Chew, C., Ritchie, M., O'Dwyer, P. J., & Edwards, R. (2011). A prospective study of percutaneous vertebroplasty in patients with myeloma and spinal metastases. Clinical Radiology, 66, 1193–1196.

DOI Link

Study Purpose

To assess the outcome and complication rate of percutaneous vertebroplasty in a large cohort of consecutive patients with myeloma and spinal metastasis treated over a nine-year period

Intervention Characteristics/Basic Study Process

Patients with cancer who were experiencing intractable pain from metastasis and vertebral collapse and were unresponsive to oral analgesia underwent percutaneous vertebroplasty. Pain and function were measured prior to and six weeks after the procedure.

Sample Characteristics

  • The study involved 128 patients who had vertebroplasty between June 2001 and June 2010. Patients who underwent the procedure prior to 2005 were evaluated retrospectively. Of the 91 patients who underwent the procedure since 2005, 50 returned completed the pre- and postprocedural pain score data, and 38 completed pre- and postvertebroplasty Rolland-Morris Questionnaires (RMQs).
  • The sample characteristics were given for all 128 patients; actual study sample demographics were not stated.
    • The mean age was 60 years with a range of 31–88.
    • The sample was 53% male and 47% female.
    • Cancer diagnoses were multiple myeloma (n = 41), spinal metastasis from breast cancer (n = 22), spinal metastasis from lung cancer (n = 22), and spinal metastasis from lymphoma (n = 11).    
  • Indications for vertebroplasty were intractable pain from metastasis, vertebral collapse unresponsive to oral analgesics, and as an adjunct to radiation therapy.
  • Exclusion criteria were uncontrolled coagulopathy, infection, spinal cord compression, and complete vertebral collapse.

Setting

This was a single-site study conducted in the United Kingdom.

Phase of Care and Clinical Applications

  • Patients were in the advanced disease state.
  • This study has clinical applicability to metastatic disease, palliative care, and late effects of treatment.

Study Design

This was a prospective, intervention trial.

Measurement Instruments/Methods

  • Pain was measured on a 0–10 visual analog scale.
  • A modified RMQ was used to measure the degree of disability on a scale of 0–23, with a higher score indicating a higher degree of disability.

Results

  • Of the 91 patients who received the procedure since 2005, 51 returned completed pre- and postprocedure pain scores.
    • Mean VAS score preprocedure was 7.57 (SD = 1.88).
    • Mean VAS score postprocedure was 4.77 (SD = 2.67) (p < 0.001).
  • Of these patients, 38 completed the modified RMQ preprocedure and 6 weeks postprocedure.
    • Mean score preprocedure was 18.55 (SD = 4.79).    
    • Mean score postprocedure was 13.5 (SD = 6.95) (p < 0.001).
  • VAS and RMQ scores were expressed as means with standard deviation.
  • Comparison between groups was made using the Mann-Whitney U, two tailed test.
  • The complication rate was 1.5%.
    • One patient experienced cement extension into the inferior vena cava.
    • One patient had a local hematoma.
    • Three patients had asymptomatic pulmonary emboli.
    • Seven patients (5%) died within 30 days of the vertebroplasty.
  • The median follow-up of the group was 3 years with a range of 1–9 years.
  • The Kaplan Meier estimate of 5-year survival from date of vertebroplasty for the myeloma group was 40%.
  • The authors concluded that the study demonstrated that most patients with pain from spinal metastasis received rapid relief from percutaneous vertebroplasty and that disability was significantly improved.

Limitations

  • The study methodology did not support or made it difficult to validate authors' inferences.
  • No appropriate control group was included. 
  • The authors' asserted that the study showed that “most patients with pain from spinal metastasis receive rapid relief from percutaneous vertebroplasty\"; however, it wasn't clear how the authors assessed \"rapid relief\" because pain and disability appeared to only be measured at two points in time (prior to the procedure and 6 weeks after the procedure). Additionally, the results indicated that 18% of patients had no reduction or a slight increase in pain scores and 24% had no improvement in disability scores. Pain scores over a longer period of time would be helpful, such as daily for the six-week period or weekly times six weeks.
  • Patients were asked to document “the worst pain during the day.” This was not clearly defined. Night pain was not assessed.  
  • The study does not address what pain medications patients were taking preprocedure or if patients were taking pain medication postprocedure (e.g., opioids versus nonopioids, dosing, use of alternative medications).
  • The authors did not identify what statistical tests were used to determine the validity and reliability of the modified RMQ.

Nursing Implications

Vertebroplasty can be considered as a possible option for patients with myeloma or spinal metastasis to help with intractable pain and physical disability.