Multidisciplinary Integrative Care vs. Chiropractic Care Alone for LBP – RCT +MP3
Research Review By Dr. Michael Haneline©
Audio:
Date Posted:
October 2022
Study Title:
Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial
Authors:
Bronfort G, Maiers M, Schulz C, Leininger B, Westrom K, Angstman G & Evans R
Author's Affiliations:
University of Minnesota, MN, USA; Northwestern Health Sciences University, MN, USA; Elizabeth’s Medical Center-Wabasha, MN, USA.
Publication Information:
Chiropractic & Manual Therapies 2022 Mar 1; 30(1): 10.
Background Information:
Low back pain (LBP) is estimated to affect 40–80% of adults at some point in their lives (1), often becoming chronic. LBP frequently leads to disability and, in fact, is a leading cause of disability worldwide (2).
While the ‘biopsychosocial model’ has been promoted for many years, it remains inadequately applied in both research and clinical settings. Many LBP cases are poorly treated, with a heavy emphasis on a symptom management approach that may not address a patient’s unique needs (3). Some LBP treatments (ex. injections and drug therapies) have been shown to be minimally effective and possibly even harmful. In conflict with clinical guidelines, complementary LBP treatment modalities that have been scientifically validated, like spinal manipulation, exercise, acupuncture, cognitive behavioral therapy, and selfcare, are often not included in LBP management (4).
Previous studies have shown that the integration of complementary modalities with conventional care can improve outcomes for LBP patients (5). By combining various viable treatment options to address the multidimensional causes of pain, a synergistic effect may exceed the therapeutic effect of any one therapy alone. A previous report on such a team-based, integrated model of care included acupuncturists, chiropractors, psychologists, exercise therapists, massage therapists, and primary care physicians, with case managers coordinating care.
The purpose of this study was to compare the primary and secondary clinical outcomes of monodisciplinary chiropractic care (CC) versus multidisciplinary integrative care (IC) for sub-acute and chronic LBP.
While the ‘biopsychosocial model’ has been promoted for many years, it remains inadequately applied in both research and clinical settings. Many LBP cases are poorly treated, with a heavy emphasis on a symptom management approach that may not address a patient’s unique needs (3). Some LBP treatments (ex. injections and drug therapies) have been shown to be minimally effective and possibly even harmful. In conflict with clinical guidelines, complementary LBP treatment modalities that have been scientifically validated, like spinal manipulation, exercise, acupuncture, cognitive behavioral therapy, and selfcare, are often not included in LBP management (4).
Previous studies have shown that the integration of complementary modalities with conventional care can improve outcomes for LBP patients (5). By combining various viable treatment options to address the multidimensional causes of pain, a synergistic effect may exceed the therapeutic effect of any one therapy alone. A previous report on such a team-based, integrated model of care included acupuncturists, chiropractors, psychologists, exercise therapists, massage therapists, and primary care physicians, with case managers coordinating care.
The purpose of this study was to compare the primary and secondary clinical outcomes of monodisciplinary chiropractic care (CC) versus multidisciplinary integrative care (IC) for sub-acute and chronic LBP.
Pertinent Results:
201 participants were enrolled in the study with 100 in the CC group (chiropractic only) and 101 in the IC group (integrated care). Baseline demographic and clinical characteristics were comparable between the 2 groups, except for pain intensity, which was included as a covariate in the statistical analysis. At baseline, participants were, on average, about 50 years of age, had chronic pain (8 to 9 years), moderate intensity low back pain (~ 5 on a 0–10 scale) and moderate disability level (~ 40%).
There was a very weak correlation between expectation of improvement and change in pain intensity (r = − 0.13).
Treatment adherence was good, with 93% of the CC group attending treatment visits as recommended and 98% of the IC group doing so as well. The average number of visits was 18.1 for the CC group and 23.8 for the IC group. 91% of the participants provided data on back pain intensity at every time point and 83% provided secondary outcomes data at every time point.
All participants in the IC group received at least 2 types of treatment and 27 of them received at least 4 types. The types of care provided were: exercise therapy (ET, n = 96), self-care education (SCE, n = 59), traditional Chinese medicine (TCM, n = 51), massage therapy (MT, n = 37), chiropractic care (CC, n = 19), cognitive behavioral therapy (CBT, n = 35) and medication (MED, n = 5). The most common treatment combinations were: TCM/SCE/ET (n = 22), ET/SCE/MT (n = 10) and ET/SCE/MT/CBT (n = 10).
The primary outcome measure of pain showed IC to be significantly superior to CC over the 1-year period. Pain intensity over weeks 4 to 52 showed a significant advantage of 0.5 (on a 0-10 scale) for IC over CC; however, over the short term, weeks 4 to 12, IC was superior to CC by 0.4, but not statistically significant. On the secondary analysis, differences for pain intensity at individual time points all favored IC, ranging from 0.4 (weeks 4 and 12) to 0.6 (week 52), but only week 52 was statistically significant.
Of the secondary outcome measures, IC was significantly superior to CC for disability, improvement, satisfaction with care, and low back symptom frequency. There were no significant differences between groups over the 1-year period for medication use, quality of life, leg symptom frequency, fear avoidance beliefs, and self-efficacy.
Five serious adverse events occurred during the trial (CC = 4, IC = 1); however, they were all unrelated to the study interventions. Minor, self-limiting adverse events (ex. unusual or increased soreness and a different type of pain) occurred during the 12 weeks of intervention with about equal frequency in both groups.
There was a very weak correlation between expectation of improvement and change in pain intensity (r = − 0.13).
Treatment adherence was good, with 93% of the CC group attending treatment visits as recommended and 98% of the IC group doing so as well. The average number of visits was 18.1 for the CC group and 23.8 for the IC group. 91% of the participants provided data on back pain intensity at every time point and 83% provided secondary outcomes data at every time point.
All participants in the IC group received at least 2 types of treatment and 27 of them received at least 4 types. The types of care provided were: exercise therapy (ET, n = 96), self-care education (SCE, n = 59), traditional Chinese medicine (TCM, n = 51), massage therapy (MT, n = 37), chiropractic care (CC, n = 19), cognitive behavioral therapy (CBT, n = 35) and medication (MED, n = 5). The most common treatment combinations were: TCM/SCE/ET (n = 22), ET/SCE/MT (n = 10) and ET/SCE/MT/CBT (n = 10).
The primary outcome measure of pain showed IC to be significantly superior to CC over the 1-year period. Pain intensity over weeks 4 to 52 showed a significant advantage of 0.5 (on a 0-10 scale) for IC over CC; however, over the short term, weeks 4 to 12, IC was superior to CC by 0.4, but not statistically significant. On the secondary analysis, differences for pain intensity at individual time points all favored IC, ranging from 0.4 (weeks 4 and 12) to 0.6 (week 52), but only week 52 was statistically significant.
Of the secondary outcome measures, IC was significantly superior to CC for disability, improvement, satisfaction with care, and low back symptom frequency. There were no significant differences between groups over the 1-year period for medication use, quality of life, leg symptom frequency, fear avoidance beliefs, and self-efficacy.
Five serious adverse events occurred during the trial (CC = 4, IC = 1); however, they were all unrelated to the study interventions. Minor, self-limiting adverse events (ex. unusual or increased soreness and a different type of pain) occurred during the 12 weeks of intervention with about equal frequency in both groups.
Clinical Application & Conclusions:
Although this study showed that IC yielded modest advantages over CC in terms of clinical outcomes, there were some disadvantages of multidisciplinary, team-based interventions that need to be considered:
- The average number of visits for the IC group was nearly 24 as compared to 18 in the CC group.
- Many of the IC visit lengths were substantially longer than the typical CC visit.
- While team-based models of care with multiple provider types have been shown to address patients’ needs more comprehensively, coordinating care across provider types can be challenging and contribute to disjointed and unsatisfactory care.
- The authors also suggested that offering these resource intensive approaches will not likely be cost-effective.
In conclusion, since the differences between the IC and CC groups were relatively small and extensive resources are needed to manage and implement team-based integrative care, IC is likely to be of little added value compared to chiropractic care alone.
EDITOR’S NOTE: As noted here, IC was slightly superior to CC for many of the outcomes but did have its own limitations and considerations. Perhaps the real-world application of this paper speaks to the idea that not all LBP patients need IC – it may be too much, too complex, too time-consuming, or simply unavailable. The fact that stand-alone chiropractic care performed similarly in this small trial is heartening to the many chiropractors that practice alone, or in more remote regions. IC may also be better-suited for more complex clinical presentations, something that requires further study.
Study Methods:
The data for this study were from a previous parallel group randomized clinical trial that was conducted from 2007 to 2010.
Participants were included if they met the following criteria:
- 18 years of age or older;
- LBP categories 1, 2, 3, or 4 according to the Quebec Task Force classification system;
- current episode of LBP 6 weeks or longer; and
- LBP rating of ≥ 3 on a 0–10 scale during the previous week.
Exclusion criteria were:
- persons with contraindications to study treatments (i.e. active inflammatory disease of the spine, blood clotting disorders, or severe osteoporosis),
- pregnancy or nursing,
- current or pending spine-related litigation,
- history of multiple lumbar surgeries, and
- progressive neurological deficits.
Participants received 12 weeks of either monodisciplinary chiropractic care (CC) or multidisciplinary, team-based, integrative care (IC) and were followed up until 52 weeks.
A team of chiropractors provided CC using any type of treatment allowed under their scope of practice that had not shown to be ineffective or harmful, including manual spinal manipulation/mobilization (SMT), hot/cold packs, massage, exercise, and provision of self-care educational materials.
A team of six different provider types delivered IC, including acupuncturists, chiropractors, psychologists, exercise therapists, massage therapists, and primary care physicians. Coordination of care delivery was handled by case managers. IC interventions included acupuncture and traditional Chinese medicine (AOM or TCM), SMT, cognitive behavioral therapy (CBT), massage therapy (MT), medication (MED), and self-care education (SCE).
There was no attempt to blind patients or providers to treatment due to the nature of the study interventions.
Evidence based treatment plans were developed based on each patient’s baseline outcomes as well as their biopsychosocial profile, which was derived from the history and clinical examination. Patient care team meetings were held weekly for each intervention group to discuss enrolled participants and achieve consensus on treatment plan recommendations. Participants were allowed to choose which individualized treatment plan options they preferred.
Patients completed a Patient Self-Assessment Form (PSAF) at each visit which allowed them to choose a symptom and an activity most affected by their LBP and then rate it on a 0–10 scale. PSAFs were used by the treating providers to monitor patient progress by comparing patients’ scores to previously published benchmarks for improvement. Cases where benchmarks for improvement were not met were reviewed at respective care team meetings, possibly altering the treatment plan.
Patients completed self-reported questionnaires at 2 baseline visits (7–14 days apart) and at 4, 8, 12, 26, and 52 weeks. The primary outcome measure was level of back pain over the previous week on a numerical rating scale (0 = no pain, 10 = the worst pain possible).
A team of chiropractors provided CC using any type of treatment allowed under their scope of practice that had not shown to be ineffective or harmful, including manual spinal manipulation/mobilization (SMT), hot/cold packs, massage, exercise, and provision of self-care educational materials.
A team of six different provider types delivered IC, including acupuncturists, chiropractors, psychologists, exercise therapists, massage therapists, and primary care physicians. Coordination of care delivery was handled by case managers. IC interventions included acupuncture and traditional Chinese medicine (AOM or TCM), SMT, cognitive behavioral therapy (CBT), massage therapy (MT), medication (MED), and self-care education (SCE).
There was no attempt to blind patients or providers to treatment due to the nature of the study interventions.
Evidence based treatment plans were developed based on each patient’s baseline outcomes as well as their biopsychosocial profile, which was derived from the history and clinical examination. Patient care team meetings were held weekly for each intervention group to discuss enrolled participants and achieve consensus on treatment plan recommendations. Participants were allowed to choose which individualized treatment plan options they preferred.
Patients completed a Patient Self-Assessment Form (PSAF) at each visit which allowed them to choose a symptom and an activity most affected by their LBP and then rate it on a 0–10 scale. PSAFs were used by the treating providers to monitor patient progress by comparing patients’ scores to previously published benchmarks for improvement. Cases where benchmarks for improvement were not met were reviewed at respective care team meetings, possibly altering the treatment plan.
Patients completed self-reported questionnaires at 2 baseline visits (7–14 days apart) and at 4, 8, 12, 26, and 52 weeks. The primary outcome measure was level of back pain over the previous week on a numerical rating scale (0 = no pain, 10 = the worst pain possible).
Secondary outcomes included:
- the 23-item Roland Morris Disability Questionnaire
- Global improvement (1 = no symptoms, 100% improvement; 9 = as bad as it could be, 100% worse)
- Days with medication use for back pain in the past week
- Quality of life measured using the EuroQol EQ5D-3L
- Satisfaction with care (1 = completely satisfied, couldn’t be better; 7 = completely dissatisfied, couldn’t be worse)
- Frequency of low back or leg symptoms (0 = none of the time; 5 = all of the time)
- Number of days in the past month with missed work or reduced activities due to back pain
- Work and physical activity subscales of the Fear Avoidance Beliefs Questionnaire (FABQ)
- Pain self-efficacy
- Pain coping strategies measured with the Vanderbilt Pain Management Inventory short form
- Kinesiophobia measured with the Tampa Scale for Kinesiophobia
Study Strengths / Weaknesses
This was a well-done study that had several strengths, including:
- This study had a long-term (1-year) follow up period.
- Excellent visit adherence and data collection rates were obtained.
- Participants’ treatment expectations were measured.
- Side effects and adverse events were collected and reported.
- Clinical care pathways were developed and applied which also informed team-based shared decision making.
Although this study was well-done, the authors pointed out several limitations, including:
- The lack of representation of participants from more diverse backgrounds.
- The clinical care pathway process was not tested for validity and reliability.
- This was a pragmatic study that was conducted similar to clinical practice, where more than 1 intervention is typically provided (ex. SMT and ET), making it difficult to determine which elements of treatment produced the observed effects.
- Neither patients nor providers were blinded as to the treatment.
- The time period between completion of the trial to publishing the results was lengthy.
Additional References:
- Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum 2012; 64(6): 2028–37.
- Hoy D, March L, Brooks P, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014; 73(6): 968–74.
- Foster N, Anema J, Cherkin D, et al. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet 2018; 391(10137): 2368–83.
- Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med 2017; 166(7): 493–505.
- Kizhakkeveettil A, Rose K, Kadar G. Integrative therapies for low back pain that include complementary and alternative medicine care: a systematic review. Glob Adv Health Med 2014; 3(5): 49–64.
