search
Back to results

Comparison of Stabilization Exercises Versus Thrust Manipulation Technique on Pelvic Girdle Pain.

Primary Purpose

Pelvic Girdle Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine physical therapy treatment with the Stabilization exercises
Routine physical therapy treatment + High-velocity thrust manipulation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Girdle Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Post-partum females with the normal vaginal delivery present with pelvic girdle pain before the next conception.

    • Aged between 18 and 45
    • Posterior pelvic girdle pain located distal and/or lateral to the L5-S1
    • Pain onset during pregnancy or within 3 weeks after delivery, most recent delivery within 6 to 16 weeks
    • Positive posterior pelvic pain provocation (P4) test

Exclusion Criteria:

  • Patients presenting with the history of:

    • Back pain indicating radiculopathy
    • Mechanical back pain
    • Back pain due to disc herniation
    • Rheumatological diseases
    • Neurological illness or recent surgery
    • Women who have gone through C-section

Sites / Locations

  • Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine physical therapy treatment with the Stabilization exercises

Routine physical therapy treatment + High-velocity thrust manipulation

Arm Description

Stabilization exercises

High-velocity thrust manipulation

Outcomes

Primary Outcome Measures

Visual analog scale
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Oswestry disability index
The ODI score (index) is calculated as: If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32% If one section is missed (or not applicable) the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
April 10, 2021
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT04818411
Brief Title
Comparison of Stabilization Exercises Versus Thrust Manipulation Technique on Pelvic Girdle Pain.
Official Title
Comparison of Stabilization Exercises Versus Thrust Manipulation Technique on Pelvic Girdle Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 18, 2019 (Actual)
Primary Completion Date
June 27, 2020 (Actual)
Study Completion Date
July 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this research is to compare the efficacy of stabilization exercise versus pelvic girdle pain thrust manipulation technique in females with postpartum pain.
Detailed Description
Pelvic-girdle pain is a mechanical disorder growing rapidly as a consequence of changing delivery pattern and changing lifestyle. Medication with synthetic drugs not only has been unable to effectively curtail the spread of this disease conditions but also is most of the times linked with co-occurring side-effects. The exercise and manual therapy-based approach could lead in reducing the functional limitations and morbidity rate in females with the postpartum pain. This research could also help in spreading the awareness globally, to Prenatal and Postnatal Hospital Caregivers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine physical therapy treatment with the Stabilization exercises
Arm Type
Active Comparator
Arm Description
Stabilization exercises
Arm Title
Routine physical therapy treatment + High-velocity thrust manipulation
Arm Type
Experimental
Arm Description
High-velocity thrust manipulation
Intervention Type
Other
Intervention Name(s)
Routine physical therapy treatment with the Stabilization exercises
Intervention Description
The program was based on specific training of the transversely oriented abdominal muscles with coactivation of the lumbar multifidus at the lumbosacral region, training of the gluteus maximus, the latissimus dorsi, the oblique abdominal muscles, the erector spinae, the quadratus lumborum, and the hip adductors and abductors. Initially, we focused on the specific contraction of the transversely oriented abdominal muscles. After approximately 2 weeks, loading was progressively increased throughout the intervention period. The women were required to exercise for 30 to 60 minutes, 3 days a week, for 3-4 weeks.
Intervention Type
Other
Intervention Name(s)
Routine physical therapy treatment + High-velocity thrust manipulation
Intervention Description
: For high-velocity thrust technique, a modified Chicago technique was used. For this procedure, the lumbopelvic region was targeted. The side to be treated was chosen, based on the subject's report of her most symptomatic side. The physical therapist, performed passively side bend the subject toward the painful side, rotate the upper body in the direction opposite to the side bending, and then deliver a quick posterior and inferior thrust at a grade V including a small-amplitude/high-velocity therapeutic movement. A maximum of 2 attempts per side was permitted if no pop was heard following the first attempt. If the subject showed improvement of 50% or less after the first treatment, the intervention was categorized as a failure, the examination and intervention were repeated, and the subjects were asked to return 2 to 4 days later. If the subject showed greater than 50% improvement, the intervention was categorized as a success, and study participation was concluded.
Primary Outcome Measure Information:
Title
Visual analog scale
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
2 months
Title
Oswestry disability index
Description
The ODI score (index) is calculated as: If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32% If one section is missed (or not applicable) the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Post-partum females with the normal vaginal delivery present with pelvic girdle pain before the next conception. Aged between 18 and 45 Posterior pelvic girdle pain located distal and/or lateral to the L5-S1 Pain onset during pregnancy or within 3 weeks after delivery, most recent delivery within 6 to 16 weeks Positive posterior pelvic pain provocation (P4) test Exclusion Criteria: Patients presenting with the history of: Back pain indicating radiculopathy Mechanical back pain Back pain due to disc herniation Rheumatological diseases Neurological illness or recent surgery Women who have gone through C-section
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Shabbir, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15866079
Citation
Bastiaanssen JM, de Bie RA, Bastiaenen CH, Essed GG, van den Brandt PA. A historical perspective on pregnancy-related low back and/or pelvic girdle pain. Eur J Obstet Gynecol Reprod Biol. 2005 May 1;120(1):3-14. doi: 10.1016/j.ejogrb.2004.11.021.
Results Reference
background
PubMed Identifier
26885363
Citation
Bergstrom C, Persson M, Mogren I. Sick leave and healthcare utilisation in women reporting pregnancy related low back pain and/or pelvic girdle pain at 14 months postpartum. Chiropr Man Therap. 2016 Feb 15;24:7. doi: 10.1186/s12998-016-0088-9. eCollection 2016.
Results Reference
background
PubMed Identifier
19863747
Citation
Vermani E, Mittal R, Weeks A. Pelvic girdle pain and low back pain in pregnancy: a review. Pain Pract. 2010 Jan-Feb;10(1):60-71. doi: 10.1111/j.1533-2500.2009.00327.x. Epub 2010 Oct 26.
Results Reference
background
PubMed Identifier
16532908
Citation
Robinson HS, Eskild A, Heiberg E, Eberhard-Gran M. Pelvic girdle pain in pregnancy: the impact on function. Acta Obstet Gynecol Scand. 2006;85(2):160-4. doi: 10.1080/00016340500410024.
Results Reference
background
PubMed Identifier
28915804
Citation
Bergstrom C, Persson M, Nergard KA, Mogren I. Prevalence and predictors of persistent pelvic girdle pain 12 years postpartum. BMC Musculoskelet Disord. 2017 Sep 16;18(1):399. doi: 10.1186/s12891-017-1760-5.
Results Reference
background
PubMed Identifier
22282770
Citation
Eggen MH, Stuge B, Mowinckel P, Jensen KS, Hagen KB. Can supervised group exercises including ergonomic advice reduce the prevalence and severity of low back pain and pelvic girdle pain in pregnancy? A randomized controlled trial. Phys Ther. 2012 Jun;92(6):781-90. doi: 10.2522/ptj.20110119. Epub 2012 Jan 26.
Results Reference
background

Learn more about this trial

Comparison of Stabilization Exercises Versus Thrust Manipulation Technique on Pelvic Girdle Pain.

We'll reach out to this number within 24 hrs