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OpenTrials
Completed

NCT Number: NCT04866355

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

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.

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Key information

Conditions

Women With Primary Dysmenorrhea

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adelina Jazmin Castillo-Sanchez, Puebla City, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumbar Spine Manipulation

Other

Lumbar spine manipulation

Hyoscine and Ibuprofen

Drug

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

Primary outcomes

  1. Pain intensity

    Time frame: Change from baseline at 3 days

    Pain intensity measured with a visual analogue scale

Secondary outcomes

  1. 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

  2. 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

  3. Low-back related disability

    Time frame: Change from baseline at 1 month

    Low-back related disability measured with the Oswestry Disability Index

  4. Anxiety and depression

    Time frame: Change from baseline at 1 month

    Anxiety and depression measured with the Hospital Anxiety and Depression Scale

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 29, 2021
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.