Primary DysmenorrheaNCT06051435
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea
A study testing lumbar proprioception training, Hot packs and Pelvic rocking exercise in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study will be to investigate the effect of lumbar proprioception training on primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 22 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- lumbar proprioception training, Hot packs and Pelvic rocking exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 30 Jun 2024
- 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 22 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All females will have moderate to severe primary dysmenorrhea (as determined by WaLIDD Scale).
- Their ages will range from 18 to 22 years old.
- All females will be virginal and non-smokers.
- Their BMI will be range from 20-25 kg/m2
- They have regular menstrual cycle with menstrual cycle length of 28-30 days.
- They have persistent primary dysmenorrhea of more than 6 months
Who cannot join
- They shouldn't have musculoskeletal or neurological disorders, chronic LBP or sacroiliac dysfunction, diabetes, pelvic pathology or any gynecological disease.
- They shouldn't experience a stressful event in the last 6 month.
- Attending regular exercise training in the last 6 months.
- Taking medications or vitamin and mineral supplements due to other medical conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lumbar Proprioception Training on Primary Dysmenorrhea: A Randomized Clinical Trial
the aim of this study will be to investigate the effect of lumbar proprioception training on primary dysmenorrhea.
Read the detailed description
Although previous studies reported the effect of physiotherapy practices through therapeutic exercises on primary dysmenorrhea as core muscles strengthening, core stability exercises, connective tissue massage and classical massage, relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga and Pilates. None of them have investigated the effect of lumbar proprioception training on primary dysmenorrhea. Therefore, this study will be the first one which aims to investigate the effect of lumbar proprioception training on primary dysmenorrhea. This trial will include 2 groups; group A composed of 20 females that will receive hot packs and pelvic rocking exercises for 4 weeks and group B also composed of 20 females that will receive hot packs and pelvic rocking exercises in addition to lumbar proprioception training for 4 weeks.
- Conditions
- Primary Dysmenorrhea
- Being tested
- lumbar proprioception training, Hot packs, Pelvic rocking exercise
- Keywords
- lumbar proprioception training, pelvic rocking exercises, primary dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar proprioception trainingOther
Also called lumbar proprioception exercises
- Sensorimotor training: Sensorimotor training and reconditioning of proprioceptive senses have recently been found to be helpful in increasing motor performance and coordination, muscle strength, sensorimotor abilities, increasing intermuscular control, and improving one's response to sensory information and muscle tone. Reconditioning of proprioceptive senses and sensorimotor training increases one's muscle adjustment ability, maximizes the sensory input in different parts of the body and aids in improving one's motor adjustment ability (Hwang et al ., 2013).
Position Exercise methods as Hollowing exercise: Participants will be asked to contract the abdominal muscles, raising the center of movement toward the navel in a quadruped position.
Hot packsOther
hot application in the form of hot packs on the lower abdomen and lower back for a total duration of 30 minutes, once per day, during the first two days of menstruation
Pelvic rocking exerciseOther
Pelvic rocking exercise
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | They will receive hot packs and pelvic rocking exercises for one menstrual cycle. Receives: Other: Hot packs; Other: Pelvic rocking exercise |
| Lumbar proprioception group | Experimental | They will receive the same lumbar proprioception training plus hot packs and pelvic rocking exercises for one menstrual cycle. Receives: Other: lumbar proprioception training; Other: Hot packs; Other: Pelvic rocking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of lumbar proprioception
It will be evaluated through Biodex system in both groups before and after treatment program through measuring the lumbar repositioning accuracy.
Measured: 4 weeks
Secondary outcomes (2)
Calculation of score of WaLIDD Scale
It will be used to identify dysmenorrhea severity in both groups before and after treatment program through measuring combination of manifestations: subjective (intensity/Wong-Baker, work ability) and objective (days of pain, location) for both groups.The total score of 0 indicates without dysmenorrhea; 1-4 indicates mild dysmenorrhea, 5-7 indicates moderate dysmenorrhea, 8-12 indicates severe dysmenorrhea (Teherán et al., 2018).
Measured: 4 weeks
lumbar curvature angle
it will be measured by Flexible ruler which is affected by the tilt of the pelvis, in both groups before and after treatment program.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Oct 2023
- Primary completion1 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Amel Mohamed Yousef, PhD, Study chair, Professor, Cairo universityHamada Ahmed Hamada, PhD, Study director, Assistant Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051435
- Sponsor's protocol ID
- P.T.REC/012/004410
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2023
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lumbar Proprioception Training on Primary Dysmenorrhea: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06051435
- Acronym / sponsor ID
- P.T.REC/012/004410
- Conditions
- Primary Dysmenorrhea
- Keywords
- lumbar proprioception training, pelvic rocking exercises, primary dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Sep 2023 (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.
the aim of this study will be to investigate the effect of lumbar proprioception training on primary dysmenorrhea.
Detailed description
Although previous studies reported the effect of physiotherapy practices through therapeutic exercises on primary dysmenorrhea as core muscles strengthening, core stability exercises, connective tissue massage and classical massage, relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga and Pilates. None of them have investigated the effect of lumbar proprioception training on primary dysmenorrhea. Therefore, this study will be the first one which aims to investigate the effect of lumbar proprioception training on primary dysmenorrhea. This trial will include 2 groups; group A composed of 20 females that will receive hot packs and pelvic rocking exercises for 4 weeks and group B also composed of 20 females that will receive hot packs and pelvic rocking exercises in addition to lumbar proprioception training for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Hot packs, Other: Pelvic rocking exerciseThey will receive hot packs and pelvic rocking exercises for one menstrual cycle. |
| Lumbar proprioception group | Experimental | Other: lumbar proprioception training, Other: Hot packs, Other: Pelvic rocking exerciseThey will receive the same lumbar proprioception training plus hot packs and pelvic rocking exercises for one menstrual cycle. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All females will have moderate to severe primary dysmenorrhea (as determined by WaLIDD Scale).
- Their ages will range from 18 to 22 years old.
- All females will be virginal and non-smokers.
- Their BMI will be range from 20-25 kg/m2
- They have regular menstrual cycle with menstrual cycle length of 28-30 days.
Key exclusion criteria (4 listed)
- They shouldn't have musculoskeletal or neurological disorders, chronic LBP or sacroiliac dysfunction, diabetes, pelvic pathology or any gynecological disease.
- They shouldn't experience a stressful event in the last 6 month.
- Attending regular exercise training in the last 6 months.
- Taking medications or vitamin and mineral supplements due to other medical conditions.
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 proprioception trainingAlso: lumbar proprioception exercisesa) Sensorimotor training: Sensorimotor training and reconditioning of proprioceptive senses have recently been found to be helpful in increasing motor performance and coordination, muscle strength, sensorimotor abilities, increasing intermuscular control, and improving one's response to sensory information and muscle tone. Reconditioning of proprioceptive senses and sensorimotor training increases one's muscle adjustment ability, maximizes the sensory input in different parts of the body and aids in improving one's motor adjustment ability (Hwang et al ., 2013). Position Exercise methods as Hollowing exercise: Participants will be asked to contract the abdominal muscles, raising the center of movement toward the navel in a quadruped position. | Other | Lumbar proprioception group |
| Hot packshot application in the form of hot packs on the lower abdomen and lower back for a total duration of 30 minutes, once per day, during the first two days of menstruation | Other | Control group, Lumbar proprioception group |
| Pelvic rocking exercisePelvic rocking exercise | Other | Control group, Lumbar proprioception group |
Primary outcome
Measurement of lumbar proprioception
Time frame: 4 weeks
It will be evaluated through Biodex system in both groups before and after treatment program through measuring the lumbar repositioning accuracy.
2 secondary outcomes
Calculation of score of WaLIDD Scale
Time frame: 4 weeks
lumbar curvature angle
Time frame: 4 weeks
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 22 Apr 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.
Amel Mohamed Yousef, PhD study chair
Professor, Cairo university
Hamada Ahmed Hamada, PhD study director
Assistant Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar proprioception training, Hot packs and Pelvic rocking exercise in people with Primary Dysmenorrhea, run by Cairo 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 6 inclusion and 4 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 22 Apr 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?
Measurement of lumbar proprioception (time frame: 4 weeks). 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 22 Apr 2025.