The Effects of Naturopathic Medicine on Health Outcomes in Low Back Pain:
A Randomized Controlled Blinded Parallel-group Study
Cooley PK, Szczurko O, Bernhardt B, Busse J, Seely D, Mills E
Canadian College of Naturopathic Medicine Trial Co-ordinators:
Orest Szczurko - email@example.com - (416) 722-9136
Kieran Cooley - firstname.lastname@example.org - (416) 407-1331
Background: A major Canadian employer working with a major Canadian union reports that diagnosed musculoskeletal complaints rose from 53% in 2001 to 59% in 2003. Health care costs under their Extended Health Care Plan are escalating. Data from this research indicated that musculoskeletal injuries were the most prevalent type of injury from 1994 to 2001. Physiotherapy, chiropractic, and massage services accounted for 83% of the total paramedical services used in 2003. A commitment was made to work to improve the health of workers, reduce health care costs, examine the impact of paramedical services, and increase overall success and satisfaction in disability claims. The Naturopathic Pilot Project was developed with the Canadian College of Naturopathic Medicine to evaluate the effectiveness of naturopathic medical treatments on chronic low back pain. This unique trial is the first of its kind. Naturopathic medicine as a whole is evaluated using a randomized controlled trial approach with functional outcomes within an industrialized setting.
Objectives: To evaluate the effectiveness of a combination of acupuncture treatment, lifestyle and dietary counseling, and the application of mind-body therapy in order to establish the effect of naturopathic medical treatment on disability, pain management and quality of life in chronic low back pain patients.
Methods: 75 employees suffering from mild to severe back pain of at least 6 weeks duration volunteered to participate in this study. Oswestry, Roland and Morris (low back disability indexes), and SF-36 (quality of life) questionnaires and a pain scale were completed to assess baseline back health, pain levels and quality of life. Baseline pain medication and adjunctive therapy use, as well as lumbar length on maximum forward flexion were established. Participants were randomly selected for treatment groups, resulting in 39 active group and 36 control group participants.
The control group received bi-monthly instruction on lumbar stretching and strengthening exercises, and was encouraged to perform relaxation exercises based on a Back Pain information booklet shown previously to be equivalent to physiotherapy. Focus of the book is on education, causes of low back pain, coping strategies and encouragement to stay active.
The active group received a twice weekly standard acupuncture protocol (Bl 23, 25, 40, GV 3, 4) with up to 4 additional points based individual presentation (TCM diagnosis, Ah-chi points), lifestyle advice and anti-inflammatory dietary suggestions emphasizing nutrients that promote muscle relaxation and repair (essential fatty acids, calcium/, magnesium, eliminating pro-inflammatory substances such as methylxanthenes, and vegetables from the night-shade family). Relaxation techniques were performed, as were stretching exercises and activities from the back pain book as implemented in the control group. Efforts were made to give a standardized, generalized treatment with room for individualized variation.
Oswestry, Roland and Morris, SF-36, and Pain Scale questionnaires were repeated at 4, 8, and 12 weeks. At those times forward lumbar flexion and weight were recorded. Medication and therapy use was recorded at each visit. 13 participants were self-selected from the control group to undergo 4 weeks of crossover naturopathic treatment with evaluation following.
Conclusions: Naturopathic treatment was shown to have significant (95% CI) benefit in decreasing disability and pain due to chronic low back pain. Pain medication use was significantly reduced, and quality of life measures dramatically improved. Crossover data as well as chronological analysis of the outcomes show the most significant changes occur within the first 4 weeks of Naturopathic treatment. In this industrialized setting, it appears that not only were Naturopathic treatments effective, but an individualized approach to back pain resulted in greater benefits compared with a physiotherapy equivalent previously shown to be effective.
Limitations: The application of this individualized approach to medicine has many challenges when being applied to randomized control trials that aim to produce generalizable evidence. Though participants were blinded to treatment arm selection, knowledge of which treatment approach was being used became evident through contact with other participants in the trial. Some control arm participants expressed dissatisfaction with the treatment they were receiving, and as a result 6 participants were lost from the control arm following the randomization process.