NCT05474599

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

July 24, 2022

Last Update Submit

September 15, 2023

Conditions

Primary Dysmenorrhea

Keywords

Cupping TherapiesPainPainful MensturationTENS

Outcome Measures

Primary Outcomes (3)

  • 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

    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")

    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

    8th week

Study Arms (2)

Dry cupping therapy

EXPERIMENTAL

For pain and severity of symptoms in primary dysmenorrhea.

Other: conventional physical therapy

Conventional physical therapy

OTHER

For management of pain and severity of symptoms

Other: Dry cupping therapy

Interventions

conventional physical therapyOTHER

TENS

Dry cupping therapy
Dry cupping therapyOTHER

Experimental group was given Dry cupping therapy along with TENS.

Conventional physical therapy

Eligibility Criteria

Age15 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Regular menstrual cycle
  • Nulliparous

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sialkot college of physical therapy

Sialkot, Punjab Province, 51040, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 27225291BACKGROUND

  • 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.

    PMID: 15928561BACKGROUND

  • 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.

    PMID: 29398923BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Afifa Safdar, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 26, 2022

Study Start

December 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)