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

Study Overview
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Brief Summary
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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.

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

Conditions
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Women With Primary Dysmenorrhea

Intervention / Treatment
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* Other: Lumbar spine manipulation
* Drug: Hyoscine and Ibuprofen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar spine manipulation<br>Application of lumbar spine manipulation by a physical therapist. | Other: Lumbar spine manipulation<br>* Lumbar spine manipulation<br>|
| Active Comparator: Lumbar spine manipulation plus pharmacological therapy<br>Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy. | Other: Lumbar spine manipulation<br>* Lumbar spine manipulation<br>Drug: Hyoscine and Ibuprofen<br>* hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.<br>|
| Active Comparator: Pharmacological therapy<br>Application of pharmacological therapy | Drug: Hyoscine and Ibuprofen<br>* hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity measured with a visual analogue scale | Change from baseline at 3 days | 

Secondary Outcome Measures

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