Effects of Vertebral Derotation on Pulmonary Functions

Impact of Vertebral Derotation on Ventilatory Functions and Chest Circumference in Adolescent Scoliosis

This study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis Idiopathic; Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Procedure: vertebral derotation

Detailed Description

Sixty patients from both sexes with idiopathic scoliosis underwent posterior correction (fusion). They were presented with idiopathic scoliosis for 6-12 month. Their mean Cobb's angle was measured in degrees and their mean angle of rotation was measured also in degrees. Before participation all the patients were examined clinically by a chest physician to exclude any cardio pulmonary or vascular disorders which may alter the pulmonary functions. All of them did not receive any physical therapy program prior to the operation.

Patients were arranged randomly into two groups (1 and 2), each containing 30 patients. Group 1 (DRG) received posterior correction, vertebral derotation technique during posterior correction and pulmonary rehabilitation program while group 2 (NDRG) received posterior correction and the same rehabilitation program given to group 1.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: KHALED T AHMED, Asso Prof; Phone Number: 01115586016; Email: khaled.takey@must.edu.eg
• Study Contact Backup: Name: abla h saleh, prof; Phone Number: 01001521055; Email: Abla_hamed2000@yahoo.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Faculty of Physical Therapy -Cu
    • Contact: ahmed s ali, lecturer; Phone Number: 01068443366; Email: dr.shawky_2011@cu.edu.eg
  • Giza, Egypt
    • Recruiting
    • faculty of PT - cu
    • Contact: NISREEN A EL AHASS, PROF; Phone Number: 0237969108; Email: Zayedsameh40@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male patients suffering from adolescent idiopathic scoliosis.
• Participant age ranged from 12- 18 years old.
• All patients had the same medical care.
• Participants have received a good explanation of the treatment and measurement device.
• Treatment was conducted surgical intervention.

Exclusion Criteria:

• Instability of patient's medical condition.
• Presence of any diseases that could affect the study results.
• Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A).	Procedure: vertebral derotation; Incentive spirometer (Mediciser): Used for breathing exercises.; Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.; Other Names: INCENTIVE SPIROMETER
Experimental: control; The Control group received only posterior correction with routine chest physiotherapy (group B).	Procedure: vertebral derotation; Incentive spirometer (Mediciser): Used for breathing exercises.; Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.; Other Names: INCENTIVE SPIROMETER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(FEV1 and MVV) were measured by using the spirometer Pulmonary functions testing	Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England).	Five months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Kim YJ, Lenke LG, Bridwell KH, Kim KL, Steger-May K. Pulmonary function in adolescent idiopathic scoliosis relative to the surgical procedure. J Bone Joint Surg Am. 2005 Jul;87(7):1534-41. doi: 10.2106/JBJS.C.00978.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: lung functions, vertebral derotation, chest intervention
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: veretebral derotation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At first study protocol and informed consent
• IPD Sharing Time Frame: January 2023 - June 2023
• IPD Sharing Access Criteria: consent
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No