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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

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

Clinical Trial Summary

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.


Description:

This is an observational study of patients with neck and back pain followed by a pain management clinic. Patients with particular pain generators in the neck and back will be defined by a positive response to one of several targeted interventional pain procedures. Each patient may undergo a physical exam to determine whether they have hypermobile joints. The study will thus evaluate the rate of hypermobility for each pain generator. In addition blood, urine, or saliva samples may be taken for biomarkers for pain or rheumatologic factors.


Recruitment information / eligibility

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)

Study Design


Intervention

Other:
Beighton score for hypermobility
The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.

Locations

Country Name City State
United States University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. Review. — View Citation

Outcome

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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