Low Back PainNCT03078114
Central Mechanism of Manual Therapy for Low Back Pain
A study testing Spinal Manipulation in people with Low Back Pain, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain. Read more about this study
- 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
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Aug 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of subacute low back pain
- Ability to read and understand English
Who cannot join
- Previous low back surgery
- Severe structural spinal deformity
- Neurological compromise resulting in current nerve root entrapment
- Spinal cord compression
- Tumor
- Severe spinal instability
Show all 18Show fewer
- Severe osteoporosis
- Psychiatric disease
- Head trauma
- Spinal infection
- Known cardiovascular or metabolic disease
- Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions
- Pregnancy
- Mini-Mental State Examination score < 25
- Body Mass Index (BMI) < 18 or > 30
- Pain or paresthesia below the knees
- Systemic illness known to affect sensation i.e. diabetes
- Acute and/or chronic pain condition unrelated to LBP
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Of Kansas Medical Center
Kansas City, Kansas, 66160
University of Saint Mary
Leavenworth, Kansas, 66048
About this study
The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.
- Conditions
- Low Back Pain
- Being tested
- Spinal Manipulation, Placebo Spinal Manipulation
- 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
The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.
Placebo Spinal ManipulationOther
The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulation | Experimental | Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks Receives: Other: Spinal Manipulation |
| Placebo Spinal Manipulation | Placebo comparator | Subjects with subacute low back pain. Subjects will be asked to visit the clinic for 6 times. The clinician will go through SM motions but the spine will not actually be manipulated. Receives: Other: Placebo Spinal Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing
Outcome will be measured using Pain Pressure Threshold (PPT) testing. Pressure will be applied to subjects using a digital algometer. Three trials for PPT will be done and the mean value will be calculated.
Measured: Change from Pre-treatment to Post-treatment, 2 Weeks
Secondary outcomes (3)
Change in function measured using the Oswestry Disability Index (ODI)
Outcome will be measured using the Oswestry Disability Index (ODI). Subjects answer to questions. Their responses indicate no impact to great impact. Scores for each question range from 0 to 5. Total score for the ODI is 50. The higher the score, the greater level of disability/function.
Measured: Change from Baseline to Week 2
Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)
Outcome will be measured using the Numerical Pain Rating Scale (NPRS). Pain intensity will be assessed using an 11-point scale. Scores on the scale range from "0" indicating no pain, "1" slight pain, and "10" strongest imaginable pain.
Measured: Change from Baseline to Week 2
Change in Fear Avoidance Beliefs Questionnaire (FABQ)
The FABQ is completed by the subject. It determines the level of fear and avoidance about work and physical activity. The measure is comprised of two subscales: a four item physical activity subscale (FABQ-W), and a seven-item work subscale (FABQ-W). An elevated FABQ score is predictive of the development of chronic disability in low back pain (LBP) patients.
Measured: Change from Baseline to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startMay 2012
- Primary completionMay 2016
- Study completionAug 2016
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 PainStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Chiropractic Mutual Insurance Company Foundation
- Responsible party
- Sponsor
- Investigators
- Wen Liu, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078114
- Sponsor's protocol ID
- 12919
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bond BM, Kinslow CD, Yoder AW, Liu W. Effect of spinal manipulative therapy on mechanical pain sensitivity in patients with chronic nonspecific low back pain: a pilot randomized, controlled trial. J Man Manip Ther. 2020 Feb;28(1):15-27. doi: 10.1080/10669817.2019.1572986. Epub 2019 Mar 5.
PubMed 30935324
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Mechanism of Manual Therapy for Low Back Pain
- ClinicalTrials.gov ID
- NCT03078114
- Acronym / sponsor ID
- 12919
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Chiropractic Mutual Insurance Company Foundation
- Study start
- May 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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 is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulation | Experimental | Other: Spinal ManipulationSubjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks |
| Placebo Spinal Manipulation | Placebo comparator | Other: Placebo Spinal ManipulationSubjects with subacute low back pain. Subjects will be asked to visit the clinic for 6 times. The clinician will go through SM motions but the spine will not actually be manipulated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of subacute low back pain
- Ability to read and understand English
Key exclusion criteria (18 listed)
- Previous low back surgery
- Severe structural spinal deformity
- Neurological compromise resulting in current nerve root entrapment
- Spinal cord compression
- Tumor
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 ManipulationThe subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine. | Other | Spinal Manipulation |
| Placebo Spinal ManipulationThe subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine. | Other | Placebo Spinal Manipulation |
Primary outcome
Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing
Time frame: Change from Pre-treatment to Post-treatment, 2 Weeks
Outcome will be measured using Pain Pressure Threshold (PPT) testing. Pressure will be applied to subjects using a digital algometer. Three trials for PPT will be done and the mean value will be calculated.
3 secondary outcomes
Change in function measured using the Oswestry Disability Index (ODI)
Time frame: Change from Baseline to Week 2
Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)
Time frame: Change from Baseline to Week 2
Change in Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Change from Baseline to Week 2
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 13 Mar 2017.
- Derived from this study: PubMed 30935324Bond BM, Kinslow CD, Yoder AW, Liu W. Effect of spinal manipulative therapy on mechanical pain sensitivity in patients with chronic nonspecific low back pain: a pilot randomized, controlled trial. J Man Manip Ther. 2020 Feb;28(1):15-27. doi: 10.1080/10669817.2019.1572986. Epub 2019 Mar 5.
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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.
Wen Liu, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Low Back Pain, run by University of Kansas Medical Center at 2 sites 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 18 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing (time frame: Change from Pre-treatment to Post-treatment, 2 Weeks). 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 NCT03078114, 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 13 Mar 2017.