Menu
Not yet recruiting NCT06796023

Comparison Between Lumbar Stabilization Exercises and Lumbar Manipulation on Multifidus Muscle in Chronic Low Back Pain This Study Will Investigate and Compare the Effect of Lumbar Stabilization Exercises and Manipulation on Multifidus Muscle in Chronic Low Back Pain

No phase Interventional Chronic Low Back Pain (CLBP)

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: Stretching and strengthening exercises for back muscles, Lumbar stabilization Exercises, Lumbar Manipulation.
Who it may be relevant to
Registry conditions: Chronic Low Back Pain (CLBP). Basic parameters: 45 years — 65 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison Between Lumbar Stabilization Exercises and Lumbar Manipulation on Multifidus Muscle in Chronic Low Back Pain: Randomized Control Trial

Overview

Histological and morphological changes of multifidus muscle have been reported in lumbar disc herniation (LDH), but there is scarce research comparing the efficacy of different treatment programs that can correct multifidus dysfunction in chronic low back pain (LBP) with LDH. The purpose: this study will be to investigate and compare the effect of lumbar stabilization exercises and manipulation on multifidus muscle in chronic LBP patients with LDH. Subjects: sixty patients aged ranged from 45 - 65 years suffering from chronic LBP with LDH will be randomly assigned into three groups, each group includes 20 patients. Method: group (A) (control group) will receive general exercises for back muscles, group (B) will receive general exercises and lumbar stabilization exercises, and group (C) will receive general exercises and lumbar manipulation (B and C experimental groups). The outcome measurements pre and post 6 weeks of treatment will be pain intensity by visual analogue scale (VAS), functional disabilities by Oswestry disability index (ODI), lumbar repositioning by Biodex system (LR), cross sectional area (CSA) and the asymmetry of both sides of multifidus muscle at the fourth and fifth lumbar vertebrae by ultrasonography.

Interventions

  • Other Stretching and strengthening exercises for back muscles
    Stretching and strengthening exercises for back muscles
  • Other Lumbar stabilization Exercises
    Lumbar stabilization Exercises
  • Other Lumbar Manipulation
    Lumbar Manipulation

Primary outcome measures

  • visual analogue scale [Time frame: pre and post 6 weeks]
  • functional disabilities by Oswestry disability index [Time frame: pre and post 6 weeks]
  • lumbar repositioning angle [Time frame: pre and post 6 weeks]
  • Cross sectional area of multifidus muscle [Time frame: pre and post 6 weeks]

Eligibility criteria

Inclusion criteria

  • The selected subjects had chronic LBP with magnetic resonance imaging (MRI) evidence of disc herniation at levels of L4-L5 and/or L5-S1 diagnosed by physician (orthopedist, neurosurgeon).
  • A period of continuous complaints of pain for more than 12 weeks.
  • All patients reported an average pain level of at least 5 on a scale of 0 to 10.

Exclusion criteria

  • Acute inflammatory diseases of musculoskeletal system.
  • Pathology or deformities of hip, knee and ankle joints.
  • History of surgical approach to their back or had special pathology or non spinal condition causing referred back symptoms.
  • Patient who indicated for surgery to treat lumbar disc herniation (i.e. sever intolerable pain, motor weakness, and cannot control urine and stool).
  • Cardiopulmonary diseases which decrease the patient's tolerance and activities.
  • Spondylolisthesis.
  • Diabetic neuropathy.
  • Osteoporosis.
  • A recent history of vestibular disorder or inner ear infection with associated balance and coordination problems.
  • A history of cerebral trauma with unresolved neurosensory symptoms or neurological deficits.

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
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06796023 · P.T.REC/012/004972

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗