Chronic Low Back Pain
Conditions
Keywords
chronic low back pain, physical activity, emotion regulation
Brief summary
This study will advance understanding on the mechanisms that mediate improved outcomes for chronic low back pain and provide specific directions for optimizing physical activity interventions for this population.
Detailed description
In this study, participants with chronic low back pain will be randomized to receive a 12-week physical activity intervention (2 times per week with encouragement for home practice). The experimental condition will entail physical activity with components for strengthening emotion regulation skills, behaviors, and attitudes while the control condition will entail physical activity alone.
Interventions
BEHAVIORALPhysical activity + emotion regulation intervention
The intervention meet twice weekly for 12 weeks, 1.25 hrs./session. This intervention will be led by certified instructors trained in working with back pain patients. The instructor leads participants through a series of physical activity exercises at a slow-moderate pace. Participants will be asked to practice every day for 20 minutes to maximize the benefit of the intervention. Participants also receive a home practice manual containing some basic, safe postures that can be performed on days they are not attending the formal in-person sessions.
BEHAVIORALPhysical activity control intervention
The interventions meet twice weekly for 12 weeks, 1.25 hrs./session. This intervention is designed to require a similar amount of physical exertion. Classes involve conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that stretch all the major muscle groups, with an emphasis on the trunk and legs. The intervention will include all 12 stretching exercises used in the exercise intervention of previous studies that have successfully used it in comparison to yoga, plus 3 additional stretches (hip internal rotators, hip adductors and hip flexion).Participants will be asked to practice every day for 20 minutes home as well. Printed handouts will be provided to facilitate home practice. In addition, a video demonstrating all the exercises will be provided to assist participants in practicing safely. Classes will be led by a licensed physical therapist who has previous experience leading exercise classes.
Sponsors
University of Connecticut
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
We will employ blinding whenever possible. Assessments, evaluations, and data analysis will be conducted without knowledge of participants' assigned group. Study personnel will be blinded to the assigned condition of subjects when conducting data collection by using unique study identification numbers, by following a strict script to refrain from discussing participant activities, and by using different members of the study team to coordinate assigned condition activities and to collect data. De-identified data with codes for assigned condition will facilitate blinded data analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Age \> 18; Report of low back pain \>3 of last 6 months; Willing to attend 12-weeks of yoga or stretching (twice per week); Willing to complete 4 assessments; English Literacy; No changes in pain treatments in the past month; Willing to not change pain treatments during study unless medically necessary; Have not practiced yoga \> 2x in the last 12 months;
Exclusion criteria
\- back surgery within the last 1 year; back pain due to specific systemic problem (e.g., lupus); lower extremity weakness (motor strength 4/5 of the quads, gluts, hamstrings, EHL); sciatica or (+) straight leg raise (SLR); coexisting chronic pain problem (migraine headaches, fibromyalgia); Serious or unstable psychiatric illness (e.g. psychosis, mania, history of suicide attempt); major coexisting medical illness (e.g., cancer, COPD, morbid obesity); Positive Romberg test (with or without sensory neuropathy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotion Regulation Abilities | Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-up | Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity/Interference | Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-ups | Brief Pain Inventory - Change over time; Brief Pain Inventory consists of 2 subscales: Pain Intensity (range from 0-10, higher scores are worse pain) and pain interference (range is 0-10, higher scores is greater interference) |
| Pain Sensitization | Baseline and 6 weeks and 3 months and 6 months | Quantitative sensory testing, Brief Pain Inventory - Change over time |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCrystal Park, PhD
University of Connecticut
Participant flow
Recruitment details
Recruitment ran from September 2021 to September 2024. Recruitment materials advertising an intervention study evaluating "benefits of movement exercise for individuals who experience back pain" were disseminated via social media advertisements, listservs, an IRB-approved pain registry, local public transportation systems, and local outpatient clinical sites and universities.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.4 Years STANDARD_DEVIATION 16.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 150 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 99 |
| other Total, other adverse events | 8 / 105 | 7 / 99 |
| serious Total, serious adverse events | 0 / 105 | 0 / 99 |
Outcome results
None listed