Surgery for Chronic Pain: Real or Sham?

Surgery for Chronic Pain: Risky and Costly  by Christopher Cheney, HealthLeaders Media – September 23, 2018

While I agree with the basic results of this study, I have great qualms about how these studies (and there are apparently more than a few) are conducted.

There is inadequate evidence to justify surgical procedures to treat chronic pain, recent research shows.

“Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain,“ researchers reported in Pain Medicine.

Most pain specialists and researchers now understand chronic pain as a bio-psycho-social disorder and involving central sensitization, ruling out any structural or biochemical problems. This kind of pain, by definition, cannot be treated with surgery.

The review of 25 clinical trials involved 2,000 patients with conditions including

• lower back pain,
• arthritis,
• angina,
• abdominal pain, and
• endometriosis.

The researchers compared outcomes for invasive procedures and sham procedures.

In a sham procedure, the patient goes through the rituals of a surgical procedure such as preparations and set up, anesthesia if needed, and tissue penetration.

How do they get patients to sign a consent form for this kind of research?

However, the tissue is not manipulated in a way that is thought to correct the underlying problem, and the patient is closed up or the instrument withdrawn.

Who would possibly consent to risking anesthesia, having themselves cut open, and having tissue manipulated NOT “to correct the underlying problem” but just “mess it around”?

For adverse events, there was a significantly higher risk for invasive procedures (12%) than for the sham procedures (4%).

Considering a doctor’s supposed ethics, and the impossibility of “blinding” the doctors who were doing the surgeries, isn’t it quite possible that the tissue wasn’t “manipulated” as much during the sham surgeries than it would have to be for the real surgery?

Cutting through inner body structures or introducing and fastening new “parts” incurs great physical trauma. What kind of doctor would be able to “simulate” this much physical harm doing only a “pretend surgery”?

“The risks of surgical and invasive procedures are not minor and appear to be higher with real compared with sham procedures.

Risks in both groups include

• anesthesia,
• permanent injury to the body,
• psychologic stress, and
• time, cost, and productivity losses.

I can’t believe they received fully informed consent and all levels of approval for this kind of medical experimentation.

Without more rigorous examination, large numbers of patients are exposed to risky and possibly unnecessary procedures.”

We can file this under the “anything but opioids” mantra that has invaded our medical system.

In today’s anti-opioid climate, it is considered less damaging to expose “large numbers of patients” “to risky and possibly unnecessary procedures” rather than prescribe opioids to control intractable pain.

physicians and chronic pain patients should consider surgery carefully.

“Right now, the scientific evidence does not justify doing these procedures for chronic pain.

However, patients and circumstances vary, and physicians and patients need to decide individually what’s appropriate for any particular patient.

Unless, of course, they decide that opioids are appropriate.

Taking this evidence and discussing it with the patient in shared decision-making is the best approach.”

Alternatives to Surgery

Surgery for chronic pain is a prime example of overutilization of healthcare services and poor care coordination.

“It takes a multidisciplinary team of healthcare professionals at its center to help manage chronic pain,” Jonas said.

“Yet one of the things the U.S. healthcare system as a whole systematically fails at is fostering coordinated care. Most care is piecemeal with little communication among providers.

So, people with chronic pain are left to jump from provider to provider, often undergoing unnecessary, costly, duplicative procedures, and taking ineffective drugs — with ultimately little relief.”

When will one of these “clever” people finally figure out that the reasons for all these wasted resources and efforts are

• that opioids are no longer being used to control patients’ pain?
• that costly and even duplicate procedures are consented and performed out of desperation for relief?
• That drugs like the ever increasingly popular Neurontin and Lyrica are ineffective for their patients’ pain?
• That patients “jump from provider to provider” because they aren’t finding relief?

And here’s the study abstract:

Are Invasive Procedures Effective for Chronic Pain? A Systematic Review – Sept 2018

Objective

To assess the evidence for the safety and efficacy of invasive procedures for reducing chronic pain and improving function and health-related quality of life compared with sham (placebo) procedures.

Design

Systematic review with meta-analysis.

Methods

Studies were identified by searching multiple electronic databases, examining reference lists, and communicating with experts. Randomized controlled trials comparing invasive procedures with identical but otherwise sham procedures for chronic pain conditions were selected.

It’s hard to believe that multiple studies found enough patients willing to consent to the barbarity of these invasive and potentially permanently damaging “sham surgeries.”

Three authors independently extracted and described study characteristics and assessed Cochrane risk of bias. Two subsets of data on back and knee pain, respectively, were pooled using random-effects meta-analysis. Overall quality of the literature was assessed through Grading of Recommendations, Assessment, Development, and Evaluation.

Results

Twenty-five trials (2,000 participants) were included in the review assessing the effect of invasive procedures over sham.

Conditions included

• low back (N = 7 trials),
• arthritis (4),
• angina (4),
• abdominal pain (3),
• endometriosis (3),
• biliary colic (2), and
• migraine (2).

Thirteen trials (52%) reported an adequate concealment of allocation.

This means that in half of these torturous studies, patients could tell whether they’d had real or sham surgery.

First of all, that means that these studies weren’t even scientifically useful and patients suffered through sham surgeries for no benefit to anyone.

Second, it seems that throwing out almost half of the results of these horrific “experiments” when they could have had a huge influence on the final results of the study would make it impossible to draw conclusions just from the “leftover” patients in the studies with “adequately concealed allocations”.

Fourteen studies (56%) reported on adverse events.

Of these, the risk of any adverse event was significantly higher for invasive procedures (12%) than sham procedures (4%; risk difference = 0.05, 95% confidence interval [CI] = 0.01 to 0.09, P = 0.01, I2 = 65%).

In the two meta-analysis subsets, the standardized mean difference for reduction of low back pain in seven studies (N = 445) was 0.18 (95% CI = –0.14 to 0.51, P = 0.26, I2 = 62%), and for knee pain in three studies (N = 496) it was 0.04 (95% CI = –0.11 to 0.19, P = 0.63, I2 = 36%).

The relative contribution of within-group improvement in sham treatments accounted for 87% of the effect compared with active treatment across all conditions.

Can anyone decipher what the above sentence means?

Conclusions

There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain.

But there IS “evidence for the specific efficacy [equal to] sham for invasive procedures”?

A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain.

This is the most mealymouthed “conclusion” I’ve ever read in a scientific abstract:

they found only “a moderate amount of evidence that does NOT support”  invasive surgeries?

This sounds almost like a double negative. What is it they are trying so hard NOT to say?

Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.

At first, I assumed that “high cost and safety concerns” were for doing “experimental” surgeries on patients in the studies, but then I realized they had no “safety concerns” for their experiments.