Primary DysmenorrheaNCT04665661
Aerobic Exercise for Primary Dysmenorrhea
A study testing High-intensity aerobic training in people with Primary Dysmenorrhea, run by The Hong Kong Polytechnic University.
Trial summary
Primary dysmenorrhea is common and can result in significant disability for many women, causing a high degree of discomfort and reduced quality of life (QoL). Our preliminary studies suggested that high-intensity aerobic training (HIAT) for 30 minutes, three times a week at 70%-85% of maximum heart rate was effective… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- High-intensity aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Aug 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 18 to 24 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women in the age group of 18-24 years old;
- non-pregnant;
- having regular menstrual cycles with cycle lengths between 24 and 30 days;
- experiencing an average menstrual pain intensity equal to or greater than 5 on a 0-10 Numerical Rating Scale; and
- scoring low (< 600 metabolic equivalent tasks [MET]/week) on the short-form of the International Physical Activity Questionnaire.
Who cannot join
- women using oral contraceptive pills, hormonal therapy, or intrauterine devices;
- women using over-the counter analgesics during menstruation to treat dysmenorrhea-associated pain and experience no pain relief with those analgesics; and
- women participating in any formal exercise programme
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Aerobic Exercise for Primary Dysmenorrhea: A Mixed-methods Study and Economic Evaluation
Primary dysmenorrhea is common and can result in significant disability for many women, causing a high degree of discomfort and reduced quality of life (QoL). Our preliminary studies suggested that high-intensity aerobic training (HIAT) for 30 minutes, three times a week at 70%-85% of maximum heart rate was effective for decreasing pain and improving QoL in women suffering from primary dysmenorrhea. However, to date, no studies have evaluated the beneficial effects of HIAT on academic performance and absenteeism or the cost-effectiveness of HIAT for women with primary dysmenorrhea. Furthermore, the mechanisms underlying aerobic exercise-induced analgesia in primary dysmenorrhea remain unclear.
Here, we propose a study to address this important knowledge gap by investigating the effects of HIAT on absenteeism and academic performance among university students with primary dysmenorrhea and examine the physiological mechanisms underlying aerobic exercise-induced analgesia by conducting a fully powered, randomised, controlled crossover trial. We also propose to conduct an economic evaluation to determine the cost-effectiveness of HIAT compared with a wait-listed control group receiving usual care, according to the societal and healthcare perspectives of Hong Kong. The results of this cutting-edge research will be important for clinicians, researchers, policymakers, and women with primary dysmenorrhea. The knowledge gained from the proposed study will be useful for researchers when designing future studies to identify the mediators of pain interventions for clinical improvements, which could themselves be the target of future interventions. The findings of the proposed study will inform decision-makers regarding the extent to which existing or standard and potential interventions can improve population health (effectiveness) and the resources required to implement these interventions (costs).
Read the detailed description
Objectives: (1): To evaluate the effectiveness of high-intensity aerobic training (HIAT) on pain intensity, absenteeism, and academic performance among university students with primary dysmenorrhea. (2): To investigate the physiological mechanism(s) underlying aerobic exercise-induced analgesia in women with primary dysmenorrhea. (3) Compare the cost-effectiveness of HIAT against that for usual care to treat pain associated with primary dysmenorrhea.
Design and subjects: A mixed-methods study, including a cross-over RCT, and semi-structured focus groups, alongside economic evaluation, will be conducted using 130 women with primary dysmenorrhea.
Interventions: Women will randomly allocated into high-intensity aerobic training (HIAT) or wait-list control (WLC) groups. Participants in the HIAT group will receive supervised treadmill training for the first 12 weeks of the trial. Following a four-week washout period the cross-over period will begin during Week 16, and the participants initially randomised to the WLC group will receive the HIAT regimen from Weeks 14-28. Participants initially randomized to HIAT group will be instructed not to engage in exercise during the remainder of the study period (i.e. Weeks 14-28).
Outcome measures: Pain intensity, absenteeism from university, academic performance, concentration, dysmenorrhea daily diary, and salivary progesterone and prostaglandin F2-alpha levels in saliva. The EQ-5D-3L will be used to determine the QoL for the HIAT and WLC groups.
Data analysis plan: A preliminary test using the independent samples t-test and a two-sided Student's unpaired t-test will be performed to rule out carryover effects and identify the within-participant differences in outcome variables between the study periods, respectively. Treatment effects will be evaluated using an ANOVA with a mixed-effects model considering the longitudinal repeated measures, including the effects of time within each study group and the interaction between time and intervention. The mediation effects will be assessed using the Sobel test. The EQ-5D responses will be converted into utility scores to estimate the gain or loss of quality-adjusted life-years (QUALYs). The seemingly unrelated regression (SUR) analyses will be used to estimate the total cost differences (ΔC) and effect differences (ΔE). Qualitative data will be analysed using the process of thematic analysis.
- Conditions
- Primary Dysmenorrhea
- Being tested
- High-intensity aerobic training, Wait-list control
- Keywords
- Dysmenorrhea, Primary dysmenorrhea, Pain, Absenteeism, Academic performance
- Medical subject headings
- Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity aerobic trainingBehavioural
Women will perform treadmill-based aerobic exercise for three days a week, at 70%-85% of MHR for 30 minutes and perceived exertion of 14-16, based on the Borg RPE scale. This range39 is considered to represent HIAT. Aerobic training will be preceded by warm-up exercises for 10 minutes and followed by cool-down exercises for 10 minutes, at a perceived exertion of 11.0 (Borg RPE).
Wait-list controlBehavioural
Women in the wait-list control group will be instructed to continue with their usual activities and manage their pain as normal (i.e., with analgesics).
| Study group | Role | What they receive |
|---|---|---|
| High-intensity aerobic training (HIAT) | Experimental | Women will perform treadmill-based aerobic exercise for three days a week, at 70%-85% of MHR for 30 minutes and perceived exertion of 14-16, based on the Borg RPE scale. This range39 is considered to represent HIAT. Aerobic training will be preceded by warm-up exercises for 10 minutes and followed by cool-down exercises for 10 minutes, at a perceived exertion of 11.0 (Borg RPE). Receives: Behavioral: High-intensity aerobic training; Behavioral: Wait-list control |
| Wait-list control (WLC) | Active comparator | Women in the wait-list control group will be instructed to continue with their usual activities and manage their pain as normal (i.e., with analgesics). Receives: Behavioral: High-intensity aerobic training; Behavioral: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Measured: Pre-intervention (baseline, 0 week)
Pain intensity
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Measured: Post-intervention at 12 weeks
Pain intensity
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Measured: Post-intervention at 28 weeks
Absenteeism from university
A prospective electronic diary will be provided for each participant to record university absenteeism.
Measured: Pre-intervention (baseline, 0 week)
Absenteeism from university
A prospective electronic diary will be provided for each participant to record university absenteeism.
Measured: Post-intervention at 12 weeks
Absenteeism from university
A prospective electronic diary will be provided for each participant to record university absenteeism.
Measured: Post-intervention at 28 weeks
Academic performance
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Measured: Pre-intervention (baseline, 0 week)
Academic performance
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Measured: Post-intervention at 12 weeks
Academic performance
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Measured: Post-intervention at 28 weeks
Progesterone levels
Salivary levels of progesterone.
Measured: Pre-intervention (baseline, 0 week)
Progesterone levels
Salivary levels of progesterone.
Measured: Post-intervention at 12 weeks
Progesterone levels
Salivary levels of progesterone.
Measured: Post-intervention at 28 weeks
Prostaglandin F2-alpha levels
Salivary levels of prostaglandin F2-alpha
Measured: Pre-intervention (baseline, 0 week)
Prostaglandin F2-alpha levels
Salivary levels of prostaglandin F2-alpha
Measured: Post-intervention at 12 weeks
Prostaglandin F2-alpha levels
Salivary levels of prostaglandin F2-alpha
Measured: Post-intervention at 28 weeks
Secondary outcomes (8)
Concentration
The 0-10 visual analogue scale will be used to measure the impact of dysmenorrhea on concentration, with 0 representing 'No difficulty concentrating' and 10 representing 'Maximum difficulty concentrating'.
Measured: Pre-intervention (baseline, 0 week)
Concentration
The 0-10 visual analogue scale will be used to measure the impact of dysmenorrhea on concentration, with 0 representing 'No difficulty concentrating' and 10 representing 'Maximum difficulty concentrating'.
Measured: Post-intervention at 12 weeks
Concentration
The 0-10 visual analogue scale will be used to measure the impact of dysmenorrhea on concentration, with 0 representing 'No difficulty concentrating' and 10 representing 'Maximum difficulty concentrating'.
Measured: Post-intervention at 28 weeks
Dysmenorrhea daily diary
dysmenorrhea. A higher score indicates worse pain.
Measured: Pre-intervention (baseline, 0 week)
Dysmenorrhea daily diary
The Dysmenorrhea daily diary is a questionnaire to measure the severity of dysmenorrhea. A higher score indicates worse pain.
Measured: Post-intervention at 12 weeks
Dysmenorrhea daily diary
dysmenorrhea. A higher score indicates worse pain.
Measured: Post-intervention at 28 weeks
3-level version of EuroQol 5-Dimension
The 3-level version of EuroQol 5-Dimension will be used to determine the quality of life. A higher score indicates better quality of life.
Measured: 12 weeks
Cost-diary
An electronic diary will be used to record cost expenditures in Hong Kong Dollars and work absenteeism
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Sep 2021 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priya Kannan, PhD, Principal investigator, The Hong Kong Polytechnic Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665661
- Sponsor's protocol ID
- APD
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise for Primary Dysmenorrhea: A Mixed-methods Study and Economic Evaluation
- ClinicalTrials.gov ID
- NCT04665661
- Acronym / sponsor ID
- APD
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhea, Primary dysmenorrhea, Pain, Absenteeism, Academic performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Dec 2020 (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.
Primary dysmenorrhea is common and can result in significant disability for many women, causing a high degree of discomfort and reduced quality of life (QoL). Our preliminary studies suggested that high-intensity aerobic training (HIAT) for 30 minutes, three times a week at 70%-85% of maximum heart rate was effective for decreasing pain and improving QoL in women suffering from primary dysmenorrhea. However, to date, no studies have evaluated the beneficial effects of HIAT on academic performance and absenteeism or the cost-effectiveness of HIAT for women with primary dysmenorrhea. Furthermore, the mechanisms underlying aerobic exercise-induced analgesia in primary dysmenorrhea remain unclear.
Here, we propose a study to address this important knowledge gap by investigating the effects of HIAT on absenteeism and academic performance among university students with primary dysmenorrhea and examine the physiological mechanisms underlying aerobic exercise-induced analgesia by conducting a fully powered, randomised, controlled crossover trial. We also propose to conduct an economic evaluation to determine the cost-effectiveness of HIAT compared with a wait-listed control group receiving usual care, according to the societal and healthcare perspectives of Hong Kong. The results of this cutting-edge research will be important for clinicians, researchers, policymakers, and women with primary dysmenorrhea. The knowledge gained from the proposed study will be useful for researchers when designing future studies to identify the mediators of pain interventions for clinical improvements, which could themselves be the target of future interventions. The findings of the proposed study will inform decision-makers regarding the extent to which existing or standard and potential interventions can improve population health (effectiveness) and the resources required to implement these interventions (costs).
Detailed description
Objectives: (1): To evaluate the effectiveness of high-intensity aerobic training (HIAT) on pain intensity, absenteeism, and academic performance among university students with primary dysmenorrhea. (2): To investigate the physiological mechanism(s) underlying aerobic exercise-induced analgesia in women with primary dysmenorrhea. (3) Compare the cost-effectiveness of HIAT against that for usual care to treat pain associated with primary dysmenorrhea.
Design and subjects: A mixed-methods study, including a cross-over RCT, and semi-structured focus groups, alongside economic evaluation, will be conducted using 130 women with primary dysmenorrhea.
Interventions: Women will randomly allocated into high-intensity aerobic training (HIAT) or wait-list control (WLC) groups. Participants in the HIAT group will receive supervised treadmill training for the first 12 weeks of the trial. Following a four-week washout period the cross-over period will begin during Week 16, and the participants initially randomised to the WLC group will receive the HIAT regimen from Weeks 14-28. Participants initially randomized to HIAT group will be instructed not to engage in exercise during the remainder of the study period (i.e. Weeks 14-28).
Outcome measures: Pain intensity, absenteeism from university, academic performance, concentration, dysmenorrhea daily diary, and salivary progesterone and prostaglandin F2-alpha levels in saliva. The EQ-5D-3L will be used to determine the QoL for the HIAT and WLC groups.
Data analysis plan: A preliminary test using the independent samples t-test and a two-sided Student's unpaired t-test will be performed to rule out carryover effects and identify the within-participant differences in outcome variables between the study periods, respectively. Treatment effects will be evaluated using an ANOVA with a mixed-effects model considering the longitudinal repeated measures, including the effects of time within each study group and the interaction between time and intervention. The mediation effects will be assessed using the Sobel test. The EQ-5D responses will be converted into utility scores to estimate the gain or loss of quality-adjusted life-years (QUALYs). The seemingly unrelated regression (SUR) analyses will be used to estimate the total cost differences (ΔC) and effect differences (ΔE). Qualitative data will be analysed using the process of thematic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity aerobic training (HIAT) | Experimental | Behavioral: High-intensity aerobic training, Behavioral: Wait-list controlWomen will perform treadmill-based aerobic exercise for three days a week, at 70%-85% of MHR for 30 minutes and perceived exertion of 14-16, based on the Borg RPE scale. This range39 is considered to represent HIAT. Aerobic training will be preceded by warm-up exercises for 10 minutes and followed by cool-down exercises for 10 minutes, at a perceived exertion of 11.0 (Borg RPE). |
| Wait-list control (WLC) | Active comparator | Behavioral: High-intensity aerobic training, Behavioral: Wait-list controlWomen in the wait-list control group will be instructed to continue with their usual activities and manage their pain as normal (i.e., with analgesics). |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women in the age group of 18-24 years old;
- non-pregnant;
- having regular menstrual cycles with cycle lengths between 24 and 30 days;
- experiencing an average menstrual pain intensity equal to or greater than 5 on a 0-10 Numerical Rating Scale; and
- scoring low (< 600 metabolic equivalent tasks [MET]/week) on the short-form of the International Physical Activity Questionnaire.
Key exclusion criteria (3 listed)
- women using oral contraceptive pills, hormonal therapy, or intrauterine devices;
- women using over-the counter analgesics during menstruation to treat dysmenorrhea-associated pain and experience no pain relief with those analgesics; and
- women participating in any formal exercise programme
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 |
|---|---|---|
| High-intensity aerobic trainingWomen will perform treadmill-based aerobic exercise for three days a week, at 70%-85% of MHR for 30 minutes and perceived exertion of 14-16, based on the Borg RPE scale. This range39 is considered to represent HIAT. Aerobic training will be preceded by warm-up exercises for 10 minutes and followed by cool-down exercises for 10 minutes, at a perceived exertion of 11.0 (Borg RPE). | Behavioural | High-intensity aerobic training (HIAT), Wait-list control (WLC) |
| Wait-list controlWomen in the wait-list control group will be instructed to continue with their usual activities and manage their pain as normal (i.e., with analgesics). | Behavioural | High-intensity aerobic training (HIAT), Wait-list control (WLC) |
Primary outcome
Pain intensity
Time frame: Pre-intervention (baseline, 0 week)
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Pain intensity
Time frame: Post-intervention at 12 weeks
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Pain intensity
Time frame: Post-intervention at 28 weeks
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Absenteeism from university
Time frame: Pre-intervention (baseline, 0 week)
A prospective electronic diary will be provided for each participant to record university absenteeism.
Absenteeism from university
Time frame: Post-intervention at 12 weeks
A prospective electronic diary will be provided for each participant to record university absenteeism.
Absenteeism from university
Time frame: Post-intervention at 28 weeks
A prospective electronic diary will be provided for each participant to record university absenteeism.
Academic performance
Time frame: Pre-intervention (baseline, 0 week)
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Academic performance
Time frame: Post-intervention at 12 weeks
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Academic performance
Time frame: Post-intervention at 28 weeks
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Progesterone levels
Time frame: Pre-intervention (baseline, 0 week)
Salivary levels of progesterone.
Progesterone levels
Time frame: Post-intervention at 12 weeks
Salivary levels of progesterone.
Progesterone levels
Time frame: Post-intervention at 28 weeks
Salivary levels of progesterone.
Prostaglandin F2-alpha levels
Time frame: Pre-intervention (baseline, 0 week)
Salivary levels of prostaglandin F2-alpha
Prostaglandin F2-alpha levels
Time frame: Post-intervention at 12 weeks
Salivary levels of prostaglandin F2-alpha
Prostaglandin F2-alpha levels
Time frame: Post-intervention at 28 weeks
Salivary levels of prostaglandin F2-alpha
8 secondary outcomes
Concentration
Time frame: Pre-intervention (baseline, 0 week)
Concentration
Time frame: Post-intervention at 12 weeks
Concentration
Time frame: Post-intervention at 28 weeks
Dysmenorrhea daily diary
Time frame: Pre-intervention (baseline, 0 week)
Dysmenorrhea daily diary
Time frame: Post-intervention at 12 weeks
Dysmenorrhea daily diary
Time frame: Post-intervention at 28 weeks
3-level version of EuroQol 5-Dimension
Time frame: 12 weeks
Cost-diary
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
Not yet recruiting
Whole-Body Vibration and Aerobic Exercise for Primary Dysmenorrhea in Young Adult Women
Primary Dysmenorrhea
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.
Priya Kannan, PhD principal investigator
The Hong Kong Polytechnic Unviersity
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity aerobic training in people with Primary Dysmenorrhea, run by The Hong Kong Polytechnic University.
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 3 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priya Kannan, PhD (3400 ext. 3277, priya.kannan@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Pre-intervention (baseline, 0 week)). The study lists 15 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 11 Dec 2020.