NCT06989138

Effects of Orthosis & Exercise on Spondylolisthesis

The Effect of Orthosis and Exercise Training on Pain, Physical Function and Quality of Life in Patients With Spondylolisthesis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylolisthesis
• Orthosis
• Exercise Training

Interventions

Type	Name	Description
OTHER	Stabilitation Exercise	Patients will be included with the guidance of a physician specialized in the relevant field. After randomization, the patients included in the groups will be given 1 session of training before the start of treatment. In this training, soft orthosis use and home exercise programs will be explained to the patients in the intervention group. Soft orthoses; It will be explained that they should use for 10-12hours during the day for 4-6weeks, take them off during rest, sleep and exercise, and use them during active hours. Home exercise program; as in the classical approach, stretching and strengthening exercises will first be explained to the patient practically by the physiotherapist and then the patient will be asked to practice. Participants will be accompanied by a physiotherapist in the clinical environment 2 days a week for 10 weeks according to the groups they are divided into. Patients will be asked to practice the home exercise program taught in the training session 6 days a week.
OTHER	Conventional Exercise	Patients will be included with the guidance of a physician specialized in the relevant field. After randomization, the patients included in the groups will be given 1 session of training before the start of treatment. In this training, soft orthosis use and home exercise programs will be explained to the patients in the intervention group. Soft orthoses; It will be explained that they should use for 10-12hours during the day for 4-6weeks, take them off during rest, sleep and exercise, and use them during active hours. Home exercise program; as in the classical approach, stretching and strengthening exercises will first be explained to the patient practically by the physiotherapist and then the patient will be asked to practice. Participants will be accompanied by a physiotherapist in the clinical environment 2 days a week for 10 weeks according to the groups they are divided into. Patients will be asked to practice the home exercise program taught in the training session 6 days a week.
OTHER	Orthosis	Patients will be included with the guidance of a physician specialized in the relevant field. After randomization, the patients included in the groups will be given 1 session of training before the start of treatment. In this training, soft orthosis use and home exercise programs will be explained to the patients in the intervention group. Soft orthoses; It will be explained that they should use for 10-12hours during the day for 4-6weeks, take them off during rest, sleep and exercise, and use them during active hours.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2025-05-25
• Last updated: 2025-05-25