants), hallux valgus (209 participants) and juvenile idiopathic arthritis (JIA) (47 participants). Comparisons to custom-made foot orthoses included sham orthoses; no intervention; standardised interventions given to all participants; non-custom (prefabricated) foot orthoses; combined manipulation, mobilisation or stretching; night splints; and surgery. Follow up ranged from one week to three years. Custom-made foot orthoses were effective for painful pes cavus (NNTB:5), rearfoot pain in rheumatoid arthritis (NNTB:4), foot pain in JIA (NNTB:3) and painful hallux valgus (NNTB:6); however, surgery was even more effective for hallux valgus and non-custom foot orthoses appeared just as effective for JIA but the analysis may have lacked sufficient power to detect a difference in effect. It is unclear if custom-made foot orthoses were effective for plantar fasciitis or metatarsophalangeal joint pain in rheumatoid arthritis. Custom-made foot orthoses were a safe intervention in all studies.
There is limited evidence on which to base clinical decisions regarding the prescription of custom-made foot orthoses for the treatment of foot pain. Currently, there is gold level evidence for painful pes cavus and silver level evidence for foot pain in JIA, rheumatoid arthritis, plantar fasciitis and hallux valgus.
Plain language summary
Custom-made foot orthoses for the treatment of foot pain
This summary of a Cochrane review presents what we know from research about the effect of custom-made foot orthoses for the treatment of foot pain;
The review shows that in adults who have had painful pes cavus (high arch), for more than one month custom foot orthoses:
Decreases foot pain after 3 months compared with fake foot orthoses.
The review shows that for people at least 5 years of age and diagnosed with juvenile idiopathic arthritis (JIA), custom foot orthoses:
Reduce foot pain after 3 months compared with supportive shoes, but do not reduce foot pain after 3 months compared with using prefabricated neoprene shoe inserts.
The review shows that in adults with rheumatoid arthritis (RA), custom foot orthoses:
Reduce rearfoot pain after 3 months, compared with doing nothing, but do not reduce foot pain after 3 years, compared with using fake foot orthoses.
May not reduce pain in the metatarsophalangeal joint (where the big toe meets the foot) after 6 weeks or 3 months any more than wearing supportive shoes or using soft non-custom foot orthoses.
The review shows that for people diagnosed with plantar fasciitis (heel pain), custom foot orthoses:
May not reduce foot pain after 3 or 12 months any more than using fake foot orthoses
May not reduce foot pain after 6 weeks or 3 months any more than using night splints to hold your feet in a stretched position while you sleep. However, using custom foot orthoses and night splints together may reduce foot pain.
May not reduce foot pain after 2-3 months or 1 year any more than non-custom foot orthoses
May not reduce foot pain after 6-8 weeks when used along with a program of stretching exercises or night splints.
May not reduce foot pain after 2 weeks any more than a combined treatment of manipulation, mobilisation and stretching.
This review shows that for people younger than 60 years of age with painful hallux vagus (a condition where the base of the big toe bulges out sideways, away from the foot) custom-made foot orthoses:
Reduce foot pain after 6 months compared to no treatment, but may not reduce foot pain after 6 or 12 months compared to surgery.
Safety of custom foot orthoses
We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Reported adverse effects included additional foot pain, ankle instability and skin irritation.
What are custom foot orthoses and what is foot pain?
This review focuses only on custom ('custom-made') foot orthoses, which are defined in this review as contoured, removable in-shoe devices that are moulded or milled from an impression of the foot (for example a plaster cast, three-dimensional laser scan) and fabricated according to practitioner-prescribed specifications.
Foot pain may be experienced following an injury; long-term overuse; infection; or systemic disease involving any tissue of the foot, including bones, joints, ligaments, muscles, tendons, nerves, skin, and nails. Foot pain can be generalised or more specifically diagnosed according to location (for example heel pain), structure (for example tendon or ligament damage) or condition (for example osteoarthritis).
Best estimate of what happens to people with foot pain caused by a high arch who use custom foot orthoses compared to a fake foot orthoses:
After 3 months, a custom-made foot orthoses improves foot pain by 11 more points on a scale of 0 to 100 (possibly as many as 19 points or as few as 3 points).
Best estimate of what happens to people with RA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes or doing nothing:
After 3 months, custom-made foot orthoses improve foot pain by 14 more points on a scale of 0 to 100 (possibly as many as 23 points or as few as 5 points).
After 2 and a half years, custom-made foot orthoses improve foot pain.
Best estimate of what happens to children with JIA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes:
After 3 months, custom-made foot orthoses improve foot pain by 19 more points on a scale of 0 to 100 (possibly as many as 36 points or as few as 3 points).
Best estimate of what happens to people with a painful bunion with hallux valgus who use custom foot orthoses:
After 6 months, custom-made foot orthoses improve foot pain by 9 more points on a scale of 0 to 100 (possibly as many as 17 points or as few as 1 point) compared to doing nothing.
After 6 months, surgery improved foot pain by 10 more points on a scale of 0 to 100 (possibly as many as 18 or as few as 2 points) compared to the custom foot orthoses.
After 12 months, surgery improved foot pain by 17 more points on a scale of 0 to 100 (possibly as many as 25 or as few as 9 points) compared to the custom foot orthoses.
搜尋包括Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2), MEDLINE (from January 1966) MBASE (from January 1980), CINAHL (from January 1982) and the Physiotherapy Evidence Database (PEDro) (to June 2007)。同時手動搜尋所選回顧文章之參考文獻及詢問相關領域之作者已獲取可能之試驗，並沒有語言或者是出版種類的限制。
這包括了11個研究包含1332例病患，其中5個研究足底筋膜炎﹝691患者﹞以訂製足輔具治療，3個研究類風濕性關節炎﹝231患者﹞以訂製足輔具治療，另外空凹足﹝154患者﹞，拇指外翻﹝209患者﹞，及幼年型風濕關節炎(47患者)各有一篇。與訂製足輔具比較包括假輔具、未治療、標準介入、固定尺寸預鑄足輔具、綜合授動與活動員或伸展、夜間護木、及手術。追蹤時間由1週到3年。訂製足輔具減少空凹足疼痛(NNTB: 5)，類風濕關節炎後足痛(NNTB: 4)，幼年型風濕關節炎(NNTB: 3)足疼痛，及拇指外翻疼痛(NNTB: 6)有效。但外科手術對於拇指外翻更有效，而幼年型風濕關節炎穿固定尺寸預鑄足輔具與訂製足輔具效果相當，但研究的檢定力可能不足。不清楚訂製足輔具在足底筋膜炎或類風濕性關節炎的蹠掌趾關節痛是否有效。訂製足輔具在各研究都是安全。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
此Cochrane 回顧摘要了我們所知道有關訂做足輔具治療足部疼痛的效果; 回顧顯示，在有高弓足疼痛的成人，使用超過 1個月的訂做足輔具：比起使用假足輔具，3個月後可減少腳部疼痛。 回顧表明，至少大於5歲被診斷為幼年型風濕關節炎(JIA)患者使用訂做足輔具：比起支持性鞋子，3個月後可減少足部疼痛，但與使用固定尺寸預鑄氯丁橡膠足墊相比，3個月後沒有減少足部疼痛。 回顧顯示，在成人類風濕關節炎(RA)使用訂做足輔具：比起不治療，3個月後減少後腳疼痛，但比起假足輔具，3年後不減少足部疼痛。與任何支持性鞋或軟性非定做足輔具相比，6週或3個月的使用不會減少蹠趾關節(大腳指與腳交接處)疼痛。 回顧表明，對於確診患有足底筋膜炎(足跟疼痛)患者使用定做足輔具：比起假足輔具，3個月或12個月後不能減少腳疼痛。與睡覺時使用夜間護木固定腳伸展相比，使用6週或3個月可能無法減輕腳疼痛。但是合併使用定做足輔具和夜間護木夾板，可減少足部疼痛。比起非定做足輔具，使用2 – 3個月或1年可能不會減少足部疼痛。若與強化伸展運動計畫或夜間護木合用，使用6週後可能無法降低足部疼痛。與合併多方式授動、活動或伸展相比，2週後可能不會減少足部疼痛，。 這項回顧表明，對於小於 60歲有疼痛的大趾外翻(大腳趾底部凸起往外遠離腳方向)使用定做足輔具：相比沒有治療，6個月可減少足部疼痛。與手術相比， 6或12個月使用可能不會減少足部疼痛。 訂做足輔具的安全性，我們往往沒有有關副作用和併發症確切的信息。尤其是罕見但嚴重的副作用。報告的不良影響包括額外的足部疼痛，踝關節不穩定和皮膚刺激。 什麼是訂做足輔具器，什麼是足痛？ 這次回顧的重點在訂做(‘客制’)足輔具，在本回顧中是，經由模製腳的形狀(例如用石膏，三維雷射掃描)，再根據醫生的處方規範來製作的可拆卸的鞋子。 足部疼痛可能是經了下列傷害之後產生；長期過度使用，感染，或全身性疾病涉及腳任何組織，包括骨骼，關節，韌帶，肌肉，肌腱，神經，皮膚和指甲。 足部疼痛，可為廣泛性或更具體地按照位置(例如足跟疼痛)，結構(如肌腱或韌帶受損)或情況(例如關節炎)定義。 相比於假足輔具，高弓足腳痛病患使用定做足輔具最佳估計會發生什麼事：3個月後，使用定做足患者改善了腳痛11分(其量表是0 – 100)(可能多達 9分或最少有3分)。 相比於使用支持性鞋或不治療，類風濕關節炎腳痛患者使用定做足輔具最樂觀估計會發生什麼事：3個月後，使用定做足輔具可改善足部疼痛超過14分(其量表是0 – 100)(可能多達 3分或最少有5分)。經過 年半，定做足輔具可改善足部疼痛。 相比於使用支持性鞋，幼年型風濕關節炎JIA兒童腳痛患者使用定做足輔具最樂觀估計會發生什麼事：經過 3個月，使用定做足輔具可改善足部疼痛超過19分(其量表是0 – 100)(可能多達36分或最少有3分)。 拇指外翻腳痛患者使用定做足輔具最樂觀估計會發生什麼事：經過6個月，相比於不治療，使用定做足輔具可改善足部疼痛超過9分(其量表是0 – 100)(可能多達17分或最少有1分)。經過6個月，相比於定做足輔具，手術可改善足部疼痛超過10分(其量表是0 – 100)(可能多達18分或最少有2分)。經過12個月，相比於定做足輔具，手術可改善足部疼痛超過17分(其量表是0 – 100)(可能多達25分或最少有9分)。