This is a prospective, multicenter, observational study focusing on assessing and managing pain in patients with metastatic spinal tumors. Pain from spinal metastases adversely impacts quality of life, function, and treatment outcomes. Advances in surgical techniques have shown significant benefits. However, previous studies either lacked nuanced differentiations or simply categorized pain as mechanical or non-mechanical; explaining the highly variable pain outcome measurements in these studies. This study employs the AO Spine Cancer-Related Pain Classification to better categorize neoplastic spinal pain by etiology.
Age 18 years and older
Patients diagnosed with metastatic spinal tumors with one index metastatic site that, confirmed by the treating clinicians, is causing spine pain
Patients experience at least one type of pain that is of interest of this study, namely, axial non-triggered pain, axial triggered/mechanical pain, radicular non-triggered pain, and radicular triggered/mechanical pain
At least one type of the pain experienced has an NRS > 4 of 10
Estimated survival < 3 months
Patients with more than one symptomatic spine metastasis site
Patients with other sources of pain that may confound the measurement of the primary outcome
Patients undergoing the following treatments alone without the surgeries listed in the inclusion criteria or radiotherapy
Adult patients with metastatic spinal tumors as per eligibility criteria.
Cohort
Prospective
Surgery
Procedure/SurgerySurgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.
Pain intensity on the Brief Pain Inventory Intensity Scale of four different types of pain caused by the index spinal metastasis, measuring pain on a numeric rating scale from 0 to 10, with 0 meaning no pain and 10 meaning as bad as one can imagine.
The primary study outcome is the intensity of the four different types of pain caused by the index spinal metastasis, ie, the index pain(s): * Axial non-triggered pain * Axial triggered/mechanical pain * Radicular non-triggered pain * Radicular triggered/mechanical pain
Patient Reported Outcome Measure: Michigan Body Map measuring pain location
The following Patient Reported Outcome Measure will be measured: Michigan body map. The Michigan Body Map is used to record the location and number of painful body regions. At baseline, patients will use the map to indicate the locations of each index pain experienced. At 1 month, 3 months, and 6 months, patients will use the map to indicate any new locations of pain, apart from the locations of the index pain, since the index treatment.
Patient Reported Outcome Measure: PainDETECT measuring neuropathic pain
The following Patient Reported Outcome Measure will be measured: PainDETECT Questionnaire. The PainDETECT Questionnaire was initially developed as a screening tool to detect neuropathic pain component in patients with chronic low back pain. The questionnaire consists of seven items describing neuropathic pain symptoms, with item responses ranging from 0 (never) to 5 (very strongly), as well as one item each describing temporal pain patterns (four patterns with scores ranging from -1 to +1) and presence of radiating pain (if yes, score of +2). The total score ranges from 0 to 38, with higher score indicating higher likelihood of a neuropathic pain component. Patients will fill in the PainDETECT Questionnaire at baseline, 1 month, 3 months, and 6 months.
Patient Reported Outcome Measure: BAT measuring breakthrough pain
The following Patient Reported Outcome Measure will be measured: Breakthrough Pain Assessment Tool (BAT). Breakthrough pain is defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain". The BAT questionnaire comprises 14 items, including nine related to pain and five related to its management. The first question uses body shape to locate the painful areas. The remaining items include free text (four questions), 10-point rating scale (six questions), and categorical scale (three questions). Patients will fill in the BAT at baseline, 1 month, 3 months, and 6 months.
Patient Reported Outcome Measure: PROMIS Bank v1.0-Fatigue measuring fatigue
The following Patient Reported Outcome Measure will be measured: PROMIS Bank v1.0-Fatigue. The PROMIS Bank v1.0-Fatigue instrument will be used to assess fatigue and fatigue interference in the past 7 days. The item responses are Likert-scale responses ranging from 1 (never) to 5 (always) with higher scores indicating greater fatigue or fatigue interference. Patients will complete the PROMIS Bank v1.0-Fatigue instrument at baseline, 1 month, 3 months, and 6 months.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
