DysmenorrheaNCT06762106
Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea
A study testing shockwave therapy and hot back in people with Dysmenorrhea and Back Pain Lower Back, run by Deraya University at 1 site in Egypt.
Trial summary
Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Back Pain Lower Back
- What is being tested?
- shockwave therapy and hot back
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 1 Jan 2025
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their ages ranged from 18 to 30 years.
- Their BMI were not exceeding 29 Kg/m2.
- All patients were clinically diagnosed as low back pain during Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guideline
Who cannot join
- Any known chronic disease (such as cardiovascular or renal diseases) or secondary dysmenorrhea.
- Being pregnant or planning to get pregnant any time during the trial.
- Having received other treatments for PD in the past half year.
- Irregular menstrual cycles.
- Mental or neurological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour
Read the detailed description
Dysmenorrhea is one of the most common gynecological conditions in women. Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour. It is accompanied by general symptoms, such as nausea and vomiting, malaise, weakness, lower backache, and diarrhea. In ovulatory cycles, women secrete high levels of or have increased sensitivity to prostaglandins. These prostaglandins may stimulate myometrial contractions and sensitize pain fibers, and thus induce pelvic pain.
Females of reproductive age often suffer from dysmenorrhea, a painful condition. Despite dysmenorrhea being generally considered a benign condition, a significant disability can result from it. Researchers suggest that dysmenorrhea has been linked to migraines, headaches, and fibromyalgia, among other painful disorders. The authors reported further evidence that dysmenorrhea can alter noxious sensory processing.
Primary dysmenorrhea usually begins six to 12 months after menarche and is characterized by spasmodic cramping pain in the lower abdomen that can radiate to the lower back and anterior or inner thighs. The pain usually has a clear temporal pattern: it begins a few hours before or at the start of menstruation, is most intense at onset, gradually waning over two to three days.
The purpose of this study was to investigate the effectiveness shockwave therapy on low back pain in primary dysmenorrhea.
- Conditions
- Dysmenorrhea, Back Pain Lower Back
- Being tested
- shockwave therapy, hot back
- Keywords
- dysmenorrhea, lower back pain, shock wave
- Medical subject headings
- Dysmenorrhea, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shockwave therapyRadiation
solid unite made with metal frame and case
hot backRadiation
thermal hot back
| Study group | Role | What they receive |
|---|---|---|
| Hot back group | Active comparator | 30 subjects were treated by hot back in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles Receives: Radiation: hot back |
| shock wave and hot back group | Experimental | 30 subjects were treated by hot back and shockwave therapy in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles Receives: Radiation: shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
VAS scoring method. 0 is the least while 10 is the highest
Measured: every month for three menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start10 Sep 2023
- Primary completion2 Mar 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762106
- Sponsor's protocol ID
- physio 12 24
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06762106
- Acronym / sponsor ID
- physio 12 24
- Conditions
- Dysmenorrhea, Back Pain Lower Back
- Keywords
- dysmenorrhea, lower back pain, shock wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 7 Jan 2025 (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.
Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour
Detailed description
Dysmenorrhea is one of the most common gynecological conditions in women. Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour. It is accompanied by general symptoms, such as nausea and vomiting, malaise, weakness, lower backache, and diarrhea. In ovulatory cycles, women secrete high levels of or have increased sensitivity to prostaglandins. These prostaglandins may stimulate myometrial contractions and sensitize pain fibers, and thus induce pelvic pain.
Females of reproductive age often suffer from dysmenorrhea, a painful condition. Despite dysmenorrhea being generally considered a benign condition, a significant disability can result from it. Researchers suggest that dysmenorrhea has been linked to migraines, headaches, and fibromyalgia, among other painful disorders. The authors reported further evidence that dysmenorrhea can alter noxious sensory processing.
Primary dysmenorrhea usually begins six to 12 months after menarche and is characterized by spasmodic cramping pain in the lower abdomen that can radiate to the lower back and anterior or inner thighs. The pain usually has a clear temporal pattern: it begins a few hours before or at the start of menstruation, is most intense at onset, gradually waning over two to three days.
The purpose of this study was to investigate the effectiveness shockwave therapy on low back pain in primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot back group | Active comparator | Radiation: hot back30 subjects were treated by hot back in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles |
| shock wave and hot back group | Experimental | Radiation: shockwave therapy30 subjects were treated by hot back and shockwave therapy in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Their ages ranged from 18 to 30 years.
- Their BMI were not exceeding 29 Kg/m2.
- All patients were clinically diagnosed as low back pain during Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guideline
Key exclusion criteria (5 listed)
- Any known chronic disease (such as cardiovascular or renal diseases) or secondary dysmenorrhea.
- Being pregnant or planning to get pregnant any time during the trial.
- Having received other treatments for PD in the past half year.
- Irregular menstrual cycles.
- Mental or neurological disorder
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 |
|---|---|---|
| shockwave therapysolid unite made with metal frame and case | Radiation | shock wave and hot back group |
| hot backthermal hot back | Radiation | Hot back group |
Primary outcome
Pain assessment
Time frame: every month for three menstrual cycle
VAS scoring method. 0 is the least while 10 is the highest
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 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shockwave therapy and hot back in people with Dysmenorrhea and Back Pain Lower Back, run by Deraya University at 1 site in Egypt.
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 3 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 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 assessment (time frame: every month for three menstrual cycle). 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 7 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.