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Completed

NCT Number: NCT04818411

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 + 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.

Primary outcomes

  1. Visual analog scale

    Time frame: 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."

  2. Oswestry disability index

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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