Mechanical Low Back PainPhase 2NCT01438203
Thrust Manipulation Versus Non-Thrust Manipulation
A Phase 2 study testing Thrust manipulation and Non-thrust manipulation in people with Mechanical Low Back Pain, run by Walsh University at 1 site in United States.
Trial summary
The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Thrust manipulation and Non-thrust manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 2
- 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
- Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study.
- For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments.
Who cannot join
- The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- Signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°
- Muscle weakness involving a major muscle group of the lower extremity,
- Diminished lower extremity muscle stretch reflex
- Diminished or absent sensation to pinprick in any lower extremity dermatome)
- Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial
The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.
Read the detailed description
Thrust manipulation is considered traditional spinal manipulation. Nonthrust manipulation is considered mobilization. The mobilization will be used in a similar manner as in clinical practice and this differs from past studies.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Thrust manipulation, Non-thrust manipulation
- Keywords
- manipulation, mobilization, low back pain, treatment
- 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.
Thrust manipulationProcedure or surgery
Also called Manipualtion (Manip)
Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region
Non-thrust manipulationProcedure or surgery
Also called Mobilization (Mob)
Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback
| Study group | Role | What they receive |
|---|---|---|
| Thrust manipulation | Experimental | Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals Receives: Procedure: Thrust manipulation |
| Non-thrust manipulation | Active comparator | Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals Receives: Procedure: Non-thrust manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
Change score
Measured: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Secondary outcomes (1)
Numeric Pain Rating Scale (NPRS)
Change score
Measured: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 Mechanical 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walsh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad Cook, Walsh University
- Investigators
- Chad E Cook, PhD, Principal investigator, Walsh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438203
- Sponsor's protocol ID
- Walsh 10-24
- Status last verified
- Aug 2012
- First submitted
- 19 Sep 2011
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cook CE, Learman KE, O'Halloran BJ, Showalter CR, Kabbaz VJ, Goode AP, Wright AA. Which prognostic factors for low back pain are generic predictors of outcome across a range of recovery domains? Phys Ther. 2013 Jan;93(1):32-40. doi: 10.2522/ptj.20120216. Epub 2012 Aug 9.
PubMed 22879443
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01438203
- Acronym / sponsor ID
- Walsh 10-24
- Conditions
- Mechanical Low Back Pain
- Keywords
- manipulation, mobilization, low back pain, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Walsh UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Sep 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.
The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.
Detailed description
Thrust manipulation is considered traditional spinal manipulation. Nonthrust manipulation is considered mobilization. The mobilization will be used in a similar manner as in clinical practice and this differs from past studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrust manipulation | Experimental | Procedure: Thrust manipulationClinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals |
| Non-thrust manipulation | Active comparator | Procedure: Non-thrust manipulationClinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study.
- For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments.
Key exclusion criteria (6 listed)
- The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- Signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°
- Muscle weakness involving a major muscle group of the lower extremity,
- Diminished lower extremity muscle stretch reflex
- Diminished or absent sensation to pinprick in any lower extremity dermatome)
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 |
|---|---|---|
| Thrust manipulationAlso: Manipualtion (Manip)Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region | Procedure or surgery | Thrust manipulation |
| Non-thrust manipulationAlso: Mobilization (Mob)Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback | Procedure or surgery | Non-thrust manipulation |
Primary outcome
Oswestry disability index
Time frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Change score
1 secondary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 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 5 Sep 2012.
- Derived from this study: PubMed 22879443Cook CE, Learman KE, O'Halloran BJ, Showalter CR, Kabbaz VJ, Goode AP, Wright AA. Which prognostic factors for low back pain are generic predictors of outcome across a range of recovery domains? Phys Ther. 2013 Jan;93(1):32-40. doi: 10.2522/ptj.20120216. Epub 2012 Aug 9.
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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.
Chad E Cook, PhD principal investigator
Walsh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thrust manipulation and Non-thrust manipulation in people with Mechanical Low Back Pain, run by Walsh University 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 6 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 Sep 2012. 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 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.
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?
Oswestry disability index (time frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 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 NCT01438203, 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 5 Sep 2012.