Yoga, Education, and Nidra for Low Back Pain

Overseen By Abigail Anderson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Non-English, Diabetes, Surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different therapies can assist individuals with chronic low back pain. Researchers aim to determine if combining yoga with either yoga nidra (a type of guided meditation) or relaxing music can reduce pain, improve well-being, and enhance sleep quality. Participants will be divided into two groups: one practicing yoga with yoga nidra and the other with relaxing music, both alongside pain education. This trial suits those who have experienced low back pain for more than three months and endure moderate daily pain. As an unphased trial, it provides a unique opportunity to explore innovative therapies for enhancing quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that yoga can safely and effectively manage chronic low back pain. However, some individuals might experience a temporary increase in back pain, affecting about 10-15%. These increases typically resolve quickly.

Yoga Nidra, a type of guided meditation, carries a similar risk. The most common side effect is increased back pain, but it poses no greater risk than other similar treatments.

Overall, both yoga and Yoga Nidra are generally well-tolerated. Most people find these treatments manageable and helpful for relieving back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for low back pain because they combine holistic practices like yoga and yoga nidra with pain education and relaxing music. Unlike traditional treatments such as medication or physical therapy, yoga nidra incorporates guided meditation focusing on pain acceptance and motor imagery, which can help patients mentally process and manage their pain. Additionally, the use of relaxing music aims to enhance the calming effects of yoga, providing a non-invasive and drug-free approach that could lead to improved pain management and overall well-being. These treatments offer a unique way to address both the physical and psychological aspects of low back pain, promising a comprehensive alternative to conventional options.

What evidence suggests that this trial's treatments could be effective for chronic low back pain?

Research has shown that yoga and yoga nidra can help reduce pain in people with chronic low back pain. One study found that yoga programs lowered back pain by 0.41 points on a pain scale over 12 weeks. Yoga nidra, a deep relaxation technique, positively affects brain activity related to relaxation and pain relief. Another study found that yoga nidra could help reduce pain intensity and fear in those with back pain. In this trial, one group will receive a combination of yoga, pain education, and yoga nidra, while another group will receive yoga, pain education, and relaxing music. These findings suggest that combining yoga and yoga nidra might effectively manage low back pain symptoms. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic low back pain. Participants will attend lab sessions and practice interventions at home twice a week for 6 weeks. They must be able to perform yoga postures and engage in either yoga nidra or listen to relaxing music as part of the study.

Inclusion Criteria

I have had chronic lower back pain for more than three months.

My pain level has been 3 or higher in the last day.

Exclusion Criteria

I have a blood clotting disorder.

Non-English speaking

I have had surgery or a bone break in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive yoga postures targeting the low back, pain education, and either yoga nidra with pain acceptance intention and motor imagery or relaxing music, 2 times per week for 6 weeks at home

6 weeks

2 visits (in-person at week 1 and week 8)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Relaxing Music
• Yoga
• Yoga Nidra

Trial Overview The study tests if yoga, combined with pain education and either yoga nidra focused on pain acceptance or listening to relaxing music, can reduce pain intensity, improve well-being, and enhance sleep quality in those suffering from chronic low back pain.

How Is the Trial Designed?

Group I: Yoga, Pain Education, Yoga Nidra Experimental Treatment 1 Intervention

Yoga postures targeting lower back, pain education, yoga nidra with pain acceptance intention and motor imagery.

Group II: Yoga, Pain Education, Relaxing Music Active Control 1 Intervention

Yoga postures targeting lower back, pain education, relaxing music

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9033521/

The Origin and Clinical Relevance of Yoga Nidra - PMC They were asked to practice yoga nidra for 30 min for 40 days regularly. The results show a significant positive change in alpha electroencephalogram (EEG) and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S152490422030151X

Twelve Weeks of Yoga for Chronic Nonspecific Lower Back ... 12 weeks of yoga programs could significantly reduce chronic nonspecific lower back pain by 0.41 within the trials.

3. karger.com karger.com/cmr/article-pdf/doi/10.1159/000549416/4462224/000549416.pdf

Yoga Nidra and Pain: A Between-, Within-Group Meta- ... Between-group meta-analysis examining the efficacy of yoga nidra on pain outcomes compared to (A) active comparators, with (B) leave-one-out ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010671.pub3/full

Yoga for chronic non‐specific low back pain - Wieland, LS Yoga probably results in a slight reduction in pain but the difference in pain reduction between groups did not reach the predetermined ...

5. researchgate.net researchgate.net/publication/368743229_Impact_of_Yoga_Nidra_in_managing_Kinesiophobia_in_women_leaders_with_lower_back_pain

(PDF) Impact of Yoga Nidra in managing Kinesiophobia in ... The objective of this study is to determine the effect of Yoga Nidra in ameliorating pain intensity and fear in people with Lower Back Pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4878447/

Yoga as a treatment for chronic low back pain Lastly, safety data from the largest and most recent trials suggest about a 10–15% incidence of temporarily increased low back pain, and two identified ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1273473/full

Efficacy and safety of yoga for the management of chronic ... Safety of yoga for low back pain. Six SRs (33, 34, 36, 37, 42, 43) showed adverse events associated with yoga for treating low back pain.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825746

Effectiveness of Virtual Yoga for Chronic Low Back Pain Findings of this study indicate that a 12-week therapeutic virtual yoga program for chronic low back pain is feasible, safe, and effective.

9. nccih.nih.gov nccih.nih.gov/health/yoga-effectiveness-and-safety

Yoga: Effectiveness and Safety | NCCIH For low-back pain, a large amount of research has been done, and the evidence suggests a slight benefit. For the other conditions, the evidence looks promising, ...