Low Back PainPhase 3NCT00916734
Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation
A Phase 3 study testing MDT (McKenzie Method) and Spinal thrust manipulation in people with Low Back Pain, run by Daemen College at 1 site in United States.
Trial summary
The purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- MDT (McKenzie Method) and Spinal thrust manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2009
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people who meet the clinical prediction rule for spinal manipulation
Who cannot join
- people receiving worker's compensation
- those who have had spinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Patient Response to Therapeutic Exercise Based on the Clinical Prediction Rule for Spinal Manipulation
The purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). The investigators do not know which of these two commonly-used treatments (manipulation or specific exercise) is better to treat low back pain.
Read the detailed description
With the trends in health care focusing on treatment effectiveness, it is important for physical therapists to select the most appropriate intervention according to patient classification. Physical therapy interventions for management of LBP include therapeutic exercises and spinal manipulation.
The purpose of this study is to determine whether patients who fit the Clinical Prediction Rule (CPR) for spinal manipulation may respond instead to exercise according to repeated lumbar movements in the direction of preference.
The subjects for this study will be comprised of individuals referred for treatment of low back pain and data will be collected by physical therapists with certification in MDT who had experience treating patients through the use of spinal manipulation. Patient functional questionnaires and impairment measures will be used to analyze the patient's perceived level of function and outcome.
Following the completion of an informed consent, subjects will undergo a physical therapy examination by a licensed physical therapist. Patients will be included in the study if they meet the CPR for spinal manipulation as describe in earlier research 6,11. Following the examination, all qualified subjects will be randomly assigned to either the (1) spinal manipulation group or (2) the McKenzie (MDT) group and will receive treatment in accordance with their assigned group. The assessment tools administered at the initial examination will be readministered for follow-up analysis.
- Conditions
- Low Back Pain
- Being tested
- MDT (McKenzie Method), Spinal thrust manipulation
- Keywords
- McKenzie, thrust manipulation, clinical prediction rule
- 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.
MDT (McKenzie Method)Procedure or surgery
Also called functional outcomes
Subjects who perform exercises in their direction of preference.
Spinal thrust manipulationProcedure or surgery
Subjects who receive spinal thrust manipulation as an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulation Group | Experimental | Subjects who received spinal thrust manipulation as an intervention. Receives: Procedure: Spinal thrust manipulation |
| McKenzie MDT Group | Active comparator | Not described Receives: Procedure: MDT (McKenzie Method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level as measured on numerical pain rating scale
Measured: 1 year
Secondary outcomes (1)
Oswestry score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daemen College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald J. Schenk, Daemen College
- Investigators
- Ronald J Schenk, PT, PhD, Principal investigator, Daemen College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916734
- Sponsor's protocol ID
- SOCH/IRB/0614
- Status last verified
- Dec 2011
- First submitted
- 8 Jun 2009
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Response to Therapeutic Exercise Based on the Clinical Prediction Rule for Spinal Manipulation
- ClinicalTrials.gov ID
- NCT00916734
- Acronym / sponsor ID
- SOCH/IRB/0614
- Conditions
- Low Back Pain
- Keywords
- McKenzie, thrust manipulation, clinical prediction rule
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Daemen CollegeUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Jun 2009 (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 purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). The investigators do not know which of these two commonly-used treatments (manipulation or specific exercise) is better to treat low back pain.
Detailed description
With the trends in health care focusing on treatment effectiveness, it is important for physical therapists to select the most appropriate intervention according to patient classification. Physical therapy interventions for management of LBP include therapeutic exercises and spinal manipulation.
The purpose of this study is to determine whether patients who fit the Clinical Prediction Rule (CPR) for spinal manipulation may respond instead to exercise according to repeated lumbar movements in the direction of preference.
The subjects for this study will be comprised of individuals referred for treatment of low back pain and data will be collected by physical therapists with certification in MDT who had experience treating patients through the use of spinal manipulation. Patient functional questionnaires and impairment measures will be used to analyze the patient's perceived level of function and outcome.
Following the completion of an informed consent, subjects will undergo a physical therapy examination by a licensed physical therapist. Patients will be included in the study if they meet the CPR for spinal manipulation as describe in earlier research 6,11. Following the examination, all qualified subjects will be randomly assigned to either the (1) spinal manipulation group or (2) the McKenzie (MDT) group and will receive treatment in accordance with their assigned group. The assessment tools administered at the initial examination will be readministered for follow-up analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulation Group | Experimental | Procedure: Spinal thrust manipulationSubjects who received spinal thrust manipulation as an intervention. |
| McKenzie MDT Group | Active comparator | Procedure: MDT (McKenzie Method) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- people who meet the clinical prediction rule for spinal manipulation
Key exclusion criteria (2 listed)
- people receiving worker's compensation
- those who have had spinal surgery
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 |
|---|---|---|
| MDT (McKenzie Method)Also: functional outcomesSubjects who perform exercises in their direction of preference. | Procedure or surgery | McKenzie MDT Group |
| Spinal thrust manipulationSubjects who receive spinal thrust manipulation as an intervention. | Procedure or surgery | Spinal Manipulation Group |
Primary outcome
Pain level as measured on numerical pain rating scale
Time frame: 1 year
1 secondary outcome
Oswestry score
Time frame: 1 year
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 Dec 2011.
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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.
Ronald J Schenk, PT, PhD principal investigator
Daemen College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MDT (McKenzie Method) and Spinal thrust manipulation in people with Low Back Pain, run by Daemen College 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 1 inclusion and 2 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 Dec 2011. 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 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?
Pain level as measured on numerical pain rating scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2011.