Chronic PainI-ABMTNCT02232100
Attentional Bias Modification Training for People With Chronic Musculoskeletal Pain
A study testing Attentional bias modification training (AMG) in people with Chronic Pain, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Chronic musculoskeletal pain is a complex medical condition associated with significant distress, disability, and reduction in quality of life. Research has shown that patients with chronic musculoskeletal pain demonstrate attentional biases towards pain-related information. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Attentional bias modification training (AMG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 1 Nov 2023
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged between 16 to 60 years old
- experiencing any type of CMSK (i.e., any condition that involves pain lasting for more than three months and arises from bones, muscles and/or joints)
- able to sit at a personal computer for forty minutes
- normal or corrected to normal vision
- access to the internet at least twice a week
- access to, and familiarity using, a Windows-based computer (g) successful completion of primary school
- living in the United Kingdom.
Who cannot join
- experiencing malignant CMSK (i.e., pain caused due to a tumour)
- a diagnosis of any psychiatric disorder, either currently or within the last 5 years
- currently under psychiatric therapy.
- No restrictions are placed on concomitant care and participants are not required to make any changes to current treatments they may be receiving.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton
Southampton, Hampshire, SO17 1BJ
Christina Liossi, DPsych, +44 23 8059 4645, c.liossi@soton.ac.uk
Daniel E Schoth, PhD, +44 23 8059 4518, d.e.schoth@soton.ac.uk
About this study
Official title: Internet-Delivered Attentional Bias Modification Training in People With Chronic Musculoskeletal Pain: A Double-Blind Randomised Control Trial and a Qualitative Investigation of Participants' Experience.
Chronic musculoskeletal pain is a complex medical condition associated with significant distress, disability, and reduction in quality of life. Research has shown that patients with chronic musculoskeletal pain demonstrate attentional biases towards pain-related information.
The purpose of this study is to determine whether internet-delivered attentional bias modification, which aims to implicitly train attention away from pain-related information, has beneficial effects upon pain and pain-related distress in patients with chronic musculoskeletal pain.
Read more
Participants will be randomised to either an attentional training condition, or to a no-training placebo condition. The primary outcome measures are pain intensity and pain interference, and secondary outcome measures include anxiety, depression, pain-related fear and sleep problems.
Data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60. It is hypothesized that participants receiving internet-delivered attentional bias modification will show significantly greater reductions in pain and pain-related distress compared to participants receiving placebo training.
Read the detailed description
Chronic musculoskeletal pain is a complex medical condition. Patients often experience increased levels of pain-related distress, including anxiety, depression and disability, impaired sleep, poor well-being and diminished quality of life. Over the past decade, numerous studies have provided evidence for the existence of attentional bias towards pain-related information in chronic pain patients. A critical question remaining unanswered is whether pain-related bias is simply an epiphenomenon of chronic pain, or whether it has a causal role in the maintenance of pain. Recently, there has been growing interest in the potential benefits of attentional retraining in individuals with various emotional disorders, with focus upon attentional bias modification (ABM).
ABM is a theory-driven intervention which uses computer-based paradigms, typically the visual-probe task, to implicitly manipulate attention away from sources of threat relevant to the individual's fears or concerns. To date, three published studies using ABM with chronic pain patients exist, the combined results of which support the therapeutic benefits of ABM on pain, pain-related distress and disability. Considering these encouraging results, it is important to expand this field of research and explore ABM in chronic pain in greater depth. In particular, all former studies assessed the clinical effectiveness of ABM in laboratory environments. The purpose of this double-blind RCT study is to determine whether internet-delivered ABM training (I-ABMT) has therapeutic benefits for patients with chronic musculoskeletal pain on pain and pain-related distress, thereby assessing training effects in real-world settings.
The visual-probe task will be used for assessment and modification of pain-related attentional biases. This is a computerised paradigm which records participant response times to a series of visual stimuli. Following an initial fixation point, each trial presents a stimulus pair in distinct locations (e.g. left and right of the initial fixation point), for a specified length of time (i.e., 500 or 1250ms). Stimuli may consist of words or images, with experimental trials featuring one pain-related stimulus and one neutral stimulus. Following this, both stimuli are removed, with a visual probe replacing one stimulus. Participants indicate the location of this probe as quickly and accurately as possible via manual response. Response times are faster to probes appearing in an attended region of the screen than an unattended region, providing a measure of attentional allocation. Averaged response times are calculated, which are converted into an index of attentional bias. In the standard and control (i.e., placebo) versions of the visual probe task, the probe replaces pain-related and neutral stimuli an equal number of times, while in the I-ABMT version, the probe always replaces neutral stimuli thus training attention away from pain-related stimuli.
Dose effects will be explored in this study, with participants randomised to one of four conditions: (i) 10-session Attentional Modification Group , (ii) 10-session Attentional Control Group, (iii) 18-session Attentional Modification Group, and (iv) 18-session Attentional Control Group. The primary outcome measures are pain intensity and pain interference, and secondary outcome measures include anxiety, depression, pain-related fear and sleeping impairment, including engagement to and satisfaction with the online visual-probe training task. It is hypothesized that participants receiving ABM training will show significantly greater reductions in pain and pain-related distress compared to participants receiving placebo training. Dose effects will be investigated in an exploratory manner, and data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60.
- Conditions
- Chronic Pain
- Being tested
- Attentional bias modification training (AMG), Attentional bias placebo (ACG)
- Keywords
- Attentional bias modification training, Chronic pain, Visual-probe task, Internet-delivered therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional bias modification training (AMG)Behavioural
Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information
Attentional bias placebo (ACG)Behavioural
Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information
| Study group | Role | What they receive |
|---|---|---|
| 10AMG | Experimental | Attentional bias modification group - 10 training sessions Receives: Behavioral: Attentional bias modification training (AMG) |
| 10ACG | Placebo comparator | Attentional control group - 10 placebo sessions Receives: Behavioral: Attentional bias placebo (ACG) |
| 18AMG | Experimental | Attentional bias modification group - 18 training sessions Receives: Behavioral: Attentional bias modification training (AMG) |
| 18ACG | Placebo comparator | Attentional control group - 18 placebo sessions Receives: Behavioral: Attentional bias placebo (ACG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to endline (4 or 8 weeks)
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
Measured: Baseline, following intervention (4 or 8 weeks)
Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to endline (4 or 8 weeks)
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
Measured: Baseline, following intervention (4 or 8 weeks)
Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to 6-month follow-up
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
Measured: Baseline, 6-month follow-up
Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to 6-month follow-up
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
Measured: Baseline, 6-month follow-up
Secondary outcomes (8)
Anxiety - change from baseline to endline (4 or 8 weeks)
State and Trait Anxiety Subscales from the State-Trait Anxiety Inventory (STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety.
Measured: Baseline, following intervention (4 or 8 weeks)
Depression - change from baseline to endline (4 or 8 weeks)
Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression.
Measured: Baseline, following intervention (4 or 8 weeks)
Pain-related fear - change from baseline to endline (4 or 8 weeks)
Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear.
Measured: Baseline, following intervention (4 or 8 weeks)
Sleeping impairment - change from baseline to endline (4 or 8 weeks)
Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep).
Measured: Baseline, following intervention (4 or 8 weeks)
Anxiety - change from baseline to 6-month follow-up
State and Trait Anxiety Subscales from State-Trait Anxiety Inventory(STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety.
Measured: Baseline, 6-month follow-up
Depression - change from baseline to 6-month follow-up
Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression.
Measured: Baseline, 6-month follow-up
Pain-related fear - change from baseline to 6-month follow-up
Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear.
Measured: Baseline, 6-month follow-up
Sleeping impairment - change from baseline to 6-month follow-up
Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep).
Measured: Baseline, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study start1 Nov 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Liossi, DPsych, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232100
- Sponsor's protocol ID
- ABMT2014
- Acronym
- I-ABMT
- Status last verified
- May 2021
- First submitted
- 1 Sep 2014
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liossi C, Georgallis T, Zhang J, Hamilton F, White P, Schoth DE. Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 20;10(2):e030607. doi: 10.1136/bmjopen-2019-030607.
PubMed 32086350
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Delivered Attentional Bias Modification Training in People With Chronic Musculoskeletal Pain: A Double-Blind Randomised Control Trial and a Qualitative Investigation of Participants' Experience.
- ClinicalTrials.gov ID
- NCT02232100
- Acronym / sponsor ID
- I-ABMT / ABMT2014
- Conditions
- Chronic Pain
- Keywords
- Attentional bias modification training, Chronic pain, Visual-probe task, Internet-delivered therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 4 Sep 2014 (estimated)
- 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.
Chronic musculoskeletal pain is a complex medical condition associated with significant distress, disability, and reduction in quality of life. Research has shown that patients with chronic musculoskeletal pain demonstrate attentional biases towards pain-related information.
The purpose of this study is to determine whether internet-delivered attentional bias modification, which aims to implicitly train attention away from pain-related information, has beneficial effects upon pain and pain-related distress in patients with chronic musculoskeletal pain.
Participants will be randomised to either an attentional training condition, or to a no-training placebo condition. The primary outcome measures are pain intensity and pain interference, and secondary outcome measures include anxiety, depression, pain-related fear and sleep problems.
Data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60. It is hypothesized that participants receiving internet-delivered attentional bias modification will show significantly greater reductions in pain and pain-related distress compared to participants receiving placebo training.
Detailed description
Chronic musculoskeletal pain is a complex medical condition. Patients often experience increased levels of pain-related distress, including anxiety, depression and disability, impaired sleep, poor well-being and diminished quality of life. Over the past decade, numerous studies have provided evidence for the existence of attentional bias towards pain-related information in chronic pain patients. A critical question remaining unanswered is whether pain-related bias is simply an epiphenomenon of chronic pain, or whether it has a causal role in the maintenance of pain. Recently, there has been growing interest in the potential benefits of attentional retraining in individuals with various emotional disorders, with focus upon attentional bias modification (ABM).
ABM is a theory-driven intervention which uses computer-based paradigms, typically the visual-probe task, to implicitly manipulate attention away from sources of threat relevant to the individual's fears or concerns. To date, three published studies using ABM with chronic pain patients exist, the combined results of which support the therapeutic benefits of ABM on pain, pain-related distress and disability. Considering these encouraging results, it is important to expand this field of research and explore ABM in chronic pain in greater depth. In particular, all former studies assessed the clinical effectiveness of ABM in laboratory environments. The purpose of this double-blind RCT study is to determine whether internet-delivered ABM training (I-ABMT) has therapeutic benefits for patients with chronic musculoskeletal pain on pain and pain-related distress, thereby assessing training effects in real-world settings.
The visual-probe task will be used for assessment and modification of pain-related attentional biases. This is a computerised paradigm which records participant response times to a series of visual stimuli. Following an initial fixation point, each trial presents a stimulus pair in distinct locations (e.g. left and right of the initial fixation point), for a specified length of time (i.e., 500 or 1250ms). Stimuli may consist of words or images, with experimental trials featuring one pain-related stimulus and one neutral stimulus. Following this, both stimuli are removed, with a visual probe replacing one stimulus. Participants indicate the location of this probe as quickly and accurately as possible via manual response. Response times are faster to probes appearing in an attended region of the screen than an unattended region, providing a measure of attentional allocation. Averaged response times are calculated, which are converted into an index of attentional bias. In the standard and control (i.e., placebo) versions of the visual probe task, the probe replaces pain-related and neutral stimuli an equal number of times, while in the I-ABMT version, the probe always replaces neutral stimuli thus training attention away from pain-related stimuli.
Dose effects will be explored in this study, with participants randomised to one of four conditions: (i) 10-session Attentional Modification Group , (ii) 10-session Attentional Control Group, (iii) 18-session Attentional Modification Group, and (iv) 18-session Attentional Control Group. The primary outcome measures are pain intensity and pain interference, and secondary outcome measures include anxiety, depression, pain-related fear and sleeping impairment, including engagement to and satisfaction with the online visual-probe training task. It is hypothesized that participants receiving ABM training will show significantly greater reductions in pain and pain-related distress compared to participants receiving placebo training. Dose effects will be investigated in an exploratory manner, and data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10AMG | Experimental | Behavioral: Attentional bias modification training (AMG)Attentional bias modification group - 10 training sessions |
| 10ACG | Placebo comparator | Behavioral: Attentional bias placebo (ACG)Attentional control group - 10 placebo sessions |
| 18AMG | Experimental | Behavioral: Attentional bias modification training (AMG)Attentional bias modification group - 18 training sessions |
| 18ACG | Placebo comparator | Behavioral: Attentional bias placebo (ACG)Attentional control group - 18 placebo sessions |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- aged between 16 to 60 years old
- experiencing any type of CMSK (i.e., any condition that involves pain lasting for more than three months and arises from bones, muscles and/or joints)
- able to sit at a personal computer for forty minutes
- normal or corrected to normal vision
- access to the internet at least twice a week
Key exclusion criteria (4 listed)
- experiencing malignant CMSK (i.e., pain caused due to a tumour)
- a diagnosis of any psychiatric disorder, either currently or within the last 5 years
- currently under psychiatric therapy.
- No restrictions are placed on concomitant care and participants are not required to make any changes to current treatments they may be receiving.
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 |
|---|---|---|
| Attentional bias modification training (AMG)Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information | Behavioural | 10AMG, 18AMG |
| Attentional bias placebo (ACG)Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information | Behavioural | 10ACG, 18ACG |
Primary outcome
Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to endline (4 or 8 weeks)
Time frame: Baseline, following intervention (4 or 8 weeks)
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to endline (4 or 8 weeks)
Time frame: Baseline, following intervention (4 or 8 weeks)
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to 6-month follow-up
Time frame: Baseline, 6-month follow-up
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to 6-month follow-up
Time frame: Baseline, 6-month follow-up
Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
8 secondary outcomes
Anxiety - change from baseline to endline (4 or 8 weeks)
Time frame: Baseline, following intervention (4 or 8 weeks)
Depression - change from baseline to endline (4 or 8 weeks)
Time frame: Baseline, following intervention (4 or 8 weeks)
Pain-related fear - change from baseline to endline (4 or 8 weeks)
Time frame: Baseline, following intervention (4 or 8 weeks)
Sleeping impairment - change from baseline to endline (4 or 8 weeks)
Time frame: Baseline, following intervention (4 or 8 weeks)
Anxiety - change from baseline to 6-month follow-up
Time frame: Baseline, 6-month follow-up
Depression - change from baseline to 6-month follow-up
Time frame: Baseline, 6-month follow-up
Pain-related fear - change from baseline to 6-month follow-up
Time frame: Baseline, 6-month follow-up
Sleeping impairment - change from baseline to 6-month follow-up
Time frame: Baseline, 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 32086350Liossi C, Georgallis T, Zhang J, Hamilton F, White P, Schoth DE. Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 20;10(2):e030607. doi: 10.1136/bmjopen-2019-030607.
- 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.
Christina Liossi, DPsych principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional bias modification training (AMG) in people with Chronic Pain, run by University of Southampton at 1 site in United Kingdom.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 May 2021. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Liossi, DPsych (+44 23 8059 4645, c.liossi@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to endline (4 or 8 weeks) (time frame: Baseline, following intervention (4 or 8 weeks)). The study lists 4 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 NCT02232100, 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 19 May 2021.