Predictive Factors for LBP Interventional Treatment Outcomes

Low Back Pain Clinical Trial

Official title:

Prospective, Observational Study Evaluating the Ability of Clinical Factors to Predict Interventional Treatment Outcomes for Low Back Pain (LBP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329951
• Other study ID #: IRB00050132
• Status: Completed
• Start date: December 2014
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, we are attempting to determine which factors are associated with interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP who are considered to be good candidates for therapeutic interventional procedures will be given a complete history and physical exam, which includes the assessment of Waddell signs, and querying them regarding factors shown in non-interventional studies or retrospective studies evaluating interventional treatments to be associated with negative treatment outcomes. These factors include the presence of Waddell and other physical exam signs, opioid use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale on expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation), procedure-related pain including from a 1 ml standardized injection, obesity, and smoking history. They will then proceed to undergo their scheduled intervention, which will be limited to epidural steroid injections (ESI), facet blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint injections. A positive outcome will be defined as 2-point or greater decrease in average pain score at 1-month and a score of > 3 on a 1-5 Likert satisfaction scale. Those with a positive outcome at 1-month will remain in the study and be followed again at 3-months.

Description:

This will be an observational study with a 3-month follow-up. The course of clinical treatment will be decided by a physician independent of the research. Besides filling out questionnaires and standardized follow-up visits, all subjects will receive the same care they would if they did not participate in the study. The study will be discussed with the subjects and they will be enrolled in the study after it is determined that they meet selection criteria and are scheduled for one of the above injections. They will then fill out 3 questionnaires (Oswestery disability index, Athens insomnia scale, QIDS SR-16. All procedures will be performed with fluoroscopy. Following each procedure, the procedure-related pain will be reported on a 0-10 scale (all patients will receive as much 1% lidocaine local anesthetic as is necessary), including the reported pain to the standardized skin wheal at the start of the procedure.

Patients will then receive standardized epidural steroid injections (transforaminal or interlaminar), sacroiliac joint injections, or facet blocks and radiofrequency denervation if they experience a positive block. Details about these procedures are available upon request.

No patients will be permitted additional interventions between the time of their procedure and follow-up visits. Rescue medications will be in the form of either tramadol, NSAIDs or if the patient is on opioids, a < 20% increase in dose. The first follow-up visit will be scheduled 1 month from the start of treatment for ESI and SI joint patients, and 1 month after RF denervation in positive diagnostic facet block responders. In those facet block patients who obtain prolonged relief from the "diagnostic" medial branch block, follow-up will be 1 month after the block (these patients may proceed to have denervation if their pain recurs after 1 month but before their final 3-month follow-up, and their 3-month follow-up will be 3 months after their medial branch block). A positive outcome will be defined as a greater or equal to 2-point decrease in average LBP (or leg pain for those who underwent an ESI) coupled with a positive satisfaction rating (> 3 on a 5-point scale). Subjects who obtain a positive outcome at their initial 1-month follow-up visit will remain in the study and return for the final 3-month follow-up visit. Those with a negative outcome will exit the study "per protocol" to receive standard care, which may consist of other injections or non-rescue medications such as antidepressants and anticonvulsants. Subjects who obtain a positive outcome at 1-month but experience a recurrence before their 3-month follow-up visit will also exit the study per protocol, with their final outcome measures recorded before they receive standard care.

In those who receive ESI, a smaller parallel study will be done evaluating the association between allergies and outcome. Allergies will be categorized as immunologically based or not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: December 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years;

2. Pain duration > 6 weeks;

3. Low back pain presumed to be secondary to herniated disc or spinal stenosis (e.g. radiculopathy), facet joint pain or SI joint pain;

4. For ESI, patients must have leg pain >/= 4/10 or comparable or greater than back pain, along with concordant MRI findings; for SI joint injections, patients must have tenderness overlying the SI joint; for facet joint pain, they must have paraspinal tenderness;

5. Patient agrees to have ESI, facet blocks or SI joint injection for diagnostic or therapeutic purposes;

6. Average pain score >/= 4/10 over the past week

Exclusion Criteria:

1. Previous ESI, facet blocks or SI joint injection within the past 2 years;

2. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);

3. Previous surgery for ESI or facet block;

4. Untreated coagulopathy;

5. Allergy to contrast dye, bupivacaine or depomethylprednisolone;

6. Pregnancy;

7. Cannot read or understand English.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lumbar Radiculopathy
• Radiculopathy

Intervention

Procedure:
• Facet intervention
Diagnostic block of the nerves innervation the lumbar facet joint. If this block is positive (greater or equal to 50% relief), the participant will proceed to radiofrequency nerve ablation when the pain returns
• Sacroiliac joint injection
Injection of steroid and local anesthetic into SI joint
• Epidural steroid injection
Transforaminal or interlaminar injection of steroid epidurally

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Landstuhl Regional Medical Center, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean reduction in average pain score	0-10 numerical rating scale for leg pain (ESI) or low back pain (facet procedure or sacroiliac joint injection). Higher scores indicate more pain.	1 month
Secondary	Average back pain score	0-10 numerical rating scale for back pain. Higher scores indicate more pain.	1 month
Secondary	Average leg pain score	0-10 numerical rating scale for leg pain for ESI only. Higher scores indicate more pain.	1 month
Secondary	Worst back pain score	0-10 numerical rating scale for back pain. Higher scores indicate more pain.	3 months
Secondary	Worst leg pain score	0-10 numerical rating scale for leg pain ESI only. Higher scores indicate more pain.	3 months
Secondary	Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	1 month
Secondary	Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	3 months
Secondary	Satisfaction score	5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)	1 month
Secondary	Satisfaction score	5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)	3 months
Secondary	Medication reduction	Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)	1 month
Secondary	Medication reduction	Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)	3 months
Secondary	Athens Insomnia Scale	0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)	1 month
Secondary	Athens Insomnia Scale	0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)	3 months
Secondary	Quick Inventory of Depressive Symptomatology (QIDS-SR 16)	0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)	1 month
Secondary	Quick Inventory of Depressive Symptomatology (QIDS-SR 16)	0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)	3 months
Secondary	Positive outcome	Greater or equal to 2-point change in back pain (facet procedure or sacroiliac joint injection) or leg pain (ESI) plus > 3 score on the 1-5 satisfaction scale. This is either yes or no.	1 month
Secondary	Positive outcome	Greater or equal to 2-point change in back pain (facet procedure or sacroiliac joint injection) or leg pain (ESI) plus > 3 score on the 1-5 satisfaction scale. This is either yes or no.	3 months