Prospective Study of Post Surgical Continued Spinal Pain Patients

NCT05401682 | Completed

• 1 other identifier: IRB000OC18MG72
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Cervical Pain; Neck Disorder; Low Back Disorder; Spine Injury

Keywords

back pain; neck pain; chiropractic; spine surgery; spine function

Outcome Measures

Primary Outcomes (1)

• change in PROMISE 29 scores from initial visit to 3 months of treatment

  Functional outcome of daily activities

  baseline to 3 months

Secondary Outcomes (3)

• change in PROMISE 29 scores from initial visit to 12 months with 3 months of treatment

  baseline to 12 months

• change in NDI scores from initial visit to 3 months of treatment

  baseline to 3 months

• change in NDI scores from initial visit to 12 months with 3 months of treatment

  baseline to 12 months

Interventions

Cox chiropractic care OTHER

Manual distraction of spine in a prone position using specially assisted table

Also known as: Flexion-distraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Keiser University College of Chiropractic Medicine: lead

Study Sites (1)

Keiser University

West Palm Beach, Florida, 33411, United States

Location

MeSH Terms

Conditions

Low Back Pain; Neck Pain; Spinal Injuries; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: June 2, 2022
• Study Start: February 1, 2019
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

US (1)