Clinical Trial: Evaluation of the usefulness of extracorporeal shock wave therapy(ESWT) for chronic secondary musculoskeletal pain in patients attending a palliative care outpatient clinic (Japan)

Tokyo, Dec. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059476) titled 'A study to evaluate the effect of extracorporeal shock wave therapy for chronic body pain in patients attending a palliative care outpatient clinic' on Dec. 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Saitama Medical University Hospital

Condition: Condition - Chronic secondary musculoskeletal pain Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to clarify the usefulness of extracorporeal shock wave therapy (ESWT) as a supportive care intervention for alleviating pain and improving activities of daily living (ADL) in patients attending a palliative care outpatient clinic. The study targets patients diagnosed with chronic secondary musculoskeletal pain based on the chronic pain classification established by the International Association for the Study of Pain (IASP) and defined in the International Classification of Diseases, 11th Revision (ICD-11).ESWT will be administered to these patients, and its analgesic effects and improvements in daily functioning will be evaluated to explore its potential role in relieving the distress of patients receiving palliative care. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - After diagnosis of chronic secondary musculoskeletal pain by the attending physician, written informed consent will be obtained by the investigator. The investigator will then determine the treatment site and set the parameters for extracorporeal shock wave therapy (ESWT).

Before treatment, the following will be assessed: Numerical Rating Scale (NRS) for pain, Activities of Daily Living (ADL), Range of Motion (ROM) related to the selected treatment site.

Extracorporeal Shock Wave Therapy (ESWT) will be performed while confirming the presence or absence of pain during treatment. Example settings are as follows: Trapezius muscle: Transmitter R10-12, 2000 shocks per site, energy level 1.0-2.0 bar. Quadratus lumborum muscle: Transmitter R10-12, 2000 shocks per site, energy level 1.0-3.0 bar. Gluteus maximus muscle: Transmitter R10-12, 2000 shocks per site, energy level 1.0-3.0 bar.

After treatment, the following will be re-evaluated: NRS, ADL, and ROM related to the treated site. Presence of any adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE).

Follow-up: The next outpatient visit will be scheduled, and at the subsequent visit, the patient will be asked about the perceived onset and duration of pain relief following ESWT.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Age, sex, and underlying disease are not limited. Patients diagnosed with chronic secondary musculoskeletal pain during outpatient visits. Patients who have provided consent to receive extracorporeal shock wave therapy (ESWT). Patients who have provided consent to participate in the study. In cases where the patient is unable to sign due to any reason, verbal consent or proxy consent will be accepted. Key exclusion criteria - Patients whom the investigator judges to be inappropriate for inclusion in the study. Patients with any lesion (e.g., malignant tumor, metastasis, or fracture) within 5 cm of the planned ESWT treatment site. Patients who develop skin disorders of CTCAE Grade 2 after ESWT. Patients who refuse ESWT after enrollment. Patients with severe cognitive impairment or psychiatric disorders that make appropriate evaluation difficult. Patients with a high risk of bleeding, such as those with coagulation disorders or taking anticoagulant medications. Patients with cardiovascular devices (e.g., pacemaker) located at or near the planned treatment site. Patients with local infection or purulent lesions at the planned treatment site. Patients who are pregnant or may be pregnant. Patients with severe osteoporosis who have an extremely high risk of fracture. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2027 Year 08 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067987

Disclaimer: Curated by HT Syndication.