Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.

June 5, 2024 updated by: Istituto Ortopedico Rizzoli

Effectiveness of Postoperative Respiratory Physiotherapy for Pain Management in Patients Undergoing Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Study

After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe intervention that can be introduced for pain management.

The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative care in patients undergoing spinal fusion for adolescent idiopathic scoliosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adolescent idiopathic scoliosis (AIS) is a common orthopedic condition with a prevalence of 2-3% in children aged from 10 to 16 years. It is a developmental deformity that affects both physical and psychological domains, interfering with self-esteem and mental well-being. Diagnosis is made within the first 18 years of life; in some cases, instrumented arthrodesis surgery is required, performed within the age of 25. Corrective surgery for scoliosis can be a stressful intervention for patients and their caregivers.

Postoperative pain is the major concern for patients undergoing orthopedic surgery. Significant postoperative pain also adversely affects other outcomes by hindering the healing process and delaying rehabilitation with loss of movement and walking. After arthrodesis the pain reported by the patients is significant.

Various strategies have been explored for acute pain management in patients undergoing surgery for scoliosis, with a focus on the first days post surgery. The link between breathing, lumbar spine function and pain perception is an aspect that has always been studied. The diaphragm plays an important role in spinal control and in the management of pain perception. Dysfunction of the diaphragm can lead to alterations in the biomechanics of the lumbar spine, with less proprioceptive abilities, less spinal mobility and reduced the spinal column's functionality of the tissues. Diaphragmatic rehabilitation techniques produce significant and clinically relevant improvements in the treatment of pathologies of the spine and especially in the management of painful symptoms.

A systematic review highlights how pain is able to influence the flow, frequency and volume of the respiratory act. At the same time, a regulation of breathing can be an useful tool in the control of painful symptoms.

After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe tool that can be introduced for the control of painful symptoms.

The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative phase in patients undergoing arthrodesis surgery for adolescent idiopathic scoliosis.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All subjects hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively enrolled.

Exclusion Criteria:

  • Subjects who cannot understand the Italian language and who do not provide consent to study will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP
Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.
Procedure: STANDARD PHYSIOTHERAPY TREATMENT

The standard postoperative rehabilitation process starts from the first postoperative day. Two sessions are provided daily, with the exception of Sunday and Saturday afternoon. A single physiotherapy session, lasting 30 minutes, can include bed exercises for upper and lower limbs and recovery of autonomy (sitting position, standing and ambulation). In this phase, the sessions are characterized by educational and counseling activities.

The patient will be encouraged to carry out the activities independently.
Experimental: EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP
Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.
Procedure: EXPERIMENTAL diaphragmatic breathing exercise
The subjects in the intervention group (EXP) will receive, in addition to standard physiotherapy treatment, diaphragmatic breathing exercise. Four exercises in different position (supine and side lying) will be provided for each physiotherapy session by a senior physiotherapist. Patients will be instructed to perform the same exercises independently to achieve relaxation and relief of pain symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensity of pain
Time Frame: The pain will be detected 3 times a day (8am/2 pm/8 pm) starting from the day of the first rehabilitation treatment until the fifth postoperative day.
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
The pain will be detected 3 times a day (8am/2 pm/8 pm) starting from the day of the first rehabilitation treatment until the fifth postoperative day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensity of pain (short term)
Time Frame: the values of the NRS scale will be detected before and after the rehabilitation treatment up to fifth day
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
the values of the NRS scale will be detected before and after the rehabilitation treatment up to fifth day
TUG - Time Up and Go
Time Frame: the TUG test will be administered during the 5th postoperative day
Timed up and go is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It consists of measuring how many seconds it takes the patient to get up from the chair, walk a distance of 3 meters, turn around, return to the chair and sit down again.
the TUG test will be administered during the 5th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: antonio culcasi, PT, Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

March 26, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RachideResp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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