Failed Drug or Surgical Trials

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:     Frankp@chiro.org

Failed Surgical Trials

	Association Between Spinal Manipulative Therapy and Lumbar Spine Reoperation After Discectomy: A Retrospective Cohort Study BMC Musculoskelet Disord 2024 (Jan 10); 25 (1): 46 ~ FULL TEXT This study found that adults receiving SMT for LSR at least one year after lumbar discectomy were less likely to undergo lumbar spine reoperation compared to those receiving usual care without SMT, a difference which persisted over two years’ follow-up. These findings highlight the potential role of SMT in reducing the likelihood of additional surgery in this patient population. However, prospective studies are needed to validate our findings and concurrently examine changes in pain, disability, and safety among those receiving SMT after discectomy.
	Association Between Chiropractic Spinal Manipulation and Lumbar Discectomy in Adults with Lumbar Disc Herniation and Radiculopathy: Retrospective Cohort Study Using United States' Data BMJ Open 2022 (Dec 16); 12 (12): e068262 ~ FULL TEXT These findings suggest that patients receiving CSMT for newly diagnosed LDH and/or LSR without serious pathology, spinal deformity or absolute indications for surgery have significantly reduced odds of discectomy through 2-year follow-up after index diagnosis compared with those receiving other care. While socioeconomic variables were unavailable in the dataset, current data suggests these unmeasured variables would not completely explain our findings. However, given the possibility of residual confounding, the efficacy of CSMT for LDH/LSR should be explored further using a randomised controlled trial.
	Effectiveness of Multimodal Chiropractic Care Featuring Spinal Manipulation for Persistent Spinal Pain Syndrome Following Lumbar Spine Surgery: Retrospective Chart Review of 31 Adults in Hong Kong Medical Science Monitor 2022 (Aug 2); 28: e937640 ~ FULL TEXT The term "persistent spinal pain syndrome type 2" (PSPS-2) has been proposed by the International Association for the Study of Pain to replace the term "failed back surgery syndrome". This retrospective study aimed to evaluate effectiveness of multimodal care featuring chiropractic spinal manipulation (CSMT) in 31 adults in Hong Kong with PSPS-2. Patients with PSPS-2 improved with multimodal care featuring CSMT, which was more effective in patients with younger age, shorter symptom duration, and higher baseline pain or disability levels.
	Morbidity and Mortality of Major Adult Spinal Surgery. A Prospective Cohort Analysis of 942 Consecutive Patients Spine J. 2012 (Jan); 12 (1): 22–34 ~ FULL TEXT Major spinal surgery in the adult is associated with a high incidence of intra- and postoperative complications. We identified a very high rate of previously unrecognized postoperative complications, which adversely affect hospital length of stay. Without strict adherence to a prospective data collection system, the true complexity of this surgery may be greatly underestimated.

Failed Drug Trials

	Association Between Chiropractic Spinal Manipulation and Gabapentin Prescription in Adults With Radicular Low Back Pain: Retrospective Cohort Study Using US Data BMJ Open 2023 (Jul 21); 13 (7): e073258 ~ FULL TEXT Our findings suggest that US adults receiving CSMT for newly diagnosed radicular low back pain (rLBP) have significantly reduced odds of receiving a gabapentin prescription over 1–year follow-up compared with those receiving usual medical care. Results may not be generalisable and should be replicated in other healthcare settings and corroborated by a prospective study to reduce confounding.
	Systematic Review of Guideline-recommended Medications Prescribed for Treatment of Low Back Pain Chiropractic & Manual Therapies 2022 (May 13); 30: 26 ~ FULL TEXT Nine CPGs, included ten medication classes for the management of LBP. NSAIDs were the most frequently recommended medication for the treatment of both acute and chronic LBP as a first line pharmacological therapy. Acetaminophen and SMRs were inconsistently recommended for acute LBP. Meanwhile, with less consensus among CPGs, acetaminophen and antidepressants were proposed as second-choice therapies for chronic LBP. There was significant heterogeneity of recommendations within many medication classes, although oral corticosteroids, benzodiazepines, anticonvulsants, and antibiotics were not recommended by any clinical practice guidelines (CPG) for acute or chronic LBP.
	Non-steroidal Anti-inflammatory Drugs for Acute Low Back Pain Cochrane Database Syst Rev 2020 (Apr 16); 4 (4): CD013581 ~ FULL TEXT NSAIDs seemed slightly more effective than placebo for short-term pain reduction (moderate certainty), disability (high certainty), and global improvement (low certainty), but the magnitude of the effects is small and probably not clinically relevant. There was no clear difference in short-term pain reduction (low certainty) when comparing selective COX-2 inhibitors to non-selective NSAIDs. We found very low evidence of no clear difference in the proportion of participants experiencing adverse events in both the comparison of NSAIDs versus placebo and selective COX-2 inhibitors versus non-selective NSAIDs. We were unable to draw conclusions about adverse events and the safety of NSAIDs for longer-term use, since we only included RCTs with a primary focus on short-term use of NSAIDs and a short follow-up. These are not optimal for answering questions about longer-term or rare adverse events.
	Inappropriate Use of Skeletal Muscle Relaxants in Geriatric Patients U. S. Pharmacist 2020 (Jan 21); 45 (1): 25–29 ~ FULL TEXT Skeletal muscle relaxants are a sedating class of medications used to treat spasticity and pain. Their sedative properties can pose a risk for geriatric patients who are predisposed to falls. It is important for the pharmacist to assess the patient before dispensing medications. Short-term use of skeletal muscle relaxants may be appropriate for certain conditions but should not be used long-term, regardless of interaction. Alternative pharmacologic options exist, but most have drawbacks. Nonpharmacologic therapy may be a better option in both the short term and the long term. Nonpharmacologic education on fall prevention is essential in patients being given skeletal muscle relaxants, regardless of duration of therapy. Not only will appropriate use of skeletal muscle relaxants improve patient outcomes, it can also improve star ratings for both insurance providers and pharmacies.
	Paracetamol Is Ineffective for Acute Low Back Pain Even for Patients Who Comply with Treatment: Complier Average Causal Effect Analysis of a Randomized Controlled Trial Pain 2019 (Dec); 160 (12): 2848–2854 ~ FULL TEXT In conclusion, paracetamol is not more effective than placebo for acute LBP in compliers of the treatment regimen. Complier average causal effect analyses using different cut points showed that paracetamol had no effect on pain intensity and secondary outcomes when compared with placebo for participants that complied to regular paracetamol in the PACE trial. These results support the original findings of the PACE trial.
	Gabapentin and Pregabalin Not Effective for Low Back Pain with or without Radiculopathy American Family Physician 2019 (Mar 15); 99 (6): Online~ FULL TEXT Particularly in this era of heightened awareness of the potential harms of opioids, anticonvulsants are often prescribed for the treatment of painful conditions. Although there is evidence of their effectiveness, primarily for peripheral and diabetic neuropathy, anticonvulsants are increasingly prescribed for other conditions, including low back pain. This systematic review included a comprehensive search of the literature, and the authors identified nine randomized trials (three of which were crossover studies) that compared topiramate (Topamax), pregabalin (Lyrica), or gabapentin with placebo in patients with low back pain with or without radiculopathy.
	Opioid Use Among Low Back Pain Patients in Primary Care: Is Opioid Prescription Associated with Disability at 6-month Follow-up? Pain 2013 (Jul); 154 (7): 1038–1044 ~ FULL TEXT Our findings indicate that even after adjusting for a substantial number of potential confounders, opioids were associated with slightly worse functioning in back pain patients at 6-month follow-up. Further research may help us to understand the mechanisms underlying these findings and inform clinical decisions regarding the usefulness of opioids for back pain.
	Spinal High-velocity Low Amplitude Manipulation in Acute Nonspecific Low Back Pain: A Double- blinded Randomized Controlled Trial in Comparison With Diclofenac and Placebo Spine 2013 (Apr 1); 38 (7): 540–548 A total of 101 patients with acute LBP (for <48 hr) were recruited from 5 outpatient practices, exclusion criteria were numerous and strict. Outcomes registered by a second and blinded investigator included self-rated physical disability, function (SF–12), off-work time, and rescue medication between baseline and 12 weeks after randomization. In a subgroup of patients with acute nonspecific LBP, spinal manipulation was significantly better than nonsteroidal anti-inflammatory drug diclofenac and clinically superior to placebo.
	A Randomized Clinical Trial Comparing Chiropractic Adjustments to Muscle Relaxants for Subacute Low Back Pain J Manipulative Physiol Ther 2004 (Jul); 27 (6): 388–398 ~ FULL TEXT Chiropractic was more beneficial than placebo in reducing pain and more beneficial than either placebo or muscle relaxants in reducing Global Impression of Severity Scale (GIS).
	The Use of Muscle Relaxant Medications in Acute Low Back Pain Spine (Phila Pa 1976) 2004 (Jun 15); 29 (12): 1346–1351 ~ FULL TEXT Muscle relaxants were used by 49% of patients; among those who sought care from doctors, 64% used muscle relaxants. Muscle relaxant users were more impaired at baseline. Over time, among patients with greater functional status impairment (Roland disability score > 12) at baseline, muscle relaxant users had somewhat slower recovery from the episode of back pain. This finding persisted after controlling for baseline functional status, age, worker's compensation status, and use of nonsteroidal inflammatory agents.

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