Samples Maintenance Care Using Spinal Manipulation for Chronic LBP: Randomized Trial +MP3
Maintenance Care Using Spinal Manipulation for Chronic LBP: Randomized Trial +MP3
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| Research Review By Dr. Michael Haneline © | |||||||
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| Date Posted: | February 2011 | ||||||
| Study Title: | Does maintained spinal manipulation therapy for chronic non-specific low back pain result in better long term outcome? | ||||||
| Authors: | Senna M & Machaly S | ||||||
| Author's Affiliations: | Rheumatology and Rehabilitation department, Faculty of Medicine, Mansoura University, Mansoura, Egypt. | ||||||
| Publication Information: | Spine - Published Ahead of Print. Acceptance, 17 January 2011 DOI: 10.1097/BRS.0b013e3181f5dfe0. | ||||||
| Background Information: | Low back pain (LBP) patients can be fit into one of three main categories; those with:
Several reviews have shown spinal manipulation (SM) to be effective in patients with acute non-specific LBP and a few studies have indicated that SM is probably effective in patients with chronic LBP. However, the majority of studies have only looked at the effects of SM for LBP over the short-term and none have considered maintenance care as a way to prevent flare-ups or reoccurrences of the condition. The purpose of this study was two-fold:
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| Pertinent Results: | The participating physicians examined and attempted to recruit 154 patients, although 61 of them were excluded for various reasons (see below for exclusion criteria). Ultimately, 93 patients were found to be eligible and enrolled in the study. After the first phase of treatment was completed, patients in both of the SMT groups reported significantly lower pain and disability scores than the control group. After 1 month of treatment:
After 10 months:
Some adverse effects were reported that mostly involved local discomfort and ‘tiredness’, although no serious complications were reported. The adverse effects were mostly transient, occurring within 24 hours after treatment, and were of mild to moderate severity. |
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| Clinical Application & Conclusions: | This study showed that chronic LBP patients who received maintenance care over a 10-month period of time following their initial treatment had better results regarding post-treatment pain and disability levels than patients who stopped treatment after 1 month of care. The maintenance care patients also had improved lumbar mobility and better perceptions of their general health than their no maintenance counterparts. Because of these findings, practitioners who are not offering their chronic LBP patients maintenance care may want to consider doing so. Also, because supporting evidence now exists, third party payers may be more likely to cover these services. (EDITOR’S NOTE: practitioners should not interpret these results to mean that other forms of active care should be abandoned. Always empower your patients by reassuring and educating them, providing them with self-management techniques, spine-sparing strategies, exercise and so on. This study did not look at a combined approach like this but this is how prudent, evidence-informed clinicians practice.) A previous study by Haas et al. (1) found a positive effect of the number of chiropractic treatments provided for chronic low back pain on pain intensity and disability at 4 weeks. That is, more treatments yielded better outcomes. They noted that relief was substantial for patients who received 3 to 4 treatments per week for 3 weeks. As a result, practitioners who base the management of chronic LCP patients on the evidence found in these studies will be in a better position to defend their treatment plans. (EDITOR’S NOTE: This is certainly an exciting study that will surely be widely discussed and debated. The results demonstrated that SMT can provide lasting relief for patients on an ongoing basis after a more intense initial phase of care. However, as always, evidence-informed clinicians will continue to integrate other active approaches into their treatment plans and eagerly await replication and expansion of these results. Be sure to read below for further interpretation and critique of this paper.) |
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| Study Methods: | The treating physicians in this study were well-trained certified MDs who had been in practice for more than 10 years with good experience in managing patients with LBP. The patients were recruited from an outpatient rheumatology and rehabilitation clinic at the Mansoura University. The patients were randomly assigned to 1 of 3 groups that were matched for age and sex. The 3 groups comprised a control group, in which patients were provided sham manipulation, and 2 treatment groups that received a standardized type of SMT. Patients in all groups received 12 sessions of manipulation or sham manipulation over a 1-month period plus a prescribed back exercise that involved pelvic tilt range-of-motion (10 repetitions after each manipulation and 10 repetitions 3 times daily on the days they did not attend a session). Manipulation was stopped in one of the treatment groups (no maintained SMT group) after 1 month, whereas the other treatment group (maintained SMT group) continued to receive manipulation every 2 weeks for an additional 9 months. The sham manipulation was also stopped in control group after 1 month. The SMT that was employed involved a long-lever manipulative technique where the supine patient interlocked their fingers behind their neck as the therapist rotated their shoulders toward them while an A- P thrust was delivered to the ipsilateral anterior superior iliac spine (EDITOR’S NOTE: this is essentially the same method used by Fritz and colleagues in the Clinical Prediction Rule studies we have reviewed on RRS, just done in the opposite manner). The most symptomatic side was manipulated first, always followed by manipulation of the opposite side. The sham manipulation consisted of manual forces of reduced magnitude that were applied to areas of the spine that would not likely result in a therapeutic effect. Since the patients could easily tell if they were in the maintained versus no maintained SMT group, they were only partially blinded. They were, however, blind as to the study’s hypothesis and they were not aware of the existence of a placebo group. All patients received a baseline evaluation prior to treatment that consisted of detailed history taking and physical examination involving a local musculoskeletal and full neurological examination. In order to rule out specific diseases, all patients received a complete blood count, Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) analysis; A-P and lateral radiographs; and lumbar spine magnetic resonance imaging. The study’s inclusion criteria were as follows:
The number of patients dropped off substantially as the study progressed, from 93 to 60 patients at the 10 month follow-up evaluation. The statistical analysis would have been inaccurate if they merely discarded these cases, so they used a statistical technique called Multiple Imputation which generates possible values for the missing values. They generated 5 complete data sets using Multiple Imputation and then pooled all of these data before performing the final analysis. |
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| Study Strengths/Weaknesses: | This was a randomized placebo-controlled study that investigated not only whether SMT was effective for chronic LBP, but also whether patients who received long-term maintenance care following their initial treatment did better than those who did not. A novel study indeed! Many chiropractors and manual medicine practitioners recommend maintenance care to their chronic LBP patients, but there has been little evidence to support that practice…now there is. Substantial improvement was observed in the placebo group as well, though significantly less than what was observed in the SMT groups. This kind of improvement makes one wonder whether the sham manipulation was therapeutic, and that the control patients actually experienced a treatment effect. This same kind of flaw may have contributed to the findings of a landmark study on childhood asthma by Balon et al. (2) which showed no difference between real and simulated manipulation groups (EDITOR’S NOTE: you may remember that the SMT group in this study did report better subjective improvements) . This study is frequently used to point to the ineffectiveness of chiropractic care for this condition. The patients in this study may be different from what would normally be seen in practice because of the large number of exclusion criteria that were implemented. Essentially, patients were excluded if they had just about any co-morbidity, whereas many of our patients have secondary conditions which might make them respond differently from the patients in this study. The Multiple Imputation statistical technique that was used fundamentally uses the average of a series of best guesses of values for missing cases (i.e., what the scores of drop-outs would have been if these patients had stayed in the study). However, one of the main worries when people withdraw from a study is that they are somehow different from those who stay in. Perhaps they had such phenomenal results that they no longer felt that they needed care, or perhaps the intervention was hurting them. Multiple Imputation is merely based on guesses and averages, but it is certainly not as accurate as having a complete data set. EDITOR’S NOTES: A few comments I would like to add:
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| Additional References: |
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| Related Reviews on RRS: | Chiropractic Maintenance Care - Review Refer also to the Lumbar Spine – Manipulation/Mobilization section of the database for further reviews. |
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