Low Back PainPhase 1NCT00922220
A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain
A Phase 1 study testing stationary bike, lumbar extension exercise and spinal manipulative therapy in people with Low Back Pain, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- stationary bike, lumbar extension exercise and spinal manipulative therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Nov 2008
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages eighteen to sixty
- currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months
Who cannot join
- non-English speaking
- systemic medical conditions (e.g. diabetes, hypertension)
- current use of psychiatric medication
- pregnancy
- signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)
- history of surgery to the low back
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Physical Interventions for Low Back Pain
The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).
- Conditions
- Low Back Pain
- Being tested
- stationary bike, lumbar extension exercise, spinal manipulative therapy
- Keywords
- low back pain, spinal manipulation, central sensitization, manual therapy
- 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.
stationary bikeOther
Participants rode a stationary bike for five minutes
lumbar extension exerciseOther
Also called press up
Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes
spinal manipulative therapyOther
Also called spinal manipulation, manual therapy
participants received spinal manipulative therapy to the low back
| Study group | Role | What they receive |
|---|---|---|
| stationary bike | Active comparator | Participants rode a stationary bike for five minutes Receives: Other: stationary bike |
| lumbar extension exercises | Active comparator | Participants performed four sets of fifteen lumbar extension exercises over five minutes Receives: Other: lumbar extension exercise |
| spinal manipulative therapy | Experimental | Participants received spinal manipulative therapy to the low back Receives: Other: spinal manipulative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Measured: Prior to and immediately following assigned intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startOct 2004
- Primary completionNov 2008
- Study completionNov 2008
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.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Z George, Phd, Principal investigator, University of Florida Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922220
- Sponsor's protocol ID
- 343-2004
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.
PubMed 16911795Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.
PubMed 19797305
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Physical Interventions for Low Back Pain
- ClinicalTrials.gov ID
- NCT00922220
- Acronym / sponsor ID
- 343-2004
- Conditions
- Low Back Pain
- Keywords
- low back pain, spinal manipulation, central sensitization, manual therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Jun 2009 (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.
The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stationary bike | Active comparator | Other: stationary bikeParticipants rode a stationary bike for five minutes |
| lumbar extension exercises | Active comparator | Other: lumbar extension exerciseParticipants performed four sets of fifteen lumbar extension exercises over five minutes |
| spinal manipulative therapy | Experimental | Other: spinal manipulative therapyParticipants received spinal manipulative therapy to the low back |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ages eighteen to sixty
- currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months
Key exclusion criteria (6 listed)
- non-English speaking
- systemic medical conditions (e.g. diabetes, hypertension)
- current use of psychiatric medication
- pregnancy
- signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)
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 |
|---|---|---|
| stationary bikeParticipants rode a stationary bike for five minutes | Other | stationary bike |
| lumbar extension exerciseAlso: press upParticipants performed four sets of fifteen lumbar extension exercises over fifteen minutes | Other | lumbar extension exercises |
| spinal manipulative therapyAlso: spinal manipulation, manual therapyparticipants received spinal manipulative therapy to the low back | Other | spinal manipulative therapy |
Primary outcome
Numeric Rating Scale
Time frame: Prior to and immediately following assigned intervention
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 22 Dec 2011.
- Results publication: PubMed 16911795George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.
- Results publication: PubMed 19797305Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.
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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.
Steven Z George, Phd principal investigator
University of Florida Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing stationary bike, lumbar extension exercise and spinal manipulative therapy in people with Low Back Pain, run by University of Florida 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 2 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 22 Dec 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Numeric Rating Scale (time frame: Prior to and immediately following assigned intervention). 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 NCT00922220, 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 22 Dec 2011.