Chronic PainE-TIPSNCT04248725
Telehealth Pain Self-Management for Employed Adults
A study testing E-TIPS in people with Chronic Pain and Brain Injuries, Traumatic, run by University of Washington at 1 site in United States.
Trial summary
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Brain Injuries, Traumatic, Multiple Sclerosis
- What is being tested?
- E-TIPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 1 Mar 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
- 18 years of age or older
- Self-reported physical disability
- Chronic pain defined as daily pain of ≥ 3 months duration and ≥ 3 average pain intensity in the past week on a 0-10 numerical rating scale
- Experiences pain for more than 45 out of the past 90 days (defined as 50% of the time or greater)
- Reads, speaks, and understands English
- Has access to and is able to communicate over the telephone with our without assistive devices
- Is employed, working 15-20 hours per week or more, on average, or earning in excess of substantial gainful activity (approximately $1200/month)
- We will enroll individuals with a range of physical disabilities to maximize the generalizability of the results, because there is no evidence that the type of disability affects responsiveness to the proposed treatment
Who cannot join
- Under the age of 18
- Cannot read, speak, or understand English
- No self-reported physical disability
- Currently unemployed
- Plans to retire or leave employment within the study period
- Working fewer than 15-20 hours per week, on average, and earning less than approximately $1200 per month
Show all 10Show fewer
- Cannot communicate or complete assessments over the phone or internet
- Chronic pain defined as daily pain of ≤ 3 months duration and ≤ 3 average pain intensity in the past week on a 0-10 numerical rating scale
- Experiences pain for fewer than 45 out of the past 90 days (defined as 50% of the time or less)
- Currently participating in another pain study or cognitive behavioral therapy (CBT) study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.
Read the detailed description
Chronic pain is one of the most prevalent, disabling, and persistent comorbid conditions associated with physical disabilities, including limb loss, spinal cord injury, traumatic brain injury, and chronic neurodegenerative conditions such as multiple sclerosis. One half to two-thirds of adults with these conditions experience chronic pain. In addition to being associated with disability, depression, sleep disruption, and physical inactivity, chronic pain has deleterious social and societal costs, including job loss and reliance on long-term disability programs.
The E-TIPS intervention aims to address common barriers encountered by employed individuals with chronic pain. People with physical disabilities may be offered face-to-face delivery of pain self-management interventions, in clinical settings during business hours, which limits access to people with physical disabilities who are employed. These individuals must take time off work to attend multiple treatment sessions, overcome transportation difficulties, and contend with the stigma of seeking behavioral healthcare. Telehealth interventions, such as E-TIPS, have considerable potential for expanding the reach of pain self-management interventions for employed people with physical disabilities.
The proposed randomized (1:1), single-blind parallel-group trial will compare the E-TIPS telehealth pain self-management intervention to a waitlist control in adults with physical disabilities and chronic pain who are employed. Outcomes will be assessed before randomization, mid-treatment (6 weeks post-randomization), post-treatment (10 weeks post-randomization; primary endpoint), and 6-month follow up (25 weeks post-randomization). Participants will be recruited from across the US, including at University of Washington (UW) and Shirley Ryan AbilityLab (SRALab).
- Conditions
- Chronic Pain, Brain Injuries, Traumatic, Multiple Sclerosis, Spinal Cord Injuries, Amputation
- Being tested
- E-TIPS
- Keywords
- chronic pain, cognitive therapy, mindfulness meditation, activation skills, pain, employment, telehealth
- Medical subject headings
- Chronic Pain, Brain Injuries, Traumatic, Multiple Sclerosis, Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-TIPSBehavioural
Chronic pain self-management strategies for employed individuals with physical disabilities
| Study group | Role | What they receive |
|---|---|---|
| E-TIPS | Experimental | The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home. Receives: Behavioral: E-TIPS |
| Usual care | No intervention | Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Interference
Patient-reported pain interference using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale-6-item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater self-reported pain interference.
Measured: Baseline (week 0) and 12 weeks (post-treatment)
Secondary outcomes (2)
Change in Pain Self-efficacy
Patient-reported pain self-efficacy for managing pain using the University of Washington Pain Self-Efficacy Scale-6 item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score.The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater patient-reported self-efficacy for managing pain.
Measured: Baseline (week 0) and 12 weeks (post-treatment)
Change in Average Pain Intensity
0-10 Numerical Pain Rating Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity; range of 0 - 10.
Measured: Baseline (week 0) and 12 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start2 Mar 2020
- Primary completion30 Sep 2023
- Study completion1 Mar 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 (14)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- A randomized (1:1), single blind parallel-group trial comparing a telehealth pain self-management intervention, adapted to address employment issues (E-TIPS), to a waitlist control in adults with physical disabilities and chronic pain who are employed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Dawn Ehde, University of Washington
- Investigators
- Dawn M Ehde, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248725
- Sponsor's protocol ID
- STUDY00005686
- Other IDs
- A133507, 90RTEM0001-01-00
- Acronym
- E-TIPS
- Status last verified
- Dec 2024
- First submitted
- 8 Jan 2020
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be deposited in a digital data repository. Direct and indirect identifiers will be removed to minimize disclosure risk. The data will be deposited with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR).
Publications
Ehde DM, Jensen MP, Engel JM, Turner JA, Hoffman AJ, Cardenas DD. Chronic pain secondary to disability: a review. Clin J Pain. 2003 Jan-Feb;19(1):3-17. doi: 10.1097/00002508-200301000-00002.
PubMed 12514452Dijkers M, Bryce T, Zanca J. Prevalence of chronic pain after traumatic spinal cord injury: a systematic review. J Rehabil Res Dev. 2009;46(1):13-29.
PubMed 19533517Ehde DM, Czerniecki JM, Smith DG, Campbell KM, Edwards WT, Jensen MP, Robinson LR. Chronic phantom sensations, phantom pain, residual limb pain, and other regional pain after lower limb amputation. Arch Phys Med Rehabil. 2000 Aug;81(8):1039-44. doi: 10.1053/apmr.2000.7583.
PubMed 10943752Krause JS, Cao Y, Clark JMR. Pain Intensity, Interference, and Medication Use After Spinal Cord Injury: Association With Risk of Mortality After Controlling for Socioeconomic and Other Health Factors. Arch Phys Med Rehabil. 2017 Dec;98(12):2464-2470. doi: 10.1016/j.apmr.2017.05.024. Epub 2017 Jun 23.
PubMed 28652067Negre-Pages L, Regragui W, Bouhassira D, Grandjean H, Rascol O; DoPaMiP Study Group. Chronic pain in Parkinson's disease: the cross-sectional French DoPaMiP survey. Mov Disord. 2008 Jul 30;23(10):1361-9. doi: 10.1002/mds.22142.
PubMed 18546344Franklin GM, Wickizer TM, Coe NB, Fulton-Kehoe D. Workers' compensation: poor quality health care and the growing disability problem in the United States. Am J Ind Med. 2015 Mar;58(3):245-51. doi: 10.1002/ajim.22399. Epub 2014 Oct 20.
PubMed 25331746Alschuler KN, Ehde DM, Jensen MP. The co-occurrence of pain and depression in adults with multiple sclerosis. Rehabil Psychol. 2013 May;58(2):217-21. doi: 10.1037/a0032008.
PubMed 23713732Kroenke K, Wu J, Bair MJ, Krebs EE, Damush TM, Tu W. Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care. J Pain. 2011 Sep;12(9):964-73. doi: 10.1016/j.jpain.2011.03.003. Epub 2011 Jun 16.
PubMed 21680251Anand P, Ben-Shalom Y. The promise of better economic outcomes for workers with musculoskeletal conditions. Roosevelt House: Public Policy Institute at Hunter College.2017.
Social Security Administration. Annual Statistical Report on the Social Security Disability Insurance Program, 2015. Washington, DC2016.
O'Connor AB, Schwid SR, Herrmann DN, Markman JD, Dworkin RH. Pain associated with multiple sclerosis: systematic review and proposed classification. Pain. 2008 Jul;137(1):96-111. doi: 10.1016/j.pain.2007.08.024. Epub 2007 Oct 24.
PubMed 17928147Warms CA, Turner JA, Marshall HM, Cardenas DD. Treatments for chronic pain associated with spinal cord injuries: many are tried, few are helpful. Clin J Pain. 2002 May-Jun;18(3):154-63. doi: 10.1097/00002508-200205000-00004.
PubMed 12048417Ehde DM, Dillworth TM, Turner JA. Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Am Psychol. 2014 Feb-Mar;69(2):153-66. doi: 10.1037/a0035747.
PubMed 24547801Clarke G, Yarborough BJ. Evaluating the promise of health IT to enhance/expand the reach of mental health services. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):339-44. doi: 10.1016/j.genhosppsych.2013.03.013. Epub 2013 May 20.
PubMed 23701698
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04248725
- Acronym / sponsor ID
- E-TIPS / STUDY00005686
- Conditions
- Chronic Pain, Brain Injuries, Traumatic, Multiple Sclerosis, Spinal Cord Injuries, Amputation
- Keywords
- chronic pain, cognitive therapy, mindfulness meditation, activation skills, pain, employment, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.
Detailed description
Chronic pain is one of the most prevalent, disabling, and persistent comorbid conditions associated with physical disabilities, including limb loss, spinal cord injury, traumatic brain injury, and chronic neurodegenerative conditions such as multiple sclerosis. One half to two-thirds of adults with these conditions experience chronic pain. In addition to being associated with disability, depression, sleep disruption, and physical inactivity, chronic pain has deleterious social and societal costs, including job loss and reliance on long-term disability programs.
The E-TIPS intervention aims to address common barriers encountered by employed individuals with chronic pain. People with physical disabilities may be offered face-to-face delivery of pain self-management interventions, in clinical settings during business hours, which limits access to people with physical disabilities who are employed. These individuals must take time off work to attend multiple treatment sessions, overcome transportation difficulties, and contend with the stigma of seeking behavioral healthcare. Telehealth interventions, such as E-TIPS, have considerable potential for expanding the reach of pain self-management interventions for employed people with physical disabilities.
The proposed randomized (1:1), single-blind parallel-group trial will compare the E-TIPS telehealth pain self-management intervention to a waitlist control in adults with physical disabilities and chronic pain who are employed. Outcomes will be assessed before randomization, mid-treatment (6 weeks post-randomization), post-treatment (10 weeks post-randomization; primary endpoint), and 6-month follow up (25 weeks post-randomization). Participants will be recruited from across the US, including at University of Washington (UW) and Shirley Ryan AbilityLab (SRALab).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized (1:1), single blind parallel-group trial comparing a telehealth pain self-management intervention, adapted to address employment issues (E-TIPS), to a waitlist control in adults with physical disabilities and chronic pain who are employed.
| Arm | Type | Receives |
|---|---|---|
| E-TIPS | Experimental | Behavioral: E-TIPSThe E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home. |
| Usual care | No intervention | –Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Self-reported physical disability
- Chronic pain defined as daily pain of ≥ 3 months duration and ≥ 3 average pain intensity in the past week on a 0-10 numerical rating scale
- Experiences pain for more than 45 out of the past 90 days (defined as 50% of the time or greater)
- Reads, speaks, and understands English
Key exclusion criteria (10 listed)
- Under the age of 18
- Cannot read, speak, or understand English
- No self-reported physical disability
- Currently unemployed
- Plans to retire or leave employment within the study period
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 |
|---|---|---|
| E-TIPSChronic pain self-management strategies for employed individuals with physical disabilities | Behavioural | E-TIPS |
Primary outcome
Change in Pain Interference
Time frame: Baseline (week 0) and 12 weeks (post-treatment)
Patient-reported pain interference using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale-6-item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater self-reported pain interference.
2 secondary outcomes
Change in Pain Self-efficacy
Time frame: Baseline (week 0) and 12 weeks (post-treatment)
Change in Average Pain Intensity
Time frame: Baseline (week 0) and 12 weeks (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12514452Ehde DM, Jensen MP, Engel JM, Turner JA, Hoffman AJ, Cardenas DD. Chronic pain secondary to disability: a review. Clin J Pain. 2003 Jan-Feb;19(1):3-17. doi: 10.1097/00002508-200301000-00002.
- Background: PubMed 19533517Dijkers M, Bryce T, Zanca J. Prevalence of chronic pain after traumatic spinal cord injury: a systematic review. J Rehabil Res Dev. 2009;46(1):13-29.
- Background: PubMed 10943752Ehde DM, Czerniecki JM, Smith DG, Campbell KM, Edwards WT, Jensen MP, Robinson LR. Chronic phantom sensations, phantom pain, residual limb pain, and other regional pain after lower limb amputation. Arch Phys Med Rehabil. 2000 Aug;81(8):1039-44. doi: 10.1053/apmr.2000.7583.
- Background: PubMed 28652067Krause JS, Cao Y, Clark JMR. Pain Intensity, Interference, and Medication Use After Spinal Cord Injury: Association With Risk of Mortality After Controlling for Socioeconomic and Other Health Factors. Arch Phys Med Rehabil. 2017 Dec;98(12):2464-2470. doi: 10.1016/j.apmr.2017.05.024. Epub 2017 Jun 23.
- Background: PubMed 18546344Negre-Pages L, Regragui W, Bouhassira D, Grandjean H, Rascol O; DoPaMiP Study Group. Chronic pain in Parkinson's disease: the cross-sectional French DoPaMiP survey. Mov Disord. 2008 Jul 30;23(10):1361-9. doi: 10.1002/mds.22142.
- Background: PubMed 25331746Franklin GM, Wickizer TM, Coe NB, Fulton-Kehoe D. Workers' compensation: poor quality health care and the growing disability problem in the United States. Am J Ind Med. 2015 Mar;58(3):245-51. doi: 10.1002/ajim.22399. Epub 2014 Oct 20.
- Background: PubMed 23713732Alschuler KN, Ehde DM, Jensen MP. The co-occurrence of pain and depression in adults with multiple sclerosis. Rehabil Psychol. 2013 May;58(2):217-21. doi: 10.1037/a0032008.
- Background: PubMed 21680251Kroenke K, Wu J, Bair MJ, Krebs EE, Damush TM, Tu W. Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care. J Pain. 2011 Sep;12(9):964-73. doi: 10.1016/j.jpain.2011.03.003. Epub 2011 Jun 16.
- BackgroundAnand P, Ben-Shalom Y. The promise of better economic outcomes for workers with musculoskeletal conditions. Roosevelt House: Public Policy Institute at Hunter College.2017.
- BackgroundSocial Security Administration. Annual Statistical Report on the Social Security Disability Insurance Program, 2015. Washington, DC2016.
- Background: PubMed 17928147O'Connor AB, Schwid SR, Herrmann DN, Markman JD, Dworkin RH. Pain associated with multiple sclerosis: systematic review and proposed classification. Pain. 2008 Jul;137(1):96-111. doi: 10.1016/j.pain.2007.08.024. Epub 2007 Oct 24.
- Background: PubMed 12048417Warms CA, Turner JA, Marshall HM, Cardenas DD. Treatments for chronic pain associated with spinal cord injuries: many are tried, few are helpful. Clin J Pain. 2002 May-Jun;18(3):154-63. doi: 10.1097/00002508-200205000-00004.
- Individual participant dataSharing planned: Yes. All collected IPD will be deposited in a digital data repository. Direct and indirect identifiers will be removed to minimize disclosure risk. The data will be deposited with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR).
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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.
Dawn M Ehde, PhD 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 E-TIPS in people with Chronic Pain and Brain Injuries, Traumatic, 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 8 inclusion and 10 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 24 Jan 2025. 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 24 Jan 2025). 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?
Change in Pain Interference (time frame: Baseline (week 0) and 12 weeks (post-treatment)). 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 NCT04248725, which also lists 14 linked publications.
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 24 Jan 2025.