Clinical trial NCT06989138: Effects of Orthosis & Exercise on Spondylolisthesis
Official title: The Effect of Orthosis and Exercise Training on Pain, Physical Function and Quality of Life in Patients With Spondylolisthesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spondylolisthesis
Orthosis
Exercise Training
Keywords: Spondylolisthesis
Orthosis
Exercise
Stabilization
Physical function
Kinesiophobia
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: Baltalimani Bone Diseases Research and Training Hospital
First posted: 2025-05-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the treatment of spondylolisthesis, conservative methods are initially preferred unless severe neurological symptoms are present; surgical treatment is only performed in refractory cases lasting at least 3-6 months. Conservative treatment consists of orthotic use, activity restriction, pain control, physiotherapy and exercise. Orthotics may promote healing by restricting movement; however, there are not enough studies on this subject. Exercise is the intervention with the highest level of evidence in chronic low back pain. The efficacy of stabilisation exercises in providing positive and long-lasting effects on pain and functional disability in patients with spondylolisthesis has been demonstrated. However, studies evaluating the effect of exercise on spinal stability and radiological findings are limited. Therefore, this study aims to compare the effects of stabilization and conventional exercises with orthosis on radiographic findings, pain, physical function and quality of life.

Detailed description: Treatment is initially conservative (in the absence of severe neurologic symptoms) and surgical treatment is only indicated for those who have been refractory to non-surgical options for at least 3 to 6 months. Conservative treatment usually consists of orthotics, activity restriction, pain control, physiotherapy program and exercise. It has been reported in the literature that the use of orthotics helps to restrict activities by acting as a physical barrier against provocative movements and allows sufficient immobilization to promote healing. However, there are not enough studies on this subject in the literature. Exercise is the intervention with the highest level of evidence for improving CLBP and is superior to all other interventions in terms of improving pain and function.

In the literature, it has been reported that stabilization exercises, one of the current types of exercises recommended for patients with spondylolisthesis, can reduce pain and functional disability in patients and that this effect can be maintained over a 30-month follow-up period. There are a limited number of studies investigating whether exercise therapy can objectively contribute to the improvement of structural stability and intervertebral motion in the spine, especially in patients with grade-I slippage preferably managed with non-invasive treatments, and the effect of exercise therapy on radiological findings in patients affected by spondylolisthesis. In the light of this information, it was planned to compare the effects of stabilization and conventional exercises combined with orthosis use on radiographic findings, pain level, physical function and quality of life in patients with spondylolisthesis.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-65
* Individuals without indication for surgery
* Individuals diagnosed with grade 1-2 spondylolysis
* Individuals without neurological deficits
* Individuals diagnosed with radicular pain or non-specific chronic low back pain for more than 3 months

Exclusion Criteria:

* Surgery recommended after diagnosis
* History of lumbar surgery
* Presence of rheumatic inflammatory diseases or diabetic polyneuropathy
* Individuals with symptoms of cauda equina or ischemic heart disease
* Presence of back pain with non-mechanical causes or non-radicular neuropathic pain
* Having received this type of exercise therapy before

Primary outcomes:
measure: World Health Organization Quality of Life Scale Short Form
timeFrame: Week 0, week 10, week 12
measure: Berg Balance Scale
timeFrame: Week 0, week 10, week 12
measure: Joint Position Sensation
timeFrame: Week 0, week 10, week 12
measure: McGill Pain Questionnaire Short Form
timeFrame: Week 0, week 10, week 12
measure: Oswestry Disability Index
timeFrame: Week 0, week 10, week 12
Secondary outcomes:
measure: Manual Muscle Test
timeFrame: Week 0, week 10, week 12
measure: Pelvic Parameters
timeFrame: Week 0, week 12
measure: Tampa Kinesiophobia Scale
timeFrame: Week 0, week 10, week 12
measure: Global Rating of Change
timeFrame: week 12
measure: Use of Orthotics and Home Exercise Diary
timeFrame: On a weekly basis up to 3 months
Other outcomes:
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