Roger Wilhelm, D.C.

The “gold standard” for health care research is the randomized controlled trial, or RCT. A lay explanation for a typical RCT study is:

• Researchers gather a group of individuals that have the same problem.
• The problem is quantified, often by using standardized measurement outcomes.
• The group is randomized to be treated differently. The quantification of the problem should be quite close between groups during this randomization.
• At the end of a pre-determined treatment period, study subjects are reassessed using the standardized measurement outcomes. This allows the researchers to determine the benefit (or lack of benefit) of the various treatment interventions.

••••

In 1990, a study was published in the British Medical Journal, titled (1):

Low Back Pain of Mechanical Origin:
Randomized Comparison of Chiropractic
and Hospital Outpatient Treatment

This study was a randomized comparison of chiropractic and hospital outpatient treatment in the management of low back pain. It is noteworthy that chiropractic care does not involve pharmacology (pain drugs). This randomized trial involved 741 patients. The patients were followed for a period between 1–3 years. The authors concluded:

“Chiropractic treatment was more effective than hospital outpatient management, mainly for patients with chronic or severe back pain.”

“There is, therefore, economic support for use of chiropractic in low back pain, though the obvious clinical improvement in pain and disability attributable to chiropractic treatment is in itself an adequate reason for considering the use of chiropractic.” 

“Chiropractic was particularly effective in those with fairly intractable pain-that is, those with a history of severe pain.”

“Patients treated by chiropractors were not only no worse off than those treated in hospital but almost certainly fared considerably better and that they maintained their improvement for at least two years.”

“The results leave little doubt that chiropractic is more effective than conventional hospital outpatient treatment.”

As noted above, this study was published in the British Medical Journal. The month after this study was published (June 1990), the medical journal Lancet published an editorial pertaining to the study, stating the following (2):

“Chiropractors and Low Back Pain”

[The study (1)] “showed a strong and clear advantage for patients with chiropractic.”

The advantage for chiropractic over conventional hospital treatment was “not a trivial amount” and “reflects the difference between having mild pain, the ability to lift heavy weights without extra pain, and the ability to sit for more than one hour, compared with moderate pain, the ability to lift heavy weights only if they are conveniently positioned, and being unable to sit for more than 30 minutes.”

“This highly significant difference occurred not only at 6 weeks, but also for 1, 2, and even (in 113 patients followed so far) 3 years after treatment.”

“Surprisingly, the difference was seen most strongly in patients with chronic symptoms.”

“Chiropractic treatment should be taken seriously by conventional medicine, which means both doctors and physiotherapists.”

The authors of the British Medical Journal study (1) note that if all back-pain patients without manipulation contraindications were referred for chiropractic instead of hospital treatment, there would be significant annual treatment cost reductions, a significant reduction in sickness days, and a significant savings in social security payments.

The authors of this study (1) wanted a longer-term follow-up on their patient population. This later study was completed and published in the British Medical Journal in 1995, and titled (3):

Randomised Comparison of Chiropractic
and Hospital Outpatient
Management for Low Back Pain:
Results from Extended Follow Up

The same authors, from the Medical Research Council Epidemiology and Medical Care Unit, Wolfson Institute of Preventive Medicine, Medical College of St. Bartholomew’s Hospital, London, reminded the readers that their original study involved 741 men and women aged 18-64 years with low back pain, and that the primary measurement outcome used was the change in the total Oswestry Low Back Questionnaire score. Like the original 1990 study, this study is also a randomized comparison design.

The objective of this study was to compare the effectiveness over three years of chiropractic and hospital outpatient management for low back pain. As noted above, the authors remind the readers that their 1990 study “reported greater improvement in patientswith low back pain treated by chiropractic compared with those receiving hospital outpatient management.” In this 3-year follow-up study, the authors asked the study subjects whether they thought their allocated treatment had helped their back pain. The authors found:

“According to total Oswestry scores improvement in all patients at three years was about 29% more in those treated by chiropractors than in those treated by the hospitals.”

“The beneficial effect of chiropractic on pain was particularly clear.”

“[More subjects] rated chiropractic helpful at three years than hospitalmanagement.”

“[Improvements] were all significantly greater in those treated by chiropractic, including the changes early on-that is, at six weeks and six months.”

“At three years the results confirm the findings of an earlier report that when chiropractic or hospital therapists treat patients with low back pain as they would in day to day practice those treated by chiropractic derive more benefit and long–term satisfaction than those treated by hospitals.”

“The substantial benefit of chiropractic on intensity of pain is evident early on and then persists.”

“The results of our trial show that chiropractic has a valuable part to play in the management of low back pain.”

“Chiropractic seems to be more effective than hospital management, possibly because more treatments are spread over longer time periods.”

The Oswestry scores in this follow-up study found more than pain improvement with chiropractic care. Also significantly improved were:

• The ability to sit for more than a shorttime
• Sleeping ability
• Personal care
• Lifting
• Walking
• Standing
• Sex life
• Social life
• Travelling

An important finding from the 1990 study that was confirmed in this 1995 study is that the longer and more serious the low back pain, the more likely the patient was to benefit from chiropractic care.

••••

In 2002, a study was published in the Annals of Internal Medicine, titled (4):

Manual Therapy, Physical Therapy,
or Continued Care by a General Practitioner
for Patients with Neck Pain:
A Randomized Controlled Trial

The authors defined “manipulation” as:

“Orthopedic manipulative (manual) therapy is a specialization within physical therapy and provides comprehensive conservative management for pain and other symptoms of neuro-musculo-articular dysfunction in the spine and extremities.”

The authors compared the effectiveness of manual therapy, physical therapy, and pharmacology care provided by a general practitioner physician for the treatment of neck pain. This study is a randomized controlled trial (RCT) design, involving 183 patients. The authors concluded:

“Manual therapy scored consistently better than the other two interventions on most outcome measures.”

“In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued [drug] care by a general practitioner.”

“The success rates for manual therapy were statistically significantly higher than those for physical therapy.”

“Manual therapy scored better than physical therapy on all outcome measures…”      

“Range of motion improved more markedly for those who received manual therapy or physical therapy than for those who received continued [physician drug] care.”

“The postulated objective of manual therapy in the restoration of normal joint motion, was achieved, as indicated by the relatively large increase in the range of motion of the cervical spine.”

“Patients receiving manual therapy had fewer absences from work than patients receiving physical therapy or continued [physician drug] care.”

“Manual therapy seems to be a favorable treatment option for patients with neck pain.”

“Primary care physicians should consider manual therapy when treating patients with neck pain.”

In this study, the primary authors are physical therapists, and they found that manual manipulative therapy was superior to traditional physical therapy in the management of neck pain.

••••

In 2003, a study published in the journal Spine, titled (5):

Chronic Spinal Pain:
A Randomized Clinical Trial Comparing
Medication, Acupuncture, and Spinal Manipulation

Important for this discussion is acknowledging that this study is a randomized controlled clinical trial design. The initial phase of the study was of nine weeks duration. The second phase was a reassessment at a one-year follow-up.

The authors randomized 115 patients suffering from chronic neck/back pain to three groups:

• Daily prescription Nonsteroidal Anti-inflammatory Drugs (NSAIDs) prescribed by a medical doctor.
• Needle Acupuncture by a certified needle acupuncturist, two patient visits per week.
• Spinal manipulation by a licensed chiropractor. The manipulations were high-velocity, low-amplitude thrust spinal manipulation to a joint with reduced mobility. Two treatments per week were given.

The measurement outcomes used included the Oswestry Back Pain Disability Index (Oswestry), the Neck Disability Index (NDI), the Short-Form-36 Health Survey questionnaire (SF-36), visual analog scales (VAS) of pain intensity, and ranges of spinal movement. Subjects were assessed initially and then again at 2, 5, and 9 weeks after the beginning of treatment.

The authors note that a pathologic cause cannot be identified for most episodes of spinal pain, and clinicians often have great difficulty establishing the underlying cause. They state that only about 15% of patients receive a definitive diagnosis for their spinal pain; it is often impossible to reach a specific diagnosis.

The authors discuss that the proportion of primary care patients with uncomplicated spinal pain who have poor outcomes appears to be higher than generally recognized by either patients and physicians. Yet, physicians are highly likely to recommend the use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs). The authors state:

“Adverse reactions to nonsteroidal anti-inflammatory (NSAID) medication have been well documented.”

“Gastrointestinal toxicity induced by NSAIDs is one of the most common serious adverse drug events in the industrialized world.”

Chiropractic care was included in this study because “numerous studies have shown that patients with low back pain exhibit abnormal spinal motion.” The authors suspected that chiropractic manipulation to joints with a reduced range of motion would be superior to acupuncture and drug care.

In the randomization of the subjects in this study, the average duration of spinal pain symptoms was 8.3 years for the chiropractic spinal manipulation group, 6.4 years for the medication group, and 4.5 years for the acupuncture group. Clearly, the chiropractic patient group was statistically much more chronic than the other treatment groups.

The outcomes for this study showed that the highest proportion of early (asymptomatic status) recovery was found for chiropractic spinal manipulation (27.3%), followed by acupuncture (9.4%), and lastly by medication (5%). The chiropractic spinal manipulation achieved the best overall results, with improvements of 50% on the Oswestry scale, 38% on the NDI, 47% on the SF-36, and 50% on the VAS for back pain, 38% for lumbar standing flexion, 20% for lumbar sitting flexion, 25% for cervical sitting flexion, and 18% for cervical sitting extension.

The authors note:

“The consistency of the results provides evidence that in patients with chronic spinal pain, [chiropractic spinal] manipulation, if not contraindicated, results in greater short-      term improvement than acupuncture or medication.”

“The highest proportion of asymptomatic patients before or at the week 9 assessment was found in the [chiropractic spinal] manipulation group (27.3%) followed by the acupuncture group (9.4%) and the medication group (5%).”

“Manipulation yielded the best results over all the main outcome measures.”

“The results of this efficacy study suggest that [chiropractic] spinal manipulation, if not contraindicated, may be superior to needle acupuncture or medication for the successful treatment of patients with chronic spinal pain syndrome.”

“In summary, the significance of the study is that for chronic spinal pain syndromes, it appears that [chiropractic] spinal manipulation provided the best overall short-term results, despite the fact that the spinal manipulation group had experienced the longest pretreatment duration of pain.”

The authors noted that the NSAIDs used in this study did not achieve a marked improvement (only 5%) in chronic spinal pain, and they caused adverse reactions in 6.1% of the patients. More subjects suffered an adverse reaction to the drugs (6.1%) than were benefited from the drugs (5%). The authors state that there is insufficient evidence for the use of NSAIDs to manage chronic low back pain.

Even though the chiropractic treatment group was the most chronic (8.3 years), 27.3% recovered with 18 spinal adjustments over a period of 9 weeks, or less. This means that better than every fourth patient became asymptomatic with 9 weeks or less of chiropractic spinal manipulation, even though they had been chronic for more than 8 years.

The chiropractic spinal manipulation group showed significantly greater improvement in subjective complaints, functional abilities, objective range of spinal motion, and in general health status than acupuncture and medication groups. The chiropractic patients recorded no adverse events to treatment.

In the treatment of chronic spinal pain, chiropractic manipulation is superior to acupuncture and medication.

As noted, this study was a nine week-duration clinical trial. The authors wanted to reassess patient clinical status, using the same measurement outcomes, more than a year later. The results were published in 2005 in the Journal of Manipulative and Physiological Therapeutics, titled (6):

Long-Term Follow-up
of a Randomized Clinical Trial
Assessing the Efficacy of Medication,
Acupuncture, and Spinal Manipulation
for Chronic Mechanical Spinal Pain Syndromes

The authors restate that chronic spinal pain is often triggered by injury or disease. Chronic spinal pain has an immense impact on public health, poses an enormous financial strain on the health systems in developed countries, and affects the economy by lost working time through illness.

They note that chronic spinal pain is recurrent in nature for many patients, is a main cause of absence from work, and it has a high incidence in society. The patients in this study had chronic spinal pain (average duration of more than 2 years) and had long histories of having sought pain relief. The authors note:

“The overall results of this extended follow-up efficacy study appear to favor the application of manipulation [which successfully achieves long-term benefits in chronic spinal pain syndrome patients].”

“Statistical testing revealed that only in the manipulation group, 5 of the 7 observed improvements were statistically significant which compares with only 1 item in each of the acupuncture and the medication groups, respectively.”

“In patients with chronic spinal pain syndromes, [chiropractic] spinal manipulation, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit.”

“Spinal manipulation appeared to provide the highest satisfaction.”

 “Patients who have chronic mechanical spinal pain syndromes and received spinal manipulation gained significant broad-based beneficial short-term and long-term outcomes.”

The authors were particularly negative on the results offered by medications for the management of chronic spinal pain, noting that “medication did not achieve an improvement in chronic spinal pain.”

••••

“Dogma” is a belief or set of beliefs that is widely accepted by the members of a group without being questioned or doubted. Dogma is often associated with religions. However, dogma is also pervasive in science. In his 2022 book Transformer, professor of evolutionary biochemistry at University College London, Nick Lane, notes that dogmas can hold scientific progress back decades.

An approach to a medical problem that for decades had been established and accepted, without question or doubt as the absolute best management to a medical problem, may be turned on its head with advancing investigations and evidence. Such an affront to established medical dogma will initially be met with great resistance, and acceptance may take a long time.

Biochemically, it is known that there is a link between inflammation and pain. Inflammation alters the threshold of the pain nerves, bringing more pain signals to the brain. Hence, anti-inflammatory efforts will help reduce pain. When it was learned that the chemistry of pain could be reduced by giving the patient nonsteroidal or steroid anti-inflammatory drugs, the pharmacological management of pain quickly became patented, and then marketed to doctors, medical associations, insurance companies, government guidelines, government insurance programs, and to the public. In fact, nonsteroidal anti-inflammatory drugs (NSAIDs) for pain were awarded the 1982 Nobel Prize in Medicine (8).

The routine uses of anti-inflammatory drugs to treat spinal pain makes biochemical sense, and they have been proven to be helpful for patients. However, there are problems that are under emphasized or completely ignored:

• Anti-inflammatory drugs do not work well as compared to nonpharmacological alternatives such as chiropractic, acupuncture, exercise, etc. (9).
• Anti-inflammatory drugs are associated with numerous and often serious side effects (5, 6).
• Using anti-inflammatory drugs for acute low back pain may predispose the patient to becoming a chronic low back pain sufferer. The irony of this statement and its challenge to orthodoxy has the potential to forever shake up the management of acute low back pain. The science behind this is reviewed below.

In May 2022, a unique and important article was published pertaining to the use of anti-inflammatory drugs (NSAIDs or steroids) and the future incidence of chronic low back pain. It was published in the journal Science Translational Medicine, titled (10): 

Acute Inflammatory Response Via Neutrophil Activation
Protects Against the Development of Chronic Pain

The authors note that chronic pain inflicts huge societal costs in terms of management, loss of work productivity, and effects on quality of life. They also note that chronic low back pain is the most frequently reported chronic pain condition, stating:

“LBP ranks the highest of all chronic conditions in terms of years lived with disability, with its prevalence and burden increasing with age.”

The authors note that the transition from acute to chronic pain is critically important but poorly understood. Therefore, they investigated the pathophysiological mechanisms underlying the transition from acute to chronic low back pain (LBP). The study involved an assessment of 98 LBP subjects. Clinicians followed the standardized protocol for treating patients with acuteLBP with NSAIDs or systemic steroidal drugs to reduce the acute inflammatory response.

Statistically, the results were shocking. Taking anti-inflammatory drugs significantly increased the odds for transitioning from acute to chronic low back pain. The authors explain their findings by noting that anti-inflammatory drugs inhibit white blood immune system cells (neutrophils) from working properly in the long-term, resulting in chronic low back pain. They state:

“Current treatments for LBP often target the immune system and include nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and corticosteroids, although all of these drug classes are minimally effective at best.”

“Early treatment with a steroid or nonsteroidal anti-  inflammatory drug (NSAID) led to prolonged pain despite being analgesic in the short term.”

“The management of acute inflammation may be counterproductive for long-term outcomes of LBP sufferers.”

“Drugs that inhibit inflammation might interfere with the natural recovery process, thus increasing the odds for chronic pain.”

“Results indicate the importance of the up-regulation of the inflammatory response at the acute stage of musculoskeletal pain as a protective mechanism against the development of chronic pain.”

“The beginning of the inflammatory process programs its resolution, and it is thus the failure to initiate an appropriate inflammatory response that may lead to chronic pain.”

The acute treatment of inflammation with either a steroid or a NSAID, “although both effectively reducing pain behavior during their administration—greatly prolonged the resolution of neuropathic, myofascial, and especially inflammatory pain states.”

“Individuals with acute back pain were at greater risk [76%] of developing chronic back pain if they reported NSAID usage than if they were not taking NSAIDs, adjusting for age, sex, [and] ethnicity.”

“Our conclusions may have a substantial impact on medical treatment of the most common presenting complaint to healthcare professionals.”

SUMMARY AND CONCLUSIONS

Pharmacology for pain management has many concerns. They are actually not very effective. They are associated with multiple serious side-effects in a linear fashion (the more one takes the greater the risks of suffering side-effects). The scariest recent discovery is that taking anti-inflammatory drugs for acute back pain may significantly increase the risks of becoming a chronic back pain sufferer.

In contrast, chiropractic care for back pain is highly effective, has high levels of patient satisfaction, routinely outperforms pain drugs in randomized clinical trials, and carries none of the risks associated with pain drugs.

REFERENCES

1. Meade TW, Dyer S, Browne W, Townsend J, Frank OA; Low Back Pain of Mechanical Origin: Randomized Comparison of Chiropractic and Hospital Outpatient Treatment; British Medical Journal; June 2, 1990; Vol. 300; pp. 1431-1437.
2. Editorial; Chiropractors and Low Back Pain; Lancet; July 28, 1990; p. 220.
3. Meade TW, Dyer s, Browne W, Frank AO;Randomised Comparison of Chiropractic and Hospital OutpatientManagement for Low Back Pain: Results from Extended Follow Up; British Medical Journal;August 5, 1995; Vol. 311; pp. 349-51.
4. Hoving JC, Koes BW, de Vet HCW, van der Windt DAWM, Assendelft WJJ, Mameren H, Devillé WLJM; Manual Therapy, Physical Therapy, or Continued Care by a General Practitioner for Patients with Neck Pain; A Randomized Controlled Trial; Annals of Internal Medicine; May 21, 2002; Vol. 136; No. 10; pp. 713-722.
5. Giles LGF; Muller R; Chronic Spinal Pain: A Randomized Clinical Trial Comparing Medication, Acupuncture, and Spinal Manipulation; Spine; July 15, 2003; Vol. 28; No. 14; pp. 1490-1502.
6. Muller R, Giles LGF; Long-Term Follow-up of a Randomized Clinical Trial Assessing the Efficacy of Medication, Acupuncture, and Spinal Manipulation for Chronic Mechanical Spinal Pain Syndromes; Journal of Manipulative and Physiological Therapeutics; January 2005; Vol. 28; No. 1; pp. 3-11.
7. Lane N; Transformer: The Deep Chemistry of Life and Death; WW Norton & Company; 2022.
8. https://www.nobelprize.org/prizes/medicine/1982/summary/ (accessed January 5, 2023).
9. Foreman J; A Nation in Pain, Healing Our Biggest Health Problem; Oxford University Press; 2014.
10. Parisien M, Lima LV, Dagostino C, El-Hachem N, and 16 more; Acute Inflammatory Response Via Neutrophil Activation Protects Against the Development of Chronic Pain;Science Translational Medicine; May 11, 2022; Vol. 14; Article eabj9954.