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

Overview

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.

Interventions

• 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 th
• 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 th
• 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 th

Primary outcome measures

• World Health Organization Quality of Life Scale Short Form [Time frame: Week 0, week 10, week 12]
• Berg Balance Scale [Time frame: Week 0, week 10, week 12]
• Joint Position Sensation [Time frame: Week 0, week 10, week 12]
• McGill Pain Questionnaire Short Form [Time frame: Week 0, week 10, week 12]
• Oswestry Disability Index [Time frame: Week 0, week 10, week 12]

Secondary outcome measures (5)

• Manual Muscle Test [Time frame: Week 0, week 10, week 12]
• Pelvic Parameters [Time frame: Week 0, week 12]
• Tampa Kinesiophobia Scale [Time frame: Week 0, week 10, week 12]
• Global Rating of Change [Time frame: week 12]
• Use of Orthotics and Home Exercise Diary [Time frame: On a weekly basis up to 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istanbul Medipol University — Istanbul

Identifiers

NCT: NCT06989138 · E-10840098-202.3.02-2220

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗