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

NCT05311826 | Completed

• 1 other identifier: RachideResp
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescent Idiopathic Scoliosis; Spinal Fusion; Pain Management; Exercise

Keywords

spinal fusion; early rehabilitation; diaphragmatic breathing exercise; Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• intensity of pain

  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 Outcomes (2)

• intensity of pain (short term)

  the values of the NRS scale will be detected before and after the rehabilitation treatment up to fifth day

• TUG - Time Up and Go

  the TUG test will be administered during the 5th postoperative day

Study Arms (2)

STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP

ACTIVE COMPARATOR

Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.

Procedure: STANDARD PHYSIOTHERAPY TREATMENT

EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP

EXPERIMENTAL

Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.

Procedure: EXPERIMENTAL diaphragmatic breathing exercise

Interventions

STANDARD PHYSIOTHERAPY TREATMENT PROCEDURE

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.

STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP

EXPERIMENTAL diaphragmatic breathing exercise PROCEDURE

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.

EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

Location

Related Publications (26)

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MeSH Terms

Conditions

Agnosia; Motor Activity

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• antonio culcasi, PT

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: it will be masking also data analyzer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 5, 2022
• Study Start: June 29, 2022
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)