Low Back PainPhase 1/2NCT01168999

The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

A Phase 1/2 study testing spinal manipulation in people with Low Back Pain, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Low Back Pain
What is being tested?: spinal manipulation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Jan 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult

Who may be able to join

currently experiencing low back pain which does not extend below the knees
rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
appropriate for conservative management of low back pain
english speaking

Who cannot join

surgery to the low back over the past 6 months
systemic disease known to effect sensation
other chronic pain condition unrelated to low back pain
fracture as a cause of low back pain

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32610

Other trials in United States

About this study

The purpose of this study is to determine whether a novel placebo for comparison to spinal manipulation is believable and creates similar expectation for treatment effectiveness as the studied spinal manipulation technique. Additionally, we wish to compare outcomes related to low back pain, function, and pain sensitivity between people receiving the placebo, spinal manipulation, and no therapy.

Conditions: Low Back Pain
Being tested: spinal manipulation, sham spinal manipulation, Enhanced sham spinal manipulation
Keywords: low back pain, spinal manipulation, manual therapy, placebo
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
Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain
sham spinal manipulationOther
Sham spinal manipulation intended to mimic the studied spinal manipulation
Enhanced sham spinal manipulationOther
Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"

Study groups in NCT01168999
Study group	Role	What they receive
spinal manipulation	Active comparator	a spinal manipulation known to be effective in the treatment of low back pain for some individuals Receives: Other: spinal manipulation
sham spinal manipulation	Placebo comparator	a sham spinal manipulation intended to mimic the studied spinal manipulation Receives: Other: sham spinal manipulation
natural history	No intervention	No intervention is provided to participants in this arm of the study
Enhanced sham spinal manipulation	Placebo comparator	a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people" Receives: Other: Enhanced sham spinal manipulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Believability of Placebo
Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
Measured: baseline
Expectation for Treatment Effectiveness
how helpful participants expect the assigned intervention will be in decreasing their low back pain
Measured: baseline
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Measured: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
Measured: Change from Baseline at 2 weeks
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".
Measured: baseline and immediately following their assigned intervention during the initial session

Secondary outcomes (4)

Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
Low back flexion range of motion was measured in degrees using a gravity inclinometer
Measured: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
Low back extension range of motion was measured in degrees using a gravity inclinometer
Measured: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
Measured: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
Measured: Change from Baseline at 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jan 2013

First posted23 Jul 2010 (estimated)
Study startSep 2009
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01168999
Sponsor's protocol ID: 345-2009
Status last verified: Oct 2015
First submitted: 22 Jul 2010
Last updated: 28 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.
PubMed 24361109

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
ClinicalTrials.gov ID: NCT01168999
Acronym / sponsor ID: 345-2009
Conditions: Low Back Pain
Keywords: low back pain, spinal manipulation, manual therapy, placebo
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: Sep 2009
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 23 Jul 2010 (estimated)
Results: Posted 23 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
spinal manipulation	Active comparator	Other: spinal manipulationa spinal manipulation known to be effective in the treatment of low back pain for some individuals
sham spinal manipulation	Placebo comparator	Other: sham spinal manipulationa sham spinal manipulation intended to mimic the studied spinal manipulation
natural history	No intervention	–No intervention is provided to participants in this arm of the study
Enhanced sham spinal manipulation	Placebo comparator	Other: Enhanced sham spinal manipulationa sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

currently experiencing low back pain which does not extend below the knees
rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
appropriate for conservative management of low back pain
english speaking

Key exclusion criteria (4 listed)

surgery to the low back over the past 6 months
systemic disease known to effect sensation
other chronic pain condition unrelated to low back pain
fracture as a cause of low back pain

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 manipulationSpinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain	Other	spinal manipulation
sham spinal manipulationSham spinal manipulation intended to mimic the studied spinal manipulation	Other	sham spinal manipulation
Enhanced sham spinal manipulationSham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"	Other	Enhanced sham spinal manipulation

Primary outcome

Believability of Placebo
Time frame: baseline
Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
Expectation for Treatment Effectiveness
Time frame: baseline
how helpful participants expect the assigned intervention will be in decreasing their low back pain
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
Time frame: Change from Baseline at 2 weeks
A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
Time frame: Change from Baseline at 2 weeks
The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
Time frame: baseline and immediately following their assigned intervention during the initial session
Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".

4 secondary outcomes

Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
Time frame: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
Time frame: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
Time frame: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
Time frame: Change from Baseline at 2 weeks

Results and safety

Results posted to the registry on 23 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Manipulative Therapy	28	26
Sham Spinal Manipulative Therapy	27	26
Enhanced Sham Spinal Manipulative Therapy	27	27
Natural History	28	28

Primary outcome: Believability of Placebo

Time frame: baseline. Number. Unit: percentage of participants

Measure	Spinal Manipulative Therapy n = 28	Sham Spinal Manipulative Therapy n = 27	Enhanced Sham Spinal Manipulative Therapy n = 27	Natural History n = 0
Value	67	37	78	–

Spinal Manipulative Therapy vs Sham Spinal Manipulative Therapy vs Enhanced Sham Spinal Manipulative Therapy: p <0.01, Chi-squared

Primary outcome: Expectation for Treatment Effectiveness

Time frame: baseline. Number. Unit: percent expecting less pain

Measure	Spinal Manipulative Therapy n = 28	Sham Spinal Manipulative Therapy n = 27	Enhanced Sham Spinal Manipulative Therapy n = 27	Natural History n = 28
Value	54	26	59	11

Spinal Manipulative Therapy vs Sham Spinal Manipulative Therapy vs Enhanced Sham Spinal Manipulative Therapy vs Natural History: p = 0.01, Chi-squared

Primary outcome: Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale

Time frame: Change from Baseline at 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Spinal Manipulative Therapy n = 26	Sham Spinal Manipulative Therapy n = 26	Enhanced Sham Spinal Manipulative Therapy n = 27	Natural History n = 28
Value	11.23 (14.01)	14.03 (17.88)	9.44 (25.90)	8.20 (12.64)

Spinal Manipulative Therapy vs Sham Spinal Manipulative Therapy vs Enhanced Sham Spinal Manipulative Therapy vs Natural History: p >0.05, Repeated Measure ANOVA

Primary outcome: Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index

Time frame: Change from Baseline at 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Spinal Manipulative Therapy n = 26	Sham Spinal Manipulative Therapy n = 26	Enhanced Sham Spinal Manipulative Therapy n = 27	Natural History n = 28
Value	4.46 (8.28)	2.08 (7.36)	2.69 (8.33)	2.54 (8.47)

Spinal Manipulative Therapy vs Sham Spinal Manipulative Therapy vs Enhanced Sham Spinal Manipulative Therapy vs Natural History: p >0.05, Repeated Measure ANOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study was conducted from November of 2009 until January of 2013. The occurrence of adverse events was monitored during the length of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Manipulative Therapy	0 of 28 (0%)	0 of 28 (0%)	Not reported
Sham Spinal Manipulative Therapy	0 of 27 (0%)	0 of 27 (0%)	Not reported
Enhanced Sham Spinal Manipulative Therapy	0 of 27 (0%)	0 of 27 (0%)	Not reported
Natural History	0 of 28 (0%)	0 of 28 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24361109Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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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.

Joel Bialosky, 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 Phase 1/2 study testing spinal manipulation 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 4 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: finished, as of the sponsor's last update on 28 Oct 2015. 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.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Believability of Placebo (time frame: baseline). The study lists 5 primary outcomes in all. 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 NCT01168999, 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 28 Oct 2015.