Low Back PainPhase 2/3NCT00376350
Dose of Spinal Manipulation for Chronic Low Back Pain
A Phase 2/3 study testing Spinal Manipulation, Light Massage and Pulsed Ultrasound in people with Low Back Pain, run by University of Western States at 1 site in United States.
Trial summary
This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal 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?
- Spinal Manipulation, Light Massage and Pulsed Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jul 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current episode of low back pain
- mechanical origin
- Threshold low back pain level
Who cannot join
- Contraindications to spinal manipulation or massage
- Complicating conditions that could confound clinical outcome
- Prophylactic use of prescription medication
- Health-related litigation, claims, or disability compensation
Trial locations and contacts
1 site in 1 country.
United States1 site
Western States Chiropractic College
Portland, Oregon, 97230
About this study
Official title: Dose-Response/Efficacy of Manipulation for Chronic LBP
This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.
- Conditions
- Low Back Pain
- Being tested
- Spinal Manipulation, Light Massage, Pulsed Ultrasound
- Keywords
- Low Back Pain, Chronic, Manipulation, Chiropractic, Massage
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationProcedure or surgery
5 minutes high velocity, low amplitude lumbar thrust
Light MassageProcedure or surgery
light pressure massage of the low back.
Pulsed UltrasoundProcedure or surgery
5 minutes pulsed ultrasound
| Study group | Role | What they receive |
|---|---|---|
| High dose manipulation | Experimental | High dose spinal manipulation + ultrasound Receives: Procedure: Spinal Manipulation; Procedure: Pulsed Ultrasound |
| Moderate dose manipulation | Experimental | Moderate dose manipulation + low dose massage + ultrasound Receives: Procedure: Spinal Manipulation; Procedure: Light Massage; Procedure: Pulsed Ultrasound |
| Low dose manipulation | Experimental | low dose spinal manipulation + moderate dose massage + ultrasound Receives: Procedure: Spinal Manipulation; Procedure: Light Massage; Procedure: Pulsed Ultrasound |
| High dose masssage | Other | high dose massage + ultrasound Receives: Procedure: Light Massage; Procedure: Pulsed Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Von Korff Pain Scale for low back pain
Measured: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Modified Von Korff Disability Scale
Measured: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Secondary outcomes (9)
Pain days
Measured: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Disability days
Measured: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Low back pain unpleasantness
Measured: baseline 2, 6, 12, 18, 24, 39, 52 weeks
Fear avoidance beliefs
Measured: baseline 2, 6, 12, 18, 24, 39, 52 weeks
General health status/QoL
Measured: baseline 2; 12, 24, 39, 52 weeks
Patient satisfaction
Measured: 12 wk
Healthcare utilization
Measured: baseline 2; 6, 12, 18, 24, 39, 52 weeks
Objective measures
Measured: Baseline 2, 6 wk
Bias monitoring
Measured: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startMar 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western States
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Mitchell Haas, University of Western States
- Investigators
- Mitchell Haas, DC, MA, Principal investigator, University of Western States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376350
- Sponsor's protocol ID
- U01AT001908
- Other IDs
- U01AT001908
- Status last verified
- Aug 2015
- First submitted
- 12 Sep 2006
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. doi: 10.1016/j.spinee.2004.02.008.
PubMed 15363431Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.
PubMed 24139233Haas M, Vavrek D, Neradilek MB, Polissar N. A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain. BMC Complement Altern Med. 2014 Jan 13;14:16. doi: 10.1186/1472-6882-14-16.
PubMed 24410959Vavrek D, Haas M, Neradilek MB, Polissar N. Prediction of pain outcomes in a randomized controlled trial of dose-response of spinal manipulation for the care of chronic low back pain. BMC Musculoskelet Disord. 2015 Aug 19;16:205. doi: 10.1186/s12891-015-0632-0.
PubMed 26286532Vavrek DA, Sharma R, Haas M. Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial. J Manipulative Physiol Ther. 2014 Jun;37(5):300-11. doi: 10.1016/j.jmpt.2014.03.002.
PubMed 24928639
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response/Efficacy of Manipulation for Chronic LBP
- ClinicalTrials.gov ID
- NCT00376350
- Acronym / sponsor ID
- U01AT001908
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Chronic, Manipulation, Chiropractic, Massage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of Western StatesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Sep 2006 (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.
This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High dose manipulation | Experimental | Procedure: Spinal Manipulation, Procedure: Pulsed UltrasoundHigh dose spinal manipulation + ultrasound |
| Moderate dose manipulation | Experimental | Procedure: Spinal Manipulation, Procedure: Light Massage, Procedure: Pulsed UltrasoundModerate dose manipulation + low dose massage + ultrasound |
| Low dose manipulation | Experimental | Procedure: Spinal Manipulation, Procedure: Light Massage, Procedure: Pulsed Ultrasoundlow dose spinal manipulation + moderate dose massage + ultrasound |
| High dose masssage | Other | Procedure: Light Massage, Procedure: Pulsed Ultrasoundhigh dose massage + ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current episode of low back pain
- mechanical origin
- Threshold low back pain level
Key exclusion criteria (4 listed)
- Contraindications to spinal manipulation or massage
- Complicating conditions that could confound clinical outcome
- Prophylactic use of prescription medication
- Health-related litigation, claims, or disability compensation
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 Manipulation5 minutes high velocity, low amplitude lumbar thrust | Procedure or surgery | High dose manipulation, Low dose manipulation, Moderate dose manipulation |
| Light Massagelight pressure massage of the low back. | Procedure or surgery | High dose masssage, Low dose manipulation, Moderate dose manipulation |
| Pulsed Ultrasound5 minutes pulsed ultrasound | Procedure or surgery | High dose manipulation, High dose masssage, Low dose manipulation, Moderate dose manipulation |
Primary outcome
Modified Von Korff Pain Scale for low back pain
Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Modified Von Korff Disability Scale
Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
9 secondary outcomes
Pain days
Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Disability days
Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Low back pain unpleasantness
Time frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks
Fear avoidance beliefs
Time frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks
General health status/QoL
Time frame: baseline 2; 12, 24, 39, 52 weeks
Patient satisfaction
Time frame: 12 wk
Healthcare utilization
Time frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks
Objective measures
Time frame: Baseline 2, 6 wk
Bias monitoring
Time frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks
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 24 Aug 2015.
- Background: PubMed 15363431Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. doi: 10.1016/j.spinee.2004.02.008.
- Results publication: PubMed 24139233Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.
- Results publication: PubMed 24410959Haas M, Vavrek D, Neradilek MB, Polissar N. A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain. BMC Complement Altern Med. 2014 Jan 13;14:16. doi: 10.1186/1472-6882-14-16.
- Results publication: PubMed 26286532Vavrek D, Haas M, Neradilek MB, Polissar N. Prediction of pain outcomes in a randomized controlled trial of dose-response of spinal manipulation for the care of chronic low back pain. BMC Musculoskelet Disord. 2015 Aug 19;16:205. doi: 10.1186/s12891-015-0632-0.
- Results publication: PubMed 24928639Vavrek DA, Sharma R, Haas M. Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial. J Manipulative Physiol Ther. 2014 Jun;37(5):300-11. doi: 10.1016/j.jmpt.2014.03.002.
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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.
Mitchell Haas, DC, MA principal investigator
University of Western States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Spinal Manipulation, Light Massage and Pulsed Ultrasound in people with Low Back Pain, run by University of Western States 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 3 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 24 Aug 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Modified Von Korff Pain Scale for low back pain (time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks). 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?
On the ClinicalTrials.gov record for NCT00376350, which also lists 5 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 24 Aug 2015.