BreastfeedingBFRNPNCT06573515
High Tone Power Therapy Versus Interferential Current Therapy in Mothers With Breastfeeding-Related Neck Pain
A study testing high tone power therapy, interferential current therapy and conventional physical therapy in people with Breastfeeding, run by October 6 University at 1 site in Egypt.
Trial summary
Breastfeeding is very essential for the growth and development of an infant. World Health Organization recommends exclusive breastfeeding of the baby for the first six months. Duration of breastfeeding ranges from 15-20 minutes and is done after every 2-3 hours. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- high tone power therapy, interferential current therapy and conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All mothers are medically stable.
- All mothers are primiparous and currently breastfeed their infants.
- All mothers will be exclusive breastfeeding mothers.
- Their ages will be 18-35 years old.
- Their body mass index will be 18.5 to 24.9 kg/m2.
- All mothers will provide an informed consent form agreeing to participate and publication of the study results.
Who cannot join
- Mothers who were pregnant and nursing with known orthopedic and neurological conditions of the spine, upper limbs and shoulder regions prior to breastfeeding.
- Mothers had cesarean delivery.
- Mothers with cerebrovascular problems, or any disorder affect the goal of the study.
- Mothers with preterm babies, low-birth weight babies, intrauterine growth restriction, with chronic diseases like cancer, human immuno-deficiency virus (HIV), tuberculosis and with postpartum complications like postpartum hemorrhage and eclampsia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Heba
Cairo
Heba ahmed, 01117671712, Heba.Ahmed.PT@o6u.edu.eg
menna Abass, 01202299885, PT@o6u.edu.eg
About this study
Official title: Effectiveness of High Tone Power Therapy Versus Interferential Current Therapy in Mothers With Breastfeeding-Related Neck Pain
Breastfeeding is very essential for the growth and development of an infant. World Health Organization recommends exclusive breastfeeding of the baby for the first six months. Duration of breastfeeding ranges from 15-20 minutes and is done after every 2-3 hours. The frequency of breastfeeding is approximately 8-12 times a day. So collectively 5-6 hours in an entire day are spent while feeding the baby. Breastfeeding mothers encounter various musculoskeletal problems. These problems arise due to the inappropriate positions acquired during breastfeeding the baby. Since these positions are maintained for longer durations, they can lead to long-term postural deformities by altering the normal curvature of spine. Moreover hormonal changes of pregnancy may last from 12 weeks postpartum to 6 months postpartum. All these changes will have a long-lasting effect while performing activities of daily living, hampering baby care and self-care (Dandekar et al., 2022). In addition to breast soreness, engorgement, maternal illness, blocked ducts, and mastitis, breastfeeding-related neck pain has a high prevalence among nursing women. It is commonly associated with the adoption of awkward postures during feeding sessions. One of the most common awkward positions adopted by nursing mothers is unsupported head/neck posture, resulting in sustained neck flexion to monitor the infant during feeding. Such a sustained awkward position with excessive repetition usually puts stress on the neck and back muscles
Read the detailed description
High tone power therapy is a new application with unique characteristics of electrotherapy and its main effects for the body are entering energy into the body to revitalize the body to affect and stimulate cells and inducing a resonance effect that makes vibration or an oscillation in the tissues and cells to relieve pain, enhance metabolism and distributing the pain mediators and inflammation, waste substances and nutrients; thus normalizing the cell and organizing metabolism and nerve regeneration The application of the high tone power therapy proved to be a very effective treatment that improved the extent of cervical spine mobility with significant pain alleviation in patients with cervical pain Interferential current therapy is a safe physical therapy method that has been used for many years in the treatment of musculoskeletal system disorders. It has analgesic, anti-inflammatory, sympatholytic, local vasodilatory, and muscle stimulatory actions. It shows significant analgesic effects in patients with neck pain
- Conditions
- Breastfeeding
- Being tested
- high tone power therapy, interferential current therapy, conventional physical therapy
- Keywords
- Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tone power therapyDevice
female patients will receive high-tone power therapy using a device (HiTop 191 Medizintechnik, Rimbach, Germany) duration 30 minutes at 2 sessions per week for 6 weeks
interferential current therapyDevice
female patients will receive interferential current therapy using Enraf-Nonius (ENDOMED 484, Germany)The electrode pairs will placed at a distance of at least 2.5 cm from each other. The utilized parameters will have a base frequency of 4,000 Hz, a modulation frequency range of 10 Hz-20 Hz, spectrum mode triangular, and slope 1/1 in a quadripolar manner with a beat frequency of 80 Hz. duration of treatment session 20 minutes 2 sessions per week for 6 weeks
conventional physical therapyDevice
female patients will receive conventional physical therapy modalities in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| high-tone power therapy group | Experimental | fifteen female patients will receive high-tone power therapy with conventional physical therapy modalities in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks Receives: Device: high tone power therapy |
| interferential current therapy group | Experimental | fifteen female patients will receive interferential current therapy with conventional physical therapy modalities in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks Receives: Device: interferential current therapy |
| conventional physical therapy group | Experimental | fifteen female patients will receive conventional physical therapy modalities only in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks Receives: Device: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
The visual analogue scale, a calibrated scale on which the patients could indicate their assessment along a 10 cm line, describes the subjective pain level. It is marked from 0 to 10, with 0 representing no pain and 10 standing for unbearable pain
Measured: 6 weeks
Neck disability index
The Neck disability index will assess functional restriction for all patients before and after the treatment. The Neck disability index will developed to measure self-perceived disability from neck pain.
It is a 10-item scaled questionnaire entitled the neck disability index, each item will recorded out of five for a maximum total score of 50 and a higher score indicates more patient-rated disability
Measured: 6 weeks
Cervical range of motion device
The cervical range of motion device is made of an unbreakable polyester material; it has a comfortable frame that adjusts to the patient's head is secured with Velcro straps and has three planes. The sagittal plane meter measures flexion and extension, while the lateral plane meter measures lateral flexion; both are fluid-damped inclinometers and work by the force of gravity as the position of the head changes. The magnetic plane meter measures rotational movement in conjugation with a magnetic yoke
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba Haridy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573515
- Sponsor's protocol ID
- 0001111
- Acronym
- BFRNP
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Tone Power Therapy Versus Interferential Current Therapy in Mothers With Breastfeeding-Related Neck Pain
- ClinicalTrials.gov ID
- NCT06573515
- Acronym / sponsor ID
- BFRNP / 0001111
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
Breastfeeding is very essential for the growth and development of an infant. World Health Organization recommends exclusive breastfeeding of the baby for the first six months. Duration of breastfeeding ranges from 15-20 minutes and is done after every 2-3 hours. The frequency of breastfeeding is approximately 8-12 times a day. So collectively 5-6 hours in an entire day are spent while feeding the baby. Breastfeeding mothers encounter various musculoskeletal problems. These problems arise due to the inappropriate positions acquired during breastfeeding the baby. Since these positions are maintained for longer durations, they can lead to long-term postural deformities by altering the normal curvature of spine. Moreover hormonal changes of pregnancy may last from 12 weeks postpartum to 6 months postpartum. All these changes will have a long-lasting effect while performing activities of daily living, hampering baby care and self-care (Dandekar et al., 2022). In addition to breast soreness, engorgement, maternal illness, blocked ducts, and mastitis, breastfeeding-related neck pain has a high prevalence among nursing women. It is commonly associated with the adoption of awkward postures during feeding sessions. One of the most common awkward positions adopted by nursing mothers is unsupported head/neck posture, resulting in sustained neck flexion to monitor the infant during feeding. Such a sustained awkward position with excessive repetition usually puts stress on the neck and back muscles
Detailed description
High tone power therapy is a new application with unique characteristics of electrotherapy and its main effects for the body are entering energy into the body to revitalize the body to affect and stimulate cells and inducing a resonance effect that makes vibration or an oscillation in the tissues and cells to relieve pain, enhance metabolism and distributing the pain mediators and inflammation, waste substances and nutrients; thus normalizing the cell and organizing metabolism and nerve regeneration The application of the high tone power therapy proved to be a very effective treatment that improved the extent of cervical spine mobility with significant pain alleviation in patients with cervical pain Interferential current therapy is a safe physical therapy method that has been used for many years in the treatment of musculoskeletal system disorders. It has analgesic, anti-inflammatory, sympatholytic, local vasodilatory, and muscle stimulatory actions. It shows significant analgesic effects in patients with neck pain
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-tone power therapy group | Experimental | Device: high tone power therapyfifteen female patients will receive high-tone power therapy with conventional physical therapy modalities in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks |
| interferential current therapy group | Experimental | Device: interferential current therapyfifteen female patients will receive interferential current therapy with conventional physical therapy modalities in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks |
| conventional physical therapy group | Experimental | Device: conventional physical therapyfifteen female patients will receive conventional physical therapy modalities only in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All mothers are medically stable.
- All mothers are primiparous and currently breastfeed their infants.
- All mothers will be exclusive breastfeeding mothers.
- Their ages will be 18-35 years old.
- Their body mass index will be 18.5 to 24.9 kg/m2.
Key exclusion criteria (4 listed)
- Mothers who were pregnant and nursing with known orthopedic and neurological conditions of the spine, upper limbs and shoulder regions prior to breastfeeding.
- Mothers had cesarean delivery.
- Mothers with cerebrovascular problems, or any disorder affect the goal of the study.
- Mothers with preterm babies, low-birth weight babies, intrauterine growth restriction, with chronic diseases like cancer, human immuno-deficiency virus (HIV), tuberculosis and with postpartum complications like postpartum hemorrhage and eclampsia.
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 |
|---|---|---|
| high tone power therapyfemale patients will receive high-tone power therapy using a device (HiTop 191 Medizintechnik, Rimbach, Germany) duration 30 minutes at 2 sessions per week for 6 weeks | Device | high-tone power therapy group |
| interferential current therapyfemale patients will receive interferential current therapy using Enraf-Nonius (ENDOMED 484, Germany)The electrode pairs will placed at a distance of at least 2.5 cm from each other. The utilized parameters will have a base frequency of 4,000 Hz, a modulation frequency range of 10 Hz-20 Hz, spectrum mode triangular, and slope 1/1 in a quadripolar manner with a beat frequency of 80 Hz. duration of treatment session 20 minutes 2 sessions per week for 6 weeks | Device | interferential current therapy group |
| conventional physical therapyfemale patients will receive conventional physical therapy modalities in the form of (ultrasound, massage, stretching, and strengthening exercises) 2 sessions per week for 6 weeks | Device | conventional physical therapy group |
Primary outcome
Visual analogue scale
Time frame: 6 weeks
The visual analogue scale, a calibrated scale on which the patients could indicate their assessment along a 10 cm line, describes the subjective pain level. It is marked from 0 to 10, with 0 representing no pain and 10 standing for unbearable pain
Neck disability index
Time frame: 6 weeks
The Neck disability index will assess functional restriction for all patients before and after the treatment. The Neck disability index will developed to measure self-perceived disability from neck pain. It is a 10-item scaled questionnaire entitled the neck disability index, each item will recorded out of five for a maximum total score of 50 and a higher score indicates more patient-rated disability
Cervical range of motion device
Time frame: 6 weeks
The cervical range of motion device is made of an unbreakable polyester material; it has a comfortable frame that adjusts to the patient's head is secured with Velcro straps and has three planes. The sagittal plane meter measures flexion and extension, while the lateral plane meter measures lateral flexion; both are fluid-damped inclinometers and work by the force of gravity as the position of the head changes. The magnetic plane meter measures rotational movement in conjugation with a magnetic yoke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tone power therapy, interferential current therapy and conventional physical therapy in people with Breastfeeding, run by October 6 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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?
Contact Heba ahmed haridy, doctoral (01117671712, Heba.Ahmed.PT@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 6 weeks). The study lists 3 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 27 Aug 2024.