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NCT05047679: B²EARS
The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy
NA trial testing Perioperative Pain Neuroscience Education in Lumbar Radiculopathy in 6 participants. Terminated before completion.
16 October 2023
Quick facts
| Lead sponsor | Vrije Universiteit Brussel |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 6 |
| Start date | 30 September 2021 |
| Primary completion | 16 October 2023 |
| Estimated completion | 16 October 2023 |
| Sites | 4 locations across Belgium |
Drugs / interventions tested
- Perioperative Pain Neuroscience Education
- Perioperative Biomedical Education
Conditions studied
- Lumbar Radiculopathy — all drugs for Lumbar Radiculopathy →
Sponsor
Vrije Universiteit Brussel — full company profile →
Who can join
18 and older, any sex, with Lumbar Radiculopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to assess the effectiveness of perioperative pain neuroscience education (PPNE) in patients who are at risk for unfavorable outcome following surgery for lumbar radiculopathy. Although most of these surgeries are successful, 23-28% of patients report chronic pain and disability following surgery. Many preoperative factors are associated with an unfavorable surgical outcome, including maladaptive cognitive and emotional factors. Yet, current preoperative education, which focuses on anatomy and biomechanics of the lumbar spine, is ineffective in changing those maladaptive factors. PPNE was introduced as an innovative therapy that addresses modifiable risk factors in patients undergoing surgery for lumbar radiculopathy. PPNE reconceptualizes pain, informs patients about their pain development and is well established for improving maladaptive cognitions in several chronic pain-populations. Hence, we hypothesize that PPNE will be more effective than perioperative biomedical education in improving postsurgical quality of life, pain, analgesic use and return to work in patients at risk for unfavorable outcome following surgery for lumbar radiculopathy. First, a multicentric randomized controlled trial will compare the therapy effects of PPNE to perioperative biomedical education in these at-risk patients. Next, the mediating role of changes in maladaptive cognitions, such as fear of movement and pain catastrophizing, on the therapy effect of PPNE will be investigated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05047679
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05047679 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vrije Universiteit Brussel
- Last refreshed: 28 November 2023
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