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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06198647
Other study ID # PT.BU.EC.2
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date March 15, 2024

Study information

Verified date January 2024
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

More than 50% of women experience pain in the lumbopelvic area during pregnancy. The prevalence of pain increases with the duration of pregnancy. Trunk muscles are needed to sustain low levels of activity for an extended duration. Preventing muscles from fatiguing is very important. Manual therapy techniques can minimize loading of the spine while improving muscular endurance and preventing fatigue. Moreover, inhibition of the trigger points of the spinal musculature is an important factor to consider.


Description:

Tui-Na massage and positional release therapy are both of the common manual therapies used recently for low back pain. However, no studies have compared their effects on pregnancy related low back pain in third trimester.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date March 15, 2024
Est. primary completion date February 27, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - low back pain - mild to moderate disability concurring to the Oswestry Disability Index (up to 40%), - age ranged from 20 - 40 years Exclusion Criteria: - Current physical therapy or medical treatment for low back pain, - contracture or surgery affecting the lumbar spine, - scoliosis, - pathologies such as inflammatory diseases, - skin diseases, - congenital diseases, - neurological diseases, - dislocations, neoplasms, - disc prolapse, - visual or auditory problems

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tui-na massage
Using Tui-na massage for the back muscles
positional release technique
using positional release manual technique to relax the back muscles

Locations

Country Name City State
Egypt Benha University Cairo Benah

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary back pain intensity will be measure by the visual analogue scale that range from 0 to 10 with higher scores indicating greater pain intensity. through study completion, an average of 2 months
Secondary The pressure pain threshold (kg/cm2) will be measured using a pressure algometer that will be placed vertically on the most tender point at the low back para spinal muscles. through study completion, an average of 2 months
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