Back Pain Clinical Trial
Official title:
Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
Verified date | June 2023 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. By using the walk test as an objective functional assessment, the aim is to better standardize the threshold for a positive response to SNRB. In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as outlined above, are multifactorial. The proposed study aims to minimize the known limitations of these injections and prospectively define their positive and negative predictive value in a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and radiculopathy. The design will define a threshold of response utilizing both subjective and objective measures and more accurately predict excellent results following surgery.
Status | Terminated |
Enrollment | 11 |
Est. completion date | December 15, 2020 |
Est. primary completion date | November 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Ages 18-80 - Diagnosis of unilateral lower extremity radiculopathy due to degenerative foraminal stenosis - Patients scheduled for an associated lumbar foraminotomy procedure - Diagnosis of radiculopathy with imaging and/or clinical history or physical exam that does not demonstrate a clear neurogenic source of their pain - Subjects must be available for the entire study duration (12 months) Exclusion Criteria: - Patients will be excluded if there is a clear correlation between imaging and radiculopathy - Radiculopathy associated with trauma, tumor or infection. Non-radicular lower extremity pain will also be excluded - Patients who cannot tolerate the SNRB without IV sedation - Surgery requiring multi-level decompression and/or fusion - Surgical indication for malignancy, injection or acute or emergency trauma - History of major surgery within 3 months prior to enrollment - Pregnant females - Presence of severe acute, chronic medical or psychiatric condition |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Main Campus | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | Lumbar Spine Research Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) Leg Pain Score | Aim: 0-2 point improvement
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit. |
12-months | |
Secondary | Oswestry Disability Index Questionnaire (ODI) | Aim: 15-point improvement
The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Structure / Content There are 10 questions. The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life. Scoring Method Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The score can be multiplied by 2 to produce a percentage. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5 Interpretation 1.0%-20%: Minimal disability. Usually no treatment is indicated. 2.20%-40% Moderate disability 3.40%-60%: Severe disability 4.60%-80%: Crippled 5.80%-100%: These patients are either bed-bound or exaggerating their symptoms. |
12-Months | |
Secondary | EQ-5D Questionnaire | Aim: Improvement in quality of life
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The questionnaire also records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
12-Months | |
Secondary | Pain Disability Questionnaire (PDQ) | Aim: 26-point improvement
The Pain Disability Questionnaire (PDQ) assesses perception of disability in relation to pain. PDQ scores: mild/moderate (0-70), severe (71-100), and extreme (101-150). |
12-months |
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