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Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial

PainSci » bibliography » Cambron et al 2017
Tags: treatment, orthotics, back pain, foot, chiropractic, massage, bad news, bad science, leg, limbs, pain problems, biomechanics, etiology, pro, self-treatment, devices, spine, manual therapy, controversy, debunkery, scientific medicine

Two articles on PainSci cite Cambron 2017: 1. The Complete Guide to Low Back Pain2. Are Orthotics Worth It?

PainSci commentary on Cambron 2017: ?This page is one of thousands in the bibliography. It is not a general article: it is focused on a single scientific paper, and it may provide only just enough context for the summary to make sense. Links to other papers and more general information are provided wherever possible.

This trial tested the efficacy of shoe orthotics and chiropractic treatment for chronic low back pain. 225 patients were divided into three groups: a wait-list control group got no care at all, another group received custom, and a third group got custom orthotics plus chiropractic and massage treatment. The authors reported positive results up: “Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared to no treatment.” But no differences after 12 weeks! And that’s even with an unfair advantage …

Wait-list groups are a crappy control. They suffer from “frustrebo” — poor outcomes caused by disappointment of knowing that you are not getting any treatment (see Power). This is a major flaw. As Dr. Stephen Ward tweeted, “Waiting list control, schwaiting list control.

The lack of a true placebo control is a deal-breaker here, especially put in the context of other studies of orthotics for back pain, which are negative (e.g. see Chuter). Without replication, I think this study’s results can be dismissed as an outlier attributable to a flawed design and a high risk of bias.

~ Paul Ingraham

original abstract Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.

OBJECTIVES: To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain as compared to no treatment.

DESIGN: Randomized Controlled Trial

SETTING: An integrative medicine teaching clinic at a Midwestern university.

PARTICIPANTS: Two hundred and twenty-five adult subjects with symptomatic low back pain of 3 months or longer were recruited from a volunteer sample.

INTERVENTIONS: Subjects were randomized into one of three treatment groups (Orthotics, Plus, and Wait-list Groups). The Orthotics Group received custom-made shoe orthotics The Plus Group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The Wait-list Group received no care.

MAIN OUTCOME MEASURES: The primary outcome measures were change in perceived back pain (Numeric Pain Rating Scale) and functional health status (Oswestry) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months.

RESULTS: After six weeks, all three groups demonstrated significant within-group improvement in average back pain, but only the Orthotics and Plus Groups had significant within-group improvement in function. When compared to the Wait-list Group, the Orthotics Group demonstrated significantly greater improvements in pain (p<0.0001) and function (p=0.0068). The addition of chiropractic to orthotics treatment demonstrated significantly greater improvements in function (p=0.0278) when compared to orthotics alone, but no significant difference in pain (p=0.3431). Group differences at 12 weeks and later were not significant.

CONCLUSIONS: Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared to no treatment. The addition of chiropractic care led to higher improvements in function.

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