NCT06640543

Brief Summary

This study aims to determine the difference between the effect of kinesiotape and myofascial release in the treatment of postnatal low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable low-back-pain

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

October 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
5 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 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

February 11, 2025

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 11, 2024

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity level

    The intensity of postnatal low back pain will be assessed using a visual analogue scale (VAS) for all participants in both groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain

    4 weeks

Secondary Outcomes (3)

  • Lumbar flexion range of motion

    4 weeks

  • Lumbar extension range of motion

    4 weeks

  • Lumbar lateral flexion range of motion

    4 weeks

Study Arms (2)

kinesiotape group

EXPERIMENTAL

The participants will be treated with kinesiotape for 4 weeks

Other: Kinesiotape

myofascial release group

EXPERIMENTAL

The participants will be treated with myofascial release for 4 weeks

Other: Myofascial release

Interventions

Postnatal women with low back pain will be treated with kinesiotape, three times per week for 4 weeks

kinesiotape group

Postnatal women with low back pain will be treated with myofascial release for 25 minutes three times per week for 4 weeks

myofascial release group

Eligibility Criteria

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

You may qualify if:

  • Their ages will be ranged from 20 to 35 years old.
  • Their body mass index (BMI) will not exceed 30 kg/m2.
  • Women will be postnatal period by 6-8 weeks.
  • All women will be diagnosed by the physician as postnatal low back pain.

You may not qualify if:

  • Spinal fracture or any other neurological disorders.
  • Lumbar disc herniation or degenerative disc disease
  • Lumbar spinal stenosis from lumbar disc herniation, degenerative joint disease, or spondylolisthesis
  • Women with BMI exceed 30 kg/m2.
  • Patients who have polyneuropathy or other neurological disorders.
  • Skin disease interferes with kinesiotape or myofascial release application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Ahmed Mahmoud

Giza, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Athletic TapeMyofascial Release Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Afaf M Botla, Professor

    Cairo University

    STUDY DIRECTOR
  • Mohamed Awad, Professor

    Cairo University

    STUDY CHAIR

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 11, 2024

First Posted

October 15, 2024

Study Start

October 20, 2024

Primary Completion

January 20, 2025

Study Completion

January 30, 2025

Last Updated

February 11, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations