Chronic Low-back PainNCT06050083

Digital Clinical Hypnosis for Chronic Pain Management

A study testing Hypnosis audio recordings in people with Chronic Low-back Pain and Chronic Pain, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low-back Pain, Chronic Pain
What is being tested?: Hypnosis audio recordings
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2024to 15 Sep 2024
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

None listed.

Who cannot join

History of (within past 5 years) or current diagnosis of primary psychotic or major thought disorder with active symptoms as noted in the medical record or disclosed during self-report screening
Psychiatric hospitalization within the past 6 months as noted in the medical record or disclosed during self-report screening
Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months as noted in the medical record or disclosed during self-report screening;
Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate subject may be inappropriate for study;
Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking;
Active malignancy (e.g., cancer not in remission) as noted in the medical record or disclosed during self-report screening;
Pain condition for which surgery is recommended and/or planned in the next six months as disclosed during self-report screening;
Currently receiving or have received hypnosis treatment for any pain condition as disclosed during self-report screening

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington, School of Medicine
Seattle, Washington, 98104

Other trials in United States

About this study

This ClinicalTrials.gov posting contains two randomized controlled trials. The study procedures were identical, except Study 1 was funded by NIH and enrolled adults with chronic low back pain, whereas Study 2 was funded by the UW Department of Rehabilitation Medicine and enrolled adults with any type of chronic pain. Study 1 and 2 each enrolled 50 adults (N = 100 total across the two studies). Although Study 2 did not use NIH funds, we are including the results here because the studies were conducted simultaneously by the same PI (Dr. Jensen) with the same study procedures.

Participants enrolled in the studies for a duration of 8 weeks. The studies test the feasibility and efficacy of a therapeutic hypnosis digital application (website), called Rose. The investigators wanted to determine if the Rose application was user-friendly and effective at improving quality of life and reducing pain for adults with chronic pain. If successfuly, the investigators hope to develop the Rose application into a mobile app that will be publicly available and managed by HypnoScientific Inc., a company that is co-owned by the investigators.

Participants completed brief (15-20min) self-report surveys that ask about pain and mental health at three timepoints: Baseline (week 0), 4 weeks, and 8 weeks.

Read the detailed description

Pain is a major public health problem that affects over 100 million adults in the United States. While pain can have profound negative impacts, current treatment remains inadequate. A focus on opioid treatments has led to over-prescription, harmful side effects, and the overuse crisis. To address this problem, the study investigators, and others, have developed and adapted hypnosis to empower individuals to self-manage pain. Findings from the investigators' research supports hypnosis as an effective non-pharmacological technique. However, a significant limitation of hypnosis treatment is access, given that hypnosis treatment is provided by a very limited number of clinicians with training in its use, as well as the significant costs of in-person treatment.

The main goal of this study is to pilot test the efficacy of hypnosis content for pain management as provided via recordings in the Rose web application.

Conditions: Chronic Low-back Pain, Chronic Pain
Being tested: Hypnosis audio recordings
Keywords: Low-back Pain, Hypnosis, Chronic Pain, Digital Health
Medical subject headings: Chronic Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypnosis audio recordingsBehavioural
A web application (Rose) that contains hypnosis audio recordings created by the investigators.

Study groups in NCT06050083
Study group	Role	What they receive
Treatment	Experimental	8 weeks of access to Rose web application (online hypnosis recordings) Receives: Behavioral: Hypnosis audio recordings
Waitlist Control	Active comparator	4 weeks of waitlist (no access to Rose application for 4 weeks and then 4 weeks of access to Rose web application) Receives: Behavioral: Hypnosis audio recordings

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Using Rose Application
Total # of hypnosis sessions listened to by participants
Measured: During the 8 weeks of study participation
Continued Interest in Using Rose Application
Participants reporting how interested they would be in continuing to use the Rose application: "If the Rose web/phone application were available to download, how interested would you be in downloading and using this application?" 4 - Extremely interested 3 - Very interested 2 - Somewhat interested
1 - Little interested 0 - Not interested
Measured: 8 week assessment
Willingness to Pay for Continued Use of Rose Application
Participants that reported a willingness to pay for continued access to the Rose application (results available for Study 2 only): "Would you be willing to pay some amount for a monthly subscription to Rose, to have continued access?"
1 - Yes 0 - No
Measured: 8 week assessment
Participant Satisfaction
Participants answered a Global Satisfaction question about their satisfaction with using the Rose application "Taking all things into account, how satisfied are you with using the Rose web application?" 4 - Very Satisfied 3 - Somewhat Satisfied 2 - Neutral
1 - Somewhat Dissatisfied 0 - Very Dissatisfied
Measured: 4 Week, 8 Week timepoints
System Usability Scale (SUS)
Scale title: System Usability Scale. Minimum - Maximum range: 0 to 100. Higher scores indicate more usability (ease of use). There are no subscale scores for this measure.
Measured: 8 Week Timepoint

Secondary outcomes (6)

Average Pain - Past Week
A 0-10 Numerical Rating scale of average pain in the past week: "Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is "no pain" and 10 is "pain as bad as you can imagine"
Measured: Baseline, 4 Weeks, 8 Weeks
Worst Pain - Past Week
A 0-10 Numerical Rating scale of worst pain in the past week: "Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is "no pain" and 10 is "pain as bad as you can imagine"
Measured: Baseline, 4 Weeks, 8 Weeks
PROMIS Sleep Disturbance Short Form 8a
Domain assessed: Sleep Disturbance. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample).
Higher scores indicate more sleep disturbance. Scores that are >= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Measured: Baseline (week 0), 4 week assessment, 8 week assessment
PROMIS Pain Interference Short Form
Domain assessed: Pain interference. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample).
Higher scores indicate more pain interference. Scores that are >= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Measured: Baseline (week 0), 4 week assessment, 8 week assessment
PROMIS Anxiety Short Form 7a
Domain assessed: Anxiety. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample).
Higher scores indicate more anxiety. Scores that are >= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Measured: Baseline (week 0), 4 week assessment, 8 week assessment
Number of Participants Using Opioids
Domain assessed: Opioid Use How assessed: Single item asking participants to indicate whether or not they currently using any opioid mediations.
Unit of measure is the number and rate of participants who indicated that they are currently using at least one opioid medication.
Measured: Baseline (week 0), 4 week assessment, 8 week assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 202415 Sep 2024

First posted22 Sep 2023
Study start4 Jan 2024
Primary completion15 Sep 2024
Study completion15 Sep 2024

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.
More trials run by University of WashingtonThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Study 1 and 2 are both 2-arm randomized controlled trials in which individuals are randomly assigned to a treatment group (8 weeks of access to hypnosis recordings) or a waitlist group (4 weeks of no access followed by 4 weeks of access to hypnosis recording access).
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06050083
Sponsor's protocol ID: STUDY00014786
Other IDs: R41AT011996
Status last verified: Dec 2025
First submitted: 16 Sep 2023
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Jensen MP, Flaster AP, Humbert A, Mendoza ME, Sugarman LI, Gottlieb O. Digital Interactive Media for Chronic Low Back Pain Management: A Feasibility Study. Int J Clin Exp Hypn. 2026 Oct 6:1-23. doi: 10.1080/00207144.2026.2741062. Online ahead of print.
PubMed 42836317

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Digital Clinical Hypnosis for Chronic Pain Management
ClinicalTrials.gov ID: NCT06050083
Acronym / sponsor ID: STUDY00014786
Conditions: Chronic Low-back Pain, Chronic Pain
Keywords: Low-back Pain, Hypnosis, Chronic Pain, Digital Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 4 Jan 2024 (actual)
Primary completion: 15 Sep 2024 (actual)
Study completion: 15 Sep 2024 (actual)
First posted: 22 Sep 2023 (actual)
Results: Posted 6 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants completed brief (15-20min) self-report surveys that ask about pain and mental health at three timepoints: Baseline (week 0), 4 weeks, and 8 weeks.

Detailed description

The main goal of this study is to pilot test the efficacy of hypnosis content for pain management as provided via recordings in the Rose web application.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Study 1 and 2 are both 2-arm randomized controlled trials in which individuals are randomly assigned to a treatment group (8 weeks of access to hypnosis recordings) or a waitlist group (4 weeks of no access followed by 4 weeks of access to hypnosis recording access).

Arm	Type	Receives
Treatment	Experimental	Behavioral: Hypnosis audio recordings8 weeks of access to Rose web application (online hypnosis recordings)
Waitlist Control	Active comparator	Behavioral: Hypnosis audio recordings4 weeks of waitlist (no access to Rose application for 4 weeks and then 4 weeks of access to Rose web application)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (8 listed)

History of (within past 5 years) or current diagnosis of primary psychotic or major thought disorder with active symptoms as noted in the medical record or disclosed during self-report screening
Psychiatric hospitalization within the past 6 months as noted in the medical record or disclosed during self-report screening
Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months as noted in the medical record or disclosed during self-report screening;
Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate subject may be inappropriate for study;
Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking;

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
Hypnosis audio recordingsA web application (Rose) that contains hypnosis audio recordings created by the investigators.	Behavioural	Treatment, Waitlist Control

Primary outcome

Frequency of Using Rose Application
Time frame: During the 8 weeks of study participation
Total # of hypnosis sessions listened to by participants
Continued Interest in Using Rose Application
Time frame: 8 week assessment
Participants reporting how interested they would be in continuing to use the Rose application: "If the Rose web/phone application were available to download, how interested would you be in downloading and using this application?" 4 - Extremely interested 3 - Very interested 2 - Somewhat interested 1 - Little interested 0 - Not interested
Willingness to Pay for Continued Use of Rose Application
Time frame: 8 week assessment
Participants that reported a willingness to pay for continued access to the Rose application (results available for Study 2 only): "Would you be willing to pay some amount for a monthly subscription to Rose, to have continued access?" 1 - Yes 0 - No
Participant Satisfaction
Time frame: 4 Week, 8 Week timepoints
Participants answered a Global Satisfaction question about their satisfaction with using the Rose application "Taking all things into account, how satisfied are you with using the Rose web application?" 4 - Very Satisfied 3 - Somewhat Satisfied 2 - Neutral 1 - Somewhat Dissatisfied 0 - Very Dissatisfied
System Usability Scale (SUS)
Time frame: 8 Week Timepoint
Scale title: System Usability Scale. Minimum - Maximum range: 0 to 100. Higher scores indicate more usability (ease of use). There are no subscale scores for this measure.

6 secondary outcomes

Average Pain - Past Week
Time frame: Baseline, 4 Weeks, 8 Weeks
Worst Pain - Past Week
Time frame: Baseline, 4 Weeks, 8 Weeks
PROMIS Sleep Disturbance Short Form 8a
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
PROMIS Pain Interference Short Form
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
PROMIS Anxiety Short Form 7a
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
Number of Participants Using Opioids
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment

Results and safety

Results posted to the registry on 6 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study 1: 8 Week Treatment	26	26
Study 1: 4 Week Waitlist	24	24
Study 2: 8 Week Treatment	26	26
Study 2: 4 Week Waitlist	24	24

Primary outcome: Frequency of Using Rose Application

Time frame: During the 8 weeks of study participation. Number. Unit: # of hypnosis sessions listened to

Measure	Study 1 n = 50	Study 2 n = 50
5 minute audio recording	81	79
10 minute audio recording	64	134
20 minute audio recording	220	274

Population analysed: The number of hypnosis sessions listened to was prespecified to be aggregated for all participants because (1) it was over the entire course of the 8-week study and participants in both arms had access and (2) the key variable of interest for feasibility was any difference in the number and rate of listening as a function of session duration (and not differences as a function of condition, as those in the waitlist condition would by default listen to fewer sessions).

Primary outcome: Continued Interest in Using Rose Application

Time frame: 8 week assessment. Mean (Standard Deviation). Unit: Score on a scale

Measure	Study 1 n = 50	Study 2 n = 50
Value	2.5 (1.3)	2.8 (1.5)

Population analysed: The number of participants who expressed expressed am interest in continued interest access to the application was prespecified to be aggregated for all participants because the milestone for this feasibility variable was the overall rate of interest in for those who used the application at least once, collapsed across condition. We were not interested in, or anticipated, any between-group difference in this variable.

Primary outcome: Willingness to Pay for Continued Use of Rose Application

Time frame: 8 week assessment. Count of participants. Unit: Participants

Measure	Study 2 n = 17
Value	11

Population analysed: The number of participants who expressed a willingness to pay fo continued access to the application was prespecified to be aggregated for all participants because the milestone for this feasibility variable was the overall rate of willingness to pay for the application for those who used the application at least once, collapsed across condition. We were not interested in, or anticipated, any between-group difference in this variable.

Primary outcome: Participant Satisfaction

Time frame: 4 Week, 8 Week timepoints. Mean (Standard Deviation). Unit: Score on a scale

Measure	Study 1 n = 50	Study 2 n = 50
Value	2.8 (0.9)	3.4 (0.9)

Population analysed: The number of participants who expressed satisfaction will using the application was prespecified to be aggregated for all participants because the milestone for this feasibility variable was the overall rates of the satisfaction ratings for those who used the application at least once (i.e., participants in both conditions), collapsed across condition. We were not interested in, or anticipated, any between-group difference in this variable.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment until the 8 week follow up timepoint. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study 1: 8 Week Treatment	0 of 26 (0%)	1 of 26 (3.8%)	0 of 26
Study 1: 4 Week Waitlist	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Study 2: 8 Week Treatment	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Study 2: 4 Week Waitlist	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42836317Jensen MP, Flaster AP, Humbert A, Mendoza ME, Sugarman LI, Gottlieb O. Digital Interactive Media for Chronic Low Back Pain Management: A Feasibility Study. Int J Clin Exp Hypn. 2026 Oct 6:1-23. doi: 10.1080/00207144.2026.2741062. Online ahead of print.

Related trials for Chronic Low-back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic 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.

Mark Jensen, MD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis audio recordings in people with Chronic Low-back Pain and Chronic Pain, run by University of Washington 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 0 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 6 Jan 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 6 Jan 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?

Frequency of Using Rose Application (time frame: During the 8 weeks of study participation). The study lists 5 primary outcomes in all. 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 NCT06050083, 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 6 Jan 2026.