Background <p>Imaging does not improve the management of non-specific spinal pain in randomised trials (RCTs) conducted in medical care settings. No RCTs have been performed to assess the benefit of imaging in chiropractic clinical settings, where it is postulated imaging may identify contraindications to, or inform application of, spinal manipulation. We aimed to assess the feasibility of performing a large-scale RCT to test whether obtaining spinal radiographs for patients receiving chiropractic care for spinal pain changes patient outcomes.</p> Methods <p>Chiropractor and patient recruitment occurred from February 2021 to June 2022. Chiropractors from Sydney, Australia screened consecutive patients for inclusion in the pilot RCT. The key inclusion criteria were being an adult with a new episode of spinal pain and uncertain need for radiographs (i.e., no definitive indications or contraindications for imaging). Participants were randomised to receive spinal radiographs, or not. Clinical outcome data were collected at baseline, 2-, 6-, and 12-weeks. Chiropractors participated in semi-structured interviews regarding their experience in the trial. Feasibility outcomes were reported descriptively, including: proportion of chiropractors and patients agreeing to be involved, patient cross-over, loss to follow-up, and acceptability.</p> Results <p>Eleven chiropractors screened 135 patients (mean 12, SD 17.0, range 0–56), with 33/135 (24%; 95%CI 18–32) meeting inclusion, and 20/33 (61%; 95%CI 44–75) participating in the trial (10 randomised to each group). Participating patients tended to be young and have low spine-related disability. 30% of those randomised to radiography did not receive imaging (95%CI 11–60; 3/10). Conversely, 20% (95%CI 6–51; 2/10) of those from the no radiography group received imaging. Follow-up data were collected from 90% of patients (95%CI 70–97) at 2-weeks and 75% (95%CI 53–89) at 12-weeks. Complete follow-up data for patients was provided by all chiropractors at 2- and 6-weeks and 16/20 (80%; 95%CI 58–92) at 12-weeks. Patient reported outcomes improved in both groups, with infrequent and mild adverse events. Chiropractors thought the research question important but highlighted key feasibility issues impacting patient recruitment.</p> Conclusion <p>Progression criteria to conduct a large-scale RCT were largely met; however, suitable strategies would be required to ensure feasibility of patient recruitment and reduce cross-over between groups.</p>

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Does radiographic imaging for spinal pain in patients receiving chiropractic care change patient outcomes? A pilot randomised controlled trial

  • Hazel J. Jenkins,
  • Mark Hancock,
  • Aron Downie,
  • Anika Young,
  • Craig Moore,
  • Stephney Whillier,
  • Simon D. French

摘要

Background

Imaging does not improve the management of non-specific spinal pain in randomised trials (RCTs) conducted in medical care settings. No RCTs have been performed to assess the benefit of imaging in chiropractic clinical settings, where it is postulated imaging may identify contraindications to, or inform application of, spinal manipulation. We aimed to assess the feasibility of performing a large-scale RCT to test whether obtaining spinal radiographs for patients receiving chiropractic care for spinal pain changes patient outcomes.

Methods

Chiropractor and patient recruitment occurred from February 2021 to June 2022. Chiropractors from Sydney, Australia screened consecutive patients for inclusion in the pilot RCT. The key inclusion criteria were being an adult with a new episode of spinal pain and uncertain need for radiographs (i.e., no definitive indications or contraindications for imaging). Participants were randomised to receive spinal radiographs, or not. Clinical outcome data were collected at baseline, 2-, 6-, and 12-weeks. Chiropractors participated in semi-structured interviews regarding their experience in the trial. Feasibility outcomes were reported descriptively, including: proportion of chiropractors and patients agreeing to be involved, patient cross-over, loss to follow-up, and acceptability.

Results

Eleven chiropractors screened 135 patients (mean 12, SD 17.0, range 0–56), with 33/135 (24%; 95%CI 18–32) meeting inclusion, and 20/33 (61%; 95%CI 44–75) participating in the trial (10 randomised to each group). Participating patients tended to be young and have low spine-related disability. 30% of those randomised to radiography did not receive imaging (95%CI 11–60; 3/10). Conversely, 20% (95%CI 6–51; 2/10) of those from the no radiography group received imaging. Follow-up data were collected from 90% of patients (95%CI 70–97) at 2-weeks and 75% (95%CI 53–89) at 12-weeks. Complete follow-up data for patients was provided by all chiropractors at 2- and 6-weeks and 16/20 (80%; 95%CI 58–92) at 12-weeks. Patient reported outcomes improved in both groups, with infrequent and mild adverse events. Chiropractors thought the research question important but highlighted key feasibility issues impacting patient recruitment.

Conclusion

Progression criteria to conduct a large-scale RCT were largely met; however, suitable strategies would be required to ensure feasibility of patient recruitment and reduce cross-over between groups.