Effects of Orthosis & Exercise on Spondylolisthesis

NCT ID: NCT06989138

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-07-31

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.

Conditions

Spondylolisthesis; Orthosis; Exercise Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stabilization Exercise Group

Participants diagnosed with spondylolisthesis after randomization and assigned to the stabilization exercise group will be treated after being evaluated by the research therapist. In this context, the physiotherapist will structure a program consisting of a combination of recommended soft orthosis, pain control, stabilization exercises, posture training and home exercises. Soft orthosis will be applied for 10-12 hours a day for 4-6 weeks; 20 minutes of TENS and 20 minutes of Hotpack for pain control; and stabilization exercises with Stabilizer Pressure Biofeedback device. The planned stabilization exercise program will be 30-35 minutes; 15 minutes of posture training will be applied. These applications will be performed in the clinical environment 2 days a week for 10 weeks with a physiotherapist. Participants will be asked to practice the home exercise program taught in the training session 6 days a week for 12 weeks, excluding clinical applications.

Group Type: EXPERIMENTAL

Stabilitation Exercise

Intervention Type: OTHER

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.

Orthosis

Intervention Type: OTHER

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.

Conventional Exercise Group

After randomization, participants assigned to the conventional exercise group and diagnosed with spondylolisthesis will be evaluated and treated by the research therapist. In this context, the physiotherapist will structure a program consisting of a combination of the recommended soft orthosis, physiotherapy (pain control and exercise) and home exercises. The soft orthosis will be applied 10-12 hours a day for 4-6 weeks; 20 minutes of TENS and 20 minutes of Hotpack for pain control; 30-35 minutes of conventional exercise program will be applied. These applications will be performed in the clinical environment 2 days a week for 10 weeks in the presence of a physiotherapist. Participants will be asked to perform the home exercise program taught in the training session 6 days a week for 12 weeks, excluding clinical applications.

Group Type: EXPERIMENTAL

Conventional Exercise

Intervention Type: OTHER

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.

Orthosis

Intervention Type: OTHER

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.

Control Group

Individuals who have been diagnosed with spondylolisthesis and have not undergone the recommended treatment will be included in the control group for the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baltalimani Bone Diseases Research and Training Hospital

OTHER_GOV

Sponsor Role: collaborator

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Dilge ASIK BOZDEMIR

Lecturer - PhD(c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatma Dilge AŞIK BOZDEMİR, Lecturer

Role: CONTACT

dilge.asik@medipol.edu.tr

+90 506 371 44 44

Other Identifiers

E-10840098-202.3.02-2220

Identifier Type: -

Identifier Source: org_study_id