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OpenTrials
Completed

NCT Number: NCT03432169

Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?

The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class)

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center

Rochester, New York, 14620, United States

About this study

The study will approach all new or existing patients within the chiropractic clinic between the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or equal to 3, who have no contraindications to active exercise. Patients will be queried as to interest and those interested will be consented. The investigators will recruit a total of 20 patients. Patients will then be randomized to receive either an 8 week active exercise class with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching class). Both groups will have home exercise requirements and will be held accountable through the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8 week intervention. Clinician open ended questionnaire will be given to both study clinicians at the end of the trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Veterans between the ages of 18-89
  • Lower back pain > 12 weeks
  • Have the ability to exercise independently.

Exclusion criteria

  • Subjects will be excluded if
  • They are currently enrolled in or maintain a home meditation practice
  • If they are currently involved in a mindfulness or cognitive behavioral therapy group.
  • If they have participated in a structured group yoga class in the last three months.
  • If they have an open workers compensation or no-fault case or have undergone spinal surgery in the past 6 months.

Treatment and study plan

Yoga (stretching plus mindfulness)

Other

Stretching plus mindfulness

Stretching

Other

Stretching alone

Primary outcomes

  1. Feasibility

    Time frame: 6 months

    The main purpose of the study is to assess feasibility of conducting a larger trial. The study team will assess number of Veterans recruited and enrolled in the study. Number of sessions completed.

Secondary outcomes

  1. PROMIS Global Health Scale (GHS):

    Time frame: baseline, immediately post intervention

    Patient reported outcome measurement information system has developed a quality of life tool that provides an overall index score for quality of life. This form has recently been validated in comparison to the EuroQual. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured.

  2. Pain, Engagement and General activity (PEG)

    Time frame: baseline, immediately post intervention

    An ultra-brief three-item scale derived from the Brief Pain Inventory (BPI), was a reliable and valid measure of pain among primary care patients with chronic musculoskeletal pain and diverse VA ambulatory patients.

Sponsors and collaborators

Lead sponsor

Canandaigua VA Medical Center

Fed

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 14, 2018
Registry last updated
Oct 10, 2019

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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