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

November 17, 2022 updated by: Prof. Dr. Daniel Pecos Martín, University of Alcala

Short-term Effects of Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea: a Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72000
        • Adelina Jazmin Castillo-Sanchez
  • Spain
      • Alcalá De Henares, Spain, 28805
        • Rubén Fernández-Matías

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumbar spine manipulation
Application of lumbar spine manipulation by a physical therapist.
Other: Lumbar spine manipulation
Lumbar spine manipulation
Active Comparator: Lumbar spine manipulation plus pharmacological therapy
Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.
Other: Lumbar spine manipulation
Lumbar spine manipulation
Drug: Hyoscine and Ibuprofen
hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.
Active Comparator: Pharmacological therapy
Application of pharmacological therapy
Drug: Hyoscine and Ibuprofen
hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Change from baseline at 3 days
Pain intensity measured with a visual analogue scale
Change from baseline at 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold measured in tibialis malleolus
Time Frame: Change from baseline at 3 days
Pressure pain threshold measured with an algometer in tibialis malleolus
Change from baseline at 3 days
Pressure pain threshold measured in peroneal malleolus
Time Frame: Change from baseline at 3 days
Pressure pain threshold measured with an algometer in peroneal malleolus
Change from baseline at 3 days
Low-back related disability
Time Frame: Change from baseline at 1 month
Low-back related disability measured with the Oswestry Disability Index
Change from baseline at 1 month
Anxiety and depression
Time Frame: Change from baseline at 1 month
Anxiety and depression measured with the Hospital Anxiety and Depression Scale
Change from baseline at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2021

Primary Completion (Actual)

June 20, 2021

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2111730

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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