NCT06899425

Brief Summary

This study will be conducted to investigate the effect of kinesio tape on neck pain in lactating 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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 29, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Pain will be assessed through visual analogue scale (VAS) for each woman in both groups before and after treatment. It is usually a horizontal line, 100 mm long, whose ends are labeled as the extreme ("no pain" and "pain as bad as it could be"). The patient is asked to put a mark on the line indicating their pain intensity. Sometimes descriptive, such as 'mild', 'moderate', 'sever', or numbers are provided along the scale for guidance. it is valid and reliable tool to assess pain intensity.

    12 weeks

  • Pain pressure threshold

    An electronic pressure algometer "Force one gauge- model FDI" (Wagner instruments, Greenwish, CT, USA) will be used to measure myofascial trigger points tenderness by determining the pain pressure threshold using a pressure probe, that's placed on the trigger point. With a 1-cm 2 rubber disc at the end of the device. Pressure will be applied perpendicularly to the skin at constant speed, and the woman will be asked to say stop at the time she started feeling pain.

    12 weeks

Secondary Outcomes (5)

  • Neck flexion range of motion

    12 weeks

  • Neck extension range of motion

    12 weeks

  • Neck lateral flexion range of motion

    12 weeks

  • Neck rotation range of motion

    12 weeks

  • Northwick park neck pain questionnaire

    12 weeks

Study Arms (2)

Hot pack group

ACTIVE COMPARATOR

The participants will be treated by hot packs on the neck for 12 weeks.

Other: Hot pack

kinesio tape and hot pack group

EXPERIMENTAL

The participants will be treated by hot packs and kinesio tape on the neck for 12 weeks.

Other: Hot packOther: Kinesio tape

Interventions

The participants will be treated by hot packs on neck for 15 minutes, 3 times per weeks for 12 weeks.

Hot pack groupkinesio tape and hot pack group

The participants will be treated by hot packs and kinesio tape. The tape will be placed for several days (3-5 days of application) then it will be removed and repeated for 12 weeks.

kinesio tape and hot pack group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All women are complaining from neck pain.
  • Their ages will be ranged from 20 to 30 years old.
  • Their body mass index will not exceed 30 kg/m².
  • They are medically stable and consented to participate in the study.

You may not qualify if:

  • Cervical spondylosis.
  • Cervical disc prolapse.
  • History of fracture of cervical spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Zahra University Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Abd El Hamid Atta Allah, PHD

    Al-Azhar University

    STUDY DIRECTOR
  • Mohamed Awad, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

March 29, 2025

Primary Completion

August 15, 2025

Study Completion

August 30, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations