NCT07803302

Brief Summary

This randomized controlled trial aims to evaluate the effects of a pelvic stabilization belt combined with exercise therapy on pelvic girdle pain and mobility in postpartum women. The study will compare combined pelvic stabilization belt and exercise therapy with exercise therapy alone. Pain, functional mobility, and pelvic girdle-related disability will be assessed to determine whether adding a pelvic stabilization belt provides additional benefits for postpartum women experiencing pelvic girdle pain.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress43%
Aug 2026Dec 2026

Study Start

First participant enrolled

August 22, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 3, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

August 27, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

Pelvic Girdle PainPostpartum womenExercise TherapyOrthotic DevicesPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • Pelvic girdle pain

    The Visual Analog Scale (VAS) will be used to assess pelvic girdle pain intensity. It consists of a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark the point that best represents their current pain intensity. Higher scores indicate greater pain severity.

    4 weeks

Study Arms (2)

Pelvic Stabilization Belt + Exercise Therapy

EXPERIMENTAL

Participants will receive a pelvic stabilization belt combined with standard pelvic floor physical therapy for 4 weeks. The belt will be worn for at least 4 hours per day during functional activities such as walking, standing, household work, and childcare, positioned around the pelvic ring at the level of the greater trochanters. Standard therapy will include patient education on spinal stability, lumbopelvic alignment, posture, ergonomics, infant care, gait, and psychological support, along with pelvic floor muscle training (Kegel exercises).

Device: Pelvic Stabilization BeltBehavioral: Standard Pelvic Floor Physical Therapy

Exercise Therapy Only

ACTIVE COMPARATOR

Participants will receive standard pelvic floor physical therapy for 4 weeks without use of a pelvic stabilization belt. Treatment will include patient education on spinal stability, lumbopelvic alignment, posture, ergonomics, breastfeeding and infant handling, gait training, and psychological support, along with pelvic floor muscle training (Kegel exercises) consisting of 5-10 second contractions, 10-15 repetitions per set, and 3-4 sets per day.

Device: Pelvic Stabilization BeltBehavioral: Standard Pelvic Floor Physical Therapy

Interventions

Participants assigned to the experimental group will use a pelvic stabilization belt in addition to standard pelvic floor physical therapy for 4 weeks. The belt will be positioned around the pelvic ring at the level of the greater trochanters to provide pelvic compression and support pelvic stability. Participants will be instructed to wear the belt for at least 4 hours per day during functional activities, including walking, standing, household work, and childcare activities.

Exercise Therapy OnlyPelvic Stabilization Belt + Exercise Therapy

Participants in both groups will receive standard pelvic floor physical therapy for 4 weeks. Treatment will include patient education regarding spinal stability, lumbopelvic alignment, posture, ergonomic strategies for breastfeeding, lifting and infant care, gait training, and psychological support. Pelvic floor muscle training will include Kegel exercises performed in supine or seated positions, with 5-10-second contractions, 10-15 repetitions per set, and 3-4 sets per day, emphasizing isolated pelvic floor muscle activation without compensatory abdominal or gluteal contraction.

Exercise Therapy OnlyPelvic Stabilization Belt + Exercise Therapy

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 22-45 years.(Yang et al., 2026)
  • Postpartum duration of 6 weeks to 6 months after delivery.(Yang et al., 2026)
  • Postpartum women diagnosed with pelvic girdle pain using diagnostic test P4 and ASLR.(Jafarian et al., 2025)
  • Presence of pelvic pain affecting functional activities such as walking, standing, or changing position.
  • Ability to understand instructions and perform basic mobility tasks.
  • Willingness to participate and provide informed consent.(Meah et al., 2020)

You may not qualify if:

  • A clinical diagnosis of any mental disorder.(Hirsch et al., 2021)
  • Severe psychiatric or cognitive disorders affecting compliance with exercise and follow-up.(Jafarian et al., 2025)
  • Previous spinal surgery or severe lumbar spine pathology that overlaps with pelvic pain presentation.(Gutke et al., 2021)
  • Rheumatological or inflammatory joint diseases such as ankylosing spondylitis.
  • Current pregnancy during the study period, due to hormonal and biomechanical changes affecting pelvic stability.
  • Any condition requiring urgent medical or surgical intervention unrelated to musculoskeletal dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Qurat ul Ain

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 3, 2026

Study Start

August 22, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 3, 2026

Record last verified: 2026-09

Locations