NCT06646367

Brief Summary

This study will be conducted to investigate the effect of the Alexander technique on neck pain and quality of life 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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

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

October 16, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 16, 2024

Last Update Submit

October 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assessment of neck pain intensity

    The pain intensity will be assessed through numeric pain rating scale for all participating women in both groups before and after the treatment program. The woman will be asked to circle the number between 0 (represents no pain) and 10 (represents the worst pain) that best represents their pain intensity. She will be asked to indicate the intensity of her current, best, and worst pain levels over the past 24 hours on the scale, the mean of these three ratings is calculated to represent the patient's overall pain intensity.

    5 weeks

  • Quality Of Life assessment

    The Short Form Survey Instrument (SF-36) will be used to assess the health-related quality of life for all women in both groups before and after the treatment program. The SF-36 is a self-administered questionnaire containing 36 items, which takes about five minutes to complete. It measures health across eight multi-item dimensions, covering functional status, well-being, and overall health evaluation, each associated with 2-10 possible answers. The response to each question is extrapolated to a standardized set of answers, and the results are transferred to a scale of 0-100, where 0 represents the worst state of health and 100 represents the best state of health measured. It has good validity and reliability and can be used as a general questionnaire to assess quality of life.

    5 weeks

Secondary Outcomes (5)

  • Measurement of neck flexion range of motion (ROM)

    5 weeks

  • Measurement of neck extension range of motion (ROM)

    5 weeks

  • Measurement of neck lateral flexion range of motion (ROM)

    5 weeks

  • Measurement of neck rotation range of motion (ROM)

    5 weeks

  • Assessment of neck function

    5 weeks

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

It will include 36 lactating females suffering from neck pain who will receive conventional therapy in the form of moist heat for 30 min, 5 times per week for 5 weeks and transcutaneous electrical nerve stimulation (TENS) that will be applied for 25 min, 5 times per week for 5 weeks.

Other: Conventional therapy

Conventional therapy + Alexander technique

EXPERIMENTAL

It will include 36 lactating females suffering from neck pain who will receive the same conventional therapy in addition to the Alexander technique which will be applied for 60 min, 2 classes per week, for 5 weeks.

Other: Conventional therapyOther: Alexander technique

Interventions

All participants in the two groups will receive conventional therapy in the form of TENS and moist heat for 5 weeks.TENS will be applied 5 times a week for 5 weeks at a frequency of 80Hz with 10- to 30-mA intensity for 25 minutes. Four surface electrodes (5x5 cm each) were situated over the painful region in the neck (two electrodes will be placed in either side of the spine high on neck, just underneath the skull and the other two electrodes will be placed about 5cm underneath them) with intensity in the tactile sensation threshold. The hot packs will be applied for 30 minutes on the cervical area, 5 times per week for 5 weeks.

Conventional therapyConventional therapy + Alexander technique

Women in the experimental group will attend 10 Alexander Technique classes (60 minutes each, twice a week for 5 weeks). The Alexander Technique focuses on body awareness, reducing muscle tension, and improving coordination through three principles: enhanced awareness, purposeful inhibition, and mental imagery. Participants will learn to release habitual muscle tension and explore alternative movement patterns, covering biomechanics and ergonomics of the neck, spine, and limbs. The sessions involve hands-on guidance, verbal instruction, and group activities. Daily practice in a semi-supine position is encouraged to improve posture, coordination, and overall well-being.

Conventional therapy + Alexander technique

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lactating females experiencing neck pain (six weeks to 1year postpartum).
  • Able to understand and follow the Alexander Technique instructions.
  • Their age will be ranged from 20-35 years old.
  • Their BMI will be less than 30 kg/m2 .
  • Their pain level is ≥ 4 on numeric pain rating scale.
  • They have mild disability on Neck Disability Index Questionnaire (NDI).
  • They have limited cervical range of motion (the normal flexion range of motion is 80° to 90°, extension 70°, lateral flexion 20° to 45°, and rotation up to 90°).

You may not qualify if:

  • Neck pain as consequence of disc protrusion or prolapse, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, neurological disorder, and psychosis.
  • Women who had invasive treatment of the spine within the previous three weeks, or spinal surgery or presence of neck history of trauma.
  • Presence of contraindications to spinal movement, such as fracture or dislocation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hala Mohamed Hanfy, PhD

    Professor, Cairo university

    STUDY CHAIR

Central Study Contacts

Aml Elsaid Hamed, B.Sc

CONTACT

Manal Ahmed El-Shafei, PhD

CONTACT

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

October 16, 2024

First Posted

October 17, 2024

Study Start

October 20, 2024

Primary Completion

January 15, 2025

Study Completion

February 1, 2025

Last Updated

October 17, 2024

Record last verified: 2024-10

Locations