Chronic PainNCT04010019
The Facing Pain Study
A study testing Enhanced Facebook Condition in people with Chronic Pain, run by Wayne State University at 1 site in United States.
Trial summary
This randomized trial will create and compare two private Facebook conditions for patients with chronic pain. The control condition will be comprised of groups of patients who communicate without much clinician / moderator input, and the experimental condition will have a clinician moderating and teaching patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Enhanced Facebook Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 13 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Must have chronic pain (i.e., pain that persists for greater than 3 months)
- Must be fluent at reading and writing in English
- Must have an active Facebook account and check Facebook at least 3 times a week
Who cannot join
- Terminal illness such as cancer
- Active psychosis (e.g., hallucinations, delusions)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Facebook Support Groups for Adults With Chronic Pain: A Randomized Clinical Trial
This randomized trial will create and compare two private Facebook conditions for patients with chronic pain. The control condition will be comprised of groups of patients who communicate without much clinician / moderator input, and the experimental condition will have a clinician moderating and teaching patients several techniques designed to facilitate social disclosure, validation, and emotional engagement with avoided activities.
Read the detailed description
This study will investigate the effectiveness of a private Facebook group for individuals in chronic pain. Currently, more than 100,000 individuals with chronic pain (ICPs) participate in Facebook groups, seeking support from others in similar situations. There are currently some online self-management programs for ICPs; however, most lack a peer support aspect, as they are individualized, self-directed, and focus on instructing patients in how to manage their pain. The goals of the proposed online pain support group are: 1) to provide peer-to-peer social support for individuals with chronic pain; and 2) to disseminate psychosocial pain management techniques using a social media platform. Screened participants will be assigned to one of two conditions: a Facebook group similar to the groups that are occurring naturally (control condition) or an enhanced Facebook group that is moderated by clinicians and offers psychosocial pain management techniques (experimental condition). Both conditions involve peer-to-peer healthcare and support, but the experimental group additionally includes components such as psychoeducation about pain neuroscience, emotional validation training, guided emotional disclosure, and activities to overcome emotional and behavioral avoidance. Findings from this study will offer important information about the impact of Facebook support groups on pain outcomes, and test whether psychosocial pain interventions can be disseminated using a social media platform.
- Conditions
- Chronic Pain
- Being tested
- Enhanced Facebook Condition, Control Facebook Condition
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Facebook ConditionBehavioural
The intervention (enhanced Facebook condition) will consist of several training components that were selected based on pain research and platform affordances. The first component will be psychoeducation on pain neurobiology. Emotional validation training will follow. The third component will consist of facilitating patients' emotional disclosure about their pain journeys and lives. The fourth and final intervention component will include prompts to engage participants in activities that they have been avoiding because of their pain.
Control Facebook ConditionBehavioural
The control condition will instruct participants to offer mutual support and will not offer psychosocial intervention.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Facebook Condition | Experimental | The enhanced Facebook group will be moderated by clinicians and offer psychosocial pain management techniques. Receives: Behavioral: Enhanced Facebook Condition |
| Control Facebook Condition | Active comparator | In the control condition, there will be no outside intervention; rather, the investigators will instruct participants to offer mutual support for the duration of the group and will not comment further. Receives: Behavioral: Control Facebook Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Brief Pain Inventory (Cleeland, 1991): Pain severity items: 1) Worst pain (0 [no pain] - 10 [pain as bad as you can imagine]), 2) Average pain (0 [no pain] - 10 [pain as bad as you can imagine]), 3) A composite of the 4 pain items (a mean pain severity score) will also be computed (0 [no pain] - 10 [pain as bad as you can imagine])
Measured: Pain severity will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in pain interference from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Brief Pain Inventory (Cleeland, 1991): Pain interference items: A composite of the 7 interference items (a mean interference score) will be computed (0 [does not interfere] - 10 [completely interferes])
Measured: Pain interference will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Secondary outcomes (12)
Change in depression from baseline to post-intervention to 1-month follow-up
PROMIS Emotional Distress - Depression - Short Form 8a v1.0: A composite of the 8 depression items (a mean depression score) will be computed (1 [low depression score] - 5 [high depression score])
Measured: Depression will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in anxiety from baseline to post-intervention to 1-month follow-up
PROMIS Emotional Distress - Anxiety - Short Form 8a v1.0: A composite of the 8 anxiety items (a mean anxiety score) will be computed (1 [low anxiety score] - 5 [high anxiety score])
Measured: Anxiety will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in perceived chronic pain social support from baseline to post-intervention to 1-month follow-up
Diabetes Support Scale (Barrera, 2002), adapted for chronic pain: A summed score of the 12 support items will be computed (12-84, higher scores indicate greater support)
Measured: Perceived chronic pain social support will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in anger from baseline to post-intervention to 1-month follow-up
PROMIS Anger - Short Form 5a v1.1: A composite of the 5 anger items (a mean anger score) will be computed (1 [low anger score] - 5 [high anger score])
Measured: Anger will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in self-efficacy for managing pain: PROMIS Self-Efficacy for Managing Symptoms v1.0
PROMIS Self-Efficacy for Managing Symptoms v1.0 (10 items from the larger 30-item measure, adapted for self-efficacy for managing pain): A composite of the 10 self-efficacy items (a mean self-efficacy score) will be computed (1 [low self-efficacy score] - 5 [high self-efficacy score])
Measured: Self-efficacy for managing pain will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in helplessness
Arthritis Helplessness Index (Nicassio et al., 1985), adapted for chronic pain: A summed score of the 15 helplessness items will be computed (15-60, higher scores indicate greater helplessness)
Measured: Helplessness will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in self-efficacy for managing emotions: PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0
PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0: A composite of the 4 self-efficacy items (a mean self-efficacy score) will be computed (1 [low self-efficacy score] - 5 [high self-efficacy score])
Measured: Self-efficacy for managing emotions will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in social isolation
PROMIS - Social Isolation - Short Form 8a v2.0: A composite of the 8 social isolation items (a mean social isolation score) will be computed (1 [low social isolation score] - 5 [high social isolation score])
Measured: Social isolation will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in pain catastrophizing: Pain Catastrophizing Scale
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Measured: Pain catastrophizing will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in alexithymia
Toronto Alexithymia Scale (TAS-20): A summed score of the 20 alexithymia items will be computed (20-100, higher scores indicate greater alexithymia)
Measured: Alexithymia will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in substance use
Substance use questionnaire: 4 question-set recommended by the NIAAA (adapted for the "past week"): 1) Frequency of drinking / opioid use / marijuana use (0 [never] - 5 [every day]), 2) Number of drinks (0 [no drinks] - 10 [25 or more drinks]), 3) Maximum drinks (0 [no drinks] - 10 [36 or more drinks], 4) Frequency of binge drinking (0 [never] - 5 [every day])
Measured: Substance use will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Perceived emotional support within the Facebook group
PROMIS - Emotional Support - Short Form 8a, adapted for in-group support: A composite of the 8 emotional support items (a mean emotional support score) will be computed (1 [low emotional support score] - 5 [high emotional support score])
Measured: Perceived emotional support within the Facebook group will be assessed at post-intervention (i.e., immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start27 Sep 2019
- Primary completion13 Apr 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interested adults will be screened, and eligible participants will be randomly assigned to one of two conditions: a Facebook group for individuals in pain similar to the groups that are occurring naturally (control condition) or an enhanced Facebook group for individuals in pain that is moderated by clinicians and offers psychosocial pain intervention techniques (experimental condition).
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010019
- Sponsor's protocol ID
- 012119B3E
- Status last verified
- Apr 2020
- First submitted
- 12 Jun 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tankha H, Pester BD, Brumley KM, Cano A, Tong S, Grekin E, Bruinsma J, Gootee J, Lumley MA. A mixed-methods investigation into the us versus them mentality in Facebook groups for chronic pain. Health Psychol. 2023 Jul;42(7):460-471. doi: 10.1037/hea0001289. Epub 2023 May 4.
PubMed 37141005Pester BD, Tankha H, Cano A, Tong S, Grekin E, Bruinsma J, Gootee J, Lumley MA. Facing Pain Together: A Randomized Controlled Trial of the Effects of Facebook Support Groups on Adults With Chronic Pain. J Pain. 2022 Dec;23(12):2121-2134. doi: 10.1016/j.jpain.2022.07.013. Epub 2022 Sep 9.
PubMed 36096353
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Facebook Support Groups for Adults With Chronic Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04010019
- Acronym / sponsor ID
- 012119B3E
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial will create and compare two private Facebook conditions for patients with chronic pain. The control condition will be comprised of groups of patients who communicate without much clinician / moderator input, and the experimental condition will have a clinician moderating and teaching patients several techniques designed to facilitate social disclosure, validation, and emotional engagement with avoided activities.
Detailed description
This study will investigate the effectiveness of a private Facebook group for individuals in chronic pain. Currently, more than 100,000 individuals with chronic pain (ICPs) participate in Facebook groups, seeking support from others in similar situations. There are currently some online self-management programs for ICPs; however, most lack a peer support aspect, as they are individualized, self-directed, and focus on instructing patients in how to manage their pain. The goals of the proposed online pain support group are: 1) to provide peer-to-peer social support for individuals with chronic pain; and 2) to disseminate psychosocial pain management techniques using a social media platform. Screened participants will be assigned to one of two conditions: a Facebook group similar to the groups that are occurring naturally (control condition) or an enhanced Facebook group that is moderated by clinicians and offers psychosocial pain management techniques (experimental condition). Both conditions involve peer-to-peer healthcare and support, but the experimental group additionally includes components such as psychoeducation about pain neuroscience, emotional validation training, guided emotional disclosure, and activities to overcome emotional and behavioral avoidance. Findings from this study will offer important information about the impact of Facebook support groups on pain outcomes, and test whether psychosocial pain interventions can be disseminated using a social media platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interested adults will be screened, and eligible participants will be randomly assigned to one of two conditions: a Facebook group for individuals in pain similar to the groups that are occurring naturally (control condition) or an enhanced Facebook group for individuals in pain that is moderated by clinicians and offers psychosocial pain intervention techniques (experimental condition).
| Arm | Type | Receives |
|---|---|---|
| Enhanced Facebook Condition | Experimental | Behavioral: Enhanced Facebook ConditionThe enhanced Facebook group will be moderated by clinicians and offer psychosocial pain management techniques. |
| Control Facebook Condition | Active comparator | Behavioral: Control Facebook ConditionIn the control condition, there will be no outside intervention; rather, the investigators will instruct participants to offer mutual support for the duration of the group and will not comment further. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have chronic pain (i.e., pain that persists for greater than 3 months)
- Must be fluent at reading and writing in English
- Must have an active Facebook account and check Facebook at least 3 times a week
Key exclusion criteria (2 listed)
- Terminal illness such as cancer
- Active psychosis (e.g., hallucinations, delusions)
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 |
|---|---|---|
| Enhanced Facebook ConditionThe intervention (enhanced Facebook condition) will consist of several training components that were selected based on pain research and platform affordances. The first component will be psychoeducation on pain neurobiology. Emotional validation training will follow. The third component will consist of facilitating patients' emotional disclosure about their pain journeys and lives. The fourth and final intervention component will include prompts to engage participants in activities that they have been avoiding because of their pain. | Behavioural | Enhanced Facebook Condition |
| Control Facebook ConditionThe control condition will instruct participants to offer mutual support and will not offer psychosocial intervention. | Behavioural | Control Facebook Condition |
Primary outcome
Change in pain severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Time frame: Pain severity will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Brief Pain Inventory (Cleeland, 1991): Pain severity items: 1) Worst pain (0 [no pain] - 10 [pain as bad as you can imagine]), 2) Average pain (0 [no pain] - 10 [pain as bad as you can imagine]), 3) A composite of the 4 pain items (a mean pain severity score) will also be computed (0 [no pain] - 10 [pain as bad as you can imagine])
Change in pain interference from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Time frame: Pain interference will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Brief Pain Inventory (Cleeland, 1991): Pain interference items: A composite of the 7 interference items (a mean interference score) will be computed (0 [does not interfere] - 10 [completely interferes])
12 secondary outcomes
Change in depression from baseline to post-intervention to 1-month follow-up
Time frame: Depression will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in anxiety from baseline to post-intervention to 1-month follow-up
Time frame: Anxiety will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in perceived chronic pain social support from baseline to post-intervention to 1-month follow-up
Time frame: Perceived chronic pain social support will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in anger from baseline to post-intervention to 1-month follow-up
Time frame: Anger will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in self-efficacy for managing pain: PROMIS Self-Efficacy for Managing Symptoms v1.0
Time frame: Self-efficacy for managing pain will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in helplessness
Time frame: Helplessness will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in self-efficacy for managing emotions: PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0
Time frame: Self-efficacy for managing emotions will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in social isolation
Time frame: Social isolation will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in pain catastrophizing: Pain Catastrophizing Scale
Time frame: Pain catastrophizing will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in alexithymia
Time frame: Alexithymia will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Change in substance use
Time frame: Substance use will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Perceived emotional support within the Facebook group
Time frame: Perceived emotional support within the Facebook group will be assessed at post-intervention (i.e., immediately after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Derived from this study: PubMed 37141005Tankha H, Pester BD, Brumley KM, Cano A, Tong S, Grekin E, Bruinsma J, Gootee J, Lumley MA. A mixed-methods investigation into the us versus them mentality in Facebook groups for chronic pain. Health Psychol. 2023 Jul;42(7):460-471. doi: 10.1037/hea0001289. Epub 2023 May 4.
- Derived from this study: PubMed 36096353Pester BD, Tankha H, Cano A, Tong S, Grekin E, Bruinsma J, Gootee J, Lumley MA. Facing Pain Together: A Randomized Controlled Trial of the Effects of Facebook Support Groups on Adults With Chronic Pain. J Pain. 2022 Dec;23(12):2121-2134. doi: 10.1016/j.jpain.2022.07.013. Epub 2022 Sep 9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Facebook Condition in people with Chronic Pain, run by Wayne State University 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 3 inclusion and 2 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 14 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory (time frame: Pain severity will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)). The study lists 2 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 NCT04010019, which also lists 2 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 14 Apr 2020.