DysmenorrhoeaNCT07845045
The Relationship Between Lower Abdominal Temperature and Pain in Women With Dysmenorrhoea During Acupuncture
A study testing Lying on a clinical bed (LCB) and Bilateral SP6 acupuncture in people with Dysmenorrhoea, run by HUEI-WEN LIAU at 1 site in Australia.
Trial summary
This clinical study examined the effects of acupuncture at Sanyinjiao (SP6) on menstrual pain and lower abdominal skin temperature in women with dysmenorrhoea. Participants first completed a 20-minute resting session without acupuncture, which served as the control condition. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhoea
- What is being tested?
- Lying on a clinical bed (LCB) and Bilateral SP6 acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Feb 2021to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of dysmenorrhoea
- Female participants aged 18 to 45 years
- History of dysmenorrhoea for more than 3 months
- Able to provide informed consent
Who cannot join
- Pregnant, planning pregnancy, or lactating
- Use of an intrauterine contraceptive device
- Irregular menstrual cycles or bleeding disorders
- Serious life-threatening primary disease
- Unstable work or living conditions, or other factors likely to interfere with completion of treatment and follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Lower Abdominal Temperature and Pain in Women With Dysmenorrhoea During Acupuncture - a Clinical Study
This clinical study examined the effects of acupuncture at Sanyinjiao (SP6) on menstrual pain and lower abdominal skin temperature in women with dysmenorrhoea. Participants first completed a 20-minute resting session without acupuncture, which served as the control condition. After a washout period of at least one day, participants received six bilateral SP6 acupuncture sessions over three consecutive menstrual cycles, with two sessions in each cycle.
Pain severity and lower abdominal skin temperature were measured immediately before and after the resting control session and each acupuncture session. In addition, peak menstrual pain on Day 1 and Day 2 was recorded during each of the three menstrual cycles in the acupuncture treatment phase and during three additional follow-up menstrual cycles after treatment. This allowed the study to examine both immediate changes in pain following acupuncture and longitudinal changes in peak menstrual pain across the treatment and follow-up periods.
The study also explored whether changes in lower abdominal skin temperature were associated with changes in pain severity, and assessed the safety and feasibility of the study procedures.
- Conditions
- Dysmenorrhoea
- Being tested
- Lying on a clinical bed (LCB), Bilateral SP6 acupuncture
- Keywords
- Acupuncture, Dysmenorrhoea, Menstrual Pain, Sanyinjiao, SP6, Lower Abdominal Temperature, Infrared Thermography, Pain Severity
- Medical subject headings
- Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lying on a clinical bed (LCB)Other
Participants lay on a clinical bed for 20 minutes without acupuncture and without any other therapeutic procedures. This session served as the control condition.
Bilateral SP6 acupunctureProcedure or surgery
Participants received acupuncture at bilateral Sanyinjiao (SP6). Six 20-minute acupuncture sessions were delivered over three consecutive menstrual cycles, with two sessions per cycle: one within seven days before menstruation and one on Day 1 or Day 2 of menstruation when dysmenorrhoea was present.
| Study group | Role | What they receive |
|---|---|---|
| Lying on a clinical bed (LCB) followed by SP6 acupuncture | Experimental | Participants first completed one 20-minute lying-on-a-clinical-bed (LCB) control session without acupuncture. After a washout period of at least one day, they received six bilateral SP6 acupuncture sessions over three menstrual cycles, with two sessions in each menstrual cycle. Each participant received both interventions in this fixed sequence and served as her own control. Receives: Other: Lying on a clinical bed (LCB); Procedure: Bilateral SP6 acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in menstrual pain severity following intervention
Pain severity was measured using the Mankoski Pain Scale (0-10) immediately before and after the 20-minute resting control session and each of the six acupuncture sessions. Change in pain severity (ΔP) was calculated as the post-intervention pain score minus the pre-intervention pain score.
Measured: Immediately before and after each intervention, across 1 control and 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Change in lower abdominal skin temperature following intervention
Mean lower abdominal skin temperature was measured using infrared thermography immediately before and after the 20-minute LCB control session and each of the six acupuncture sessions. Change in temperature (ΔT) was calculated as the post-intervention temperature minus the pre-intervention temperature.
Measured: Immediately before and after each intervention, across 1 control LCB and 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Pearson correlation between change in lower abdominal skin temperature and change in menstrual pain severity following acupuncture
Pearson's correlation coefficient (r) was used to assess the linear correlation between change in lower abdominal skin temperature (ΔT) and change in menstrual pain severity (ΔP) following acupuncture. Lower abdominal skin temperature was measured in degrees Celsius (°C) using infrared thermography immediately before and after acupuncture, and ΔT was calculated as the post-acupuncture temperature minus the pre-acupuncture temperature. Menstrual pain severity was measured using the Mankoski Pain Scale (0-10) immediately before and after acupuncture, and ΔP was calculated as the post-acupuncture pain score minus the pre-acupuncture pain score. The reported outcome was Pearson's r, a unitless coefficient ranging from -1 to +1, with values closer to -1 or +1 indicating a stronger linear correlation and values closer to 0 indicating a weaker linear correlation.
Measured: Across 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Change in mean peak menstrual pain across acupuncture treatment and follow-up menstrual cycles
Peak menstrual pain was recorded on Day 1 and Day 2 of each menstrual cycle using the Mankoski Pain Scale (0-10). The mean of the Day 1 and Day 2 peak pain scores was calculated and used for longitudinal comparison across the three acupuncture treatment cycles and the three follow-up menstrual cycles. Day 1 and Day 2 peak pain scores were also examined separately as supplementary analyses.
Measured: Across 3 acupuncture treatment menstrual cycles and 3 subsequent follow-up cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Secondary outcomes (4)
Total score on the Acupuncture Safety Assessment Questionnaire
Safety was assessed after each acupuncture session using the Acupuncture Safety Assessment Questionnaire (ASQ), which comprised the Safety Assessment Scoring System (SASS) and the Safety Result Categorization Table (SRT). The SASS recorded post-treatment pain, bruising, bleeding, and adverse or serious events. Pain and bruising were scored from 4 to 1 according to symptom duration, with shorter duration receiving a higher score: 4 = no symptoms, 3 = <1 day, 2 = 1-2 days, and 1 = >2 days. Bleeding was scored as 4 if absent and 1 if present. Adverse or serious events were scored as 0 if absent and -12 if present; if an adverse or serious event occurred, the final total safety score was recorded as -12 and all other item scores were disregarded. The total score ranged from -12 to 12, with higher scores indicating greater safety. According to the predefined classification criteria in the SRT, scores of -12 to 2 were classified as unsafe, 3 as potentially unsafe, and 4 to 12 as safe.
Measured: Immediately after each of the 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Pearson correlation between MASS Index and change in menstrual pain severity following acupuncture
Pearson's correlation coefficient (r) was used to assess the linear correlation between Deqi sensation intensity, measured by the MASS Index, and change in menstrual pain severity (ΔP) following acupuncture. Deqi sensation was assessed after each acupuncture session using the Massachusetts General Hospital Acupuncture Sensation Scale (MASS). Twelve sensation descriptors were each rated from 0 (no sensation) to 10 (extremely strong sensation), and a composite MASS Index ranging from 0 to 10 was calculated, with higher scores indicating greater Deqi sensation intensity. Menstrual pain severity was measured using the Mankoski Pain Scale (0-10) immediately before and after acupuncture, and ΔP was calculated as the post-acupuncture pain score minus the pre-acupuncture pain score. The outcome was Pearson's r, a unitless coefficient ranging from -1 to +1, with values closer to -1 or +1 indicating a stronger linear correlation and values closer to 0 indicating a weaker linear correlation.
Measured: Across 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Pearson correlation between MASS Index and change in lower abdominal skin temperature following acupuncture
Pearson's correlation coefficient (r) was used to assess the linear correlation between Deqi sensation intensity, measured by the MASS Index, and change in lower abdominal skin temperature (ΔT) following acupuncture. Deqi sensation was assessed after each acupuncture session using the Massachusetts General Hospital Acupuncture Sensation Scale (MASS). Twelve sensation descriptors were each rated from 0 (no sensation) to 10 (extremely strong sensation), and a composite MASS Index ranging from 0 to 10 was calculated, with higher scores indicating greater Deqi sensation intensity. Lower abdominal skin temperature was measured in degrees Celsius (°C) using infrared thermography immediately before and after acupuncture, and ΔT was calculated as the post-acupuncture temperature minus the pre-acupuncture temperature. The reported outcome was Pearson's r, a unitless coefficient ranging from -1 to +1, with greater absolute values indicating stronger linear correlation.
Measured: Across 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Feasibility assessment using recruitment, retention, acupuncture completion, and crossover compliance rates
Study protocol feasibility was assessed using four predefined indicators: recruitment rate, retention rate, acupuncture completion rate, and crossover compliance rate.
- Recruitment rate was calculated as participants recruited divided by the planned sample size;
- retention rate as participants completing the full protocol divided by participants enrolled;
- acupuncture completion rate as participants completing all six acupuncture sessions divided by participants completing the study;
- crossover compliance rate as participants completing the fixed intervention sequence (LCB followed by acupuncture) divided by participants completing the study.
Each indicator was compared with its predefined, literature-informed benchmark: ≥70%, ≥80%, ≥80%, and ≥85%, respectively. Feasibility was interpreted by assessing whether each indicator met its benchmark and by considering all four indicators collectively to evaluate overall protocol feasibility.
Measured: Recruitment: start to target reached; retention: enrolment to 6 acupuncture sessions + 3 follow-up cycles; acupuncture completion: 6 sessions over 3 cycles; crossover compliance: LCB to completion of 6 acupuncture sessions. Cycles ~28 days (21-35).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start5 Feb 2021
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrhoeaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received both interventions in a fixed sequence. Participants first completed a 20-minute lying-on-a-clinical-bed (LCB) control session, followed by a washout period of at least one day, and then received six bilateral SP6 acupuncture sessions over three menstrual cycles. Each participant served as her own control.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUEI-WEN LIAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HUEI-WEN LIAU, University of Technology, Sydney
- Investigators
- Christopher Zaslawski, PhD, Study chair, University of Technology Sydney, Faculty of Science / School of Life SciencesIan Menz, PhD, Study chair, University of Technology Sydney, Faculty of Science, School of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845045
- Sponsor's protocol ID
- ETH21-6103
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no formal data-sharing plan was established for this study. Participant data are held under the study's ethics and confidentiality requirements and are not intended for external distribution.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Lower Abdominal Temperature and Pain in Women With Dysmenorrhoea During Acupuncture - a Clinical Study
- ClinicalTrials.gov ID
- NCT07845045
- Acronym / sponsor ID
- ETH21-6103
- Conditions
- Dysmenorrhoea
- Keywords
- Acupuncture, Dysmenorrhoea, Menstrual Pain, Sanyinjiao, SP6, Lower Abdominal Temperature, Infrared Thermography, Pain Severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HUEI-WEN LIAUUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 28 Sep 2026 (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.
This clinical study examined the effects of acupuncture at Sanyinjiao (SP6) on menstrual pain and lower abdominal skin temperature in women with dysmenorrhoea. Participants first completed a 20-minute resting session without acupuncture, which served as the control condition. After a washout period of at least one day, participants received six bilateral SP6 acupuncture sessions over three consecutive menstrual cycles, with two sessions in each cycle.
Pain severity and lower abdominal skin temperature were measured immediately before and after the resting control session and each acupuncture session. In addition, peak menstrual pain on Day 1 and Day 2 was recorded during each of the three menstrual cycles in the acupuncture treatment phase and during three additional follow-up menstrual cycles after treatment. This allowed the study to examine both immediate changes in pain following acupuncture and longitudinal changes in peak menstrual pain across the treatment and follow-up periods.
The study also explored whether changes in lower abdominal skin temperature were associated with changes in pain severity, and assessed the safety and feasibility of the study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received both interventions in a fixed sequence. Participants first completed a 20-minute lying-on-a-clinical-bed (LCB) control session, followed by a washout period of at least one day, and then received six bilateral SP6 acupuncture sessions over three menstrual cycles. Each participant served as her own control.
| Arm | Type | Receives |
|---|---|---|
| Lying on a clinical bed (LCB) followed by SP6 acupuncture | Experimental | Other: Lying on a clinical bed (LCB), Procedure: Bilateral SP6 acupunctureParticipants first completed one 20-minute lying-on-a-clinical-bed (LCB) control session without acupuncture. After a washout period of at least one day, they received six bilateral SP6 acupuncture sessions over three menstrual cycles, with two sessions in each menstrual cycle. Each participant received both interventions in this fixed sequence and served as her own control. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of dysmenorrhoea
- Female participants aged 18 to 45 years
- History of dysmenorrhoea for more than 3 months
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Pregnant, planning pregnancy, or lactating
- Use of an intrauterine contraceptive device
- Irregular menstrual cycles or bleeding disorders
- Serious life-threatening primary disease
- Unstable work or living conditions, or other factors likely to interfere with completion of treatment and follow-up
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 |
|---|---|---|
| Lying on a clinical bed (LCB)Participants lay on a clinical bed for 20 minutes without acupuncture and without any other therapeutic procedures. This session served as the control condition. | Other | Lying on a clinical bed (LCB) followed by SP6 acupuncture |
| Bilateral SP6 acupunctureParticipants received acupuncture at bilateral Sanyinjiao (SP6). Six 20-minute acupuncture sessions were delivered over three consecutive menstrual cycles, with two sessions per cycle: one within seven days before menstruation and one on Day 1 or Day 2 of menstruation when dysmenorrhoea was present. | Procedure or surgery | Lying on a clinical bed (LCB) followed by SP6 acupuncture |
Primary outcome
Change in menstrual pain severity following intervention
Time frame: Immediately before and after each intervention, across 1 control and 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Pain severity was measured using the Mankoski Pain Scale (0-10) immediately before and after the 20-minute resting control session and each of the six acupuncture sessions. Change in pain severity (ΔP) was calculated as the post-intervention pain score minus the pre-intervention pain score.
Change in lower abdominal skin temperature following intervention
Time frame: Immediately before and after each intervention, across 1 control LCB and 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Mean lower abdominal skin temperature was measured using infrared thermography immediately before and after the 20-minute LCB control session and each of the six acupuncture sessions. Change in temperature (ΔT) was calculated as the post-intervention temperature minus the pre-intervention temperature.
Pearson correlation between change in lower abdominal skin temperature and change in menstrual pain severity following acupuncture
Time frame: Across 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Pearson's correlation coefficient (r) was used to assess the linear correlation between change in lower abdominal skin temperature (ΔT) and change in menstrual pain severity (ΔP) following acupuncture. Lower abdominal skin temperature was measured in degrees Celsius (°C) using infrared thermography immediately before and after acupuncture, and ΔT was calculated as the post-acupuncture temperature minus the pre-acupuncture temperature. Menstrual pain severity was measured using the Mankoski Pain Scale (0-10) immediately before and after acupuncture, and ΔP was calculated as the post-acupuncture pain score minus the pre-acupuncture pain score. The reported outcome was Pearson's r, a unitless coefficient ranging from -1 to +1, with values closer to -1 or +1 indicating a stronger linear correlation and values closer to 0 indicating a weaker linear correlation.
Change in mean peak menstrual pain across acupuncture treatment and follow-up menstrual cycles
Time frame: Across 3 acupuncture treatment menstrual cycles and 3 subsequent follow-up cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Peak menstrual pain was recorded on Day 1 and Day 2 of each menstrual cycle using the Mankoski Pain Scale (0-10). The mean of the Day 1 and Day 2 peak pain scores was calculated and used for longitudinal comparison across the three acupuncture treatment cycles and the three follow-up menstrual cycles. Day 1 and Day 2 peak pain scores were also examined separately as supplementary analyses.
4 secondary outcomes
Total score on the Acupuncture Safety Assessment Questionnaire
Time frame: Immediately after each of the 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Pearson correlation between MASS Index and change in menstrual pain severity following acupuncture
Time frame: Across 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Pearson correlation between MASS Index and change in lower abdominal skin temperature following acupuncture
Time frame: Across 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.
Feasibility assessment using recruitment, retention, acupuncture completion, and crossover compliance rates
Time frame: Recruitment: start to target reached; retention: enrolment to 6 acupuncture sessions + 3 follow-up cycles; acupuncture completion: 6 sessions over 3 cycles; crossover compliance: LCB to completion of 6 acupuncture sessions. Cycles ~28 days (21-35).
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 28 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no formal data-sharing plan was established for this study. Participant data are held under the study's ethics and confidentiality requirements and are not intended for external distribution.
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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.
Christopher Zaslawski, PhD study chair
University of Technology Sydney, Faculty of Science / School of Life Sciences
Ian Menz, PhD study chair
University of Technology Sydney, Faculty of Science, School of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lying on a clinical bed (LCB) and Bilateral SP6 acupuncture in people with Dysmenorrhoea, run by HUEI-WEN LIAU 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 4 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: finished, as of the sponsor's last update on 28 Sep 2026. 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. 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 menstrual pain severity following intervention (time frame: Immediately before and after each intervention, across 1 control and 6 acupuncture sessions over 3 consecutive menstrual cycles. Cycles were participant-specific; average ~28 days, with 21-35 days considered normal. Irregular cycles were excluded.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026.