Low Back PainNCT01406847
Central Mechanisms of Intervention for Low Back Pain
A study testing Spinal Manipulation, Spinal Mobilization and Static Touch in people with Low Back Pain, run by University of Florida at 1 site in United States.
Trial summary
Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Spinal Manipulation, Spinal Mobilization and Static Touch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 1 May 2017
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18 to 40 years
- able to read and understand spoken English
Who cannot join
- Previous participation in a conditioning program specific to trunk extensors in the past 6 months
- Any report of back or leg pain in the past 3 months
- Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder
- History of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction
- Consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation
- Performance of any intervention for symptoms induced by exercise and before the termination of their participation or the protocol
- Recent illness
- Any contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible (e.g. aneurysm clip), pregnancy and severe claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32610-0154
About this study
Official title: Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain
Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.
Read the detailed description
170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.
- Conditions
- Low Back Pain
- Being tested
- Spinal Manipulation, Spinal Mobilization, Static Touch
- Keywords
- Spinal Manipulation, Body-based intervention, Experimental pain
- 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.
Spinal ManipulationOther
Also called SMT
High velocity low amplitude joint-biased intervention
Spinal MobilizationOther
Also called Mobilization, Mobs
Low velocity, large amplitude oscillating joint biased technique
Static TouchOther
The investigators maintains hand contact with both hands over the lumbar area of the participant
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulation | Experimental | High-velocity manual technique applied to the pelvis with the participant in supine Receives: Other: Spinal Manipulation |
| Static Touch | Sham comparator | Practitioner hands are placed on the lumbar spine with the participant in prone. Receives: Other: Static Touch |
| Spinal Mobilization | Active comparator | Oscillation of the third lumbar level performed with the participant in prone Receives: Other: Spinal Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in temporal sensory summation
We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.
Measured: 10 minutes post-intervention
Change in temporal sensory summation
The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention
Measured: 48 hours post-intervention
Secondary outcomes (1)
Change in Physical Impairment Index
Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance
Measured: 48 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2012
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Mark D Bishop, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406847
- Sponsor's protocol ID
- IRB201602462-N
- Other IDs
- 1R01AT006334-01, 439-2010
- Status last verified
- Apr 2018
- First submitted
- 26 Jul 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain
- ClinicalTrials.gov ID
- NCT01406847
- Acronym / sponsor ID
- IRB201602462-N
- Conditions
- Low Back Pain
- Keywords
- Spinal Manipulation, Body-based intervention, Experimental pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2012
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 1 Aug 2011 (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.
Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.
Detailed description
170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulation | Experimental | Other: Spinal ManipulationHigh-velocity manual technique applied to the pelvis with the participant in supine |
| Static Touch | Sham comparator | Other: Static TouchPractitioner hands are placed on the lumbar spine with the participant in prone. |
| Spinal Mobilization | Active comparator | Other: Spinal MobilizationOscillation of the third lumbar level performed with the participant in prone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 18 to 40 years
- able to read and understand spoken English
Key exclusion criteria (8 listed)
- Previous participation in a conditioning program specific to trunk extensors in the past 6 months
- Any report of back or leg pain in the past 3 months
- Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder
- History of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction
- Consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation
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 |
|---|---|---|
| Spinal ManipulationAlso: SMTHigh velocity low amplitude joint-biased intervention | Other | Spinal Manipulation |
| Spinal MobilizationAlso: Mobilization, MobsLow velocity, large amplitude oscillating joint biased technique | Other | Spinal Mobilization |
| Static TouchThe investigators maintains hand contact with both hands over the lumbar area of the participant | Other | Static Touch |
Primary outcome
Immediate change in temporal sensory summation
Time frame: 10 minutes post-intervention
We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.
Change in temporal sensory summation
Time frame: 48 hours post-intervention
The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention
1 secondary outcome
Change in Physical Impairment Index
Time frame: 48 hours post-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 5 Apr 2018.
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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.
Mark D Bishop, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation, Spinal Mobilization and Static Touch 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 8 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 5 Apr 2018. 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. Some participants in this study may receive a placebo. 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?
Immediate change in temporal sensory summation (time frame: 10 minutes post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2018.