Primary DysmenorrheaNCT05474599
Dry Cupping Therapy And Primary Dysmenorrhea
A study testing conventional physical therapy and Dry cupping therapy in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
There is growing evidence of the effects of dry cupping therapy on pain in primary dysmenorrhea. However, very few studies have explored the effects of dry cupping therapy on the severity of symptoms in primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- conventional physical therapy and Dry cupping therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 1 Aug 2022
- 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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Regular menstrual cycle
- Nulliparous
Who cannot join
- Allergic to cupping therapy,
- Endometriosis,
- PCOS
- Skin disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sialkot college of physical therapy
Sialkot, Punjab Province, 51040
About this study
Official title: Effects Of Dry Cupping Therapy on Pain and Symptoms Severity in Primary Dysmenorrhea
There is growing evidence of the effects of dry cupping therapy on pain in primary dysmenorrhea. However, very few studies have explored the effects of dry cupping therapy on the severity of symptoms in primary dysmenorrhea. The study aims to explore the effects of dry cupping therapy and the severity of symptoms in primary dysmenorrhea
Read the detailed description
A randomized, standard controlled clinical trial was conducted from August 2014 to February 2016. Diagnosed case of primary dysmenorrhea aged between 12-30 years were included in the research. A total of 60 subjects were assigned randomly to the interventions. They divide subjects into three groups randomly using computer software (graph pad software quickcals) each group has 20 number of subjects .The test group A received 3gm of herbal drug namely hulba twice in a day from day 1 to day 3 of menstrual cycle. The test group B received same dose of hulba with dry cupping. For dry cupping three medium cups were applied below the umbilicus for 15 minutes on day 1 and day 3 of menstruation. Group C is controlled group which received standard drug mefanamic acid, 500 mg twice daily for same duration as the test drug. These interventions were given for three consecutive cycles by the end of three months results were analyzed. The parameters were evaluated before and after the trial. after the completion of statistical analysis they find out that the dry cupping was more effective than mefanamic acid in reducing pain intensity in dysmenorrhea .they also notice the overall improvement in other associated symptoms like nausea vomiting fatigue and headache .No adverse effects had observed either in the subjects of test group or standard group .
Another research in 2018 was conducted they divide subjects into two groups In the intervention group, dry cupping therapy from 3 days before to 3 days after the onset of menstruation for three successive menstrual cycles they placed two cups on the lower back on each side of the spine and another on the supra pubic area for 10-15 min once daily. Students in the control group did not receive cupping therapy but their PD severity symptoms were assessed and documented for three menstrual cycle .Results indicated a significant decrease in PD severity after dry cupping for three menstrual cycles. Similarly, a study in India found that cupping therapy significantly reduced the PD by improving the local blood to uterus and reduces blood congestion. This study concludes that dry cupping can be effective in significantly reducing PD and its associated symptoms. Given its effectiveness, inexpensiveness, and safety, individuals with PD can refer to cupping technicians to receive dry cupping for PD management. More studies with larger samples are still needed to provide conclusive evidence about the effectiveness of dry cupping in reducing PD .
According to research in 2018 conducted the highest incidence of PD (57.5%) was observed in the group of 15-25years and less (8.57%) in the age group of above 35 years The highest incidence of dysmenorrhea (27.5%)was observed in10th class students while lowest incidence(5%) was observed in post-graduation students. It has been concluded that cupping is very effective for relief of it is cheaper and well tolerated by patient and there are no observed side effects of cupping therapy on patient .
Reviewing the previous literature on the effects of dry cupping therapy provides sufficient evidences on pain management with Primary dysmenorrhea but controlling the other associated symptoms through dry cupping is not enough. Hence dry cupping is an effective intervention to control symptoms associated with dysmenorrhea but its clinical application is very limited. In this study dry cupping will be used to minimize pain and manage backache during menstruation.
- Conditions
- Primary Dysmenorrhea
- Being tested
- conventional physical therapy, Dry cupping therapy
- Keywords
- Cupping Therapies, Pain, Painful Mensturation, TENS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
TENS
Dry cupping therapyOther
Experimental group was given Dry cupping therapy along with TENS.
| Study group | Role | What they receive |
|---|---|---|
| Dry cupping therapy | Experimental | For pain and severity of symptoms in primary dysmenorrhea. Receives: Other: conventional physical therapy |
| Conventional physical therapy | Other | For management of pain and severity of symptoms Receives: Other: Dry cupping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal multi-dimensional dysmenorrhea severity scoring system
Changes from the baseline verbal multidimensional scoring system were used. This scoring system measures pain severity and takes into account the impacts of pains on daily activities, systemic symptoms, and analgesic requirements
Measured: 8th week
Numeric pain rating scale
Changes from baseline the Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 8th week
Working Ability, Location, Intensity, Days Of Pain, Dysmenorrhea (WaLIDD) scale
Changes from the baseline this scale-type survey (working ability, location, intensity, days of pain, dysmenorrhea [WaLIDD] score) was designed, which integrated features of dysmenorrhea such as: 1) number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region), 2) Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more),19 3) number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and 4) frequency of disabling pain to perform their activities (never, almost never, almost always, always). Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Dec 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afifa Safdar, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474599
- Sponsor's protocol ID
- REC/RCR&AHS/22/0522
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inanmdar W, Sultana A, Mubeen U, Rahman K. Clinical efficacy of Trigonella foenum graecum (Fenugreek) and dry cupping therapy on intensity of pain in patients with primary dysmenorrhea. Chin J Integr Med. 2016 May 25. doi: 10.1007/s11655-016-2259-x. Online ahead of print.
PubMed 27225291Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
PubMed 15928561Teheran AA, Pineros LG, Pulido F, Mejia Guatibonza MC. WaLIDD score, a new tool to diagnose dysmenorrhea and predict medical leave in university students. Int J Womens Health. 2018 Jan 17;10:35-45. doi: 10.2147/IJWH.S143510. eCollection 2018.
PubMed 29398923
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Dry Cupping Therapy on Pain and Symptoms Severity in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05474599
- Acronym / sponsor ID
- REC/RCR&AHS/22/0522
- Conditions
- Primary Dysmenorrhea
- Keywords
- Cupping Therapies, Pain, Painful Mensturation, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is growing evidence of the effects of dry cupping therapy on pain in primary dysmenorrhea. However, very few studies have explored the effects of dry cupping therapy on the severity of symptoms in primary dysmenorrhea. The study aims to explore the effects of dry cupping therapy and the severity of symptoms in primary dysmenorrhea
Detailed description
A randomized, standard controlled clinical trial was conducted from August 2014 to February 2016. Diagnosed case of primary dysmenorrhea aged between 12-30 years were included in the research. A total of 60 subjects were assigned randomly to the interventions. They divide subjects into three groups randomly using computer software (graph pad software quickcals) each group has 20 number of subjects .The test group A received 3gm of herbal drug namely hulba twice in a day from day 1 to day 3 of menstrual cycle. The test group B received same dose of hulba with dry cupping. For dry cupping three medium cups were applied below the umbilicus for 15 minutes on day 1 and day 3 of menstruation. Group C is controlled group which received standard drug mefanamic acid, 500 mg twice daily for same duration as the test drug. These interventions were given for three consecutive cycles by the end of three months results were analyzed. The parameters were evaluated before and after the trial. after the completion of statistical analysis they find out that the dry cupping was more effective than mefanamic acid in reducing pain intensity in dysmenorrhea .they also notice the overall improvement in other associated symptoms like nausea vomiting fatigue and headache .No adverse effects had observed either in the subjects of test group or standard group .
Another research in 2018 was conducted they divide subjects into two groups In the intervention group, dry cupping therapy from 3 days before to 3 days after the onset of menstruation for three successive menstrual cycles they placed two cups on the lower back on each side of the spine and another on the supra pubic area for 10-15 min once daily. Students in the control group did not receive cupping therapy but their PD severity symptoms were assessed and documented for three menstrual cycle .Results indicated a significant decrease in PD severity after dry cupping for three menstrual cycles. Similarly, a study in India found that cupping therapy significantly reduced the PD by improving the local blood to uterus and reduces blood congestion. This study concludes that dry cupping can be effective in significantly reducing PD and its associated symptoms. Given its effectiveness, inexpensiveness, and safety, individuals with PD can refer to cupping technicians to receive dry cupping for PD management. More studies with larger samples are still needed to provide conclusive evidence about the effectiveness of dry cupping in reducing PD .
According to research in 2018 conducted the highest incidence of PD (57.5%) was observed in the group of 15-25years and less (8.57%) in the age group of above 35 years The highest incidence of dysmenorrhea (27.5%)was observed in10th class students while lowest incidence(5%) was observed in post-graduation students. It has been concluded that cupping is very effective for relief of it is cheaper and well tolerated by patient and there are no observed side effects of cupping therapy on patient .
Reviewing the previous literature on the effects of dry cupping therapy provides sufficient evidences on pain management with Primary dysmenorrhea but controlling the other associated symptoms through dry cupping is not enough. Hence dry cupping is an effective intervention to control symptoms associated with dysmenorrhea but its clinical application is very limited. In this study dry cupping will be used to minimize pain and manage backache during menstruation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry cupping therapy | Experimental | Other: conventional physical therapyFor pain and severity of symptoms in primary dysmenorrhea. |
| Conventional physical therapy | Other | Other: Dry cupping therapyFor management of pain and severity of symptoms |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Regular menstrual cycle
- Nulliparous
Key exclusion criteria (4 listed)
- Allergic to cupping therapy,
- Endometriosis,
- PCOS
- Skin disorders
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 |
|---|---|---|
| conventional physical therapyTENS | Other | Dry cupping therapy |
| Dry cupping therapyExperimental group was given Dry cupping therapy along with TENS. | Other | Conventional physical therapy |
Primary outcome
Verbal multi-dimensional dysmenorrhea severity scoring system
Time frame: 8th week
Changes from the baseline verbal multidimensional scoring system were used. This scoring system measures pain severity and takes into account the impacts of pains on daily activities, systemic symptoms, and analgesic requirements
Numeric pain rating scale
Time frame: 8th week
Changes from baseline the Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Working Ability, Location, Intensity, Days Of Pain, Dysmenorrhea (WaLIDD) scale
Time frame: 8th week
Changes from the baseline this scale-type survey (working ability, location, intensity, days of pain, dysmenorrhea [WaLIDD] score) was designed, which integrated features of dysmenorrhea such as: 1) number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region), 2) Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more),19 3) number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and 4) frequency of disabling pain to perform their activities (never, almost never, almost always, always). Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points
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 18 Sep 2023.
- Background: PubMed 27225291Inanmdar W, Sultana A, Mubeen U, Rahman K. Clinical efficacy of Trigonella foenum graecum (Fenugreek) and dry cupping therapy on intensity of pain in patients with primary dysmenorrhea. Chin J Integr Med. 2016 May 25. doi: 10.1007/s11655-016-2259-x. Online ahead of print.
- Background: PubMed 15928561Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
- Background: PubMed 29398923Teheran AA, Pineros LG, Pulido F, Mejia Guatibonza MC. WaLIDD score, a new tool to diagnose dysmenorrhea and predict medical leave in university students. Int J Womens Health. 2018 Jan 17;10:35-45. doi: 10.2147/IJWH.S143510. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afifa Safdar, PhD* principal investigator
Riphah International 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 conventional physical therapy and Dry cupping therapy in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 4 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 18 Sep 2023. 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 Pakistan. 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?
Verbal multi-dimensional dysmenorrhea severity scoring system (time frame: 8th week). 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?
On the ClinicalTrials.gov record for NCT05474599, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.