Prospective Study of Post Surgical Continued Spinal Pain Patients

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401682
• Other study ID #: IRB000OC18MG72
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: November 23, 2020

Study information

• Verified date: August 2022
• Source: Keiser University College of Chiropractic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Cervical Pain
• Disease
• Low Back Disorder
• Low Back Pain
• Neck Disorder
• Neck Pain
• Spine Injury

Intervention

Other:
• Cox chiropractic care
Manual distraction of spine in a prone position using specially assisted table

Locations

Country	Name	City	State
United States	Keiser University	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Keiser University College of Chiropractic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in PROMISE 29 scores from initial visit to 3 months of treatment	Functional outcome of daily activities	baseline to 3 months
Secondary	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
Secondary	change in NDI scores from initial visit to 3 months of treatment	Functional outcome of daily activities	baseline to 3 months
Secondary	change in NDI scores from initial visit to 12 months with 3 months of treatment	Functional outcome of daily activities	baseline to 12 months