Low Back Pain, MechanicalHypermobleNCT02761928
Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
An observational study of Low Back Pain, Mechanical and Spinal Stenosis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Mechanical, Spinal Stenosis, Nerve Root Disorder
- What is being tested?
- Beighton score for hypermobility
- Type of treatment
- Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with low back pain who are determined to be candidates for a pain procedure
Who may be able to join
- 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
Show all 9Show fewer
- Piriformis syndrome: piriformis injection
- Greater trochanteric bursitis: greater trochanteric bursa injection
- Able to provide HIPAA authorization to share prior medical records/imaging.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
Read the detailed 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.
- Conditions
- Low Back Pain, Mechanical, Spinal Stenosis, Nerve Root Disorder, Radiculopathy, Cervical, Benign Hypermobility Syndrome
- Being tested
- Beighton score for hypermobility
- Keywords
- Facet Joint, Sacroiliac Joint, Myofascial Trigger Point Pain, Injectables
- Medical subject headings
- Low Back Pain, Spinal Stenosis, Radiculopathy, Ehlers-Danlos syndrome type 3, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beighton score for hypermobilityOther
The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Positive response (>50% pain relief) to any epidural (e.g. interlaminar/paramedian, transforaminal, caudal) Receives: Other: Beighton score for hypermobility | |
| Selective nerve root block | Positive response (>50% pain relief) to selective nerve root block Receives: Other: Beighton score for hypermobility | |
| Facet injection | Positive response (>50% pain relief) to intra-articular facet injection Receives: Other: Beighton score for hypermobility | |
| Medial branch block | Positive response (>50% pain relief) to median branch nerve block Receives: Other: Beighton score for hypermobility | |
| Medial branch RFA | Positive response (>50% pain relief) to median branch nerve radiofrequency ablation Receives: Other: Beighton score for hypermobility | |
| SIJ injection | Positive response (>50% pain relief) to sacroiliac joint injection Receives: Other: Beighton score for hypermobility | |
| Lateral branch block | Positive response (>50% pain relief) to lateral branch nerve block for SIJ Receives: Other: Beighton score for hypermobility | |
| Greater trochanter injection | Positive response (>50% pain relief) to greater trochanteric bursa injection Receives: Other: Beighton score for hypermobility | |
| Piriformis injection | Positive response (>50% pain relief) to piriformis injection Receives: Other: Beighton score for hypermobility | |
| Trigger point injection | Positive response (>50% pain relief) to trigger point injection Receives: Other: Beighton score for hypermobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beighton hypermobility score
9 point standardized scale
Measured: Prior to injection (2 weeks prior to injection for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Why it stopped: Insufficient enrollment, lack of funding to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark J Burish, The University of Texas Health Science Center, Houston
- Investigators
- Mark Burish, MD PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761928
- Sponsor's protocol ID
- HSC-MS-15-0809
- Acronym
- Hypermoble
- Status last verified
- Nov 2020
- First submitted
- 24 Apr 2016
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. doi: 10.1007/s11916-009-0070-5.
PubMed 19889283
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT02761928
- Acronym / sponsor ID
- Hypermoble / HSC-MS-15-0809
- Conditions
- Low Back Pain, Mechanical, Spinal Stenosis, Nerve Root Disorder, Radiculopathy, Cervical, Benign Hypermobility Syndrome
- Keywords
- Facet Joint, Sacroiliac Joint, Myofascial Trigger Point Pain, Injectables
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment, lack of funding to continue
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Epidural | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to any epidural (e.g. interlaminar/paramedian, transforaminal, caudal) |
| Selective nerve root block | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to selective nerve root block |
| Facet injection | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to intra-articular facet injection |
| Medial branch block | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to median branch nerve block |
| Medial branch RFA | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to median branch nerve radiofrequency ablation |
| SIJ injection | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to sacroiliac joint injection |
| Lateral branch block | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to lateral branch nerve block for SIJ |
| Greater trochanter injection | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to greater trochanteric bursa injection |
| Piriformis injection | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to piriformis injection |
| Trigger point injection | – | Other: Beighton score for hypermobilityPositive response (>50% pain relief) to trigger point injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low back pain who are determined to be candidates for a pain procedure
Key inclusion criteria (9 listed)
- 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:
- Able to provide HIPAA authorization to share prior medical records/imaging.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beighton score for hypermobilityThe beighton score is a 9 point score of flexibility, used for patients with disorders of collagen. | Other | Epidural, Facet injection, Greater trochanter injection, Lateral branch block, Medial branch RFA, Medial branch block, Piriformis injection, SIJ injection, Selective nerve root block, Trigger point injection |
Primary outcome
Beighton hypermobility score
Time frame: Prior to injection (2 weeks prior to injection for each patient)
9 point standardized scale
Results and safety
The study was stopped early (reason given: Insufficient enrollment, lack of funding to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 19889283Grahame R. Joint hypermobility syndrome pain. Curr Pain Headache Rep. 2009 Dec;13(6):427-33. doi: 10.1007/s11916-009-0070-5.
Related trials for Low Back Pain, Mechanical
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Burish, MD PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, Mechanical and Spinal Stenosis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment, lack of funding to continue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beighton hypermobility score (time frame: Prior to injection (2 weeks prior to injection for each patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.