Prospective Study of Post Surgical Continued Spinal Pain Patients

Prospective Study of Post Surgical Continued Pain (PSCP) Patients Undergoing Flexion Distraction Decompression Spinal Manipulation

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Cervical Pain; Spine Injury; Neck Disorder; Low Back Disorder
• Intervention / Treatment: Other: Cox chiropractic care

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33411
      • Keiser University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had a prior surgery to the spine and reporting to chiropractic care for spinal pain

Description

Inclusion Criteria:

• Age 21 years and older.
• Have neck pain and associated radiating symptoms,thoracic pain, back pain and/or associated radiating symptoms and have undergone at least one spine surgery in the respective regions.
• Willing to undergo FDD chiropractic care in the painful regions of the spine.

Exclusion Criteria:

• Systemic arthropathies or other co-morbid conditions that may require care outside study and may affect ability to deliver study treatments or interfere with study ssessments;
• Inability to read or verbally comprehend English;
• Intention to move from the area during the next 3 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in PROMISE 29 scores from initial visit to 3 months of treatment	Functional outcome of daily activities	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in PROMISE 29 scores from initial visit to 12 months with 3 months of treatment	Functional outcome of daily activities	baseline to 12 months
change in NDI scores from initial visit to 3 months of treatment	Functional outcome of daily activities	baseline to 3 months
change in NDI scores from initial visit to 12 months with 3 months of treatment	Functional outcome of daily activities	baseline to 12 months

Collaborators and Investigators

• Sponsor: Keiser University College of Chiropractic Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): November 23, 2020

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: back pain; neck pain; spine surgery; chiropractic; spine function
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Back Injuries; Back Pain; Low Back Pain; Disease; Neck Pain; Spinal Injuries
• Other Study ID Numbers: IRB000OC18MG72

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Any request for data will be shared according to University protocols

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No