- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06899425
Effect of Kinesio Tape on Neck Pain in Lactating Women
Effect of Kinesio Tape on Neck Pain in Lactating Women. A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neck pain is widely prevalent and can be exacerbated by poor posture and prolonged or repetitive positions-both of which are common in lactating mothers. Research shows that a significant percentage of breastfeeding women experience musculoskeletal pain, often linked to specific postures such as the cross-cradle hold. Prolonged forward head posture (FHP) and muscle imbalances in the neck-shoulder region further contribute to mechanical neck pain by placing excessive strain on muscles, joints, and connective tissues.
Kinesio taping (KT) is a non-pharmacological technique aimed at alleviating pain and improving functional movement. By lifting the skin slightly, KT is proposed to enhance local blood and lymphatic flow, reduce nociceptive signals, and stimulate proprioceptive feedback. Multiple studies suggest KT can help correct posture, relieve muscle fatigue, and improve range of motion, thus offering a promising intervention for mechanical neck pain. These benefits are potentially valuable for lactating mothers, who are especially prone to postural stresses and neck discomfort due to the physical demands of breastfeeding.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara A. Amr
- Phone Number: +201099831333
- Email: sosaasem.88@gmail.com
Study Contact Backup
- Name: Afaf Botla, PHD
- Phone Number: 01283126608
- Email: drafafmohamed@cu.edu.eg
Study Locations
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-
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Cairo, Egypt
- Al Zahra University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cervical spondylosis.
- Cervical disc prolapse.
- History of fracture of cervical spine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hot pack group
The participants will be treated by hot packs on the neck for 12 weeks.
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The participants will be treated by hot packs on neck for 15 minutes, 3 times per weeks for 12 weeks.
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Experimental: kinesio tape and hot pack group
The participants will be treated by hot packs and kinesio tape on the neck for 12 weeks.
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The participants will be treated by hot packs on neck for 15 minutes, 3 times per weeks for 12 weeks.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 12 weeks
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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.
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12 weeks
|
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Pain pressure threshold
Time Frame: 12 weeks
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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.
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck flexion range of motion
Time Frame: 12 weeks
|
Goniometer will be used to measure neck flexion range of motion for all women in both groups before and after treatment.
The axis of the goniometer will be placed over the external auditory meatus.
The stationary arm placed vertically or perpendicular to the floor and the moving arm placed on the base of the nose.
The participants will be asked to flex neck and the angle will be recorded.
Normal cervical flexion range of motion is usually approximately 80º.
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12 weeks
|
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Neck extension range of motion
Time Frame: 12 weeks
|
Goniometer will be used to measure neck extension range of motion for all women in both groups before and after treatment.
The axis of the goniometer will be placed over the external auditory meatus.
The stationary arm placed vertically or perpendicular to the floor and the moving arm placed on the base of the nose.
The participants will be asked to extend neck and the angle will be recorded.
Normal cervical extension range of motion is usually approximately 50º.
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12 weeks
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Neck lateral flexion range of motion
Time Frame: 12 weeks
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Goniometer will be used to measure neck extension range of motion for all women in both groups before and after treatment.
The axis of the goniometer will be placed over the spinous process of the C7.
The stationary arm placed along the imaginary line between the two acromion processes either vertically or perpendicular to the floor or horizontal and parallel to the floor and the moving arm placed over the external occipital protuberance.
The participants will be asked to perform lateral flexion of the neck and the angle will be recorded.
Normal cervical lateral flexion range of motion is usually approximately 45º.
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12 weeks
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Neck rotation range of motion
Time Frame: 12 weeks
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Goniometer will be used to measure neck extension range of motion for all women in both groups before and after treatment.
The axis of the goniometer will be placed over the over to the center of the patients' head.
The stationary arm placed along an imaginary line between the two acromion processes and the moving arm placed at the tip of the nose.
the participants will be asked to perform neck rotation and the angle will be recorded.
Normal cervical rotation range of motion is usually approximately 80º.
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12 weeks
|
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Northwick park neck pain questionnaire
Time Frame: 12 weeks
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A neck pain questionnaire using nine five-part sections has been devised to overcome this problem.
Questions on duration and intensity of pain were good indicators of a patient's global assessment.
The questionnaire is easy for patients to complete, simple to score and provides an objective measure to evaluate outcome in patients with acute or chronic neck pain.
The questionnaire consists of 9 sections about daily activities.
Each section contains 1 question and 5 statements.
Each section is scored on a 0-4 scale, 4 representing the greatest disability, and 0 representing the least disability.
The total score is obtained by summing the scores for the 9 sections (possible score: 0-36).
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohamed Awad, Professor, Cairo university
- Study Director: Abd El Hamid Atta Allah, PHD, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003812
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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