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Customized or Prefabricated Shoe Inserts for Chronic, Non-Cancer Pain: A Review of Clinical Effectiveness

Last updated: April 20, 2020
Project Number: RC1259-000
Product Line: Rapid Response
Research Type: Device
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of customized foot orthotics or prefabricated shoe inserts for chronic non-cancer pain?

Key Message

​There were inconsistencies regarding the effectiveness of foot orthoses compared with control (standard insole, placebo, or none) in alleviating pain in adult patients with foot pain based on findings from three systematic reviews and two randomized controlled trials (RCTs); reported results from these studies included statistically significant improvements in pain with foot orthoses compared to control (one systematic review, and two RCTs), no statistically significant between group difference (one systematic review) and inconsistent findings for between group differences (one systematic review describing studies individually).

There were inconsistencies regarding the effectiveness of foot orthoses compared with control (standard insole, placebo, or none) in improving function in adult patients with foot pain based on findings from two systematic reviews and one RCT; reported results from these studies included a statistically significant improvement with foot orthoses compared to control (one RCT) and no statistically significant between group differences (two systematic reviews and one RCT).

Limited evidence (one RCT) showed improvement in pain and function with foot orthoses compared to no foot orthoses, in adult patients with chronic low back pain.

Findings need to be interpreted with caution considering the limitations (such as unclear or variable quality of included studies, small sample size and overlap of studies included in the systematic reviews). 

No studies were identified that compared treatments with foot orthoses with pharmacological treatments for non-cancer pain in adults.