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

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT04818411

Collaborator

(none)

Enrollment

Location

Arms

11.3

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Girdle Pain	Other: Routine physical therapy treatment with the Stabilization exercises Other: Routine physical therapy treatment + High-velocity thrust manipulation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 18, 2019

Actual Primary Completion Date :

Jun 27, 2020

Actual Study Completion Date :

Jul 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Routine physical therapy treatment with the Stabilization exercises Stabilization exercises	Other: Routine physical therapy treatment with the Stabilization exercises 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.
Experimental: Routine physical therapy treatment + High-velocity thrust manipulation High-velocity thrust manipulation	Other: Routine physical therapy treatment + High-velocity thrust manipulation : 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.

Arm

Intervention/Treatment

Active Comparator: Routine physical therapy treatment with the Stabilization exercises

Stabilization exercises

Other: Routine physical therapy treatment with the Stabilization exercises

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.

Experimental: Routine physical therapy treatment + High-velocity thrust manipulation

High-velocity thrust manipulation

Other: Routine physical therapy treatment + High-velocity thrust manipulation

: 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.

Outcome Measures

Primary Outcome Measures

Visual analog scale [2 months]
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 [2 months]
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%

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riphah Rehabilitation Center	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Maryam Shabbir, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT04818411

Other Study ID Numbers:

IRB-UOL-FAHS/659 Anam Naz

First Posted:

Mar 26, 2021

Last Update Posted:

Apr 14, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pelvic Girdle Pain

Study Results

No Results Posted as of Apr 14, 2021