NCT07789067

Brief Summary

The aim of this study is to investigate the effects of physiotherapy on pulmonary function tests and psychosocial status in patients with lumbar discopathy. Participants undergo a 15-session physiotherapy program. Respiratory function tests and questionnaires, including the Visual Analogue Scale (VAS) for pain, Short Form-36 (SF-36), and Roland Morris Disability Questionnaire (RMQ), are performed before and after the physiotherapy program to evaluate the outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 12, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

PhysiotherapyPsychosocial statusLumbar discopathyPulmonary function tests

Outcome Measures

Primary Outcomes (1)

  • Change in Pulmonary Function (FVC and FEV1)

    Baseline (pre-treatment) and at the end of the 15-session physiotherapy program (approximately 3 weeks).

Secondary Outcomes (1)

  • Change in Roland Morris Disability Questionnaire (RMQ) Score

    Baseline (pre-treatment) and at the end of the 15-session physiotherapy program (approximately 3 weeks).

Study Arms (1)

Physiotherapy Group

EXPERIMENTAL

All patients received a 15-session physiotherapy program administered 5 days a week. The protocol included Ultrasound, Hotpack, TENS, posture/core stabilization exercises, and a respiratory exercise program

Other: Physiotherapy Program

Interventions

A 15-session physiotherapy program applied to the lumbar region, 5 days a week. The daily protocol consists of Ultrasound (1.5 W/cm2 for 10 minutes), Hotpack (20 minutes), TENS (conventional mode for 20 minutes), and a 10-minute exercise program including core stabilization, posture, and respiratory exercises.

Physiotherapy Group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with lumbar disc herniation (bulging, protrusion, and extruded herniation) based on a lumbar MRI taken within the past 1 year. -
  • Patients with normal hemogram and C-reactive protein (CRP) values within the past 1 month.
  • Patients who intended to undergo physiotherapy as a component of their treatment.

You may not qualify if:

  • Moderate to advanced scoliosis.
  • Previous surgery for lumbar disc herniation.
  • Diagnosis or suspicion of rheumatological disease.
  • Diagnosis of cancer.
  • Epilepsy.
  • Cardiac pacemaker or advanced heart failure.
  • Neurological deficit that significantly affects walking, progressive neurologic deficit, or cauda equina syndrome.
  • Osteoporotic vertebral fracture or rib fracture.
  • Current active upper or lower respiratory tract infection.
  • History of respiratory system abnormalities or a disease affecting the rib cage.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Pendik Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients included in the study received the same 15-session physiotherapy program without being divided into different intervention groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 27, 2026

Study Start

November 2, 2020

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations