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

Not Applicable

Completed

• Conditions: Women With Primary Dysmenorrhea
• Interventions: Other: Lumbar spine manipulation; Drug: Hyoscine and Ibuprofen

• Registration Number: NCT04866355
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-28
• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Primary Completion: 2021-06-20
• Status Verified: 2022-11
• Study Completion: 2022-11-10
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar spine manipulation plus pharmacological therapy	Hyoscine and Ibuprofen	Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.
Lumbar spine manipulation	Lumbar spine manipulation	Application of lumbar spine manipulation by a physical therapist.
Pharmacological therapy	Hyoscine and Ibuprofen	Application of pharmacological therapy
Lumbar spine manipulation plus pharmacological therapy	Lumbar spine manipulation	Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.

Primary Outcome Measures

Name	Time	Method
Pain intensity	Change from baseline at 3 days	Pain intensity measured with a visual analogue scale

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Adelina Jazmin Castillo-Sanchez; 🇲🇽 Puebla, Mexico

Ruben Fernandez-Matias; 🇪🇸 Alcalá De Henares, Spain