Low Back PainNCT05401682
Prospective Study of Post Surgical Continued Spinal Pain Patients
An observational study of Low Back Pain and Cervical Pain, run by Keiser University College of Chiropractic Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Cervical Pain, Neck Disorder
- What is being tested?
- Cox chiropractic care
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 23 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had a prior surgery to the spine and reporting to chiropractic care for spinal pain
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Cervical Pain, Neck Disorder, Low Back Disorder, Spine Injury
- Being tested
- Cox chiropractic care
- Keywords
- back pain, neck pain, chiropractic, spine surgery, spine function
- Medical subject headings
- Low Back Pain, Neck Pain, Spinal Injuries, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cox chiropractic careOther
Also called Flexion-distraction
Manual distraction of spine in a prone position using specially assisted table
What is being measured
The primary outcome is the main question the study is designed to answer.
change in PROMISE 29 scores from initial visit to 3 months of treatment
Functional outcome of daily activities
Measured: baseline to 3 months
Secondary outcomes (3)
change in PROMISE 29 scores from initial visit to 12 months with 3 months of treatment
Functional outcome of daily activities
Measured: baseline to 12 months
change in NDI scores from initial visit to 3 months of treatment
Functional outcome of daily activities
Measured: baseline to 3 months
change in NDI scores from initial visit to 12 months with 3 months of treatment
Functional outcome of daily activities
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Feb 2019
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keiser University College of Chiropractic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maruti Gudavalli, Keiser University College of Chiropractic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401682
- Sponsor's protocol ID
- IRB000OC18MG72
- Status last verified
- Aug 2022
- First submitted
- 28 Mar 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Any request for data will be shared according to University protocols
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Post Surgical Continued Pain (PSCP) Patients Undergoing Flexion Distraction Decompression Spinal Manipulation
- ClinicalTrials.gov ID
- NCT05401682
- Acronym / sponsor ID
- IRB000OC18MG72
- Conditions
- Low Back Pain, Cervical Pain, Neck Disorder, Low Back Disorder, Spine Injury
- Keywords
- back pain, neck pain, chiropractic, spine surgery, spine function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Keiser University College of Chiropractic MedicineUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a prior surgery to the spine and reporting to chiropractic care for spinal pain
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cox chiropractic careAlso: Flexion-distractionManual distraction of spine in a prone position using specially assisted table | Other | – |
Primary outcome
change in PROMISE 29 scores from initial visit to 3 months of treatment
Time frame: baseline to 3 months
Functional outcome of daily activities
3 secondary outcomes
change in PROMISE 29 scores from initial visit to 12 months with 3 months of treatment
Time frame: baseline to 12 months
change in NDI scores from initial visit to 3 months of treatment
Time frame: baseline to 3 months
change in NDI scores from initial visit to 12 months with 3 months of treatment
Time frame: baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: Undecided. Any request for data will be shared according to University protocols
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Cervical Pain, run by Keiser University College of Chiropractic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in PROMISE 29 scores from initial visit to 3 months of treatment (time frame: baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.