A Phase 3 interventional study of Manual Therapy and Mind Body Intervention in Chronic Lower Back Pain, sponsored by Canandaigua VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Canandaigua VA Medical Center · Phase 3, Interventional, and Treatment
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.
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 4 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Canandaigua VA Medical Center is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Manual Therapy
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.
Procedure: Manual Therapy · Procedure: Mind Body Intervention
Manual Therapy Arm
Also known as: Spinal Manipulative Therapy, Spinal Mobilization, Flexion Distraction Therapy
Combination of manual therapy and cognitive behavioral therapy for pain.
Also known as: Manual Therapy, Cognitive Behavioral Therapy for Pain
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.
Time frame: Baseline and 6 weeks post baseline (immediately post intervention)
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.
Time frame: Baseline and 6 weeks post baseline (immediately post intervention)
Patient Satisfaction Questionnaire
Cherkin et al, in the evaluation of a physician education program developed a patient satisfaction questionnaire which was found to be reliable and valid. The questionnaire utilized in this study will incorporate these same questions. Additional questions to be included focus on the burden of the data collection activities, and suggestions for subject recruitment.
Time frame: Baseline and post intervention
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Jul 2013, a primary completion of Aug 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Canandaigua VA Medical Center