A prospective, randomized, parallel-controlled clinical trial to evaluate the effectiveness and safety of chronic pain rehabilitation training software in assisting in the relief of chronic secondary musculoskeletal pain
Males and females ≥18 years old.
Average pain intensity≥4 on a 0-10 numerical rating scale (NRS) in the past 24 hours.
Be able to communicate in Chinese.
Be able to read and write Chinese.
Shingles on the eyes, ears, head, face, or hands.
Trigeminal neuralgia.
Severe vision impairment. (Patients with clear vision wearing glasses or contact lenses are allowed)
Severe hearing impairment.
Crossover
Mixed Reality based analgesic therapy
DeviceThe intervention is a single 15 min MR therapy. The MR therapy is consisted of MR device and software. The model of MR device used is Pico Neo 3 Pro. The software run on the MR device delivers two types of contents: 1) A 7min of computer-generated 360 video of underwater scene with therapeutic music to distract patients' attention on pain and make patients passively relax. 2) An 8min guided relaxation in which patients are transported to seaside with narrative to achieve image and breathing relaxation. And the placebo-group used the same non-mixed reality(Non-MR) scenario to treat patients, although the scenario is completely identical, it is not presented in a mixed reality scenario. It only presents the scene in normal display mode.
Change in pain intensity before and after MR therapy
The pain intensity is measured using a 0-10 numerical rating scale (NRS) of pain. The anchors for the numerical rating scale were "Ten is the worst pain anyone could ever have and zero is no pain at all." Before the MR therapy started, the participant would be asked what his or her pain level is on the 0-10 numerical rating scale. After the 15 minute MR therapy, the participant would be asked what his or her pain level at that moment, again using the 0-10 numerical rating scale. The change in pain intensity before and after MR therapy is then obtained with the two pain level numbers subtracted.
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