Low Back PainNCT01981382
Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain
An observational study of Low Back Pain, run by University of Connecticut.
Trial summary
This research study will examine whether enhanced pain sensitivity increases the risk of persistent low back pain. The study will address the highly prevalent and costly condition of persistent low back pain and a major obstacle for the implementation of clinical strategies to improve patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2016
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Men and women between the ages of 18-50 years of age who are diagnosed with an acute nonspecific LBP episode defined as pain anywhere in the region of the low back bound superiorly by T12 and inferiorly by the buttock crease, which has been present for >24 hours but <4 weeks duration and was preceded by at least 1 pain-free month.
Who may be able to join
- 18-50 years of age;
- diagnosed with an acute episode of nonspecific LBP present for >24 hours but <4 weeks duration and preceded by at least 1 pain-free month; and
- comprehend English
Who cannot join
- <18 or >50 years of age;
- chronic pain at another site or associated with a painful condition (eg., fibromyalgia, neuropathy, rheumatoid arthritis);
- previous spinal surgery;
- presence of neurological deficits;
- history of comorbidities that affect sensorimotor function (eg., multiple sclerosis, spinal cord injury, diabetes); and
- untreated psychological disorders (major depression, bipolar disorder, schizophrenia)
About this study
Official title: Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain
This research study will examine whether enhanced pain sensitivity increases the risk of persistent low back pain. The study will address the highly prevalent and costly condition of persistent low back pain and a major obstacle for the implementation of clinical strategies to improve patient outcomes. The knowledge gained from this study may lead to a better understanding of the biological mechanisms that contribute to persistent low back pain and will inform future work to develop predictive measures of persistent low back pain risk, evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to identify patients who are at increased risk of persistent low back pain.
Read the detailed description
The specific aims (SA) of the proposed study are to:
Specific Aim 1. Characterize (A) the differences in pain sensitivity between incident cases and controls at low back pain onset and (B) changes in pain sensitivity over time in incident cases.
H1.A Incident cases will have increased pain sensitivity compared with controls at low back pain onset.
H1.B Incident cases will have increased pain sensitivity over time.
Specific Aim 2. Compare (A) genetic polymorphisms at low back pain onset between incident cases and controls and mRNA expression of candidate genes at LBP onset and at 6 weeks between incident cases and controls; and (B) differential expression levels of candidate genes over time in incident cases.
H2.A Incident cases will have a higher frequency of polymorphisms and differential expression levels of candidate genes at low back pain onset compared with controls.
H2.B Examine expression levels of candidate genes over time in incident cases.
Specific Aim 3. Determine the contribution of enhanced pain sensitivity, cofactors (clinical/psychosocial/environmental), genetic polymorphisms, and mRNA expression of candidate genes on the risk of persistent low back pain.
- Conditions
- Low Back Pain
- Keywords
- low back pain, pain sensitivity, genes, gene expression,, quantitative sensory testing
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Incident cases | Persistent nonspecific low back pain | |
| Controls | Acute low back pain that resolves in <6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experimental Pain Threshold
Quantitative sensory testing will be used to evaluate pain sensitivity over time
Measured: 6 months
Secondary outcomes (1)
mRNA expression of pain sensitivity genes
Expression of pain sensitivity genes will be measured over time
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Angela R Starkweather, PhD, RN, Principal investigator, University of Connecticut School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981382
- Sponsor's protocol ID
- 1R01NR013932-01
- Other IDs
- R01NR013932-01
- Status last verified
- Nov 2016
- First submitted
- 4 Nov 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified data will be available upon completion of study and final acceptance of publications
Publications
Starkweather AR, Lyon DE, Kinser P, Heineman A, Sturgill JL, Deng X, Siangphoe U, Elswick RK, Greenspan J, Dorsey SG. Comparison of Low Back Pain Recovery and Persistence: A Descriptive Study of Characteristics at Pain Onset. Biol Res Nurs. 2016 Jul;18(4):401-10. doi: 10.1177/1099800416631819. Epub 2016 Feb 16.
PubMed 26883808Starkweather AR, Ramesh D, Lyon DE, Siangphoe U, Deng X, Sturgill J, Heineman A, Elswick RK Jr, Dorsey SG, Greenspan J. Acute Low Back Pain: Differential Somatosensory Function and Gene Expression Compared With Healthy No-Pain Controls. Clin J Pain. 2016 Nov;32(11):933-939. doi: 10.1097/AJP.0000000000000347.
PubMed 26736025
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT01981382
- Acronym / sponsor ID
- 1R01NR013932-01
- Conditions
- Low Back Pain
- Keywords
- low back pain, pain sensitivity, genes, gene expression,, quantitative sensory testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Nov 2013 (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.
This research study will examine whether enhanced pain sensitivity increases the risk of persistent low back pain. The study will address the highly prevalent and costly condition of persistent low back pain and a major obstacle for the implementation of clinical strategies to improve patient outcomes. The knowledge gained from this study may lead to a better understanding of the biological mechanisms that contribute to persistent low back pain and will inform future work to develop predictive measures of persistent low back pain risk, evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to identify patients who are at increased risk of persistent low back pain.
Detailed description
The specific aims (SA) of the proposed study are to:
Specific Aim 1. Characterize (A) the differences in pain sensitivity between incident cases and controls at low back pain onset and (B) changes in pain sensitivity over time in incident cases.
H1.A Incident cases will have increased pain sensitivity compared with controls at low back pain onset.
H1.B Incident cases will have increased pain sensitivity over time.
Specific Aim 2. Compare (A) genetic polymorphisms at low back pain onset between incident cases and controls and mRNA expression of candidate genes at LBP onset and at 6 weeks between incident cases and controls; and (B) differential expression levels of candidate genes over time in incident cases.
H2.A Incident cases will have a higher frequency of polymorphisms and differential expression levels of candidate genes at low back pain onset compared with controls.
H2.B Examine expression levels of candidate genes over time in incident cases.
Specific Aim 3. Determine the contribution of enhanced pain sensitivity, cofactors (clinical/psychosocial/environmental), genetic polymorphisms, and mRNA expression of candidate genes on the risk of persistent low back pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incident cases | – | –Persistent nonspecific low back pain |
| Controls | – | –Acute low back pain that resolves in <6 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men and women between the ages of 18-50 years of age who are diagnosed with an acute nonspecific LBP episode defined as pain anywhere in the region of the low back bound superiorly by T12 and inferiorly by the buttock crease, which has been present for >24 hours but <4 weeks duration and was preceded by at least 1 pain-free month.
Key inclusion criteria (3 listed)
- 18-50 years of age;
- diagnosed with an acute episode of nonspecific LBP present for >24 hours but <4 weeks duration and preceded by at least 1 pain-free month; and
- comprehend English
Key exclusion criteria (6 listed)
- <18 or >50 years of age;
- chronic pain at another site or associated with a painful condition (eg., fibromyalgia, neuropathy, rheumatoid arthritis);
- previous spinal surgery;
- presence of neurological deficits;
- history of comorbidities that affect sensorimotor function (eg., multiple sclerosis, spinal cord injury, diabetes); and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experimental Pain Threshold
Time frame: 6 months
Quantitative sensory testing will be used to evaluate pain sensitivity over time
1 secondary outcome
mRNA expression of pain sensitivity genes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Results publication: PubMed 26883808Starkweather AR, Lyon DE, Kinser P, Heineman A, Sturgill JL, Deng X, Siangphoe U, Elswick RK, Greenspan J, Dorsey SG. Comparison of Low Back Pain Recovery and Persistence: A Descriptive Study of Characteristics at Pain Onset. Biol Res Nurs. 2016 Jul;18(4):401-10. doi: 10.1177/1099800416631819. Epub 2016 Feb 16.
- Results publication: PubMed 26736025Starkweather AR, Ramesh D, Lyon DE, Siangphoe U, Deng X, Sturgill J, Heineman A, Elswick RK Jr, Dorsey SG, Greenspan J. Acute Low Back Pain: Differential Somatosensory Function and Gene Expression Compared With Healthy No-Pain Controls. Clin J Pain. 2016 Nov;32(11):933-939. doi: 10.1097/AJP.0000000000000347.
- Individual participant dataSharing planned: Yes. Deidentified data will be available upon completion of study and final acceptance of publications
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Low 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.
Angela R Starkweather, PhD, RN principal investigator
University of Connecticut School of Nursing
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Connecticut.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Experimental Pain Threshold (time frame: 6 months). 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 NCT01981382, which also lists 2 linked publications.
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 15 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.