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Not yet recruiting NCT07734909

Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability

No phase Interventional Lumbar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diaphragm strengthening, Core stability exercises.
Who it may be relevant to
Registry conditions: Lumbar. Basic parameters: 25 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of this study is to compare the effect of combining diaphragmatic strengthening with core stability exercises versus core stability exercises alone on recovery time, pain, and stability in lumbar instability individuals.

Detailed description

Lumbar instability is a common medical problem. There is a 50-70% chance of a person suffering from LBP during his or her lifetime having lumbar instability. It is often referred to as clinical spinal instability. Clinical spinal instability is controversial and poorly understood. Properly conducted clinical studies of patients with spinal pain and documented clinical instability would be good to explore this concept. However, pursuing such a course is difficult.

The diaphragm has a dual role in respiration and postural control. Evidence suggests that current core stability exercises for low back pain are superior to minimal or no treatment, however, no more beneficial than general exercises and/or manual therapy. There appears to be a higher focus on the transverses abdominis and multifidi muscles and minimal attention to the diaphragm.

We propose that any form of core stabilization exercises for low back pain rehabilitation should consider the diaphragm. Core stabilization program could commence with facilitation of normal breathing patterns and progressive systematic restoration of the postural control role of the diaphragm muscle.

So, the aim of this trial is to determine whether combining diaphragmatic strengthening exercises with core stability training leads to faster improvements in pain and instability in individuals with lumbar instability, compared to traditional core exercises alone.

Interventions

  • Other Diaphragm strengthening
    Participants will receive supervised diaphragm strengthening exercises combined with core stability training, three sessions per week for 8 weeks (45 minutes/session). Diaphragm strengthening will be performed using an elastic TheraBand wrapped around the thoracolumbar junction to provide progressive inspiratory resistance, with intensity progressed according to the Borg Rating of Perceived Exertion (RPE: 11 during weeks 1-2, 13 during weeks 3-5, and 15 during weeks 6-8).
  • Other Core stability exercises
    Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session). The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks. Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.

Primary outcome measures

  • Pain intensity assessed using the Visual Analogue Scale (VAS) [Time frame: 8 weeks]
  • Pressure pain threshold assessed by pressure algometry [Time frame: 8 weeks]
Secondary outcome measures (2)
  • Core muscle stability assessed using a Pressure Biofeedback Unit (PBU) [Time frame: 8 weeks]
  • Functional disability assessed using the Oswestry Disability Index (ODI) [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • Age between 25 and 35 years.
  • Positive prone instability test.
  • Straight leg raising >90 degrees.
  • Pain assessment on VAS >5/10.
  • All patients will suffer from clinical lumber instability (characterized by excessive movement in specific segments during active movement and posterior-anterior spring test causing large movements and pain)

Exclusion criteria

  • Patients with cardiovascular diseases.
  • Patients with cerebrovascular diseases.
  • Patients with neurological diseases.
  • Patients with any attention disorders or physical disability.
  • Patients with any diseases/conditions preventing physical activity participation.
  • Patients with history of back surgery, inflammatory spinal disorder, deformed vertebrae, fracture, or neurological radiating pain.
  • Patients with central obesity (A waist to hip ratio >0.90 in males or > 0.85 in females).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Outpatient clinic of the faculty of physical therapy, Cairo University — Cairo

Identifiers

NCT: NCT07734909 · P.T.REC/012/006064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗