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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04866355
Enrollment
42
Registered
2021-04-29
Start date
2021-02-28
Completion date
2022-11-10
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women With Primary Dysmenorrhea

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.

Interventions

Lumbar spine manipulation

DRUGHyoscine and Ibuprofen

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

Sponsors

University of Alcala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityChange from baseline at 3 daysPain intensity measured with a visual analogue scale

Secondary

MeasureTime frameDescription
Pressure pain threshold measured in tibialis malleolusChange from baseline at 3 daysPressure pain threshold measured with an algometer in tibialis malleolus
Pressure pain threshold measured in peroneal malleolusChange from baseline at 3 daysPressure pain threshold measured with an algometer in peroneal malleolus
Low-back related disabilityChange from baseline at 1 monthLow-back related disability measured with the Oswestry Disability Index
Anxiety and depressionChange from baseline at 1 monthAnxiety and depression measured with the Hospital Anxiety and Depression Scale

Countries

Mexico, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026