An observational study in Low Back Pain, Cervical Pain and Neck Disorder, sponsored by Keiser University College of Chiropractic Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-08.
Sponsored by Keiser University College of Chiropractic Medicine · Observational
Continued spinal pain following spine surgery is reported in up to 50% of patients. Disability and pain following spine surgery occurs. Repeat back surgery outcomes on Workers Compensation low back patients demonstrated larger number of patients did not come back to work. Such continued pain has biopsychosocial health relationships between the physical and the psychological and social factors that are associated with back pain and disability. Chiropractic consultation by post surgical continued pain (PSCP) patients occurs but the frequency, clinical treatment and outcomes of chiropractic treatment are not sufficiently documented. Conditions reported in continued pscp patients seeking care following spinal fusion are reported as sacroiliac joint pain, internal disc disruption, and zygapohyseal joint pain. Sacroiliac joint pain is more common after fusion, while internal disc disruption is more common in nonfusion patients. Very few studies are available on the outcomes of PSCP patients seen by chiropractic. This study proposes to investigate the clinical outcomes of PSCP patients presenting with pain in lumbar, thoracic, and cervical regions and had prior surgery in the respective regions, seeking care from field Doctors of Chiropractic (DCs) certified in Cox flexion distraction decompression procedures.
Continued spinal pain following spine surgery is reported in up to 50% of patients. Disability and pain following spine surgery occurs. Repeat back surgery outcomes on Workers Compensation low back patients demonstrated larger number of patients did not come back to work. Such continued pain has biopsychosocial health relationships between the physical and the psychological and social factors that are associated with back pain and disability. Chiropractic consultation by post surgical continued pain (PSCP) patients occurs but the frequency, clinical treatment and outcomes of chiropractic treatment are not sufficiently documented. Conditions reported in continued pscp patients seeking care following spinal fusion are reported as sacroiliac joint pain, internal disc disruption, and zygapohyseal joint pain. Sacroiliac joint pain is more common after fusion, while internal disc disruption is more common in nonfusion patients. Very few studies are available on the outcomes of PSCP patients seen by chiropractic. This study proposes to investigate the clinical outcomes of PSCP patients presenting with pain in lumbar, thoracic, and cervical regions and had prior surgery in the respective regions, seeking care from field Doctors of Chiropractic (DCs) certified in Cox flexion distraction decompression procedures.
Research questions:
The specific aims of the study are:
Specific Aim 1: Descriptively document the subjective clinical outcomes (at visit one, at 3 months and at 12 months following intervention) regarding pain (using the VAS pain scale) and disability outcomes (using Roland Morris, Neck Disability Index, and PROMIS 29 questionnaires). Descriptively document the objective clinical outcome response (using a proforma exam form). This data will be collected regarding all patients who had undergone surgery to the lumbar, thoracic and/or cervical spines and choose to undergo care in the regions they had surgery with a Cox Certified Flexion-distraction decompression (FDD) practitioner. We expect to include 50 DCs and approximately 500 patients (an average of 10 patients per DC). Specific Aim 2: Descriptively document the treatment received during visits over a maximum of 3-month intervention. Determine the intervention details used by licensed Doctors of Chiropractic (DC) who are certified FDD and providing care to PSCP patients.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 61 is below the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Keiser University College of Chiropractic Medicine is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who had a prior surgery to the spine and reporting to chiropractic care for spinal pain
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Manual distraction of spine in a prone position using specially assisted table
Also known as: Flexion-distraction
change in PROMISE 29 scores from initial visit to 3 months of treatment
Functional outcome of daily activities
Time frame: baseline to 3 months
change in PROMISE 29 scores from initial visit to 12 months with 3 months of treatment
Functional outcome of daily activities
Time frame: baseline to 12 months
change in NDI scores from initial visit to 3 months of treatment
Functional outcome of daily activities
Time frame: baseline to 3 months
change in NDI scores from initial visit to 12 months with 3 months of treatment
Functional outcome of daily activities
Time frame: baseline to 12 months
Plan to share: Undecided — Any request for data will be shared according to University protocols
No publications or documents are linked to this record.
Ran from Feb 2019 to primary completion in Nov 2020, 21 months.
Of 175 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's 21 months is below that.
Counting every sponsor, half of 185 studies reached it within 24 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Keiser University College of Chiropractic Medicine