Leg Cramps in Pregnant WomenNCT07683494
Kinesiotape Versus Compression Stockings on Pregnant Leg Cramps and Sleep Quality
A study testing Kinesiotape group and Compression stockings group in people with Leg Cramps in Pregnant Women, run by Kafrelsheikh University at 2 sites in Egypt.
Trial summary
Kinesiotape versus compression stockings on pregnant leg cramps and sleep quality Read more about this study
- Who is it for?
- Ages 25 to 35 weeks, women only
- Conditions the study is for
- Leg Cramps in Pregnant Women
- What is being tested?
- Kinesiotape group and Compression stockings group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 35 weeks
- Women only
- No healthy volunteers
- Child
Who may be able to join
- -Pregnant female suffering from calf cramps. 2-Their ages range from 25to 35 years. 3-Their body mass index ranges from 25 to 29.9kg/m2. 4-Pregnant female in the second or third trimester.
Who cannot join
- Skin abnormalities [malignancy or burn in the treated area]. 2-History of previous back surgery. 3-Present of any neuromuscular disease [like multiple sclerosis]. 4-Sensory disturbances. 5-Evidence of previous vertebral fractures or spinal structural abnormalities. 6-Women who have eclampsia or pre-eclampsia. 7-History of edema, thrombosis, venous thrombosis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Elnasria medical centre
Samannoud, Elgharbia
Noha Fathy Khalifa, Bachelor, 021558281224, nohapt44@gmail.com
Elnasria medical centre
Samanonud, Elgharbia
Noha Fathy Khalifa, Bachelor, 0201558281224, nohapt44@gmail.com
About this study
Official title: Effect of Kinesiotape Versus Compression Stockings on Leg Cramps and Sleep Quality in Pregnant Women :A Randomized Controlled Trial
Kinesiotape versus compression stockings on pregnant leg cramps and sleep quality
Read the detailed description
Effect of kinesiotape versus compression stockings on leg cramps and sleep quality in pregnant women A Randomized controlled trial
- Conditions
- Leg Cramps in Pregnant Women
- Being tested
- Control group, Kinesiotape group, Compression stockings group
- Keywords
- Leg cramps in pregnant women, Kinesiotape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Receive instructions about dealing with leg cramps at bedtime as sustained stretch,massage and optimal sleeping position
Kinesiotape groupOther
Application of kinesiology tape to the lower leg muscles for 48 hours, applied twice a week for 4 weeks, in addition to standard instructions for managing leg cramps at bedtime
Compression stockings groupOther
Use of graduated compression stockings worn daily for a period of 4 weeks, in addition to standard instructions for managing leg cramps at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control group receive instructions about dealing with leg cramps at bedtime Receives: Other: Control group |
| Kinesiotape group | Experimental | Application of kinesiology tape to the lower leg muscles for 48 hours, applied twice a week for 4 weeks, in addition to standard instructions for managing leg cramps at bedtime Receives: Other: Control group; Other: Kinesiotape group |
| Compression stockings group | Experimental | Use of graduated compression stockings worn daily for a period of 4 weeks, in addition to standard instructions for managing leg cramps at bedtime. Receives: Other: Control group; Other: Compression stockings group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle cramp characteristics measured using The Cramp Questionnaire
Change in leg cramp frequency assessed using the Leg Cramp Questionnaire. Higher scores indicate greater cramp frequency.
Measured: Baseline and after4weeks
Leg cramp pain intensty measured using visual analogue scale
Pain intensity using visual analogue scale 0=no pain,10=wirst pain
Measured: Baseline and after4weeks
Secondary outcomes (2)
Sleep quality measured using sleep quality index
Sleep quality assesed using the Pittsburgh sleep quality index score range 0-21 higher score means poor sleep quality
Measured: Baseline and after4weeks
Quality of life measured using 12-item short form health survey
Health related quality of life assesed using the SF-12questionnaire.higher score indicates better health status
Measured: Baseline and after4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Cramps in Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha fathy abdelhamid khalifa, Kafrelsheikh University
- Investigators
- Noha Fathy khalifa, Bachelor, Principal investigator, Faculty of physical therapy kafrelsheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683494
- Sponsor's protocol ID
- KFSIRB200-1065
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participants data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotape Versus Compression Stockings on Leg Cramps and Sleep Quality in Pregnant Women :A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07683494
- Acronym / sponsor ID
- KFSIRB200-1065
- Conditions
- Leg Cramps in Pregnant Women
- Keywords
- Leg cramps in pregnant women, Kinesiotape
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (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.
Kinesiotape versus compression stockings on pregnant leg cramps and sleep quality
Detailed description
Effect of kinesiotape versus compression stockings on leg cramps and sleep quality in pregnant women A Randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control groupControl group receive instructions about dealing with leg cramps at bedtime |
| Kinesiotape group | Experimental | Other: Control group, Other: Kinesiotape groupApplication of kinesiology tape to the lower leg muscles for 48 hours, applied twice a week for 4 weeks, in addition to standard instructions for managing leg cramps at bedtime |
| Compression stockings group | Experimental | Other: Control group, Other: Compression stockings groupUse of graduated compression stockings worn daily for a period of 4 weeks, in addition to standard instructions for managing leg cramps at bedtime. |
Who may qualify
- Ages
- 25 to 35 weeks
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Pregnant female suffering from calf cramps. 2-Their ages range from 25to 35 years. 3-Their body mass index ranges from 25 to 29.9kg/m2. 4-Pregnant female in the second or third trimester.
Key exclusion criteria (1 listed)
- Skin abnormalities [malignancy or burn in the treated area]. 2-History of previous back surgery. 3-Present of any neuromuscular disease [like multiple sclerosis]. 4-Sensory disturbances. 5-Evidence of previous vertebral fractures or spinal structural abnormalities. 6-Women who have eclampsia or pre-eclampsia. 7-History of edema, thrombosis, venous thrombosis.
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 |
|---|---|---|
| Control groupReceive instructions about dealing with leg cramps at bedtime as sustained stretch,massage and optimal sleeping position | Other | Compression stockings group, Control, Kinesiotape group |
| Kinesiotape groupApplication of kinesiology tape to the lower leg muscles for 48 hours, applied twice a week for 4 weeks, in addition to standard instructions for managing leg cramps at bedtime | Other | Kinesiotape group |
| Compression stockings groupUse of graduated compression stockings worn daily for a period of 4 weeks, in addition to standard instructions for managing leg cramps at bedtime. | Other | Compression stockings group |
Primary outcome
Muscle cramp characteristics measured using The Cramp Questionnaire
Time frame: Baseline and after4weeks
Change in leg cramp frequency assessed using the Leg Cramp Questionnaire. Higher scores indicate greater cramp frequency.
Leg cramp pain intensty measured using visual analogue scale
Time frame: Baseline and after4weeks
Pain intensity using visual analogue scale 0=no pain,10=wirst pain
2 secondary outcomes
Sleep quality measured using sleep quality index
Time frame: Baseline and after4weeks
Quality of life measured using 12-item short form health survey
Time frame: Baseline and after4weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. Individual participants data will not be shared
Related trials for Leg Cramps in Pregnant Women
Not yet recruiting
Weighted Blanket in Pregnancy
Leg Cramps, Nocturnal, Poor Sleep Quality
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.
Noha Fathy khalifa, Bachelor principal investigator
Faculty of physical therapy kafrelsheikh university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape group and Compression stockings group in people with Leg Cramps in Pregnant Women, run by Kafrelsheikh University at 2 sites 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Fathy Khalifa, Bachelor (0201558281224, nohapt44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle cramp characteristics measured using The Cramp Questionnaire (time frame: Baseline and after4weeks). The study lists 2 primary outcomes in all. 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 6 Jul 2026.