Spinal Stenosis Clinical Trial
— HypermobleOfficial title:
Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
NCT number | NCT02761928 |
Other study ID # | HSC-MS-15-0809 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | August 1, 2017 |
Verified date | November 2020 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Observational study of axial spine pain and hyperflexibility. Patients will receive physical exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's hypermobility score) and blood / urine / saliva collection. They will also be separated into pain groups based on their response to injections. A correlation between exam findings and procedure group will be measured.
Status | Terminated |
Enrollment | 31 |
Est. completion date | August 1, 2017 |
Est. primary completion date | August 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Clinical diagnosis of axial back pain (neck, mid-back, lower back) or pain radiating to the extremity, with suspected diagnosis of a specific pain generator amenable to a pain procedure, including disorders of the nerves, joints, and muscles as listed immediately below. - Clinical decision to schedule patient for a pain procedure, including procedures targeting the following disorders: - Facet arthropathy: intra-articular facet joint injection, medial branch block, medial branch radiofrequency ablation - Sacroiliac joint dysfunction: sacroiliac joint injection, lateral branch block, lateral branch radiofrequency ablation - Myofascial pain syndrome: trigger point injection - Radiculopathy, spinal stenosis, or herniated nucleus pulposus: epidural steroid injection, selective nerve root block - Piriformis syndrome: piriformis injection - Greater trochanteric bursitis: greater trochanteric bursa injection - Able to provide HIPAA authorization to share prior medical records/imaging. Exclusion Criteria: - Previous diagnosis of cancer. - Currently pregnant. - Previously enrolled for the same procedure or the same pain generator site. (For example, this would exclude a patient who had an intra-articular facet joint injection at the right L5/S1 if: 1) he had the same injection 3 months ago and was enrolled at that time, or 2) the patient was already enrolled for a medial branch block at the right L5 and sacral ala, as this targets the same facet joint.) - Inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state) |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Beighton hypermobility score | 9 point standardized scale | Prior to injection (2 weeks prior to injection for each patient) |
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