Back to resultsLumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea
Primary Purpose
Women With Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lumbar spine manipulation
Hyoscine and Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Women With Primary Dysmenorrhea
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.
Sites / Locations
- Adelina Jazmin Castillo-Sanchez
- Ruben Fernandez-Matias
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Lumbar spine manipulation
Lumbar spine manipulation plus pharmacological therapy
Pharmacological therapy
Arm Description
Application of lumbar spine manipulation by a physical therapist.
Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.
Application of pharmacological therapy
Outcomes
Primary Outcome Measures
Pain intensity
Pain intensity measured with a visual analogue scale
Secondary Outcome Measures
Pressure pain threshold measured in tibialis malleolus
Pressure pain threshold measured with an algometer in tibialis malleolus
Pressure pain threshold measured in peroneal malleolus
Pressure pain threshold measured with an algometer in peroneal malleolus
Low-back related disability
Low-back related disability measured with the Oswestry Disability Index
Anxiety and depression
Anxiety and depression measured with the Hospital Anxiety and Depression Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04866355
Brief Title
Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea
Official Title
Short-term Effects of Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2021 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
November 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women With Primary Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumbar spine manipulation
Arm Type
Experimental
Arm Description
Application of lumbar spine manipulation by a physical therapist.
Arm Title
Lumbar spine manipulation plus pharmacological therapy
Arm Type
Active Comparator
Arm Description
Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.
Arm Title
Pharmacological therapy
Arm Type
Active Comparator
Arm Description
Application of pharmacological therapy
Intervention Type
Other
Intervention Name(s)
Lumbar spine manipulation
Intervention Description
Lumbar spine manipulation
Intervention Type
Drug
Intervention Name(s)
Hyoscine and Ibuprofen
Intervention Description
hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity measured with a visual analogue scale
Time Frame
Change from baseline at 3 days
Secondary Outcome Measure Information:
Title
Pressure pain threshold measured in tibialis malleolus
Description
Pressure pain threshold measured with an algometer in tibialis malleolus
Time Frame
Change from baseline at 3 days
Title
Pressure pain threshold measured in peroneal malleolus
Description
Pressure pain threshold measured with an algometer in peroneal malleolus
Time Frame
Change from baseline at 3 days
Title
Low-back related disability
Description
Low-back related disability measured with the Oswestry Disability Index
Time Frame
Change from baseline at 1 month
Title
Anxiety and depression
Description
Anxiety and depression measured with the Hospital Anxiety and Depression Scale
Time Frame
Change from baseline at 1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Adelina Jazmin Castillo-Sanchez
City
Puebla
ZIP/Postal Code
72000
Country
Mexico
Facility Name
Ruben Fernandez-Matias
City
Alcalá De Henares
ZIP/Postal Code
28805
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea
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