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

NCT04818411 | Completed DMC

• 1 other identifier: IRB-UOL-FAHS/659 Anam Naz
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Girdle Pain

Outcome Measures

Primary Outcomes (2)

• 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."

  2 months

• 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%

  2 months

Study Arms (2)

Routine physical therapy treatment with the Stabilization exercises

ACTIVE COMPARATOR

Stabilization exercises

Other: Routine physical therapy treatment with the Stabilization exercises

Routine physical therapy treatment + High-velocity thrust manipulation

EXPERIMENTAL

High-velocity thrust manipulation

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

Interventions

Routine physical therapy treatment with the Stabilization exercises OTHER

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.

Routine physical therapy treatment with the Stabilization exercises

Routine physical therapy treatment + High-velocity thrust manipulation OTHER

: 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.

Routine physical therapy treatment + High-velocity thrust manipulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 15866079 BACKGROUND

• 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.

  PMID: 26885363 BACKGROUND

• 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.

  PMID: 19863747 BACKGROUND

• 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.

  PMID: 16532908 BACKGROUND

• 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.

  PMID: 28915804 BACKGROUND

• 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.

  PMID: 22282770 BACKGROUND

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Maryam Shabbir, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: August 18, 2019
• Primary Completion: June 27, 2020
• Study Completion: July 26, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)