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Completed

NCT Number: NCT01894282

Mind Body Intervention for Chronic Lower Back Pain

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rochester Outpatient Clinic

Rochester, New York, 14620, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 69 years of age with CLBP who are
  • "high risk" for poor prognosis based on SBST
  • currently undergoing chiropractic care.

Exclusion criteria

  • 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.

Treatment and study plan

Manual Therapy

Procedure

Manual Therapy Arm

Other names: Spinal Manipulative Therapy, Spinal Mobilization, Flexion Distraction Therapy

Mind Body Intervention

Procedure

Combination of manual therapy and cognitive behavioral therapy for pain.

Other names: Manual Therapy, Cognitive Behavioral Therapy for Pain

Primary outcomes

  1. 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.

Secondary outcomes

  1. PROMIS Global Health Scale (GHS)

    Time frame: Baseline and 6 weeks post baseline (immediately post intervention)

    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.

Other outcomes

  1. Patient Satisfaction Questionnaire

    Time frame: Baseline and post intervention

    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.

Sponsors and collaborators

Lead sponsor

Canandaigua VA Medical Center

Fed

Registry information

Official study title

Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 10, 2013
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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