Yoga for Chronic Low Back Pain

NCT00865358 | Completed Phase 2

• 1 other identifier: AT002915
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic low back pain is the most common cause of pain in the United States. Common treatments such as medication, physical therapy, and surgery often do not provide adequate relief. Yoga has shown promise for improving low back pain in studies of predominantly middle class white individuals. We will assess the feasibility and collect preliminary data on yoga for chronic low back pain in predominantly minority individuals in a community health center setting in a low income neighborhood of Boston, Massachusetts. We hypothesize that offering yoga for this population is feasible and will show promising efficacy and safety data.

Conditions

Chronic Low Back Pain

Keywords

yoga; complementary alternative medicine; low back pain; minority health; health care disparities; community health centers

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Previous 7 days

• Back related function (Modified Roland Morris Disability Scale)

  previous 7 days

Secondary Outcomes (4)

• Pain medication use

  previous 7 days

• Global improvement

  previous 12 weeks

• Health Related Quality of Life (SF-36)

  previous 7 days

• Adverse events

  12 weeks

Study Arms (2)

Yoga Group

EXPERIMENTAL

A standardized hatha yoga protocol delivered in 12 weekly classes.

Behavioral: Yoga Group

Usual care

NO INTERVENTION

Participants continue to receive their usual medical care for their back pain

Interventions

Yoga Group BEHAVIORAL

Reproducible standardized 12 week series of hatha yoga classes specifically developed for patients with chronic low back pain and little or no experience with yoga

Also known as: Hatha yoga classes

Yoga Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old. The rationale for including adults only less than 65 years old is that the causes of low back pain in older persons are more likely to be multifactorial (e.g., degenerative disk disease, spinal canal stenosis, fractures) and less likely to be the non-specific muscular type that our yoga protocol was designed to address. A study of yoga for low back pain in individuals \> 65 years old is important. However, the ideal design would likely benefit from a yoga protocol specifically designed for this purpose.

You may not qualify if:

• Average pain intensity during the week prior to enrollment is 4 or greater on a 0 to 10 numerical pain scale (0=no pain, 10=worst possible pain).
• Compliant with filling out a 2 week daily pain score dairy during the eligibility screening processes.
• Ability to comprehend, read, and write English at a level necessary to understand the yoga class instructions and complete data collection forms. Given that this is the first pilot for the yoga protocol and the first trial of yoga for low back pain for predominantly minority adults at BMC and affiliated clinics, we have decided to enhance feasibility by focusing on English speakers first. Our goal is ultimately to study and offer this intervention in other languages commonly spoken by BMC patients (e.g., Spanish). We fully anticipate that this trial will provide the necessary experience to return to the IRB in the near future with a proposal for a pilot trial of Spanish speakers with chronic low back pain.
• Individuals with sufficient English language ability from all ethnic groups can enroll. However, since this pilot study is specifically targeting minorities with chronic low back pain, we will purposefully allocate 80% (24 of 30) of the openings in the study to minority subjects (ascertained by self-report).
• Consent to participate.
• Age \> 64 years old.
• Yoga use in the previous 12 months.
• Inability to understand English at a level necessary to follow yoga class instructions.
• Pregnancy - although back pain in pregnancy is common and may be amenable to yoga, the causes of the pain are likely different than non specific chronic low back pain in nonpregnant adults.
• Change in pain medications four weeks or fewer prior to enrollment.
• Other back pain treatments (e.g., physical therapy, epidural steroid injection, chiropractic, acupuncture) anticipated to begin in the next 6 months or initiated less than four weeks prior to enrollment.
• Suicidal thoughts detected through the eligibility interview. Those who report suicidal thoughts will immediately be referred to their PCP and/or the BMC Department of Psychiatry.
• Lack of consent to participate.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (2)

Dorchester Multi-Service Center

Dorchester, Massachusetts, 02122, United States

Location

Codman Square Health Center

Dorchester, Massachusetts, 02124, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert B Saper, MD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 19, 2009
• Study Start: February 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: January 1, 2008
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

US (2)