NCT02663050

Brief Summary

Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment strategies are being held. But invasive and pharmacological therapies have good outcome with systemic side effects. Kinesio taping is being widely used in different pain conditions. Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention method which can be used in outpatient practice without systemic side effects.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

January 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

29 days

First QC Date

January 19, 2016

Last Update Submit

February 26, 2016

Conditions

Keywords

Dysmenorrheakinesio tape

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    At the begining of the Dysmenorrhea before taping we will measure the VAS level (pretreatment)and 4 days after taping we will measure the second VAS level (after treatment)

    0- 4th day

Study Arms (3)

Kinesio taping group

EXPERIMENTAL

only Kinesio taping treatment group

Other: Kinesio taping

NSAID treatment group

ACTIVE COMPARATOR

only NSAIDs taking group

Drug: NSAID's

Combination treatment group

ACTIVE COMPARATOR

NSAIDs plus Kinesio taping group

Other: Kinesio tapingDrug: NSAID's

Interventions

Patients will be taped for four days , ıt will start at the begining of the Dysmenorrhea

Combination treatment groupKinesio taping group

twice a daily

Also known as: Diclophenac Potassium
Combination treatment groupNSAID treatment group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Dysmenorrhea

You may not qualify if:

  • pregnancy
  • surgical abdominal emergency
  • metabolic or inflammatory illnesses or cardiovascular diseases,
  • endocrine disorders such as diabetes, thyroid disorders, androgen excess (hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumor),
  • smokers
  • using pharmaceutical agents such as anti-inflammatory agents that could possibly impact on endocrine and liver enzymes
  • musculoskeletal pain
  • inguinal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Mustafa Öztürk, M.D.

    Etimesgut Military Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Öztürk, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.,Obstetrics and Gynecology, Specialist

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 26, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

February 29, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

We will share the data monthly