NCT04930575

Brief Summary

The purpose of this study will determine the effect of muscle energy technique versus mulligan technique on neck pain in breastfeeding women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 11, 2021

Last Update Submit

June 11, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessing the change in Cervical pain level

    Assessment via using Visual Analogue Scale that continuous data analysis and uses a 10 cm long with 0 (no pain) and 10 (worst pain). Patient will be asked to place a mark along the line to denote their level of pain.

    Baseline and 4 weeks post-intervention

  • Assessing the change in Functional disability

    Assessment via using Neck pain disability index questionnaire consists of 10 items each of them is scored from 0 to 5. The total maximum score is therefore 50.The original report provided scoring interval for interpretation, as; (0-4) = no disability, (5-14) mild, (15-24) moderate, (25-34) sever, (above34) complete disability.

    Baseline and 4 weeks post-intervention

  • Assessing the change in Cervical Range Of Motion

    Assessment via using Digital goniometer is valid and has good reliability for measuring cervical spine range of motion.

    Baseline and 4 weeks post-intervention

Study Arms (2)

Muscle Energy Technique group

EXPERIMENTAL

Patients in the group (B) will receive muscle energy technique on tonic muscles in the neck (sternocleidomastoid, scalenes, levator scapulae, and upper trapezius) in addition to strengthening exercise for deep cervical flexors and advice to correct positions three times per week for 4 weeks. The aim of the Muscle Energy Technique in the context of NP is to decrease pain, improve movement, motor control, and function and thereby reduce disability. A biomechanical correction approach can lead to the normalization of spinal curvatures and a decrease in the compressional and tensional stress on joints and soft tissues of the body thus alleviating the patient's signs and symptoms.

Other: Muscle Energy Technique

Mulligan Technique group

EXPERIMENTAL

Patient in group A will receive specialized SNAGs technique adapted from Mulligan (2005), in addition to strengthening exercise for DNF muscles and advice to correct position three times per week for 4 weeks.

Other: Mulligan Technique

Interventions

A biomechanical correction approach can lead to the normalization of spinal curvatures and a decrease in the compressional and tensional stress on joints and soft tissues of the body.

Muscle Energy Technique group

* The patient will be in a supportive low back chair, thus cervical region will be in a vertical position (Weight-bearing position) with the therapist position will be behind the patient. * Then the therapist will move the spinous process up in the direction that must follow the apophyseal joint plane under treatment, that is, toward the eye ball. While sustaining this pain-free accessory glide, the patient will be instructed to actively perform the physiological movement gradually until the end ROM with over pressure at the end of the range.

Mulligan Technique group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast feeding women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will be examined by a physician before the study and will be chosen according to the following criteria:
  • All patients will be in the breastfeeding period at least 6 weeks after delivery.
  • All patients will be clinically diagnosed with neck pain (with no neurological or rheumatological problem).
  • Their ages will range from 25-35years.
  • Their BMI will be less than 30 kg/m².
  • Their parity will not be more than 3 times.

You may not qualify if:

  • The patients will be excluded if they have any of the followings:
  • Any contraindication to spinal mobilization (e.g., inflammation, infection, advanced degeneration, congenital malformation, trauma, cerebrovascular abnormalities).
  • Positive neurological examination (presence of positive motor reflex, or sensory abnormalities indicating spinal root compression).
  • Cervical spine surgery or stenosis, metabolic or systemic disorder, or cancer.
  • Associated pathology of the upper cervical region or upper limb that may cause overlapping with the clinical finding as referred pain from the costotransverse joint, rotator cuff tendonitis, and cervical rib syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Neck PainBreast Feeding

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Central Study Contacts

Heba Elbasiony, Physical Therapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 18, 2021

Study Start

March 1, 2021

Primary Completion

June 15, 2021

Study Completion

June 30, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations