Mechanical Low Back PainNCT01744015
Influence of Patient-Informed Choice in a Novel Treatment Model for LBP
A study testing Patient Decision Making tool in people with Mechanical Low Back Pain, run by Walsh University at 1 site in United States.
Trial summary
1. (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain. 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?
- Patient Decision Making tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older with mechanically producible LBP
Who cannot join
- the presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.), or 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, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Proaxis Physical Therapy
Greenville, South Carolina, 29602
About this study
Official title: Influence of Patient-Informed Choice in a Novel Treatment Model for LBP: A Randomized Controlled Trial
- (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain. (We hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach)
- (Secondary) To qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (We hypothesize that dialogue method of patient guided choice will be identified as most useful)
Read the detailed description
The purpose of this research study proposal is to evaluate patient choice within this physical therapist-led model for non-specific low back pain. Evidence exists that patients are eager to play an active role in decisions concerning their health. Recent evidence from research supports the benefit of decision aides for consumers, especially those that were accurate and refined to the specific problems of each patient. In our proposed randomized controlled trial (RCT), one group of patients in the study will have the opportunity to drive choices within their healthcare model; but only after receiving useful information on what the consequences of their selections will be. Patients will receive decision making information to assist in making an informed choice. The structured information will organize known results from the research literature to assist patients in understanding the likely outcome of their condition and what they need to adequately manage their own care. The control group of patients will receive the Physical therapist-directed care model that is presently used and has shown success. Patient outcomes will involve patient self report of improvement and whether or not the patient pursued care for the same condition over a 1 year period of time.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Patient Decision Making tool, Standard of care
- Keywords
- 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.
Patient Decision Making toolBehavioural
The experimental group will consist of typical care from the physical therapist (as with the control group) with the addition of the patient decision support tool and information dissemination. The process of information dissemination for informed decision making. Based on the literature, we have deemed three points of informational contact as necessary to improve informed decision making. We plan to inform patients through the use of a) pre-material, b) dialogue, and c) reinforcement means.
Standard of careOther
A control group will receive typical care from the physical therapist. Typical care includes physical therapist directed care of patients with low back pain, using standardized treatment algorithms (guideline oriented) for referral to physicians during cases of concern. In this model, a physician is consulted when the physical therapists feel it is necessary; or when directly requested by a patient. Physician consult is not normally provided as an option for the control group, unless evidence exists within the examination to suggest the need from a mutually agreed upon examination scheme including identification of red flags between the PT and physician. In the current model, because most of patients seen are diagnosed with non-specific LBP and do not require imaging or prescriptive medications, a majority are treated actively by the physical therapists-only during the initial visit.
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Making Tool | Experimental | Patients will be given an opportunity to use a decision making tool to assist in decision making of their care Receives: Behavioral: Patient Decision Making tool |
| Standard of care | Active comparator | Control group consisting of normal care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Seeking Behavior (recurrence of back pain) at 1 year
Care seeking behavior is defined as a recurrence of symptoms, no resolution of symptoms at 1 year
Measured: 1 year status post discharge from formal physical therapy care
Secondary outcomes (1)
Oswestry Disability Index
At discharge (after care) the Oswestry will be measured and compared
Measured: participants will be followed for the duration of the treatment which is on average 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: We did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walsh University
- Sponsor type
- University, hospital or other
- Collaborators
- Proaxis Therapy
- Responsible party
- Principal investigator, Chad Cook, Walsh University
- Investigators
- Chad E Cook, phd, Principal investigator, Walsh U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744015
- Sponsor's protocol ID
- 6291965
- Other IDs
- WalshU1
- Status last verified
- Dec 2012
- First submitted
- 2 Dec 2012
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Patient-Informed Choice in a Novel Treatment Model for LBP: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01744015
- Acronym / sponsor ID
- 6291965
- Conditions
- Mechanical Low Back Pain
- Keywords
- Low back pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Walsh UniversityUniversity, hospital or other
- Collaborators
- Proaxis Therapy
- Study start
- Apr 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 Dec 2012 (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.
- (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain. (We hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach)
- (Secondary) To qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (We hypothesize that dialogue method of patient guided choice will be identified as most useful)
Detailed description
The purpose of this research study proposal is to evaluate patient choice within this physical therapist-led model for non-specific low back pain. Evidence exists that patients are eager to play an active role in decisions concerning their health. Recent evidence from research supports the benefit of decision aides for consumers, especially those that were accurate and refined to the specific problems of each patient. In our proposed randomized controlled trial (RCT), one group of patients in the study will have the opportunity to drive choices within their healthcare model; but only after receiving useful information on what the consequences of their selections will be. Patients will receive decision making information to assist in making an informed choice. The structured information will organize known results from the research literature to assist patients in understanding the likely outcome of their condition and what they need to adequately manage their own care. The control group of patients will receive the Physical therapist-directed care model that is presently used and has shown success. Patient outcomes will involve patient self report of improvement and whether or not the patient pursued care for the same condition over a 1 year period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Making Tool | Experimental | Behavioral: Patient Decision Making toolPatients will be given an opportunity to use a decision making tool to assist in decision making of their care |
| Standard of care | Active comparator | Other: Standard of careControl group consisting of normal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older with mechanically producible LBP
Key exclusion criteria (1 listed)
- the presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.), or 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, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy.
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 |
|---|---|---|
| Patient Decision Making toolThe experimental group will consist of typical care from the physical therapist (as with the control group) with the addition of the patient decision support tool and information dissemination. The process of information dissemination for informed decision making. Based on the literature, we have deemed three points of informational contact as necessary to improve informed decision making. We plan to inform patients through the use of a) pre-material, b) dialogue, and c) reinforcement means. | Behavioural | Patient Decision Making Tool |
| Standard of careA control group will receive typical care from the physical therapist. Typical care includes physical therapist directed care of patients with low back pain, using standardized treatment algorithms (guideline oriented) for referral to physicians during cases of concern. In this model, a physician is consulted when the physical therapists feel it is necessary; or when directly requested by a patient. Physician consult is not normally provided as an option for the control group, unless evidence exists within the examination to suggest the need from a mutually agreed upon examination scheme including identification of red flags between the PT and physician. In the current model, because most of patients seen are diagnosed with non-specific LBP and do not require imaging or prescriptive medications, a majority are treated actively by the physical therapists-only during the initial visit. | Other | Standard of care |
Primary outcome
Care Seeking Behavior (recurrence of back pain) at 1 year
Time frame: 1 year status post discharge from formal physical therapy care
Care seeking behavior is defined as a recurrence of symptoms, no resolution of symptoms at 1 year
1 secondary outcome
Oswestry Disability Index
Time frame: participants will be followed for the duration of the treatment which is on average 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
Related trials for Mechanical Low Back Pain
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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
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Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
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Fusion or Not - a Study on Low Back Pain
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Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
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Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
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 U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Decision Making tool 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 Jul 2013. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Care Seeking Behavior (recurrence of back pain) at 1 year (time frame: 1 year status post discharge from formal physical therapy care). 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 10 Jul 2013.