Endometriosis-related PainNCT05152264
Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain
A study testing Transcutaneous electrical nerve stimulation (TENS) and Conventional analgesic treatment in people with Endometriosis-related Pain, run by Göteborg University at 1 site in Sweden.
Trial summary
The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Endometriosis-related Pain
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS) and Conventional analgesic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 12 Nov 2021to Dec 2028
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Consents to participation in the study
- Verified endometriosis (by laparoscopy or ultrasound).
- Chronic endometriosis-related pain (> 3 months), available for TENS treatment
- Functioning, stable endometriosis-specific hormonal drug therapy. The endometriosis-specific drug therapy must be unchanged for the last 3 months and no gynecological surgical procedures for the treatment of endometriosis are planned during the next 7 months (during study participation). The endometriosis-specific drug therapy does not refer to analgesic therapy for symptom relief of endometriosis-related pain.
Who cannot join
- Patient with inability to understand and use written and spoken Swedish
- Patient with pacemaker and/or ICD or other electronic implants
- Patient with impaired sensation over the painful area
- Malignant disease with an expected survival <12 months
- Alcohol or substance abuse
- Serious untreated psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
Show all 10Show fewer
- Participating in another intervention study with possible impact on current study outcome measures
- Patient who is using >90 morphine equivalents/day
- Patient who is electro-acupuncture
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland
Gothenburg
Paulin Andréll, MD, PhD
Josefin Larsson, RN
About this study
Official title: High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial
The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity will be randomized to additional treatment with TENS or conventional treatment for 8 weeks to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment.
Read the detailed description
Endometriosis affects approximately one in ten women of childbearing age and may involve both acute pain related to the menstrual cycle and chronic pain. Usual analgesic therapy is often inadequate and/or involves unacceptable side effects and risks with long-term use. Transcutaneous electrical nerve stimulation (TENS) is a patient controlled treatment for pain relief with few side-effects. To date there is limited knowledge of how TENS treatment should be carried out for optimal pain relief in this patient group. The aim of the study is asses the effect of TENS as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) will be randomized to additional treatment with TENS or conventional treatment for 8 weeks in order to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment in chronic endometriosis-related pain. Prior to start of TENS treatment, all patients receive education on chronic endometriosis-related pain and TENS treatment. Study participants will be asked to participate in a qualitative follow-up within the study including a semi-structured individual interview (n=10-15) before intervention and a semi-structured focus group (n=9-15) interview after completion of TENS treatment.
- Conditions
- Endometriosis-related Pain
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), Conventional analgesic treatment
- Keywords
- Endometriosis, Chronic pain, Transcutaneous electrical nerve stimulation
- Medical subject headings
- Endometriosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
Conventional analgesic treatmentOther
Conventional analgesic treatment. Conventional analgesic treatment may include no pharmacological treatment if the patient does not use any analgesics.
| Study group | Role | What they receive |
|---|---|---|
| TENS (transcutaneous electrical nerve stimulation) | Active comparator | Patients with endometriosis-related chronic frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) randomized to transcutaneous electrical nerve stimulation as add-on treatment in addition to conventional analgesic treatment. Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks. Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Conventional analgesic treatment | Active comparator | Patients with endometriosis related chronic frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) randomized to conventional analgesic treatment for 8 weeks. After 8 weeks the patients are treated with transcutaneous electrical nerve stimulation (TENS) during 16 weeks. Receives: Other: Conventional analgesic treatment |
| External control group | Active comparator | Patients with endometriosis-related pain that is not frequent or without high pain intensity (< 4 according to Numeric Rating Scale, NRS) constitute an external control group. The patients are treated with transcutaneous electrical nerve stimulation as add-on treatment in addition to conventional analgesic treatment. Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks. Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to endometriosis-related chronic pain
Measured: 8 weeks after randomization
Secondary outcomes (19)
Pain intensity
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to endometriosis-related chronic pain
Measured: 16 weeks after start of TENS treatment
Physical activity
Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry
Measured: 16 weeks after start of TENS treatment
Self-assessed physical activity
Minutes of physical activity per week (physical exercise and daily exercise) and minutes of sedentary behaviour per week.
Measured: 16 weeks after start of TENS treatment
Consumption of analgetics
Consumption of primary and secondary analgetics including opioid consumption in morphine equivalent doses
Measured: 8 weeks after randomization
Consumption of analgetics
Consumption of primary and secondary analgetics including opioid consumption in morphine equivalent doses
Measured: 16 weeks after start of TENS treatment
Change in pain intensity
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to endometriosis-related chronic pain, Likert scale (1= "worse," 2= "unchanged," 3= "slightly improved," 4= "much improved," 5 = "very much improved,"and 6= "completely improved").
Measured: 8 weeks after randomization
Change in pain intensity
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to endometriosis-related chronic pain, Likert scale (1= "worse," 2= "unchanged," 3= "slightly improved," 4= "much improved," 5 = "very much improved,"and 6= "completely improved").
Measured: 16 weeks after start of TENS treatment
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Measured: 8 weeks after randomization
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Measured: 16 weeks after start of TENS treatment
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: 8 weeks after randomization
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: 16 weeks after start of TENS treatment
Health Related Quality of Life (HRQL) assessed with EHP 30
Assessed with Endometriosis Health Profile 30. The EHP score indicate the extent of self-reported ill health on each of the 5 domains measured (Pain, Control and powerlessness, Social support, Emotional well-being, Self-image). Each scale is standardised on a scale of 0 - 100, where 0 indicates the best health status through to 100 worst health status.
Measured: 8 weeks after randomization
Health Related Quality of Life (HRQL) assessed with EHP 30
Assessed with Endometriosis Health Profile 30. The EHP score indicate the extent of self-reported ill health on each of the 5 domains measured (Pain, Control and powerlessness, Social support, Emotional well-being, Self-image). Each scale is standardised on a scale of 0 - 100, where 0 indicates the best health status through to 100 worst health status.
Measured: 16 weeks after start of TENS treatment
General Self-Efficacy Scale
The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life, Likert scale (1= Not at all true 2= Hardly true 3= Moderately true 4= Exactly true)
Measured: 8 weeks after randomization
General Self-Efficacy Scale
The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life, Likert scale (1= Not at all true 2= Hardly true 3= Moderately true 4= Exactly true)
Measured: 16 weeks after start of TENS treatment
Insomnia Severity
Total score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Measured: 8 weeks after randomization
Insomnia Severity
Total score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Measured: 16 weeks after start of TENS treatment
Days of sick-leave
Number of days of sick-leave
Measured: 8 weeks after randomization
Days of sick-leave
Number of days of sick-leave
Measured: 16 weeks after start of TENS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start12 Nov 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis-related PainStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) will be randomized to additional treatment with TENS or conventional analgesic treatment for 8 weeks in order to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment in chronic endometriosis-related pain.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Paulin Andéll, MD, Principal investigator, Göteborgs Universitet/Västra Götalands Regionen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152264
- Sponsor's protocol ID
- 274998
- Status last verified
- May 2025
- First submitted
- 29 Nov 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05152264
- Acronym / sponsor ID
- 274998
- Conditions
- Endometriosis-related Pain
- Keywords
- Endometriosis, Chronic pain, Transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Dec 2021 (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 study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity will be randomized to additional treatment with TENS or conventional treatment for 8 weeks to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment.
Detailed description
Endometriosis affects approximately one in ten women of childbearing age and may involve both acute pain related to the menstrual cycle and chronic pain. Usual analgesic therapy is often inadequate and/or involves unacceptable side effects and risks with long-term use. Transcutaneous electrical nerve stimulation (TENS) is a patient controlled treatment for pain relief with few side-effects. To date there is limited knowledge of how TENS treatment should be carried out for optimal pain relief in this patient group. The aim of the study is asses the effect of TENS as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) will be randomized to additional treatment with TENS or conventional treatment for 8 weeks in order to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment in chronic endometriosis-related pain. Prior to start of TENS treatment, all patients receive education on chronic endometriosis-related pain and TENS treatment. Study participants will be asked to participate in a qualitative follow-up within the study including a semi-structured individual interview (n=10-15) before intervention and a semi-structured focus group (n=9-15) interview after completion of TENS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) will be randomized to additional treatment with TENS or conventional analgesic treatment for 8 weeks in order to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment in chronic endometriosis-related pain.
| Arm | Type | Receives |
|---|---|---|
| TENS (transcutaneous electrical nerve stimulation) | Active comparator | Device: Transcutaneous electrical nerve stimulation (TENS)Patients with endometriosis-related chronic frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) randomized to transcutaneous electrical nerve stimulation as add-on treatment in addition to conventional analgesic treatment. Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks. |
| Conventional analgesic treatment | Active comparator | Other: Conventional analgesic treatmentPatients with endometriosis related chronic frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) randomized to conventional analgesic treatment for 8 weeks. After 8 weeks the patients are treated with transcutaneous electrical nerve stimulation (TENS) during 16 weeks. |
| External control group | Active comparator | Device: Transcutaneous electrical nerve stimulation (TENS)Patients with endometriosis-related pain that is not frequent or without high pain intensity (< 4 according to Numeric Rating Scale, NRS) constitute an external control group. The patients are treated with transcutaneous electrical nerve stimulation as add-on treatment in addition to conventional analgesic treatment. Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Consents to participation in the study
- Verified endometriosis (by laparoscopy or ultrasound).
- Chronic endometriosis-related pain (> 3 months), available for TENS treatment
- Functioning, stable endometriosis-specific hormonal drug therapy. The endometriosis-specific drug therapy must be unchanged for the last 3 months and no gynecological surgical procedures for the treatment of endometriosis are planned during the next 7 months (during study participation). The endometriosis-specific drug therapy does not refer to analgesic therapy for symptom relief of endometriosis-related pain.
Key exclusion criteria (10 listed)
- Patient with inability to understand and use written and spoken Swedish
- Patient with pacemaker and/or ICD or other electronic implants
- Patient with impaired sensation over the painful area
- Malignant disease with an expected survival <12 months
- Alcohol or substance abuse
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks. | Device | External control group, TENS (transcutaneous electrical nerve stimulation) |
| Conventional analgesic treatmentConventional analgesic treatment. Conventional analgesic treatment may include no pharmacological treatment if the patient does not use any analgesics. | Other | Conventional analgesic treatment |
Primary outcome
Pain intensity
Time frame: 8 weeks after randomization
Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to endometriosis-related chronic pain
19 secondary outcomes
Pain intensity
Time frame: 16 weeks after start of TENS treatment
Physical activity
Time frame: 16 weeks after start of TENS treatment
Self-assessed physical activity
Time frame: 16 weeks after start of TENS treatment
Consumption of analgetics
Time frame: 8 weeks after randomization
Consumption of analgetics
Time frame: 16 weeks after start of TENS treatment
Change in pain intensity
Time frame: 8 weeks after randomization
Change in pain intensity
Time frame: 16 weeks after start of TENS treatment
Health Related Quality of Life (HRQL) according to SF36
Time frame: 8 weeks after randomization
Health Related Quality of Life (HRQL) according to SF36
Time frame: 16 weeks after start of TENS treatment
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 8 weeks after randomization
Health Related Quality of Life (HRQL) assessed with EQ-5D
Time frame: 16 weeks after start of TENS treatment
Health Related Quality of Life (HRQL) assessed with EHP 30
Time frame: 8 weeks after randomization
Health Related Quality of Life (HRQL) assessed with EHP 30
Time frame: 16 weeks after start of TENS treatment
General Self-Efficacy Scale
Time frame: 8 weeks after randomization
General Self-Efficacy Scale
Time frame: 16 weeks after start of TENS treatment
Insomnia Severity
Time frame: 8 weeks after randomization
Insomnia Severity
Time frame: 16 weeks after start of TENS treatment
Days of sick-leave
Time frame: 8 weeks after randomization
Days of sick-leave
Time frame: 16 weeks after start of TENS treatment
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 23 May 2025.
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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.
Paulin Andéll, MD principal investigator
Göteborgs Universitet/Västra Götalands Regionen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) and Conventional analgesic treatment in people with Endometriosis-related Pain, run by Göteborg University at 1 site in Sweden.
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 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 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 Sweden. 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?
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 Paulin Andréll, MD, PhD (+46-31-3438259, paulin.andrell@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 8 weeks after randomization). 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 23 May 2025.