Effects of Orthosis & Exercise on Spondylolisthesis

NCT06989138 | Not Yet Recruiting

• 1 other identifier: E-10840098-202.3.02-2220
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spondylolisthesis; Orthosis; Exercise Training

Keywords

Spondylolisthesis; Orthosis; Exercise; Stabilization; Physical function; Kinesiophobia

Outcome Measures

Primary Outcomes (5)

• World Health Organization Quality of Life Scale Short Form

  The scale, consists of 4 sections (physical health, psychological health, social relations and environment) and a total of 27 questions. The individual is asked to score the questions between 1-5, taking into account the last 15 days. Higher scores in the total score and subscales indicate better quality of life.

  Week 0, week 10, week 12

• Berg Balance Scale

  This scale is a 14-question test assessing postural control and fall risk. Each question is scored between 0-4 and the maximum score is 56. 0-20 points are defined as impaired balance / high fall risk, 21-40 points as acceptable balance / moderate fall risk, 41-56 points as good balance / low fall risk.

  Week 0, week 10, week 12

• Joint Position Sensation

  It will be assessed by joint position sense, which measures the patients' ability to actively reposition the lower back to their neutral position. The patient will be seated with feet on the floor, hands on the thighs, hip-knee flexed 90 degrees with the back on a hard surface and the patient will be instructed to assume a neutral lumbar spine position. The stabilizer pressure biofeedback device will be placed between the neutral spine and the hard surface and inflated to 70 mmHg. The participant will be asked to perform maximal anterior and posterior pelvic tilts 2 times in succession, waiting 5 seconds at each end point, and then return to the neutral position. The pressure difference between the initial and final measurement will be recorded.

  Week 0, week 10, week 12

• McGill Pain Questionnaire Short Form

  In the questionnaire, pain level is defined with 15 words consisting of 11 sensory and 4 affective words (0-3 points). The pain felt at the time of the questionnaire is measured with the VAS 6-point Likert scale (0-5). In total, pain is scored between 0-45 (no pain=0, severe pain=45).

  Week 0, week 10, week 12

• Oswestry Disability Index

  Disability will be assessed with the Oswestry Disability Index (ODI), which consists of 10 questions that determine functional disability for activities such as sitting, walking, personal care, standing, social life, traveling, and sleeping. Each question has 6 options and the patient is asked to choose the statement that best describes his/her condition. Each question is evaluated between 0-5 points. The question about sexual life may not be answered if it is not appropriate for the person's situation. The higher the score, the higher the level of limitation. The total score percentage varies between 0-100. In scoring, a score of 0-20% indicates minimal disability, 20-40% indicates moderate disability, 40-60% indicates severe disability, and over 60% indicates severe disability. The total score percentage is calculated as follows. "Total Score Percentage= Total Score/(5x Number of Questions Answered) x 100".

  Week 0, week 10, week 12

Secondary Outcomes (5)

• Manual Muscle Test

  Week 0, week 10, week 12

• Pelvic Parameters

  Week 0, week 12

• Tampa Kinesiophobia Scale

  Week 0, week 10, week 12

• Global Rating of Change

  week 12

• Use of Orthotics and Home Exercise Diary

  On a weekly basis up to 3 months

Study Arms (3)

Stabilization Exercise Group

EXPERIMENTAL

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.

Other: Stabilitation Exercise; Other: Orthosis

Conventional Exercise Group

EXPERIMENTAL

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.

Other: Conventional Exercise; Other: Orthosis

Control Group

NO INTERVENTION

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

Interventions

Stabilitation Exercise 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.

Stabilization Exercise Group

Conventional Exercise 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.

Conventional Exercise Group

Orthosis 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; Stabilization Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead
• Baltalimani Bone Diseases Research and Training Hospital: collaborator

MeSH Terms

Conditions

Spondylolisthesis; Motor Activity; Kinesiophobia

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Fatma Dilge AŞIK BOZDEMİR, Lecturer

CONTACT

+90 506 371 44 44; dilge.asik@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer - PhD(c)

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 25, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share