Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea

NCT ID: NCT04866355

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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Women With Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lumbar spine manipulation

Application of lumbar spine manipulation by a physical therapist.

Group Type EXPERIMENTAL

Lumbar spine manipulation

Intervention Type OTHER

Lumbar spine manipulation

Lumbar spine manipulation plus pharmacological therapy

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

Group Type ACTIVE_COMPARATOR

Lumbar spine manipulation

Intervention Type OTHER

Lumbar spine manipulation

Hyoscine and Ibuprofen

Intervention Type DRUG

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

Pharmacological therapy

Application of pharmacological therapy

Group Type ACTIVE_COMPARATOR

Hyoscine and Ibuprofen

Intervention Type DRUG

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

Interventions

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Lumbar spine manipulation

Lumbar spine manipulation

Intervention Type OTHER

Hyoscine and Ibuprofen

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Presented any other gynecological pathologies
* Systemic diseases
* Previous surgical interventions for gynecological complaints
* Depression
* Were receiving any other treatment for primary dysmenorrhea.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Daniel Pecos Martín

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adelina Jazmin Castillo-Sanchez

Puebla City, , Mexico

Site Status

Ruben Fernandez-Matias

Alcalá de Henares, , Spain

Site Status

Countries

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Mexico Spain

Other Identifiers

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2111730

Identifier Type: -

Identifier Source: org_study_id

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