Primary DysmenorrheaNCT06578013
Effect of Acupressure-Ice Message on Primary Dysmenorrhea
A study testing acupressure ice massage and pelvic rocking exercises in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of acupressure ice massage on primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- acupressure ice massage and pelvic rocking exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 15 Dec 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 17 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Fifty adolescents' females who are clinically diagnosed as primary dysmenorrhea.
- Their ages will be ranged from 17-25 years old.
- Their BMI will be less than 30 kg/m².
- All of them are virgin.
- Their pain level will be more than 3 on visual analogue scale.
- Having mild to moderate score on Menstrual Distress questionnaire (MDQ) ( ≥ 50).
- Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).
Who cannot join
- Systematic chronic diseases or any pelvic inflammatory diseases.
- Secondary dysmenorrhea.
- Menstrual irregularity.
- Nerve damage resulting in loss of feeling.
- Swelling, scar or skin infection.
- Diabetic patients.
Trial locations and contacts
1 site in 1 country.
Manal Ahmed El-Shafei, PhD contact
Egypt1 site
Doaa Ashraf Abd El-Ghany
Cairo
Doaa Ashraf Abd El-Ghany, B.Sc, 01090052117, doaaashrafabdelghany@gmail.com
Manal Ahmed El-Shafei, PhD
About this study
This study will be conducted to determine the effect of acupressure ice massage on primary dysmenorrhea.
Read the detailed description
Dysmenorrhea is considered the most common gynecological complaint by young women and affects approximately 60-80% of the female population. Around 8-18% of that population report intense discomfort, causing absenteeism in several daily activities while suffering pain.
Analgesics are considered the first line of treatment, but they are known for their undesirable effects such as renal, cardiovascular and gastrointestinal complications that can negatively affect patients' health. Physical therapy has alternative techniques that assist in analgesia in a practical and effective way; among them is acupressure and cryo therapy.
The effect of application of ice on the skin has a direct action on neurons and pain receptors, lowering the speed and the number of nerve impulses. This effect is due to its action on the gate control of pain mechanism, leading to the release of endorphins and enkephalins that are pain-relieving substances.
It was proved from previous studies that using ice massage on L14 or SP6 points reduce pain intensity in females suffering from PD. So, further studies are needed to investigate the effect of acupressure ice massage not only on pain intensity but also on other symptoms severity and quality of life of females suffering from PD. Therefore, this study will be conducted for this issue which will be of valuable benefits for medical service organization and increase body of knowledge of physical therapy in scientific field.
- Conditions
- Primary Dysmenorrhea
- Being tested
- acupressure ice massage, pelvic rocking exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure ice massageOther
- It will be used for participants in group (A), 2 cm diameter circular ice pieces will be placed inside plastic bags and covered with a thin gauze to prevent moisture transmission and direct ice contact with the skin to apply ice massage.
- Ice massage will carried out rotationally each 1 minute (30 seconds clockwise and 30 seconds counterclockwise) on L14 point for 10 minutes and on SP6 point for another 10 minutes.
pelvic rocking exercisesOther
- Pelvic rocking exercise will be used for all participants in both groups (A \& B).
- Each participant will be encouraged to lie down on her back on matrix with a pillow under head then bend her knees and keep her foot flat on the floor and place one hand under curve of her back and the other hand on the top of. her abdomen then tighten buttocks and abdominal muscles simultaneously. After that each participant will be encouraged to inhale and hold (1-2-3-4) then exhale and hold 4-3-2-1 then relax muscles and feel her back flat on the underneath hand. Finally, each participant will be encouraged to repeat the last two steps about 10 times each session.
- The exercise will be repeated for 15times/ session, 3 times /week, for 3 successive menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| acupressure ice massage + pelvic rocking exercises | Experimental | It will include 25 participants suffering from primary dysmenorrhea who will receive acupressure ice massage on SP6 and L14 acupoints, 10 minutes on each point for 20 minutes each session, 5 sessions per cycle (through the 5 days before menstruation) for 3 consecutive menstrual cycles, in addition to pelvic rocking exercises, 15 minute/session, 3 times /week, for 3 successive menstrual cycles. Receives: Other: acupressure ice massage; Other: pelvic rocking exercises |
| pelvic rocking exercises | Active comparator | It will include 25 participants suffering from primary dysmenorrhea, who will perform pelvic rocking exercises only, 15 minutes/session, 3 times /week, for 3 successive menstrual cycles. Receives: Other: pelvic rocking exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessment
It will be assessed for each participant in both groups (A \& B) before and after treatment, using the visual analogue scale (VAS). The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of " no pain at all " and " worst pain imaginable ". It's simplicity, reliability and validity as well as its ratio scale properties make the VAS the optional tool for describing pain intensity.
Measured: 3 months
Assessment of pain pressure threshold
A pressure algometer will be used to measure pain pressure thresholds (PPTs) for all participants in both groups before and after treatment, coinciding with peak menstrual pain on the first day of menstruation. Six specific points around the umbilicus and lower back will be assessed, with each point measured twice using a 1-cm² probe applied at 30kPa/s. The areas will be cleaned with alcohol before testing. Two points will be measured 4cm bilaterally from the umbilicus, two more 4cm below these, one 4cm below the umbilicus, and one in the lumbar region at S2-S4. The mean values of these points will be used for PPT data analysis.
Measured: 3 months
Menstrual distress questionnaire (MDQ)
It will be used pre and post- treatment to assess the severity of symptoms of primary dysmenorrhea for all participants in both groups (A \& B). The MDQ consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5 point rating scale from 0-4. For each items, there is 5 options i.e. No, mild, moderate, severe and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven sub-scales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, arousal control). Overall Score was interpreted as follows :< 50 - mild , 50 to 70 - moderate and >70 severe.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 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.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ashraf Abd El-Ghany, Cairo University
- Investigators
- Azza Barmoud Nashed Kassab, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578013
- Sponsor's protocol ID
- P.T.REC/012/005306
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 29 Aug 2024
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure-Ice Message on Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06578013
- Acronym / sponsor ID
- P.T.REC/012/005306
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 29 Aug 2024 (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 study will be conducted to determine the effect of acupressure ice massage on primary dysmenorrhea.
Detailed description
Dysmenorrhea is considered the most common gynecological complaint by young women and affects approximately 60-80% of the female population. Around 8-18% of that population report intense discomfort, causing absenteeism in several daily activities while suffering pain.
Analgesics are considered the first line of treatment, but they are known for their undesirable effects such as renal, cardiovascular and gastrointestinal complications that can negatively affect patients' health. Physical therapy has alternative techniques that assist in analgesia in a practical and effective way; among them is acupressure and cryo therapy.
The effect of application of ice on the skin has a direct action on neurons and pain receptors, lowering the speed and the number of nerve impulses. This effect is due to its action on the gate control of pain mechanism, leading to the release of endorphins and enkephalins that are pain-relieving substances.
It was proved from previous studies that using ice massage on L14 or SP6 points reduce pain intensity in females suffering from PD. So, further studies are needed to investigate the effect of acupressure ice massage not only on pain intensity but also on other symptoms severity and quality of life of females suffering from PD. Therefore, this study will be conducted for this issue which will be of valuable benefits for medical service organization and increase body of knowledge of physical therapy in scientific field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure ice massage + pelvic rocking exercises | Experimental | Other: acupressure ice massage, Other: pelvic rocking exercisesIt will include 25 participants suffering from primary dysmenorrhea who will receive acupressure ice massage on SP6 and L14 acupoints, 10 minutes on each point for 20 minutes each session, 5 sessions per cycle (through the 5 days before menstruation) for 3 consecutive menstrual cycles, in addition to pelvic rocking exercises, 15 minute/session, 3 times /week, for 3 successive menstrual cycles. |
| pelvic rocking exercises | Active comparator | Other: pelvic rocking exercisesIt will include 25 participants suffering from primary dysmenorrhea, who will perform pelvic rocking exercises only, 15 minutes/session, 3 times /week, for 3 successive menstrual cycles. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Fifty adolescents' females who are clinically diagnosed as primary dysmenorrhea.
- Their ages will be ranged from 17-25 years old.
- Their BMI will be less than 30 kg/m².
- All of them are virgin.
- Their pain level will be more than 3 on visual analogue scale.
Key exclusion criteria (6 listed)
- Systematic chronic diseases or any pelvic inflammatory diseases.
- Secondary dysmenorrhea.
- Menstrual irregularity.
- Nerve damage resulting in loss of feeling.
- Swelling, scar or skin infection.
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 |
|---|---|---|
| acupressure ice massage* It will be used for participants in group (A), 2 cm diameter circular ice pieces will be placed inside plastic bags and covered with a thin gauze to prevent moisture transmission and direct ice contact with the skin to apply ice massage. * Ice massage will carried out rotationally each 1 minute (30 seconds clockwise and 30 seconds counterclockwise) on L14 point for 10 minutes and on SP6 point for another 10 minutes. | Other | acupressure ice massage + pelvic rocking exercises |
| pelvic rocking exercises* Pelvic rocking exercise will be used for all participants in both groups (A \& B). * Each participant will be encouraged to lie down on her back on matrix with a pillow under head then bend her knees and keep her foot flat on the floor and place one hand under curve of her back and the other hand on the top of. her abdomen then tighten buttocks and abdominal muscles simultaneously. After that each participant will be encouraged to inhale and hold (1-2-3-4) then exhale and hold 4-3-2-1 then relax muscles and feel her back flat on the underneath hand. Finally, each participant will be encouraged to repeat the last two steps about 10 times each session. * The exercise will be repeated for 15times/ session, 3 times /week, for 3 successive menstrual cycles. | Other | acupressure ice massage + pelvic rocking exercises, pelvic rocking exercises |
Primary outcome
Pain intensity assessment
Time frame: 3 months
It will be assessed for each participant in both groups (A \& B) before and after treatment, using the visual analogue scale (VAS). The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of " no pain at all " and " worst pain imaginable ". It's simplicity, reliability and validity as well as its ratio scale properties make the VAS the optional tool for describing pain intensity.
Assessment of pain pressure threshold
Time frame: 3 months
A pressure algometer will be used to measure pain pressure thresholds (PPTs) for all participants in both groups before and after treatment, coinciding with peak menstrual pain on the first day of menstruation. Six specific points around the umbilicus and lower back will be assessed, with each point measured twice using a 1-cm² probe applied at 30kPa/s. The areas will be cleaned with alcohol before testing. Two points will be measured 4cm bilaterally from the umbilicus, two more 4cm below these, one 4cm below the umbilicus, and one in the lumbar region at S2-S4. The mean values of these points will be used for PPT data analysis.
Menstrual distress questionnaire (MDQ)
Time frame: 3 months
It will be used pre and post- treatment to assess the severity of symptoms of primary dysmenorrhea for all participants in both groups (A \& B). The MDQ consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5 point rating scale from 0-4. For each items, there is 5 options i.e. No, mild, moderate, severe and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven sub-scales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, arousal control). Overall Score was interpreted as follows :< 50 - mild , 50 to 70 - moderate and >70 severe.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
Manal Ahmed El-Shafei, PhD contact
Azza Barmoud Nashed Kassab, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure ice massage and pelvic rocking exercises in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 6 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 29 Aug 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Ashraf Abd El-Ghany, B.Sc (01090052117, doaaashrafabdelghany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessment (time frame: 3 months). The study lists 3 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 29 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.