- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474599
Dry Cupping Therapy And Primary Dysmenorrhea
Effects Of Dry Cupping Therapy on Pain and Symptoms Severity in Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Punjab
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Sialkot, Punjab, Pakistan, 51040
- Sialkot college of physical therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Regular menstrual cycle
- Nulliparous
Exclusion Criteria:
- Allergic to cupping therapy,
- Endometriosis,
- PCOS
- Skin disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry cupping therapy
For pain and severity of symptoms in primary dysmenorrhea.
|
TENS
|
Other: Conventional physical therapy
For management of pain and severity of symptoms
|
Experimental group was given Dry cupping therapy along with TENS.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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8th week
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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")
|
8th week
|
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
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8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Afifa Safdar, PhD*, Riphah International University
Publications and helpful links
General Publications
- Childs 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.
- 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.
- Teheran 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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