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Clinical Trials/NCT06573515
NCT06573515RecruitingNot Applicable

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

October 6 University1 site in 1 country45 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
45
Locations
1
Primary Endpoint
Visual analogue scale

Study Overview

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

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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/m
  • •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.

Arms & Interventions

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

Intervention: conventional physical therapy (Device)

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

Intervention: high tone power therapy (Device)

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

Intervention: interferential current therapy (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

heba Haridy

lecturer of basic science department

October 6 University

Study Sites (1)

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