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NCT Number: NCT06573515

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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

High Tone Power Therapy

Device

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 therapy

Device

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 therapy

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Heba ahmed haridy, doctoral

CONTACT

[email protected]

01117671712

Menna mohmed, doctoral

CONTACT

[email protected]

01118758578

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Effectiveness of High Tone Power Therapy Versus Interferential Current Therapy in Mothers With Breastfeeding-Related Neck Pain

Acronym: BFRNP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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