A trial based in the UK compared interventions in two groups of patients managing chronic pain with opioid usage.
A multimodal intervention—rooted in teaching skills, one-to-one care, and group support—helped stop opioid usage in one in five people.
The trial also found that the intervention improved patient mental health, pain self-efficacy, and health-related quality of life.
Researchers at the University of Warwick and the James Cook University Hospital in Middlesbrough, England, led a clinical trial designed to help reduce opioid use in patients with nonmalignant chronic pain. The treatment included a multicomponent, group-based, self-management intervention.
Why is this trial so important right now?
In the UK, over 1 million people take prescription opioids, with over 50,000 people turning to them for over six months or longer, costing the National Health Service (NHS) £500 million annually, according to the authors. This is not without consequences. As the researchers write, “Opioid use for chronic nonmalignant pain can be harmful.”
In fact, the journal Pain found that “the potentially devastating effects of addiction can substantially offset the benefits of opioid pain relief,” underscoring how important it is to “reexamine addiction mechanisms and their relevance to the practice of long-term opioid treatment for pain.”
Researchers in Experimental and Clinical Psychopharmacology write, “Chronic pain is a major public health problem, which is associated with devastating consequences to patients and families, a high rate of health care utilization, and huge society costs related to lost work productivity.”
In response to this crisis, providers in England are already cutting opioid prescriptions per the NHS’s new framework to “reduce inappropriate prescribing of high-strength painkillers and other addiction-causing medicines, like opioids and benzodiazepines, where they may no longer be the most clinically appropriate treatment for patients – —and in some cases can become harmful without intervention.”
But cutting medication is tricky, as researchers still don’t know the best intervention for reducing opioid use. Tapering opioids too quickly can harm the patient, leading to an increased risk of mental health crisis and suicide. “However,” the authors note, “prior studies that used pain self-management, complementary medicine, pharmacological and biomedical intervention, and opioid replacement to reduce chronic opioid use were limited by poor trial methodology or lack of evidence of safety.”
To address this, the researchers created Improving the Wellbeing of people with Opioid Treated Chronic Pain (I-WOTCH) “to test whether a multimodal approach that facilitated opioid tapering in people with chronic nonmalignant pain could reduce opioid use and improve pain control among people using opioids to treat chronic pain from nonmalignant causes.”
The trial’s design
I-WOTCH included 608 adult participants found across 191 primary care centers in England between 2017 and 2019—with a final follow-up in 2020. Its participants used potent opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to manage nonmalignant pain “over the last three months and on most days in the preceding month.” The mean age of participants was 61, 60% of whom were female and 96% of whom were white.
The researchers split the participants into two groups. Both groups received three tools: My Opioid Manager, “an educational and informational resource to help patients suffering from chronic pain understand and manage their pain with opioid use,” a self-help booklet containing information about pain and opioid tapering, and a relaxation CD.
The intervention group was also offered a “group-based educational intervention designed to encourage opioid cessation with a mutually agreeable decision plan between the participant and nurse.” This intervention focused on increasing the participants’ confidence while helping them implement self-management strategies for pain and improve well-being.
This group was also given weekly group meetings; a patient with chronic nonmalignant pain and a trained intervention nurse facilitated these sessions.
The clinical trial’s leader, Harbinder Kaur Sandhu, professor of health psychology at the University of Warwick, tells MDLinx that these components—especially the inclusion of another patient with chronic pain—were “highly valued by the participants in the trial.”
In the group meetings, participants discussed several relevant topics, including education about opioids, opioid tapering, and skills to manage their pain better. In addition, the intervention group received an educational DVD, a relaxation CD, and a mindfulness CD. They were also given distraction techniques.
Finally, the intervention group was provided with more focused care, including “an individual, 1-hour consultation (based on motivational interviewing) with a nurse, two monitoring telephone calls (30 minutes each), and a face-to-face consultation (1 hour),” the authors write.
The nurses working with the participants were provided with a tapering app specifically designed for the I-WOTCH trial. The app “computed a standard opioid tapering plan consisting of a reduction of 10% of the baseline dose each week until 30% of the baseline dose was reached, then a reduction of 10% of the remaining dose per week...The tapering program was individualized according to opioid preparation and individual circumstances,” the researchers explain.
“The tapering was flexible, and could be paused if needed depending on the participants' circumstances,” Sandhu tells MDLinx. “The programme was based on a shared agreement to taper between the patient and clinician. Important aspects included building the therapeutic relationship, which involved listening to the patient’s concerns and questions, especially regarding concerns around withdrawal of opioids and pain.”
The researchers focused on two primary outcomes measured at follow-up after 12 months: a patient-reported outcomes form and the proportion of participants reporting no opioid use over the previous four weeks prior to the 12-month follow-up.
The researchers also looked at secondary outcomes measured at four, eight, and 12 months. These included—but were not limited to—pain intensity, severity of opioid withdrawal symptoms, health-related quality of life, sleep quality, emotional well-being, and the proportion of participants who reduced opioids by 50% from baseline. Secondary outcomes were measured at baseline and at four, eight, and 12 months.
It’s important to note that this trial has several limitations. First, patients self-reported results and opioid usage; no blood or urine samples were collected. The participants also weren’t blind to group assignments. Not every participant in the intervention group adhered to the intervention itself. In fact, only 47% of participants adhered to the program. The kind of patients the trial attracted might have also influenced the results, as “individuals in this trial volunteered to participate and, therefore, were likely more committed to reduce use of opioid medications than people who did not participate,” the authors write.
Furthermore, the trial results may not reflect all patients in all settings. 33% of patients used a low dosage of opioid at baseline, meaning that the results of I-WOTCH might be different in patients using a higher MED (morphine equivalent dose).
Regarding the primary outcome of this research, 29% of participants in the intervention group were able to discontinue their use of opioids at 12 months, compared to the 7% in the usual care group.
As for secondary outcomes, 57% of participants in the intervention group and 27% in the usual care group reduced their daily MED by 50% or more from baseline. And after four months, the intervention group showed statistically significant improvements in mental health, pain self-efficacy, and health-related quality of life.
There were no significant differences between the intervention and the usual care group regarding pain intensity, opioid withdrawal symptoms, or sleep quality.
The researchers note some adverse events in patients, which affected patients’ psychology and nervous systems. These occurred in 2% of the intervention group and in 1% of the usual care group.
This intervention has the capacity to save lives Sandhu says that I-WOTCH's results were far better than the team expected. “That we have helped an additional one in five people to come off their opioids, without any adverse impact on how their pain affected their lives, is well beyond what we expected at the start of the trial,” he says.
America is also experiencing an opioid crisis. Could this program help patients with chronic pain in the United States? Sandhu says “yes”—even if some of the initial design is based on the UK’s system. “Our model could be adapted for delivery on the American system…Doctors, nurse practitioners, and pharmacists could be trained [on] how to deliver this intervention. There are many valuable components of the programme, including the involvement of a lay person with chronic pain who had successfully tapered opioids.”
Professor Sam Eldabe, clinical trial co-lead and Consultant in Pain Medicine at the James Cook University Hospital, told Newswise, “‘Our study shows clearly that opioids can be gradually reduced and stopped within [sic] no actual worsening of the pain. This confirms our suspicions that opioids have very little long-term impact on persistent pain.”