Manual Therapy for Pregnancy Related Back Pain

NCT06198647 | Unknown DMC

• 1 other identifier: PT.BU.EC.2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

manual therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The pressure pain threshold (kg/cm2)

  through study completion, an average of 2 months

Study Arms (2)

tui-na

EXPERIMENTAL

Application of tui-na techniques for the women while being in prone lying position.

Procedure: Tui-na massage

positional release techniques

ACTIVE COMPARATOR

Application of positional release techniques for the women while being in prone lying position.

Procedure: positional release technique

Interventions

Tui-na massage PROCEDURE

Using Tui-na massage for the back muscles

tui-na

positional release technique PROCEDURE

using positional release manual technique to relax the back muscles

positional release techniques

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• low back pain
• mild to moderate disability concurring to the Oswestry Disability Index (up to 40%),
• age ranged from 20 - 40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Cairo, Benah, 13518, Egypt

Location

Related Publications (1)

• Elabd AM, Hasan S, Alghadir AH, Elabd OM, Shawky GM, Iqbal A, Marwan YN. Effect of Tui-Na versus positional release techniques on pregnancy-related low back pain in the third-trimester: A randomized comparative trial. Medicine (Baltimore). 2024 Dec 13;103(50):e40879. doi: 10.1097/MD.0000000000040879.

  PMID: 39686497 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aliaa M Elabd

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, basic science department, faculty of physical therapy, benha university

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 10, 2024
• Study Start: January 15, 2024
• Primary Completion: February 27, 2024
• Study Completion: March 15, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: upon completion
• Access Criteria: URL will be created after the ending of data acquisition.

Locations

EG (1)