Women With Primary DysmenorrheaNCT04866355
Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea
A study testing Lumbar spine manipulation and Hyoscine and Ibuprofen in people with Women With Primary Dysmenorrhea, run by University of Alcala at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Women With Primary Dysmenorrhea
- What is being tested?
- Lumbar spine manipulation and Hyoscine and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Feb 2021to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presented with persistent primary dysmenorrhea lasting for three or more consecutive menstrual periods
- Presented menstrual cycles no longer than 35 days
Who cannot join
- Presented any other gynecological pathologies
- Systemic diseases
- Previous surgical interventions for gynecological complaints
- Depression
- Were receiving any other treatment for primary dysmenorrhea.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Short-term Effects of Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea: a Randomized Controlled Trial.
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.
- Conditions
- Women With Primary Dysmenorrhea
- Being tested
- Lumbar spine manipulation, Hyoscine and Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar spine manipulationOther
Lumbar spine manipulation
Hyoscine and IbuprofenDrug
hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spine manipulation | Experimental | Application of lumbar spine manipulation by a physical therapist. Receives: Other: Lumbar spine manipulation |
| Lumbar spine manipulation plus pharmacological therapy | Active comparator | Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy. Receives: Other: Lumbar spine manipulation; Drug: Hyoscine and Ibuprofen |
| Pharmacological therapy | Active comparator | Application of pharmacological therapy Receives: Drug: Hyoscine and Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity measured with a visual analogue scale
Measured: Change from baseline at 3 days
Secondary outcomes (4)
Pressure pain threshold measured in tibialis malleolus
Pressure pain threshold measured with an algometer in tibialis malleolus
Measured: Change from baseline at 3 days
Pressure pain threshold measured in peroneal malleolus
Pressure pain threshold measured with an algometer in peroneal malleolus
Measured: Change from baseline at 3 days
Low-back related disability
Low-back related disability measured with the Oswestry Disability Index
Measured: Change from baseline at 1 month
Anxiety and depression
Anxiety and depression measured with the Hospital Anxiety and Depression Scale
Measured: Change from baseline at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start28 Feb 2021
- Primary completion20 Jun 2021
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866355
- Sponsor's protocol ID
- 2111730
- Status last verified
- Nov 2022
- First submitted
- 23 Apr 2021
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04866355
- Acronym / sponsor ID
- 2111730
- Conditions
- Women With Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar spine manipulation | Experimental | Other: Lumbar spine manipulationApplication of lumbar spine manipulation by a physical therapist. |
| Lumbar spine manipulation plus pharmacological therapy | Active comparator | Other: Lumbar spine manipulation, Drug: Hyoscine and IbuprofenApplication of lumbar spine manipulation by a physical therapist along with pharmacological therapy. |
| Pharmacological therapy | Active comparator | Drug: Hyoscine and IbuprofenApplication of pharmacological therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presented with persistent primary dysmenorrhea lasting for three or more consecutive menstrual periods
- Presented menstrual cycles no longer than 35 days
Key exclusion criteria (5 listed)
- Presented any other gynecological pathologies
- Systemic diseases
- Previous surgical interventions for gynecological complaints
- Depression
- Were receiving any other treatment for primary dysmenorrhea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar spine manipulationLumbar spine manipulation | Other | Lumbar spine manipulation, Lumbar spine manipulation plus pharmacological therapy |
| Hyoscine and Ibuprofenhyoscine (20 mg) and ibuprofen (400 mg) administered by oral via. | Drug | Lumbar spine manipulation plus pharmacological therapy, Pharmacological therapy |
Primary outcome
Pain intensity
Time frame: Change from baseline at 3 days
Pain intensity measured with a visual analogue scale
4 secondary outcomes
Pressure pain threshold measured in tibialis malleolus
Time frame: Change from baseline at 3 days
Pressure pain threshold measured in peroneal malleolus
Time frame: Change from baseline at 3 days
Low-back related disability
Time frame: Change from baseline at 1 month
Anxiety and depression
Time frame: Change from baseline at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar spine manipulation and Hyoscine and Ibuprofen in people with Women With Primary Dysmenorrhea, run by University of Alcala at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Change from baseline at 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.