Effects of Orthosis & Exercise on Spondylolisthesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18-65
Individuals without indication for surgery
Individuals diagnosed with grade 1-2 spondylolysis
Individuals without neurological deficits
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Stabilitation Exercise
Other interventionPatients 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
Other interventionPatients 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
Other interventionPatients 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.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Stabilization Exercise GroupExperimental treatment 2 interventions
Group B: Conventional Exercise GroupExperimental treatment 2 interventions
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 0, week 10, week 122
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.
Time frame
Week 0, week 10, week 123
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.
Time frame
Week 0, week 10, week 124
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).
Time frame
Week 0, week 10, week 12Secondary outcomes
1
Manual Muscle Test
Abdominal muscle strength and lumbar extensor muscle strength will be assessed by manual muscle testing as described in the literature.
Time frame
Week 0, week 10, week 122
Pelvic Parameters
Pelvic parameters (sacral slope angle in degrees, pelvic incidence in degrees, lumbar lordosis in degrees, pelvic tilt in degrees) will be evaluated by the physician on lateral radiographs before treatment and at 3 months. Lateral radiographs will be evaluated in the presence of standard lateral radiographs required for diagnosis and at the 3rd month control, and will not be requested extra from the patients.
Time frame
Week 0, week 123
Tampa Kinesiophobia Scale
Kinesiophobia will be assessed with the 17-item Tampa Kinesiophobia Scale with 4-point Likert scoring. A total score is calculated after reversing items 4, 8, 12 and 16. The person receives a total score between 17-68 and a high score indicates high kinesiophobia.
Time frame
Week 0, week 10, week 124
Global Rating of Change
Overall satisfaction and the change perceived by the participants after the training program will be assessed using the Global Rating of Change (GROC). The GROC requires the participant to recall their health status at a time point prior to the intervention and assess their current health status after the intervention, then calculate the difference between the two. The magnitude of this difference is scored by the person on a numeric or visual analog scale. In our study, a numeric scale with descriptive statements at 7 points on it, which is considered reliable in the literature (r = 0.87), will be used.
Time frame
week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medipol University
Lead sponsor
Baltalimani Bone Diseases Research and Training Hospital
Collaborator
Source ClinicalTrials.gov