Trial of trigger point injections for myofascial pain in patients with cancer

JRCT ID: jRCTs051210132

Registered date:16/12/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Myofasical pain
• Date of first enrollment: 16/12/2021
• Target sample size: 50
• Study type: Interventional

Intervention(s)

TPI+ usual care group: For the TPI treatment, 1 mL of 1% lidocaine was injected into each trigger point (maximum 2 sites) using a 26G, 13 mm needle on day 1.
Usual care group: For the Usual care, the analgesic drugs and exercise therapies used for MPS before registration were given during the study period.

Outcome(s)

• Primary Outcome: Percentage of patients whose average NRS score for the past 24 hours of MPS decreased by 50% or more from before the intervention to 72 hours after the intervention
• Secondary Outcome: Personalized pain goal achievement, change rate of pain pressure threshold, patient satisfaction, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Non-curable solid cancers
2) The reference diagnostic criteria of the MRS of Rivers are met
3) Average NRS of pain 24 hours before registration is greater than 4 or 4
4) Hospitalization at the registration within 14 days before registration
5) Age at registration is over 20 years old
6) Sustained main organ function
7) Witten informed consent

Exclude criteria

1) There are cancer lesions in the same site as MPS by imaging examination within 4 weeks before registration
2) Change of regular analgesic drugs within 24 hours before registration
3) Psychiatric diseases or conditions that made communication difficult, such as cognitive impairment or disturbance of consciousness
4) Allergy to local anesthetics of the amide type
5) Pregnant and nursing
6) Patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator

Related Information

• Primary Sponsor: Hasuo Hideaki
• Source(s) of Monetary Support: Japanese Society for Palliative Medicine