Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial.
Study Goal
The researchers aimed to determine whether the addition of manual soft tissue massage (as part of a combined treatment) improved back pain and function compared to orthotics alone or no treatment.
Results Summary
The study found that the group receiving orthotics plus chiropractic care (including massage) showed significantly greater functional improvement compared to orthotics alone, but no significant difference in pain relief. Massage was part of a multimodal intervention, making its isolated effects unclear.
Population
Adult subjects (N=225) with chronic low back pain (≥3 months).
Effective Dosage
Not specified (manual soft tissue massage was part of a combined intervention).
Duration
6 weeks (with follow-ups up to 12 months).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
shoe orthotic | decrease | pain | Adult subjects with symptomatic low back pain of ≥3 months | - | demonstrated significantly greater improvements | #1 |
shoe orthotic | increase | function | Adult subjects with symptomatic low back pain of ≥3 months | - | demonstrated significantly greater improvements | #2 |
shoe orthotic plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage | increase | function | Adult subjects with symptomatic low back pain of ≥3 months | - | demonstrated significantly greater improvements | #3 |
shoe orthotic plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage | no change | pain | Adult subjects with symptomatic low back pain of ≥3 months | - | no significant difference | #4 |
shoe orthotic | decrease | back pain | Adult subjects with symptomatic low back pain of ≥3 months | - | significantly improved | #5 |
shoe orthotic | decrease | dysfunction | Adult subjects with symptomatic low back pain of ≥3 months | - | significantly improved | #6 |
chiropractic care | increase | function | Adult subjects with symptomatic low back pain of ≥3 months | - | led to higher improvements | #7 |
OBJECTIVES: To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. DESIGN: Randomized controlled trial. SETTING: Integrative medicine teaching clinic at a university. PARTICIPANTS: Adult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. INTERVENTIONS: Subjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic 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 waitlist group received no care. MAIN OUTCOME MEASURES: The primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) 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 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (P<.0001) and function (P=.0068). The addition of chiropractic to orthotics treatment demonstrated significantly greater improvements in function (P=.0278) when compared with orthotics alone, but no significant difference in pain (P=.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 with no treatment. The addition of chiropractic care led to higher improvements in function.