NCT04235595

Brief Summary

this study was to compare the early and short-term effects of high-frequency transcutaneous electrical nerve stimulation (TENS) versus connective tissue manipulation (CTM) in participants with primary dysmenorrhea. Half of the participants received CTM, while the other half received TENS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

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

September 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 13, 2020

Last Update Submit

January 16, 2020

Conditions

Primary Dysmenorrhea

Keywords

Primary dysmenorrheaConnective tissue manipulation (CTM)Transcutaneous electrical nerve stimulation (TENS)Pain

Outcome Measures

Primary Outcomes (1)

  • Assessment of Pain Severity

    To determine the localization of pain, the participants were asked to point out and mark the place(s) they felt the most pain on a body diagram. The severity of the pain of dysmenorrhea was assessed on a 10-cm Visual Analog Scale (VAS).

    Change from Pain severity at 3 months

Secondary Outcomes (4)

  • Assessment of Sleep Disorders and Fatigue

    Change from Sleep Disorders and Fatigue severity at 3 months

  • Assessment of Depressive Symptoms

    Change from Beck Depression Inventory score at 3 months

  • Assessment of Anxiety

    Change from Beck Anxiety Inventory score at 3 months

  • Assessment of General Health Status

    Change from General Health Questionnaire score at 3 months

Study Arms (2)

Connective Tissue Manipulation

EXPERIMENTAL

The participants were administered CTM by a physiotherapist with 11 years of experience in the application from the point at which their menstrual cycles had ended to the beginning of the next cycle. Another assessment was made immediately after the treatment and this was repeated at the second, third and fourth menstrual cycles. The CTM took an average of 20-30 minutes to complete.

Other: Connective Tissue Manipulation

Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL

Following the assessment made in the participants' first menstrual cycle, on the most painful day of their second cycle (1st or 2nd day of the cycle), high-frequency TENS was applied at a frequency of 120 Hertz, at intervals of 100 µsn for 20 minutes. The intensity of the current was increased until the participant felt it.

Other: Transcutaneous Electrical Nerve Stimulation

Interventions

Connective Tissue ManipulationOTHER

The application was delivered with the participant in a sitting position, with the entire back and sacral regions left exposed. The treatment was administered to the sacral, lower thoracic and pelvic regions.

Also known as: CTM
Connective Tissue Manipulation
Transcutaneous Electrical Nerve StimulationOTHER

TENS was administered with the participant lying face down with a flat cushion underneath the abdomen. TENS was administered via 2 channels of electrodes placed with the sacral region in the middle. The intensity of the current was increased until the participant felt it.

Also known as: TENS
Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenstrual cycle
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being between the ages of 18-30
  • having a diagnosis of primary dysmenorrhea

You may not qualify if:

  • having used an oral contraceptive in the last 3 months,
  • having an active sexual life,
  • pregnancy,
  • having gone through childbirth,
  • having a neurological deficit,
  • any kind of systemic condition,
  • a diagnosed gynecological condition (pelvic inflammatory diseases, endometriosis, uterus cancers, ovarian cysts, etc.),
  • taking psychotherapeutic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Nesrin Yağcı

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 22, 2020

Study Start

September 1, 2015

Primary Completion

March 15, 2016

Study Completion

August 30, 2016

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share