Chronic Lower Back PainPhase 3NCT01894282
Mind Body Intervention for Chronic Lower Back Pain
A Phase 3 study testing Manual Therapy and Mind Body Intervention in people with Chronic Lower Back Pain, run by Canandaigua VA Medical Center at 1 site in United States.
Trial summary
This pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain (CBT-p). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Chronic Lower Back Pain
- What is being tested?
- Manual Therapy and Mind Body Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2017
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 69 years of age with CLBP who are
- "high risk" for poor prognosis based on SBST
- currently undergoing chiropractic care.
Who cannot join
- Contraindications to either MT or CBT-p.
- Patients who are currently undergoing CBT-p
- who have been treated for substance abuse in the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Outpatient Clinic
Rochester, New York, 14620
About this study
Official title: Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study
This pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the combined intervention of CBT-p and MT and those undergoing MT alone.
Read the detailed description
Given that this is a pilot study we will use simple descriptive statistics for patient characteristics, including age, sex, BMI and baseline scores on outcome measures. In addition we will assess the inter-rater reliability of the scoring of the delivery of the CBT-p by the two trained practitioners utilizing kappa statistics. We will perform data analyses using SPSS.
- Conditions
- Chronic Lower Back Pain
- Being tested
- Manual Therapy, Mind Body Intervention
- Keywords
- Chronic Lower Back Pain, Manual Therapy, Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyProcedure or surgery
Also called Spinal Manipulative Therapy, Spinal Mobilization, Flexion Distraction Therapy
Manual Therapy Arm
Mind Body InterventionProcedure or surgery
Also called Manual Therapy, Cognitive Behavioral Therapy for Pain
Combination of manual therapy and cognitive behavioral therapy for pain.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy | Active comparator | Spinal Manipulative therapy (SMT) for the purpose of this study we will allow the use of other types of MT, including non-thrust spinal mobilization and flexion-distraction technique. Receives: Procedure: Manual Therapy |
| Mind Body Intervention (MBI) | Experimental | Mind Body Intervention will consist of a combination of the previously described "manual therapy" and Cognitive Behavioral Therapy for pain (CBT-p). Cognitive Behavioral Therapy for pain management has three basic components. The treatment rationale, coping skills training and application and maintenance of learned coping skills. Receives: Procedure: Manual Therapy; Procedure: Mind Body Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The VAS is a patient completed analogue measure that evaluates pain intensity on a 100 mm long horizontal line, which is anchored at each end with a statement representing the extremes of the dimension being measured. In this case the left hand side reads, "no pain" and the right hand side reads "worst pain possible". The VAS scale utilized will assess pain at the current time. The VAS has been established as a reliable, valid and generalizable measure that can be administered in a wide range of clinical and experimental settings.
Measured: Baseline and 6 weeks post baseline (immediately post intervention)
Secondary outcomes (1)
PROMIS Global Health Scale (GHS)
Health outcomes assessment has advanced to a point where generic health-related quality of life (HRQL) measures are often used to examine the health status of populations and the effects of medical interventions. Generic HRQL profile measures, such as the SF-36 Health Survey, provide multiple health domains scores (e.g., physical function, mental health, pain, vitality, etc.), but not an overall index score. Patient reported outcome measurement information system has developed a quality of life tool that provides an overall index score for quality of life. The main advantage of the PROMIS measures over other static health status measures is that the PROMIS domain item banks and scores allow flexibility in administration using either targeted short forms or computerized adaptive testing. This form has recently been validated in comparison to the EuroQual.
Measured: Baseline and 6 weeks post baseline (immediately post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Dougherty, DC, Canandaigua VA Medical Center
- Investigators
- Paul Dougherty, DC, Principal investigator, Canandaigua VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894282
- Sponsor's protocol ID
- MBI001
- Status last verified
- Mar 2022
- First submitted
- 1 Jul 2013
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT01894282
- Acronym / sponsor ID
- MBI001
- Conditions
- Chronic Lower Back Pain
- Keywords
- Chronic Lower Back Pain, Manual Therapy, Cognitive Behavioral Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Study start
- Jul 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 10 Jul 2013 (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 pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the combined intervention of CBT-p and MT and those undergoing MT alone.
Detailed description
Given that this is a pilot study we will use simple descriptive statistics for patient characteristics, including age, sex, BMI and baseline scores on outcome measures. In addition we will assess the inter-rater reliability of the scoring of the delivery of the CBT-p by the two trained practitioners utilizing kappa statistics. We will perform data analyses using SPSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy | Active comparator | Procedure: Manual TherapySpinal Manipulative therapy (SMT) for the purpose of this study we will allow the use of other types of MT, including non-thrust spinal mobilization and flexion-distraction technique. |
| Mind Body Intervention (MBI) | Experimental | Procedure: Manual Therapy, Procedure: Mind Body InterventionMind Body Intervention will consist of a combination of the previously described "manual therapy" and Cognitive Behavioral Therapy for pain (CBT-p). Cognitive Behavioral Therapy for pain management has three basic components. The treatment rationale, coping skills training and application and maintenance of learned coping skills. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 69 years of age with CLBP who are
- "high risk" for poor prognosis based on SBST
- currently undergoing chiropractic care.
Key exclusion criteria (3 listed)
- Contraindications to either MT or CBT-p.
- Patients who are currently undergoing CBT-p
- who have been treated for substance abuse in the past year.
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 TherapyAlso: Spinal Manipulative Therapy, Spinal Mobilization, Flexion Distraction TherapyManual Therapy Arm | Procedure or surgery | Manual Therapy, Mind Body Intervention (MBI) |
| Mind Body InterventionAlso: Manual Therapy, Cognitive Behavioral Therapy for PainCombination of manual therapy and cognitive behavioral therapy for pain. | Procedure or surgery | Mind Body Intervention (MBI) |
Primary outcome
Visual Analogue Scale
Time frame: Baseline and 6 weeks post baseline (immediately post intervention)
The VAS is a patient completed analogue measure that evaluates pain intensity on a 100 mm long horizontal line, which is anchored at each end with a statement representing the extremes of the dimension being measured. In this case the left hand side reads, "no pain" and the right hand side reads "worst pain possible". The VAS scale utilized will assess pain at the current time. The VAS has been established as a reliable, valid and generalizable measure that can be administered in a wide range of clinical and experimental settings.
1 secondary outcome
PROMIS Global Health Scale (GHS)
Time frame: Baseline and 6 weeks post baseline (immediately post intervention)
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 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Paul Dougherty, DC principal investigator
Canandaigua VA Medical Center
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 Manual Therapy and Mind Body Intervention in people with Chronic Lower Back Pain, run by Canandaigua VA Medical Center 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 3 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 31 Mar 2022. 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?
Visual Analogue Scale (time frame: Baseline and 6 weeks post baseline (immediately post intervention)). 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 31 Mar 2022.