Chronic Low Back PainPATHNCT04678297
Physical Activity Interventions To Heal Chronic Low Back Pain
A study testing Physical activity + emotion regulation intervention in people with Chronic Low Back Pain, run by University of Connecticut at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Physical activity + emotion regulation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs Mansfield, Connecticut, 06269
About this study
Official title: Role of Emotion Regulation on Low Back Pain Outcomes
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Physical activity + emotion regulation intervention, Physical activity control intervention
- Keywords
- chronic low back pain, physical activity, emotion regulation
- Medical subject headings
- Motor Activity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity + emotion regulation interventionBehavioural
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.
Physical activity control interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity + emotion regulation group | Experimental | Participants randomized to the experimental group attend two group-based class sessions per week, each 1.25hours long, that are led by certified instructors who guide participants through various exercises. Participants are encouraged to practice the activities at home for 20 minutes each day. Receives: Behavioral: Physical activity + emotion regulation intervention |
| Physical activity control group | Active comparator | Participants randomized to the control group attend two group-based class sessions per week, each 1.25hours long, that are led by trained therapists who guide participants through a series of stretching exercises. Participants are encouraged to practice the activities at home for 20 minutes each day. Receives: Behavioral: Physical activity control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Regulation Abilities
Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation
Measured: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-up
Secondary outcomes (2)
Pain Severity/Interference
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)
Measured: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-ups
Pain Sensitization
Quantitative sensory testing, Brief Pain Inventory - Change over time
Measured: Baseline and 6 weeks and 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Crystal Park, University of Connecticut
- Investigators
- Crystal Park, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678297
- Sponsor's protocol ID
- H19-191
- Other IDs
- R01AT010555
- Acronym
- PATH
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2020
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data that are part of National Institute of Health (NIH) designated common data elements collected during the trial, after de-identification have been submitted to NIH. Data can be accessed by directly submitting requests at that website.
Publications
Starkweather AR, Xu W, Gnall KE, Emrich M, Garnsey CL, Magin ZE, Wu W, Fetta J, Groessl EJ, Park C. Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 14;13:e56016. doi: 10.2196/56016.
PubMed 38483469
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Emotion Regulation on Low Back Pain Outcomes
- ClinicalTrials.gov ID
- NCT04678297
- Acronym / sponsor ID
- PATH / H19-191
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, physical activity, emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity + emotion regulation group | Experimental | Behavioral: Physical activity + emotion regulation interventionParticipants randomized to the experimental group attend two group-based class sessions per week, each 1.25hours long, that are led by certified instructors who guide participants through various exercises. Participants are encouraged to practice the activities at home for 20 minutes each day. |
| Physical activity control group | Active comparator | Behavioral: Physical activity control interventionParticipants randomized to the control group attend two group-based class sessions per week, each 1.25hours long, that are led by trained therapists who guide participants through a series of stretching exercises. Participants are encouraged to practice the activities at home for 20 minutes each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity + emotion regulation interventionThe 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. | Behavioural | Physical activity + emotion regulation group |
| Physical activity control interventionThe 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. | Behavioural | Physical activity control group |
Primary outcome
Emotion Regulation Abilities
Time frame: 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
2 secondary outcomes
Pain Severity/Interference
Time frame: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-ups
Pain Sensitization
Time frame: Baseline and 6 weeks and 3 months and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38483469Starkweather AR, Xu W, Gnall KE, Emrich M, Garnsey CL, Magin ZE, Wu W, Fetta J, Groessl EJ, Park C. Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 14;13:e56016. doi: 10.2196/56016.
- Individual participant dataSharing planned: Yes. All of the individual participant data that are part of National Institute of Health (NIH) designated common data elements collected during the trial, after de-identification have been submitted to NIH. Data can be accessed by directly submitting requests at that website.
Related trials for Chronic Low Back Pain
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Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Park, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity + emotion regulation intervention in people with Chronic Low Back Pain, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Abilities (time frame: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.