NCT00225836

Brief Summary

Dysmenorrhoea (menstrual pain) is a common complaint among women, leading to use of analgesics, reduced quality of life, and interference with daily activities such as going to work or school. Transcutaneous electrical nerve stimulation (TENS) is a well established method for treatment of pain. Several clinical studies have shown TENS treatment to be effective against dysmenorrhoea. A TENS apparatus specifically developed for the treatment of dysmenorrhoea has now become commercially available (OVA), but is has not been tested in clinical studies. This study will be done to evaluate the clinical utility of treatment with OVA in women with primary dysmenorrhoea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 17, 2007

Status Verified

January 1, 2007

First QC Date

September 22, 2005

Last Update Submit

January 12, 2007

Conditions

Dysmenorrhoea

Keywords

DysmenorrhoeaWomenPainTENS

Outcome Measures

Primary Outcomes (1)

  • Change in VAS pain score

Interventions

OVA (TENS apparatus)DEVICE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary dysmenorrhoea

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Ob/Gyn, The Hospital of Vestfold

Tønsberg, N-3103, Norway

Location

MeSH Terms

Conditions

DysmenorrheaPain

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hjalmar A Schiotz, MD, PhD

    Consultant Gynecologist, The Hospital of Vestfold, Tonsberg, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

September 1, 2005

Study Completion

May 1, 2006

Last Updated

January 17, 2007

Record last verified: 2007-01

Locations

NO(1)