Calf Cramps During PregnancyNCT05281289
Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy
A study testing kinesio-tape, stretching exercise and instructions about dealing with calf cramps in people with Calf Cramps During Pregnancy, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Calf Cramps During Pregnancy
- What is being tested?
- kinesio-tape, stretching exercise and instructions about dealing with calf cramps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2021to 1 Apr 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women who are suffering from calf cramps.
- Their age range from 25 to 35 years.
- Their body mass index range from 25 to 29.9 kg/m2 .
Who cannot join
- Skin abnormalities (skin malignancy in the treated area or burned).
- History of previous back surgery.
- Neuromuscular diseases like multiple sclerosis.
- Sensory disturbances.
- Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolisthesis or spinal stenosis.
- Systemic disease of musculoskeletal system.
- Viscerogenic cause of back pain.
- Also, women who have eclampsia or pre-eclampsia.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy
Read the detailed description
Up to 30% to 50% of pregnant women suffered from leg cramps, especially in the third trimester. Almost two-thirds of these women experience leg cramps twice per week and they can occur at any time, particularly at night.In mild and moderate cases, calf cramps may last for seconds, but in severe cases, leg cramps in pregnancy may last for minutes .In many cases calf cramps are very painful , which can affect daily activities, restrict exercise and performance, motive sleep disturbance and reduce the quality of life.Non-drug treatments are found to being effective for the treatment of muscle cramps. Non-drug treatments such as muscle stretching, physical exercise, avoidance of physical fatigue, massage, relaxation, heat therapy, weight loss, sensory nerve stimulation, ankle splints worn while sleeping, and changes to sleeping and sitting positions.This study has two groups; one recieved kinesio-tape application and stretching exercises and the second one recieved instructions about dealing with cramps with self low sustained stretch
- Conditions
- Calf Cramps During Pregnancy
- Being tested
- kinesio-tape, stretching exercise, instructions about dealing with calf cramps
- Keywords
- kinesio-tape,stretching exercises, calf cramps, pregnants, cramp questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio-tapeOther
KT is comprised of a polymer elastic strand warped by 100% cotton fibers and designed to allow a longitudinal stretch of 55-60% of its resting length.
stretching exerciseOther
15 seconds of passive stretching exercise for calf muscle followed by 30 seconds of rest
instructions about dealing with calf crampsOther
instructions about dealing with calf cramps by self low sustained stretch of calf muscle
| Study group | Role | What they receive |
|---|---|---|
| Kinesio-tape application+stretchinge exercises | Experimental | the patient received A"Ystrip"of KT was applied to the testing leg 30% tension for 48h and was asked to assume comfortable supine position and the therapist applied 15 seconds of passive stretch to the calf muscle followed by 30 seconds of rest and this exercise was repeated 6 times per session for 2 days and ecieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle. Receives: Other: kinesio-tape; Other: stretching exercise; Other: instructions about dealing with calf cramps |
| self low sustained strestch | Experimental | the patient recieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle. Receives: Other: instructions about dealing with calf cramps |
What is being measured
The primary outcome is the main question the study is designed to answer.
calf pain intensity
cramp VAS is used to measure pain intensity
Measured: 2days
Secondary outcomes (2)
weight bearing ankle dorsiflexion ROM
weight bearing ankle dorsiflexion ROM is measured by digital inclinometer
Measured: 2days
straight leg raising ROM
straight leg raising ROM is measured by digital inclinometer
Measured: 2days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start20 Mar 2021
- Primary completion30 Nov 2021
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calf Cramps During PregnancyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281289
- Sponsor's protocol ID
- 012/003151
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy
- ClinicalTrials.gov ID
- NCT05281289
- Acronym / sponsor ID
- 012/003151
- Conditions
- Calf Cramps During Pregnancy
- Keywords
- kinesio-tape,stretching exercises, calf cramps, pregnants, cramp questionnaire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 16 Mar 2022 (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 is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy
Detailed description
Up to 30% to 50% of pregnant women suffered from leg cramps, especially in the third trimester. Almost two-thirds of these women experience leg cramps twice per week and they can occur at any time, particularly at night.In mild and moderate cases, calf cramps may last for seconds, but in severe cases, leg cramps in pregnancy may last for minutes .In many cases calf cramps are very painful , which can affect daily activities, restrict exercise and performance, motive sleep disturbance and reduce the quality of life.Non-drug treatments are found to being effective for the treatment of muscle cramps. Non-drug treatments such as muscle stretching, physical exercise, avoidance of physical fatigue, massage, relaxation, heat therapy, weight loss, sensory nerve stimulation, ankle splints worn while sleeping, and changes to sleeping and sitting positions.This study has two groups; one recieved kinesio-tape application and stretching exercises and the second one recieved instructions about dealing with cramps with self low sustained stretch
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio-tape application+stretchinge exercises | Experimental | Other: kinesio-tape, Other: stretching exercise, Other: instructions about dealing with calf crampsthe patient received A"Ystrip"of KT was applied to the testing leg 30% tension for 48h and was asked to assume comfortable supine position and the therapist applied 15 seconds of passive stretch to the calf muscle followed by 30 seconds of rest and this exercise was repeated 6 times per session for 2 days and ecieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle. |
| self low sustained strestch | Experimental | Other: instructions about dealing with calf crampsthe patient recieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant women who are suffering from calf cramps.
- Their age range from 25 to 35 years.
- Their body mass index range from 25 to 29.9 kg/m2 .
Key exclusion criteria (8 listed)
- Skin abnormalities (skin malignancy in the treated area or burned).
- History of previous back surgery.
- Neuromuscular diseases like multiple sclerosis.
- Sensory disturbances.
- Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolisthesis or spinal stenosis.
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 |
|---|---|---|
| kinesio-tapeKT is comprised of a polymer elastic strand warped by 100% cotton fibers and designed to allow a longitudinal stretch of 55-60% of its resting length. | Other | Kinesio-tape application+stretchinge exercises |
| stretching exercise15 seconds of passive stretching exercise for calf muscle followed by 30 seconds of rest | Other | Kinesio-tape application+stretchinge exercises |
| instructions about dealing with calf crampsinstructions about dealing with calf cramps by self low sustained stretch of calf muscle | Other | Kinesio-tape application+stretchinge exercises, self low sustained strestch |
Primary outcome
calf pain intensity
Time frame: 2days
cramp VAS is used to measure pain intensity
2 secondary outcomes
weight bearing ankle dorsiflexion ROM
Time frame: 2days
straight leg raising ROM
Time frame: 2days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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 kinesio-tape, stretching exercise and instructions about dealing with calf cramps in people with Calf Cramps During Pregnancy, 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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?
Results are not available in the source record.
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?
calf pain intensity (time frame: 2days). 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 16 Mar 2022.