NCT07590232

Brief Summary

The main aim is to investigate the effects of acupuncture on pain intensity and health-related quality of life in women with primary dysmenorrhea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

acupuncturepainquality of life

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    VAS measures pain severity

    3 months

Secondary Outcomes (2)

  • The Functional and Emotional Dysmenorrhea Scale (FEDS)

    3 months

  • Short Form-36 (SF-36)

    3 months

Study Arms (2)

Acupuncture Group (AG)

EXPERIMENTAL

Patients in the AG received classical body acupuncture. The acupuncture points used were: LI-4, LIV-3, KID-3, SP-6, SP-8, HT-7, LU-9, P-6, BL-57, ST-25,28,29,30,36, GV-20, CV-2,3,4,5,6.

Other: acupuncture

Control Group (CG)

ACTIVE COMPARATOR

The control group received no acupuncture session but continued NSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up.

Drug: NSAIDs

Interventions

classical body acupuncture with needle without electrical stimulation

Acupuncture Group (AG)
NSAIDsDRUG

NSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up

Control Group (CG)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to be women aged 18-35 years with a confirmed diagnosis of primary dysmenorrhea for at least one year
  • regular menstrual cycles (28 ± 7 days)
  • a VAS score ≥4 in the previous cycle

You may not qualify if:

  • secondary dysmenorrhea
  • currently pregnant, postpartum, or breastfeeding
  • used oral contraceptives or intrauterine devices in the last 3 months,
  • received acupuncture in the past 6 months, had open wounds at acupuncture points
  • presented with severe psychiatric disorder or cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Hospital

Erzurum, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Acupuncture TherapyAnti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 15, 2026

Study Start

April 1, 2022

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations