NCT07749248

Brief Summary

Background and Objective: Information regarding the effects of physiotherapy on quality of life and alterations in pulmonary function tests among patients with thoracic discopathy is notably limited in the literature. This study aims to compare the effects of the classical physiotherapy approach and the addition of breathing exercises to classical physiotherapy on quality of life and respiratory function tests in patients with thoracic discopathy. Study Design and Methods: This controlled and randomized study includes 40 patients diagnosed with thoracic discopathy. Participants are divided into two groups. The first group undergoes 15 sessions of classical physiotherapy consisting of ultrasound, TENS, hot packs, and posture exercises. The second group receives the same classical physiotherapy program with the addition of respiratory exercises. The patients' disability, psychosocial well-being, and pulmonary function are assessed using standardized scales and questionnaires at baseline (pre-treatment) and after the 15-session intervention (post-treatment).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

July 28, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

PhysiotherapyBreathing ExercisesPulmonary Function TestsPsychosocial Well-BeingQuality of Life

Outcome Measures

Primary Outcomes (4)

  • Change in Forced Expiratory Volume in 1 Second (FEV1)

    FEV1 measures the volume of air forcefully exhaled in the first second of a forced exhalation, assessed via spirometry. The unit of measure is Liters (L). A higher value indicates better pulmonary function.

    Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program.

  • Change in 36-Item Short Form Survey (SF-36) Physical Functioning Score

    The SF-36 questionnaire assesses health-related quality of life. The physical functioning subscale evaluates limitations in performing physical activities. The score ranges from 0 to 100. Higher scores represent better physical functioning and a higher quality of life.

    Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program

  • Change in Resting Pain Intensity assessed by Visual Analog Scale (VAS)

    Pain intensity at rest is evaluated using a visual analog scale. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents the "worst imaginable pain". A lower score indicates a reduction in pain intensity and clinical improvement.

    Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program.

  • Change in FEV1/FVC Ratio Percentage

    The ratio of Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity (FVC), expressed as a percentage (%). This is measured via spirometry to assess airflow limitation. A higher percentage generally indicates better respiratory capacity.

    Baseline (before treatment) and immediately after the completion of the 15-session physiotherapy program.

Study Arms (2)

Only Physiotherapy

ACTIVE COMPARATOR

Patients in this group underwent 15 sessions of traditional physiotherapy consisting of ultrasound, TENS, hot packs, and posture exercises.

Other: Traditional Physiotherapy

Physiotherapy and Breathing Exercise

EXPERIMENTAL

Patients in this group participated in a breathing exercise program in addition to undergoing the same 15 sessions of traditional physiotherapy procedures (ultrasound, TENS, hot packs, and posture exercises).

Other: Traditional PhysiotherapyOther: Breathing Exercise

Interventions

Application of 15 sessions of ultrasound, TENS, hot packs, and posture exercises.

Only PhysiotherapyPhysiotherapy and Breathing Exercise

Implementation of a respiratory exercise program.

Physiotherapy and Breathing Exercise

Eligibility Criteria

Age25 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of thoracic discopathy
  • Planned to receive physiotherapy as part of their treatment

You may not qualify if:

  • Participants with pre-existing respiratory system abnormalities
  • Participants with a disease affecting the rib cage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Pendik Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back PainDyspnea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study was designed as single-blinded; the researcher responsible for conducting the pre- and post-treatment clinical questionnaires and pulmonary assessments was blinded to the patients' group allocation to minimize detection bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 40 eligible patients with thoracic discopathy were randomly assigned in a 1:1 ratio to one of two parallel groups: one group received traditional physiotherapy alone, and the other group received traditional physiotherapy combined with a respiratory exercise program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 6, 2026

Study Start

November 20, 2020

Primary Completion

February 18, 2021

Study Completion

March 20, 2021

Last Updated

August 10, 2026

Record last verified: 2026-08

Locations