Dolore e Patologie

Opioid Painkillers: What the Trials Show

Revisione clinica: Daniele Carretto, Fisioterapista (Albo 2019) · Aggiornato il 23 settembre 2026

Pistola massaggiante impugnata a due mani vicino alla coscia della paziente seduta, poltrona blu dello studio sullo sfondo.
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On musculoskeletal pain there are two randomised trials that almost nobody cites when the subject is strong painkillers. One concerns pain that has just started, the other pain that has lasted for months. They point in the same direction, and it is an uncomfortable one.

A preliminary note, so there are no misunderstandings: nobody is being told here to stop a treatment. Opioids are stopped with the prescriber, and never abruptly. What we are discussing is the decision that comes first: whether to start them or not.

Acute pain: OPAL, and the placebo that wins narrowly

Published in the Lancet in 2023, OPAL is a triple-blind, placebo-controlled study: 347 adults who arrived at 157 general practice and emergency department sites in Australia with back or neck pain lasting less than twelve weeks, of at least moderate intensity.

Everyone received the care recommended by the guidelines. In addition, half received an opioid (oxycodone-naloxone, up to 20 mg of oxycodone a day) and half an identical placebo, for six weeks.

At six weeks, average pain on a scale from 0 to 10:

  • opioid group: 2.78
  • placebo group: 2.25

The adjusted difference is 0.53 in favour of placebo (confidence interval from −0.00 to 1.07, p=0.051). Put simply: the opioid did no better than an empty pill, and the raw number was slightly worse.

On side effects, the total number of people with at least one event was similar (35% versus 30%), but the typical opioid effects were more frequent in the group taking them: constipation, for example, at 7.5% against 3.5%.

The authors' conclusion is literal: opioids should not be recommended for acute non-specific back pain and neck pain.

Close-up of a physiotherapist's hands pressing on the lower back of a person lying down.
In acute back pain, what changes the numbers is not the pill: it is getting moving again early.

Chronic pain: SPACE, and twelve months of follow-up

Published in JAMA in 2018, SPACE followed 240 people for twelve months, all with chronic back pain or hip and knee osteoarthritis who already had moderate to severe pain despite analgesics.

It was not "opioid versus nothing": both groups followed a strategy with a target to reach, with more medications available in three steps. In the opioid group one started with morphine, oxycodone or hydrocodone; in the other with paracetamol or an anti-inflammatory.

After twelve months:

  • pain-related function: no difference (3.4 versus 3.3);
  • pain intensity: better in the group without opioids (4.0 versus 3.5), a statistically significant difference;
  • medication-related symptoms: more frequent in the opioid group.

One limitation needs stating: participants came from the clinics of US veterans, so 87% were men, with a mean age of 58. It is not a sample that resembles the Italian population with back pain.

Why these two things go together

Because together they cover the two phases in which the question really arises: "my back has just locked, shall I get something strong?" and "I have been in pain for a year, maybe it is time to move to something more serious".

The answer from the trials is the same in both: the stronger drug is not the better drug, for this type of pain. And it carries a cost (side effects, tolerance, dependence) that the alternatives do not carry.

This is not an ideological position against medicines. For the same conditions, 152 randomised trials involving 17,431 people find no differences between exercise and oral anti-inflammatories or paracetamol: paracetamol, there, holds its own. It is the next step, the opioid, that does not keep its promise.

The physiotherapist sitting beside the couch rests a hand on the thigh of the patient lying down.
The useful question is not which pill, it is what gets you moving again and how quickly.

So what do you do

Three concrete things, which apply to both acute and persistent back pain.

In the acute phase, time works for you. Most episodes improve anyway, and what shortens the story is getting moving sooner, not waiting until it no longer hurts. The rest is in how long recovery really takes.

Once it has passed, work on the relapse. This is the part with the most recent and most solid evidence: a progressive walking programme nearly doubled the pain-free days.

If the pain has lasted months, the drug alone is not the way: you need to get the load, the sleep and the confidence in the avoided movements back into motion. On how such a pathway works: therapeutic exercise, how well it really works.

And if you are in a situation where medicines are limited by necessity, such as pregnancy, the numbers on the other route are set out here.

In summary

In 347 people with acute back or neck pain, the opioid did not beat an identical placebo at six weeks. In 240 people with chronic pain followed for a year, the group without opioids had less pain and fewer side effects. There remain situations where they are needed (cancer pain, after an operation, major trauma), and these studies do not cover them. For back pain, neck pain and osteoarthritis, the evidence says to look elsewhere.

And on the most common obstacle to moving, namely the fear of doing harm: if it hurts, should I stop?

On another front where movement and medication are compared: high blood pressure and movement.

Sources

Last source check: September 2026.

Need a consultation?

Start with the Ri-Hub questionnaire: a few questions about your case, you sign up, and you see who will follow you: a physiotherapist on the Italian professional register, whom you write to in chat whenever you like. If you would rather talk it through by voice, the first consultation is free, lasts twenty minutes and commits you to nothing: they arrive having already read what you wrote, and together you decide whether and how to go on.

Domande frequenti

Do opioids work for acute back pain?

In the OPAL study, published in the Lancet in 2023, 347 people with back or neck pain lasting less than twelve weeks received, on top of the recommended care, either an opioid or an identical placebo for six weeks. At six weeks the average pain was 2.78 in the opioid group and 2.25 in the placebo group: no advantage, and if anything a slightly worse number. The authors' conclusion is that opioids should not be recommended in these cases.

And for pain that has lasted months?

The SPACE study, published in JAMA in 2018, followed 240 people for twelve months, all with chronic back pain or hip and knee osteoarthritis, randomly assigned to an opioid strategy or a non-opioid one. There was no difference in pain-related function; for pain intensity the group without opioids did significantly better (4.0 versus 3.5), and had fewer medication side effects.

So should I stop taking them?

No, and this page does not say that. An opioid should be stopped only by the person who prescribed it and at the right pace: stopping it on your own, especially after weeks or months, is something you pay for. What these studies say is something else: if you are deciding now whether to start them for back pain, the numbers are not on their side.

Are there situations where they are needed?

Yes, and the studies here do not cover them: cancer pain, post-operative phases, major trauma. Both trials are on non-specific musculoskeletal pain (back, neck, osteoarthritis), which is the situation in which opioids are prescribed most in Italy without there being evidence for it.

What works instead?

For the same conditions, the best evidence is for movement and exercise: 152 randomised trials involving 17,431 people find no differences between exercise and oral anti-inflammatories or paracetamol in osteoarthritis, and for back pain relapses a programme of progressive walking nearly doubled the number of pain-free days. It is not an instant solution: it is a solution that holds over time.

Dal singolo esercizio al percorso

Questi esercizi sono generici. Il tuo no.

Quelli che hai appena letto valgono per tutti, e per questo non valgono per nessuno in particolare. Un fisioterapista iscritto all'Albo guarda il tuo caso nel primo colloquio — gratuito, venti minuti — e da lì costruisce il programma su di te: da casa quando basta, in uno studio vicino a te quando servono le mani. Il dolore che torna non toglie solo il movimento: toglie il sonno, la pazienza, la voglia di uscire di casa. Rimetterti in movimento è il nostro mestiere.

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