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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432169
• Other study ID #: IRBnet 1135250
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: Canandaigua VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Yoga (stretching plus mindfulness)
Stretching plus mindfulness
• Stretching
Stretching alone

Locations

Country	Name	City	State
United States	Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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.	6 months
Secondary	PROMIS Global Health Scale (GHS):	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.	baseline, immediately post intervention
Secondary	Pain, Engagement and General activity (PEG)	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.	baseline, immediately post intervention