NCT04866355

Brief Summary

Many treatments like acupuncture, manipulative therapy and pharmacological therapy have been proposed to alleviate symptoms associated with dysmenorrhea. However, no study has previously compared lumbar spine manipulation to pharmacological therapy in the treatment of primary dysmenorrhea.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
2 countries

2 active sites

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

February 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

April 23, 2021

Last Update Submit

November 17, 2022

Conditions

Women With Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity measured with a visual analogue scale

    Change from baseline at 3 days

Secondary Outcomes (4)

  • Pressure pain threshold measured in tibialis malleolus

    Change from baseline at 3 days

  • Pressure pain threshold measured in peroneal malleolus

    Change from baseline at 3 days

  • Low-back related disability

    Change from baseline at 1 month

  • Anxiety and depression

    Change from baseline at 1 month

Study Arms (3)

Lumbar spine manipulation

EXPERIMENTAL

Application of lumbar spine manipulation by a physical therapist.

Other: Lumbar spine manipulation

Lumbar spine manipulation plus pharmacological therapy

ACTIVE COMPARATOR

Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.

Other: Lumbar spine manipulationDrug: Hyoscine and Ibuprofen

Pharmacological therapy

ACTIVE COMPARATOR

Application of pharmacological therapy

Drug: Hyoscine and Ibuprofen

Interventions

Lumbar spine manipulationOTHER

Lumbar spine manipulation

Lumbar spine manipulationLumbar spine manipulation plus pharmacological therapy
Hyoscine and IbuprofenDRUG

hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.

Lumbar spine manipulation plus pharmacological therapyPharmacological therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presented with persistent primary dysmenorrhea lasting for three or more consecutive menstrual periods
  • Presented menstrual cycles no longer than 35 days

You may not qualify if:

  • Presented any other gynecological pathologies
  • Systemic diseases
  • Previous surgical interventions for gynecological complaints
  • Depression
  • Were receiving any other treatment for primary dysmenorrhea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adelina Jazmin Castillo-Sanchez

Puebla City, 72000, Mexico

Location

Ruben Fernandez-Matias

Alcalá de Henares, 28805, Spain

Location

MeSH Terms

Interventions

ScopolamineIbuprofen

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 29, 2021

Study Start

February 28, 2021

Primary Completion

June 20, 2021

Study Completion

November 10, 2022

Last Updated

November 18, 2022

Record last verified: 2022-11

Locations

ME(1)ES(1)