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Clinical Trials/NCT04866355
NCT04866355
Completed
Not Applicable

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

University of Alcala2 sites in 2 countries42 target enrollmentFebruary 28, 2021

Overview

Phase
Not Applicable
Intervention
Lumbar spine manipulation
Conditions
Women With Primary Dysmenorrhea
Sponsor
University of Alcala
Enrollment
42
Locations
2
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2021
End Date
November 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Alcala
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Daniel Pecos Martín

Doctor

University of Alcala

Eligibility Criteria

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.

Arms & Interventions

Lumbar spine manipulation

Application of lumbar spine manipulation by a physical therapist.

Intervention: Lumbar spine manipulation

Lumbar spine manipulation plus pharmacological therapy

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

Intervention: Lumbar spine manipulation

Lumbar spine manipulation plus pharmacological therapy

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

Intervention: Hyoscine and Ibuprofen

Pharmacological therapy

Application of pharmacological therapy

Intervention: Hyoscine and Ibuprofen

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Change from baseline at 3 days

Pain intensity measured with a visual analogue scale

Secondary Outcomes

  • Pressure pain threshold measured in tibialis malleolus(Change from baseline at 3 days)
  • Low-back related disability(Change from baseline at 1 month)
  • Pressure pain threshold measured in peroneal malleolus(Change from baseline at 3 days)
  • Anxiety and depression(Change from baseline at 1 month)

Study Sites (2)

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