Tokyo, July 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062112) titled 'Effectiveness of mental practice in preventing persistent postoperative pain in patients with knee osteoarthritis' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - Knee Osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Surgical treatment is sometimes selected for patients with knee osteoarthritis (KOA). However, among patients who undergo surgery, some experience persistent pain that becomes chronic postoperatively, resulting in persistent postoperative pain. In recent years, psychosocial factors related to pain perception have been identified as contributing to the development of persistent postoperative pain. However, no effective treatment targeting these factors has yet been established, making this issue an urgent clinical challenge.
Mental practice (MP) has been reported to be effective as an intervention targeting psychosocial factors associated with pain in patients with chronic pain, and this approach is considered to have sufficient potential for application to persistent postoperative pain. Therefore, the present study aims to develop an MP program for the prevention of persistent postoperative pain in patients following surgery for KOA and to examine its effectiveness.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Interventions: Tablet-based MP with electrical stimulation + standard physical therapy
Interventions/Control_2 - Control: Standard physical therapy
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients with knee osteoarthritis who are scheduled to undergo an around-the-knee osteotomy (AKO) or total knee arthroplasty (TKA) at participating institutions and are undergoing their first unilateral surgery.
Key exclusion criteria - Exclusion criteria: cognitive impairment (HDS-R score < 20), clinically significant neurological or musculoskeletal disorders affecting outcome measurements, and severe cardiac or respiratory disease limiting exercise performance.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 01 Day
Date of IRB - 2026 Year 04 Month 12 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070272
Disclaimer: Curated by HT Syndication.
