Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061637) titled 'The effect of press needles on myofascial pain syndrome in patients with advanced cancer: a randomized controlled trial' on July 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - NHO Hokkaido Cancer Center

Condition: Condition - myofascial pain syndrome Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - We aim to evaluate the analgesic effect of press needles on myofascial pain syndrome, which occurs in terminally ill cancer patients who are bedridden for long periods of time, and to establish a non-pharmacological analgesic treatment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Press needle placement is performed on patients with advanced cancer who are hospitalized in a palliative care ward and have myofascial pain syndrome. Before inserting the Press needles, the painful areas that meet the diagnostic criteria for MPS are identified by palpation based on Rivers' diagnostic criteria. After identifying the pain site, the physician places 1.5 mm press needles (Pyonex, Seirin TM) in patients in the acupuncture group. Pain assessment and treatment are performed by different physicians. The treatment is performed in a way that the shape of the needles is not visible to the patients, and they are not informed which type of needle was placed (the practitioners are not blinded because the needles have different shapes). Interventions/Control_2 - Press needle placement is performed on patients with advanced cancer who are hospitalized in a palliative care ward and have myofascial pain syndrome. Before inserting the Press needles, the painful areas that meet the diagnostic criteria for MPS are identified by palpation based on Rivers' diagnostic criteria. After identifying the pain site, the physician places sham needles (brand names: Pyonex Zero, Seirin TM) in patients in the acupuncture-free group. Pain assessment and treatment are performed by different physicians. The treatment is performed in a way that the shape of the needles is not visible to the patients, and they are not informed which type of needle was placed (the practitioners are not blinded because the needles have different shapes).

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1)Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 2-4 2)Those diagnosed with MPS who meet Rivers' diagnostic criteria 3)Those with pain in the area affected by MPS of NRS 4/10 4)Those whose MPS is caused by being bedridden for more than one week Key exclusion criteria - 1)Those who are likely to bleed easily 2)Those who are likely to be susceptible to infection 3)Those who have skin abnormalities such as redness, swelling, or edema at the site of pain that may be MPS Target Size - 16

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2028 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070520

Disclaimer: Curated by HT Syndication.