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

NCT06573515 | Recruiting

• 1 other identifier: 0001111
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Breastfeeding

Keywords

Breastfeeding

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  6 weeks

Study Arms (3)

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

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

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

Device: conventional physical therapy

Interventions

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

high-tone power therapy group

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

interferential current therapy group

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

conventional physical therapy group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Heba

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Heba ahmed haridy, doctoral

CONTACT

01117671712; Heba.Ahmed.PT@o6u.edu.eg

Menna mohmed, doctoral

CONTACT

01118758578; Mennamohmed.PT@o6u.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of basic science department

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 27, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

EG (1)