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NCT02761928

Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients

NCT ID: NCT02761928

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Back Pain, Mechanical Spinal Stenosis Nerve Root Disorder Radiculopathy, Cervical Benign Hypermobility Syndrome

Keywords

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Facet Joint Sacroiliac Joint Myofascial Trigger Point Pain Injectables

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epidural

Positive response (\>50% pain relief) to any epidural (e.g. interlaminar/paramedian, transforaminal, caudal)

Beighton score for hypermobility

Intervention Type OTHER

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

Selective nerve root block

Positive response (\>50% pain relief) to selective nerve root block

Beighton score for hypermobility

Intervention Type OTHER

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

Facet injection

Positive response (\>50% pain relief) to intra-articular facet injection

Beighton score for hypermobility

Intervention Type OTHER

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

Medial branch block

Positive response (\>50% pain relief) to median branch nerve block

Beighton score for hypermobility

Intervention Type OTHER

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

Medial branch RFA

Positive response (\>50% pain relief) to median branch nerve radiofrequency ablation

Beighton score for hypermobility

Intervention Type OTHER

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

SIJ injection

Positive response (\>50% pain relief) to sacroiliac joint injection

Beighton score for hypermobility

Intervention Type OTHER

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

Lateral branch block

Positive response (\>50% pain relief) to lateral branch nerve block for SIJ

Beighton score for hypermobility

Intervention Type OTHER

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

Greater trochanter injection

Positive response (\>50% pain relief) to greater trochanteric bursa injection

Beighton score for hypermobility

Intervention Type OTHER

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

Piriformis injection

Positive response (\>50% pain relief) to piriformis injection

Beighton score for hypermobility

Intervention Type OTHER

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

Trigger point injection

Positive response (\>50% pain relief) to trigger point injection

Beighton score for hypermobility

Intervention Type OTHER

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

Interventions

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Beighton score for hypermobility

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Mark J Burish

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Burish, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. doi: 10.1007/s11916-009-0070-5.

Reference Type BACKGROUND

PMID: 19889283 (View on PubMed)

Other Identifiers

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HSC-MS-15-0809

Identifier Type: -

Identifier Source: org_study_id