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Dry Cupping Therapy And Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional physical therapy
Dry cupping therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Cupping Therapies, Pain, Painful Mensturation, TENS

Eligibility Criteria

15 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Regular menstrual cycle
  • Nulliparous

Exclusion Criteria:

  • Allergic to cupping therapy,
  • Endometriosis,
  • PCOS
  • Skin disorders

Sites / Locations

  • Sialkot college of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dry cupping therapy

Conventional physical therapy

Arm Description

For pain and severity of symptoms in primary dysmenorrhea.

For management of pain and severity of symptoms

Outcomes

Primary Outcome Measures

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
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")
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

Secondary Outcome Measures

Full Information

First Posted
July 24, 2022
Last Updated
September 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05474599
Brief Title
Dry Cupping Therapy And Primary Dysmenorrhea
Official Title
Effects Of Dry Cupping Therapy on Pain and Symptoms Severity in Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Cupping Therapies, Pain, Painful Mensturation, TENS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry cupping therapy
Arm Type
Experimental
Arm Description
For pain and severity of symptoms in primary dysmenorrhea.
Arm Title
Conventional physical therapy
Arm Type
Other
Arm Description
For management of pain and severity of symptoms
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
TENS
Intervention Type
Other
Intervention Name(s)
Dry cupping therapy
Intervention Description
Experimental group was given Dry cupping therapy along with TENS.
Primary Outcome Measure Information:
Title
Verbal multi-dimensional dysmenorrhea severity scoring system
Description
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
Time Frame
8th week
Title
Numeric pain rating scale
Description
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")
Time Frame
8th week
Title
Working Ability, Location, Intensity, Days Of Pain, Dysmenorrhea (WaLIDD) scale
Description
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
Time Frame
8th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Regular menstrual cycle Nulliparous Exclusion Criteria: Allergic to cupping therapy, Endometriosis, PCOS Skin disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afifa Safdar, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sialkot college of physical therapy
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51040
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27225291
Citation
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.
Results Reference
background
PubMed Identifier
15928561
Citation
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.
Results Reference
background
PubMed Identifier
29398923
Citation
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.
Results Reference
background

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Dry Cupping Therapy And Primary Dysmenorrhea

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