Type 2 DiabetesNCT06908486
Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain
A study testing Cognitive Bias Modification for Interpretation in people with Type 2 Diabetes and Persistent Pain, run by University of Sydney at 1 site in Australia.
Trial summary
The goal of this clinical trial is to examine the efficacy of cognitive bias modification for interpretation (CBM-I) in people with Type 2 Diabetes and persistent pain. The main question[s] it aims to answer is whether interpretation bias training away from pain improves pain outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Persistent Pain
- What is being tested?
- Cognitive Bias Modification for Interpretation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Apr 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Over 18 years of age
- Have a diagnosis of Type 2 diabetes.
- Have persistent pain (pain present on more days than not, for 3 months or longer).
- Score ≥ 3 on average pain severity on the Brief Pain Inventory (BPI).
- Fluent in English
- Have access to internet and ability to use a computer over a three month period.
Who cannot join
- Under 18 years of age
- No diagnosis of Type 2 diabetes
- No persistent pain
- Not fluent in English
- No access to internet nor ability to use a computer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
University of Sydney
Camperdown, New South Wales, 2006
Tessa Rooney, +61449610131, tessa.rooney@sydney.edu.au
About this study
Official title: Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain
The goal of this clinical trial is to examine the efficacy of cognitive bias modification for interpretation (CBM-I) in people with Type 2 Diabetes and persistent pain. The main question[s] it aims to answer is whether interpretation bias training away from pain improves pain outcomes.
Participants in the CBM-I group will complete 4 online training sessions approximately half an hour each. Each session will present participants with ambiguous scenarios which may be pain-related, however the final word of the sentence will resolve the scenario as benign (thus training participants to make benign interpretations). A measure of interpretation bias will be administered following the fourth training session, and pain severity and interference will be measured at baseline, post-training, two week follow up, and three month follow up.
The study hypothesises that participants in the CBM-I group will demonstrate a greater reduction in the co-primary outcomes of pain severity and pain interference over time compared to those in the placebo control.
Read the detailed description
Pre-intervention stage The study will employ a dual consent process. First, participants will complete an "expression of interest" survey which contains the eligibility survey. Given it is crucial for the study to include people with diabetes and persistent pain, this eligibility survey will be used to ensure the sample meets our eligibility criteria of being 1) are over 18 years of age; 2) have been diagnosed with type 2 diabetes; 3) have persistent pain; 4) score ≥ 3 on pain severity subscale on BPI; 5) fluent in English; 6) have access to internet and ability to use a computer over three months.
Participants deemed eligible for the study will be provided with the Participant Information Statement and consent form via Qualtrics, which will provide detailed information about the study, the nature of their participation, and their rights as participants, including the right to withdraw at any point. Participants who do not consent to participate will be redirected to the end-of-survey.
After providing consent, participants will be asked to complete the baseline questionnaires: Brief Pain Inventory (BPI), Depression, Anxiety and Stress Scale (DASS-21), 12-Item Short Form Survey (SF-12), the Worries about Recurrence or Progression Scale (WARPS) and the Treatment adherence perception (TAPQ). The rationale of these measures is that they are theoretically related to interpretation biases and are hypothesised to change following training. This is expected to take approximately 15-20 minutes of their time.
Intervention stage Immediately following completion of baseline questionaries, participants will be randomised to either the CBM-I or placebo groups automatically using a computer algorithm in Qualtrics and invited to participate in the first session (training session 1) (day 1). Neither the participants nor the researchers will be aware of which group the participant has been allocated to.
Three days after completion of the first training session (day 4), participants will be invited via email automated by Qualtrics to the next training session (training session 2). On day 7, participants will be invited to the next training session (training session 3). Each training session is expected to take 10-15 minutes.
On day 14, participants will be invited to the final training session (training session 4), which will be followed immediately by the follow-up questions (follow-up 1). Participants will therefore complete four training sessions in total over the course of 14 days.
Participants will complete the BPI questionnaire prior to each CBM-I training session. Such that, BPI is measured at baseline, prior to CBM-I training session, and at two follow-up points: 2 weeks and 3 months post-intervention.
Note that participants will be asked to complete the training within two days of being email the link. The training sessions are not mandatory, and whether the participants complete each training session they will be still sent the links for the remaining training sessions.
Post-treatment On day 14, following the final training, participants will complete a series of questionnaires: BPI, DASS-21, SF-12, WARPS, TAPQ, Ambiguous cues task, Recognition Task, Post-Intervention Questionnaire. This survey is estimated to take up to approximately 30-35 minutes (inclusive of training time).
Follow-up 1 Exactly two weeks after post-treatment (day 28), participants will be invited via email and asked to complete the follow-up questionnaires (same as baseline), and the post-intervention questionnaire. This is estimated to take 15-20 minutes.
Follow-up 2 Three months after post-treatment, participants will be invited via email and asked to complete the follow-up questionnaires (same as baseline) and the post-intervention questionnaire. This is estimated to take 15-20 minutes. As outlined in the debrief statement, if the CBM-I intervention appears to be beneficial at the conclusion of the study, access to the training will be provided for all placebo group participants.
- Conditions
- Type 2 Diabetes, Persistent Pain
- Being tested
- Cognitive Bias Modification for Interpretation, Placebo
- Keywords
- cognitive bias modification, interpretation bias, type 2 diabetes, pain
- Medical subject headings
- Diabetes Mellitus, Type 2, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias Modification for InterpretationBehavioural
Cognitive Bias Modification involves administering the Ambiguous Scenarios paradigm. This is a series of ambiguous scenarios which could be resolved to be associated with pain. The task consists of 30 unique scenarios and an associated comprehension question (pertaining to the pain-relatedness of the scenario), which are presented in a random order to participants.
Each scenario presents an ambiguous sentence, ending with a word fragment which the participant must complete. The statement remains ambiguous until the completion of the word fragment, which resolves the statement as either pain-related or benign. For example, the statement "You are bush walking. Suddenly, you trip over and fall onto your knees. Your knees feel all wet, and you look down to see..." can be followed by "le_v_s [leaves]" for a benign resolution, or "bl__d [blood]" for a pain-related resolution. In the intervention group, all 30 scenarios will be followed with the benign word fragment.
PlaceboBehavioural
The Ambiguous Scenarios paradigm described previously will be used for the placebo intervention. The same 30 scenarios will be presented to participants, however 50% (15) trials will be followed by the benign word fragment, ad 50% (15) trials will be followed by the pain-related word fragment.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Bias Modification for Interpretation | Experimental | The Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. All scenarios in this arm are resolved to be benign. Receives: Behavioral: Cognitive Bias Modification for Interpretation |
| Placebo Cognitive Bias Modification for Interpretation | Placebo comparator | The placebo Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. Scenarios are resolved as either benign or pain-related, with equal numbers (15) of each per session. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Intensity subscale of the Brief Pain Inventory (range 0 - 40; lower scores represent less pain severity, i.e. better outcome)
Measured: Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
Pain interference
Interference subscale of the Brief Pain Inventory (range 0 - 70; lower scores represent less pain interference, i.e. better outcome)
Measured: Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
Secondary outcomes (8)
Interpretation bias to pain (1)
Bias score on the Interpretation Bias Recognition Task (range -4 to 4; lower scores represent smaller interpretation bias to pain, i.e. better outcome)
Measured: Post intervention (day 14)
Interpretation bias to pain (2)
Bias score on the Ambiguous Cues task (range from 0 - 14; lower scores represent smaller interpretation bias to pain, i.e. better outcome)
Measured: Post intervention (day 14)
Health-related quality of life
12 Item Short Form Health Survey score (scores are reported as Z scores, with a mean of 50 and a standard deviation of 10. Scores greater than 50 are indicative of better than average health-related quality of life).
Measured: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Depression
Depression subscale of the 21 item Depression Anxiety Stress Scales (range 0 - 21; lower scores represent less depression, i.e. better outcome)
Measured: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Anxiety
Anxiety subscale of the 21 item Depression Anxiety Stress Scales (range 0 - 21; lower scores represent less anxiety, i.e. improved outcome)
Measured: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Stress
Stress subscale of the 21 item Depression Anxiety Stress Scales (range 0 - 21; lower scores represent less stress, i.e. improved outcome)
Measured: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Fear of disease progression
Worries about Recurrence or Progression Scale score (range 18 - 90; lower scores represent less worry about progression, i.e. better outcome)
Measured: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Treatment Adherence
Treatment Adherence Perception Questionnaire (range 16 - 97; higher scores represent greater treatment adherence, i.e. better outcome)
Measured: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start15 Apr 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 319 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Sharpe, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908486
- Sponsor's protocol ID
- 2024/HE000161
- Status last verified
- May 2025
- First submitted
- 1 Apr 2025
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain
- ClinicalTrials.gov ID
- NCT06908486
- Acronym / sponsor ID
- 2024/HE000161
- Conditions
- Type 2 Diabetes, Persistent Pain
- Keywords
- cognitive bias modification, interpretation bias, type 2 diabetes, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 319 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 3 Apr 2025 (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.
The goal of this clinical trial is to examine the efficacy of cognitive bias modification for interpretation (CBM-I) in people with Type 2 Diabetes and persistent pain. The main question[s] it aims to answer is whether interpretation bias training away from pain improves pain outcomes.
Participants in the CBM-I group will complete 4 online training sessions approximately half an hour each. Each session will present participants with ambiguous scenarios which may be pain-related, however the final word of the sentence will resolve the scenario as benign (thus training participants to make benign interpretations). A measure of interpretation bias will be administered following the fourth training session, and pain severity and interference will be measured at baseline, post-training, two week follow up, and three month follow up.
The study hypothesises that participants in the CBM-I group will demonstrate a greater reduction in the co-primary outcomes of pain severity and pain interference over time compared to those in the placebo control.
Detailed description
Pre-intervention stage The study will employ a dual consent process. First, participants will complete an "expression of interest" survey which contains the eligibility survey. Given it is crucial for the study to include people with diabetes and persistent pain, this eligibility survey will be used to ensure the sample meets our eligibility criteria of being 1) are over 18 years of age; 2) have been diagnosed with type 2 diabetes; 3) have persistent pain; 4) score ≥ 3 on pain severity subscale on BPI; 5) fluent in English; 6) have access to internet and ability to use a computer over three months.
Participants deemed eligible for the study will be provided with the Participant Information Statement and consent form via Qualtrics, which will provide detailed information about the study, the nature of their participation, and their rights as participants, including the right to withdraw at any point. Participants who do not consent to participate will be redirected to the end-of-survey.
After providing consent, participants will be asked to complete the baseline questionnaires: Brief Pain Inventory (BPI), Depression, Anxiety and Stress Scale (DASS-21), 12-Item Short Form Survey (SF-12), the Worries about Recurrence or Progression Scale (WARPS) and the Treatment adherence perception (TAPQ). The rationale of these measures is that they are theoretically related to interpretation biases and are hypothesised to change following training. This is expected to take approximately 15-20 minutes of their time.
Intervention stage Immediately following completion of baseline questionaries, participants will be randomised to either the CBM-I or placebo groups automatically using a computer algorithm in Qualtrics and invited to participate in the first session (training session 1) (day 1). Neither the participants nor the researchers will be aware of which group the participant has been allocated to.
Three days after completion of the first training session (day 4), participants will be invited via email automated by Qualtrics to the next training session (training session 2). On day 7, participants will be invited to the next training session (training session 3). Each training session is expected to take 10-15 minutes.
On day 14, participants will be invited to the final training session (training session 4), which will be followed immediately by the follow-up questions (follow-up 1). Participants will therefore complete four training sessions in total over the course of 14 days.
Participants will complete the BPI questionnaire prior to each CBM-I training session. Such that, BPI is measured at baseline, prior to CBM-I training session, and at two follow-up points: 2 weeks and 3 months post-intervention.
Note that participants will be asked to complete the training within two days of being email the link. The training sessions are not mandatory, and whether the participants complete each training session they will be still sent the links for the remaining training sessions.
Post-treatment On day 14, following the final training, participants will complete a series of questionnaires: BPI, DASS-21, SF-12, WARPS, TAPQ, Ambiguous cues task, Recognition Task, Post-Intervention Questionnaire. This survey is estimated to take up to approximately 30-35 minutes (inclusive of training time).
Follow-up 1 Exactly two weeks after post-treatment (day 28), participants will be invited via email and asked to complete the follow-up questionnaires (same as baseline), and the post-intervention questionnaire. This is estimated to take 15-20 minutes.
Follow-up 2 Three months after post-treatment, participants will be invited via email and asked to complete the follow-up questionnaires (same as baseline) and the post-intervention questionnaire. This is estimated to take 15-20 minutes. As outlined in the debrief statement, if the CBM-I intervention appears to be beneficial at the conclusion of the study, access to the training will be provided for all placebo group participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Modification for Interpretation | Experimental | Behavioral: Cognitive Bias Modification for InterpretationThe Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. All scenarios in this arm are resolved to be benign. |
| Placebo Cognitive Bias Modification for Interpretation | Placebo comparator | Behavioral: PlaceboThe placebo Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. Scenarios are resolved as either benign or pain-related, with equal numbers (15) of each per session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years of age
- Have a diagnosis of Type 2 diabetes.
- Have persistent pain (pain present on more days than not, for 3 months or longer).
- Score ≥ 3 on average pain severity on the Brief Pain Inventory (BPI).
- Fluent in English
Key exclusion criteria (5 listed)
- Under 18 years of age
- No diagnosis of Type 2 diabetes
- No persistent pain
- Not fluent in English
- No access to internet nor ability to use a computer.
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 |
|---|---|---|
| Cognitive Bias Modification for InterpretationCognitive Bias Modification involves administering the Ambiguous Scenarios paradigm. This is a series of ambiguous scenarios which could be resolved to be associated with pain. The task consists of 30 unique scenarios and an associated comprehension question (pertaining to the pain-relatedness of the scenario), which are presented in a random order to participants. Each scenario presents an ambiguous sentence, ending with a word fragment which the participant must complete. The statement remains ambiguous until the completion of the word fragment, which resolves the statement as either pain-related or benign. For example, the statement "You are bush walking. Suddenly, you trip over and fall onto your knees. Your knees feel all wet, and you look down to see..." can be followed by "le_v_s [leaves]" for a benign resolution, or "bl__d [blood]" for a pain-related resolution. In the intervention group, all 30 scenarios will be followed with the benign word fragment. | Behavioural | Cognitive Bias Modification for Interpretation |
| PlaceboThe Ambiguous Scenarios paradigm described previously will be used for the placebo intervention. The same 30 scenarios will be presented to participants, however 50% (15) trials will be followed by the benign word fragment, ad 50% (15) trials will be followed by the pain-related word fragment. | Behavioural | Placebo Cognitive Bias Modification for Interpretation |
Primary outcome
Pain severity
Time frame: Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
Intensity subscale of the Brief Pain Inventory (range 0 - 40; lower scores represent less pain severity, i.e. better outcome)
Pain interference
Time frame: Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
Interference subscale of the Brief Pain Inventory (range 0 - 70; lower scores represent less pain interference, i.e. better outcome)
8 secondary outcomes
Interpretation bias to pain (1)
Time frame: Post intervention (day 14)
Interpretation bias to pain (2)
Time frame: Post intervention (day 14)
Health-related quality of life
Time frame: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Depression
Time frame: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Anxiety
Time frame: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Stress
Time frame: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Fear of disease progression
Time frame: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Treatment Adherence
Time frame: Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification will be made available.
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
Louise Sharpe principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification for Interpretation in people with Type 2 Diabetes and Persistent Pain, run by University of Sydney at 1 site in Australia.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Jun 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tessa Rooney (+61449610131, tessa.rooney@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)). 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?
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 2 Jun 2025.