Cancer PainNCT05581784
Effectiveness of a Pain Neuroscience Education Program in Adults With Cancer Pain
A study testing Pain neuroscience education in people with Cancer Pain, run by Instituto Neurociencia Del Dolor at 4 sites in 3 countries.
Trial summary
IASP defines "pain" as "an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage". In some patients, pain is one of the reasons they initially consult a doctor and will be strongly related to cancer itself, is connected to receiving the cancer… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Pain neuroscience education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 22 Feb 2023to 1 Mar 2024
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a life expectancy of more than three months (Karnofski Scales (KPS), Eastern Cooperative Oncology Group Scale (ECOG), survival prognosis PAP score, Palliative Prognosis Index PPI).
- Acceptance of informed consent.
- Educational level (high school diploma).
- No pain hospitalizations in the previous month
- Capable of establishing a team communication process
- at least 21 points on the MOCA scale for preserved cognitive function
- Understanding of the Spanish language.
Who cannot join
- Surgery scheduled within the next three months
- Visual and auditory sensory system deficiency (deafness or blindness).
- The presence of a recent traumatic injury
- Atrial or ventricular arrhythmias that are uncontrolled.
- Aortic aneurysm dissection
- Aortic stenosis severe
Show all 12Show fewer
- Endocarditis or pericarditis that is acute
- Uncontrollable hypertension
- Thromboembolic disease, acute.
- Acute severe heart failure
- Acute severe respiratory failure
- Fracture within the last month
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Colombia2 sites
Universidad Santiago de Cali
Cali, Valle del Cauca Department, 760033
Clinica de Occidente
Cali, Valle del Cauca Department, 760046
About this study
Official title: The Effectiveness of a Pain Neuroscience Education Program Compared to Conventional Treatment on Pain, Biopsychosocial Variables, and Functional Capacity in Adults With Cancer Pain
IASP defines "pain" as "an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage". In some patients, pain is one of the reasons they initially consult a doctor and will be strongly related to cancer itself, is connected to receiving the cancer diagnosis, and therefore may become an uncertain threat of disease recurrence in cancer survivors. Neuropathic pain is the most prevalent type of pain, but a mixed type of pain is also common, reflecting the complexity of the pain experience. There is increasing evidence in oncology that quality of life and survival are linked to early and effective palliative care, including pain management. Although improvements have been seen, undertreatment of pain remains a problem in a significant subset of cancer patients. Regarding the interventional options in cancer pain, multiple possibilities range from pharmacological modulation, the use of modalities or physical means, as well as the practice of physical exercise as a mechanism of pain modulation, which has been established according to the background grade of recommendation. Regarding education in neuroscience, this has gained momentum in chronic pain since previous interventions have generated recommendations to include neurocognitive interventions in pain processes. Therefore, it seeks to determine the effectiveness of a neuroscience education program compared to conventional treatment in adults with cancer pain in biopsychosocial variables.
Read the detailed description
A parallel group randomized controlled clinical trial will be conducted during the months of November 2022 to December 2023. The proposed research will be a quantitative experimental design type controlled clinical trial following the SPIRIT guidelines for clinical trial protocols and CONSORT for the execution of clinical trials.
A total of 80 patients, where 40 will be assigned to (PNE) and 40 to conventional management. experimental group: based on education in neuroscience of pain for 9 sessions in a period of 10 weeks. Work will be done to prepare the content for an adapted and illustrated guide as a complementary material for patients. An expert judgment test will be carried out to validate the content of the material. Each patient must complete at least 8 sessions to comply with the protocol. These sessions will be personalized and will include the guide as complementary material for each session. This group remains with pharmacological treatment and the usual guidelines given by the doctor. Results will be assessed at baseline (t1) and at week 10 (t2). Written informed consent will be obtained from all participants prior to their participation.
- Conditions
- Cancer Pain
- Being tested
- Pain neuroscience education, Conventional management or Usual care
- Keywords
- Pain Neuroscience education, Cancer pain, Paliative therapy, Neoplasm
- Medical subject headings
- Cancer Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
Also called Explaining Pain, Therapeutic Neuroscience Education
PNE sessions will be led by an experienced physical therapist certified in PNE in 35-minute face-to-face group sessions. Here elements of the neurophysiology of pain are addressed, as well as the different psychosocial dimensions that influence it. The distribution of themes will be carried out as follows:
Week One: Coping with Pain. Week 2: Pain and Cognition Week 3: Your security system Week 4: Altered Alarm System (extra sensitive). Week 5: The defense system is in distress. Week 6: Fatigue, anxiety, and stress Week 7: Current Models of Treatment Week 8: Achievements and goals Week 9: Pain emphasis and differentiation This group remains with pharmacological treatment and the usual guidelines given by the doctor.
Conventional management or Usual careOther
Also called Usual care, Conventional management
This group will only have pharmacological treatment and the usual guidelines given by the doctor. Without educational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education. | Experimental | This consists of generating elements from neurobiology and neurophysiology for the understanding of pain from the development of metaphors. Receives: Other: Pain neuroscience education |
| Conventional treatment or Usual Care | Other | Pharmacological treatment and indications estimated by a specialist in palliative care and pain. Receives: Other: Conventional management or Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Pain Inventory (Impact of pain)
The BPI or brief pain questionnaire is a self-administered questionnaire that contains two dimensions: one related to the intensity of pain and the impact of pain on the activities of the patient's life. Its use has increased in the evaluation of patients with cancer pain. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. the higher the score, the greater the severity of the pain.
Measured: At baseline and through intervention's completion, 10 weeks
Change in Visual Analog Scale-Pain (EVA)
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
Measured: At baseline and through intervention's completion, 10 weeks
Secondary outcomes (8)
Change in Central Sensitization Inventory Score (CSI)
Central Sensitization Inventory (CSI) is a scale used to detect patients with symptoms associated with central sensitization or types of central sensitization syndrome such as fibromyalgia, temporomandibular joint disease, tension type headache, migraine.
The Central Sensitization Inventory (CSI) consists of two parts:
Part A consists of 25 questions about central sensitization syndrome (CNS) symptoms; Section B examines the patient's condition of being diagnosed with certain CNS diseases or CNS related diseases such as anxiety and depression.
The patient answers 25 questions in section A with a score between 0 and 4. The total score will be between 0-100. Results above 40 points indicate central sensitization.
Measured: At baseline and through intervention's completion, 10 weeks
Change in Pain Catastrophizing Scale (PCS)
The PCS is measured with a self-administered questionnaire. Is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.
Measured: At baseline and through intervention's completion, 10 weeks
Change in Tampa Scale for Kinesiophobia (TSK-11)
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Measured: At baseline and through intervention's completion, 10 weeks
Change in Beck Depression Inventory Score
Beck Depression Criterion (BDI) is a commonly used evaluation criterion for diagnosis and follow-up parameters in assessing depression status.It contains 21 categories to measure physical, emotional, cognitive and motivational symptoms such as hopelessness, irritability, guilt, feeling of punishment, fatigue, and weight loss in each depression, and each category is scored between 0-3. The patient is asked to mark the most appropriate one for the four options in each category. Scoring progressively increases from the absence of symptoms to severe symptoms. 0-10 points: No depression, 11-17 points: Mild depression, 18-23 points: Moderate depression, 24 and above points: Severe depression.
Measured: At baseline and through intervention's completion, 10 weeks
Change in DN4 neuropathic pain
We will work with the DN4 scale that evaluates 4 questions with a possibility of being qualified up to 10 points to determine the presence of neuropathic pain.
Measured: At baseline and through intervention's completion, 10 weeks
Change in Moca test Cognitive function
It is made up of 19 items and eight cognitive domains that assess skills such as visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. a maximum score of 30, with the cut-off points for cognitive impairment being 25/26.
Measured: At baseline and through intervention's completion, 10 weeks
Change in EORTC QLQ C-30 Quality of life
has been defined as the way in which the individual perceives his/her place in life, The standard model consists of 14 domains and an empirical solution with five domains (physical, psychological, frailty, socioeconomic, and global score). This widely used questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social function), a global quality of life (QoL) scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six individual. items (loss of appetite, diarrhea, dyspnea, constipation, insomnia, economic impact). For the functional and global quality of life scales, a higher score indicates better health. For the symptom scales, a higher score indicates a higher symptom burden.
Measured: At baseline and through intervention's completion, 10 weeks
Change in Sleep quality Pittsburgh Sleep Quality Index
This is one of the most reliable tests to define the quality of sleep and its disorders. It contains a total of 19 questions, grouped into 10 questions. The questions are combined to form seven areas with their corresponding score, each one of which shows a range between 0 and 3 points.
Measured: At baseline and through intervention's completion, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start22 Feb 2023
- Primary completion22 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer 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
- Parallel Assignment Masking: Simple (result evaluator)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Neurociencia Del Dolor
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Santiago de Cali, Clínica de Occidente S.A
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581784
- Sponsor's protocol ID
- INeurocienciaDolor02
- Status last verified
- Nov 2026
- First submitted
- 1 Oct 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nijs J, Wijma AJ, Leysen L, Pas R, Willaert W, Hoelen W, Ickmans K, Wilgen CPV. Explaining pain following cancer: a practical guide for clinicians. Braz J Phys Ther. 2019 Sep-Oct;23(5):367-377. doi: 10.1016/j.bjpt.2018.12.003. Epub 2018 Dec 21.
PubMed 30606621Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
PubMed 20332511Ordonez-Mora LT, Rosero ID, Morales-Osorio MA, Guil R, Quintero Jordan G, Agudelo Jimenez JA, Gonzalez-Ruiz K, Avila-Valencia JC. NEUROCANTRIAL: study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain. BMJ Open. 2023 Sep 27;13(9):e071493. doi: 10.1136/bmjopen-2022-071493.
PubMed 37758676
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Pain Neuroscience Education Program Compared to Conventional Treatment on Pain, Biopsychosocial Variables, and Functional Capacity in Adults With Cancer Pain
- ClinicalTrials.gov ID
- NCT05581784
- Acronym / sponsor ID
- INeurocienciaDolor02
- Conditions
- Cancer Pain
- Keywords
- Pain Neuroscience education, Cancer pain, Paliative therapy, Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Instituto Neurociencia Del DolorUniversity, hospital or other
- Collaborators
- Universidad Santiago de Cali, Clínica de Occidente S.A
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 17 Oct 2022 (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.
IASP defines "pain" as "an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage". In some patients, pain is one of the reasons they initially consult a doctor and will be strongly related to cancer itself, is connected to receiving the cancer diagnosis, and therefore may become an uncertain threat of disease recurrence in cancer survivors. Neuropathic pain is the most prevalent type of pain, but a mixed type of pain is also common, reflecting the complexity of the pain experience. There is increasing evidence in oncology that quality of life and survival are linked to early and effective palliative care, including pain management. Although improvements have been seen, undertreatment of pain remains a problem in a significant subset of cancer patients. Regarding the interventional options in cancer pain, multiple possibilities range from pharmacological modulation, the use of modalities or physical means, as well as the practice of physical exercise as a mechanism of pain modulation, which has been established according to the background grade of recommendation. Regarding education in neuroscience, this has gained momentum in chronic pain since previous interventions have generated recommendations to include neurocognitive interventions in pain processes. Therefore, it seeks to determine the effectiveness of a neuroscience education program compared to conventional treatment in adults with cancer pain in biopsychosocial variables.
Detailed description
A parallel group randomized controlled clinical trial will be conducted during the months of November 2022 to December 2023. The proposed research will be a quantitative experimental design type controlled clinical trial following the SPIRIT guidelines for clinical trial protocols and CONSORT for the execution of clinical trials.
A total of 80 patients, where 40 will be assigned to (PNE) and 40 to conventional management. experimental group: based on education in neuroscience of pain for 9 sessions in a period of 10 weeks. Work will be done to prepare the content for an adapted and illustrated guide as a complementary material for patients. An expert judgment test will be carried out to validate the content of the material. Each patient must complete at least 8 sessions to comply with the protocol. These sessions will be personalized and will include the guide as complementary material for each session. This group remains with pharmacological treatment and the usual guidelines given by the doctor. Results will be assessed at baseline (t1) and at week 10 (t2). Written informed consent will be obtained from all participants prior to their participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Masking: Simple (result evaluator)
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education. | Experimental | Other: Pain neuroscience educationThis consists of generating elements from neurobiology and neurophysiology for the understanding of pain from the development of metaphors. |
| Conventional treatment or Usual Care | Other | Other: Conventional management or Usual carePharmacological treatment and indications estimated by a specialist in palliative care and pain. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a life expectancy of more than three months (Karnofski Scales (KPS), Eastern Cooperative Oncology Group Scale (ECOG), survival prognosis PAP score, Palliative Prognosis Index PPI).
- Acceptance of informed consent.
- Educational level (high school diploma).
- No pain hospitalizations in the previous month
- Capable of establishing a team communication process
Key exclusion criteria (12 listed)
- Surgery scheduled within the next three months
- Visual and auditory sensory system deficiency (deafness or blindness).
- The presence of a recent traumatic injury
- Atrial or ventricular arrhythmias that are uncontrolled.
- Aortic aneurysm dissection
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 |
|---|---|---|
| Pain neuroscience educationAlso: Explaining Pain, Therapeutic Neuroscience EducationPNE sessions will be led by an experienced physical therapist certified in PNE in 35-minute face-to-face group sessions. Here elements of the neurophysiology of pain are addressed, as well as the different psychosocial dimensions that influence it. The distribution of themes will be carried out as follows: Week One: Coping with Pain. Week 2: Pain and Cognition Week 3: Your security system Week 4: Altered Alarm System (extra sensitive). Week 5: The defense system is in distress. Week 6: Fatigue, anxiety, and stress Week 7: Current Models of Treatment Week 8: Achievements and goals Week 9: Pain emphasis and differentiation This group remains with pharmacological treatment and the usual guidelines given by the doctor. | Other | Pain neuroscience education. |
| Conventional management or Usual careAlso: Usual care, Conventional managementThis group will only have pharmacological treatment and the usual guidelines given by the doctor. Without educational intervention. | Other | Conventional treatment or Usual Care |
Primary outcome
Change in Brief Pain Inventory (Impact of pain)
Time frame: At baseline and through intervention's completion, 10 weeks
The BPI or brief pain questionnaire is a self-administered questionnaire that contains two dimensions: one related to the intensity of pain and the impact of pain on the activities of the patient's life. Its use has increased in the evaluation of patients with cancer pain. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. the higher the score, the greater the severity of the pain.
Change in Visual Analog Scale-Pain (EVA)
Time frame: At baseline and through intervention's completion, 10 weeks
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
8 secondary outcomes
Change in Central Sensitization Inventory Score (CSI)
Time frame: At baseline and through intervention's completion, 10 weeks
Change in Pain Catastrophizing Scale (PCS)
Time frame: At baseline and through intervention's completion, 10 weeks
Change in Tampa Scale for Kinesiophobia (TSK-11)
Time frame: At baseline and through intervention's completion, 10 weeks
Change in Beck Depression Inventory Score
Time frame: At baseline and through intervention's completion, 10 weeks
Change in DN4 neuropathic pain
Time frame: At baseline and through intervention's completion, 10 weeks
Change in Moca test Cognitive function
Time frame: At baseline and through intervention's completion, 10 weeks
Change in EORTC QLQ C-30 Quality of life
Time frame: At baseline and through intervention's completion, 10 weeks
Change in Sleep quality Pittsburgh Sleep Quality Index
Time frame: At baseline and through intervention's completion, 10 weeks
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 4 Nov 2026.
- Background: PubMed 30606621Nijs J, Wijma AJ, Leysen L, Pas R, Willaert W, Hoelen W, Ickmans K, Wilgen CPV. Explaining pain following cancer: a practical guide for clinicians. Braz J Phys Ther. 2019 Sep-Oct;23(5):367-377. doi: 10.1016/j.bjpt.2018.12.003. Epub 2018 Dec 21.
- Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Background: PubMed 20332511Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
- Derived from this study: PubMed 37758676Ordonez-Mora LT, Rosero ID, Morales-Osorio MA, Guil R, Quintero Jordan G, Agudelo Jimenez JA, Gonzalez-Ruiz K, Avila-Valencia JC. NEUROCANTRIAL: study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain. BMJ Open. 2023 Sep 27;13(9):e071493. doi: 10.1136/bmjopen-2022-071493.
- 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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuroscience education in people with Cancer Pain, run by Instituto Neurociencia Del Dolor at 4 sites in 3 countries.
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 12 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, Chile, Mexico. 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 Brief Pain Inventory (Impact of pain) (time frame: At baseline and through intervention's completion, 10 weeks). 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 NCT05581784, which also lists 4 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 4 Nov 2026.