NCT06988241

Brief Summary

Purpose of the study: To determine the efficacy of neck muscles positional release for Neck Pain during lactation.Methods:Fifty patient with postpartum neck pain will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive posture correction advices during lactation and posture correction exercises but group A will receive additional positional release for upper trapezius. All patients will be evaluated for Pressure pain threshold (PPT) of upper trapezius by algometry, neck disability using Arabic version of neck disability index, pain intensity using 11-numerical rating scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 23, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

May 17, 2025

Last Update Submit

December 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intensity of neck pain

    Neck pain intensity will be measured by 11- numerical rating scale.Primary outcome updated to pain intensity to better reflect the study objective.

    baseline and four weeks

Secondary Outcomes (2)

  • Pressure pain threshold (PPT)

    baseline and four weeks

  • functional status related to neck disability

    baseline and four weeks

Study Arms (2)

Positional Release

EXPERIMENTAL

Positional Release For upper trapezius + Posture correction advices during lactation + posture correction exercises

Other: positional releaseOther: Posture correction

Posture correction

OTHER

Posture correction advices during lactation + posture correction exercises

Other: Posture correction

Interventions

All participants in group (A) will receive the same program of group B added to positional release . In order to make the positional release , the therapist will pick up the trigger points by palpation in the upper trapezius muscle by pincer palpation method and distinguished with dots on the skin. Participants will be made supine lying and relaxed by maintaining the cervical spine in a neutral position. Lateral flexion of subject's head toward the side of a tender point, the therapist grasps the subject's forearm and abducts shoulder to approximately 90° and adds slight flexion or extension to fine-tune.The most comfortable position achieved will be held for 90 seconds and after that passive return of the body part to an anatomically neutral position will be maintained for 5 minutes. All participants will be treated three times per week for 4 consecutive weeks and will be instructed to maintain their normal activities while avoiding any undue stress to the neck.

Also known as: strain counter strain
Positional Release

Posture correction advices during lactation + posture correction exercises

Positional ReleasePosture correction

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • lactating mothers.
  • Age between 25-35 years old.
  • six weeks to one year after childbirth.
  • at least a moderate level of education.

You may not qualify if:

  • Mothers were excluded if they had facet joint, neurological, or cardio vascular and respiratory conditions.
  • History of breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy kafr Elsheikh university

KafrElSheikh, kafrElsheikh, 33516, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 23, 2025

Study Start

May 23, 2025

Primary Completion

November 25, 2025

Study Completion

November 25, 2025

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations