Low Back PainNCT01211613

Chiropractic Manipulation and Medical Care for Low Back Pain

A study testing Manual Manipulation, Mechanically-assisted manipulation and Standard Medical Care in people with Low Back Pain, run by University of Pittsburgh 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

The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Manual Manipulation, Mechanically-assisted manipulation and Standard Medical Care
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Oct 2013
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: ≥ 18 years of age
Ability to read and write English
Experiencing a new episode of low back pain (LBP) with onset in the past 3 months
Oswestry Disability Index score between 20-70 points (0-100 scale)
Numeric pain rating score between 3-8 points (0-10 scale)

Who cannot join

Prior history of lumbar spine surgery
History of unstable spondylolisthesis, spinal stenosis, or scoliosis > 20°
Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity
History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of >10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication
Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months)
Receiving any on-going medical care for this episode of low back pain
Current use of opiate or other prescription medications for low back pain

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh Medical Center: Center for Integrative Medicine
Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Comparison of Chiropractic Manipulation Methods and Standard Medical Care for Low Back Pain

Conditions: Low Back Pain
Being tested: Manual Manipulation, Mechanically-assisted manipulation, Standard Medical Care
Keywords: Manipulation, Chiropractic, Low Back 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.

Manual ManipulationProcedure or surgery
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Mechanically-assisted manipulationDevice
Also called Activator IV Instrument: FDA approval# K003185
Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
Standard Medical CareOther
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

Study groups in NCT01211613
Study group	Role	What they receive
Manual Manipulation	Experimental	Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. Receives: Procedure: Manual Manipulation
Mechanical Manipulation	Experimental	Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument. Receives: Device: Mechanically-assisted manipulation
Standard Medical Care	Active comparator	Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. Receives: Other: Standard Medical Care

What is being measured

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

Oswestry Low Back Pain Disability Index
The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).
Measured: 4 weeks (post treatment)

Secondary outcomes (1)

Numeric Pain Rating Score.
Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating "no pain" and 10 indicating "unbearable pain". Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment).
Measured: 4 weeks (post treatment)

Timeline

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

Nov 2010Oct 2013

First posted29 Sep 2010 (estimated)
Study startNov 2010
Primary completionMar 2013
Study completionOct 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 (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 PittsburghThe 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: Investigator
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211613
Sponsor's protocol ID: PRO10040327
Other IDs: 4R00AT004196-03
Status last verified: Dec 2016
First submitted: 28 Sep 2010
Last updated: 30 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A. Mechanical vs manual manipulation for low back pain: an observational cohort study. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200. doi: 10.1016/j.jmpt.2010.01.010.
PubMed 20350672
Tonelli Enrico V, Schneider M, Haas M, Vo N, Huang W, McFarland C, Weber N, Sowa G. The association of biomarkers with pain and function in acute and subacute low back pain: a secondary analysis of an RCT. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1059. doi: 10.1186/s12891-022-06027-9.
PubMed 36471334

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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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Chiropractic Manipulation Methods and Standard Medical Care for Low Back Pain
ClinicalTrials.gov ID: NCT01211613
Acronym / sponsor ID: PRO10040327
Conditions: Low Back Pain
Keywords: Manipulation, Chiropractic, Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Nov 2010
Primary completion: Mar 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 29 Sep 2010 (estimated)
Results: Posted 24 Nov 2014

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 (investigator)
Number of arms: 3

Arm	Type	Receives
Manual Manipulation	Experimental	Procedure: Manual ManipulationDoctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Mechanical Manipulation	Experimental	Device: Mechanically-assisted manipulationDoctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Standard Medical Care	Active comparator	Other: Standard Medical CarePatients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age: ≥ 18 years of age
Ability to read and write English
Experiencing a new episode of low back pain (LBP) with onset in the past 3 months
Oswestry Disability Index score between 20-70 points (0-100 scale)
Numeric pain rating score between 3-8 points (0-10 scale)

Key exclusion criteria (7 listed)

Prior history of lumbar spine surgery
History of unstable spondylolisthesis, spinal stenosis, or scoliosis > 20°
Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity
History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of >10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication
Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months)

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
Manual ManipulationDoctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.	Procedure or surgery	Manual Manipulation
Mechanically-assisted manipulationAlso: Activator IV Instrument: FDA approval# K003185Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.	Device	Mechanical Manipulation
Standard Medical CarePatients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.	Other	Standard Medical Care

Primary outcome

Oswestry Low Back Pain Disability Index
Time frame: 4 weeks (post treatment)
The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).

1 secondary outcome

Numeric Pain Rating Score.
Time frame: 4 weeks (post treatment)

Results and safety

Results posted to the registry on 24 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Manual Manipulation	37	34
Mechanical Manipulation	35	33
Standard Medical Care	35	33

Primary outcome: Oswestry Low Back Pain Disability Index

Time frame: 4 weeks (post treatment). Mean (Standard Deviation). Unit: units on a scale

Measure	Manual Manipulation n = 37	Mechanical Manipulation n = 35	Standard Medical Care n = 35
Value	-16.0 (14.1)	-8.9 (11.9)	-9.5 (14.4)

Manual Manipulation vs Mechanical Manipulation vs Standard Medical Care: Mean Difference (Final Values): 10, p = 0.009, Regression, Linear

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected at each treatment visit in each of the 3 treatment arms, over the course of the entire 4-week treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Manual Manipulation	0 of 37 (0%)	0 of 37 (0%)	Not reported
Mechanical Manipulation	0 of 35 (0%)	0 of 35 (0%)	Not reported
Standard Medical Care	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20350672Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A. Mechanical vs manual manipulation for low back pain: an observational cohort study. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200. doi: 10.1016/j.jmpt.2010.01.010.
Derived from this study: PubMed 36471334Tonelli Enrico V, Schneider M, Haas M, Vo N, Huang W, McFarland C, Weber N, Sowa G. The association of biomarkers with pain and function in acute and subacute low back pain: a secondary analysis of an RCT. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1059. doi: 10.1186/s12891-022-06027-9.

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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Not yet recruiting
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.

Michael J Schneider, PhD, DC principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Manual Manipulation, Mechanically-assisted manipulation and Standard Medical Care in people with Low Back Pain, run by University of Pittsburgh 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 5 inclusion and 7 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 30 Jan 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2014). 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?

Oswestry Low Back Pain Disability Index (time frame: 4 weeks (post treatment)). 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 NCT01211613, 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 30 Jan 2017.