NCT06303401

Brief Summary

compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

September 27, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 4, 2024

Last Update Submit

March 4, 2024

Conditions

Low Back Pain, Post Partum

Outcome Measures

Primary Outcomes (2)

  • Numeric pain rating scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain).

    4th week

  • Modified Oswestry Disability Index (ODI)

    The ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) minimum to maximum.

    4th week

Study Arms (2)

SI joint thrust Manipulation

EXPERIMENTAL

The patient was supine and the therapist stood contralateral to the side which was to be manipulated. The patient was passively moved into side bending toward the side to be manipulated. The therapist passively rotated the patient, and then delivered a quick thrust to the Anterior Superior Iliac Spine (ASIS) in a posterior and inferior direction

Other: SI joint thrust manipulation

Pelvic Stabilization Exercises

ACTIVE COMPARATOR

Heating pad for 10- 15 mints Pelvic stabilization exercises. Bridging (3 sets x 10 reps with 10 secs hold), Pelvic Tilt exercise (3 sets x 10 reps with 10 secs hold), Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold), clamshell Exercise (3 sets x 10 reps with 10 secs hold).

Other: pelvic stabilization exercises

Interventions

SI joint thrust manipulationOTHER

experimental group given the thrust manipulation along with heating pad. 3 sessions per week will be given for 4 weeks. The pain measure by using NPRS, functional status and disability through ODI will be evaluated. after every 3 sessions.

SI joint thrust Manipulation
pelvic stabilization exercisesOTHER

Heating pad for 10- 15 mints Pelvic stabilization exercises include Bridging (3 sets x 10 reps with 10 secs hold) Pelvic Tilt exercise(3 sets x 10 reps with 10 secs hold) Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold) clamshell Exercise (3 sets x 10 reps with 10 secs hold) .3 sessions per week will be given for 4 weeks. The pain using NPRS , functional status and disability will be evaluated by using ODI after every 3 sessions.

Pelvic Stabilization Exercises

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-40 years
  • Postpartum women (after 6 weeks)(3, 12)
  • Postpartum LBP patient
  • Patient pain increased by provocation test i.e. Faber test, High thrust test and Gaenslen test

You may not qualify if:

  • C-section
  • inflammatory or malignant type of pain
  • Neurological deficit
  • Severe trauma
  • Pelvic fracture
  • Osteoporosis, spinal stenosis, spondylolysis, spondoloesthesisi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Reading Hospital and Shahab Orthopedic & General Hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Asmar Fatima, MS OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

September 27, 2023

Primary Completion

July 31, 2024

Study Completion

August 30, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)