Effectiveness of a Visual Feedback Exercise Program Following Lumbar Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSuleyman Demirel University
About this trial
The aim of this study is to compare the effectiveness of stabilization exercises performed with visual feedback guided by a laser pointer after lumbar microdiscectomy surgery with that of standard stabilization exercises. The study, planned as a randomized controlled trial, will include 42 individuals aged 18-65 who have undergone lumbar microdiscectomy. Participants will be divided into two groups: a control group and a laser-guided exercise group. Both groups will undergo supervised stabilization exercises 3 days a week for 8 weeks, starting from the 6th postoperative week. The outcome measures were defined as pain, disability, back awareness, trunk muscle endurance, reaction time, balance, function, and lumbar proprioception. The findings are expected to demonstrate the effectiveness of visual feedback-assisted stabilization exercises in postoperative rehabilitation and contribute to clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
To be between 18 and 65 years of age
Patients who underwent lumbar microdiscectomy surgery
Individuals who are literate in Turkish
Disqualifiers
Patients who have previously undergone lumbar disc herniation surgery
The surgical procedure involving fusion has been performed.
Having a body mass index above 30
Suspected or confirmed tumors in the lumbar spine and spinal canal
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionParticipants undergo supervised stabilization exercises for a total of 24 sessions over 8 weeks, starting 6 weeks after lumbar microdiscectomy surgery, 3 days a week. The exercises will be performed with visual feedback provided by a laser pointer placed on the lumbar region. Participants will be asked to keep the laser pointer fixed on a designated point or line on the reference diagram in front of them during the exercises. The program includes posterior pelvic tilt, partial sit-ups, bird-dog, abdominal bracing in the supine position (progression with limb movements), straight and side planks, bridge building, pelvic floor, and diaphragmatic breathing exercises. Repetitive exercises will be performed in 3 sets of 10 repetitions, while plank exercises will initially be performed in 3 repetitions of 15-30 seconds, with progression based on the individual's performance and weeks. All participants will be provided with a post-operative training program in video format.
Control
Other interventionStarting 6 weeks after surgery, a supervised stabilization exercise program consisting of 24 sessions over 8 weeks, 3 days a week, will be implemented. The same exercises as in the laser group will be performed, but without the use of visual feedback. All participants will be provided with a post-operative training program in video format.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Laser-Guided Exercise GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Assessment
It will be assessed using the Numerical Rating Scale (NRS).
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).2
Disability Assessment
It will be measured using the Oswestry Disability Index (ODI).
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).3
Lumbar Proprioception Assessment
It will be measured using a smartphone-based inclinometer application.
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).4
Back Awareness Assessment
It will be assessed using the Fremantle Back Awareness Questionnaire.
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).Secondary outcomes
1
Trunk Muscle Endurance Assessment
The McGill Endurance Tests will measure the endurance of the trunk flexor and lateral muscles.
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).2
Lower Extremity Reaction Time Assessment
The motor response time to visual stimuli will be evaluated using the FITLIGHT® system.
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).3
Balance Assessment
Static postural control will be measured using the one-leg stance test.
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).4
Functional Performance Assessment
Functional mobility will be assessed using the timed up and go test.
Time frame
All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).Other outcomes
1
Level of compliance with educational recommendations
Participants' level of compliance with the back training and daily life recommendations provided to them during the postoperative period will be assessed using a self-report form.
Time frame
Postoperative week 62
Additional interventions
Participants will be asked whether they are receiving any other physical therapy, exercise program, or conservative treatment, and this information will be recorded.
Time frame
Up to 8 weeks3
Adverse event and adverse reaction monitoring
Any increase in pain, musculoskeletal complaints, or other potential adverse events that may occur during the exercise will be questioned and recorded during the sessions. Intervention will be terminated if necessary.
Time frame
Up to 8 weeks4
Drop-out and withdrawal reasons
The reasons for participants leaving the study (lack of motivation, health issues, incompatibility, etc.) will be documented and reported in the analyses.
Time frame
Up to 8 weeksSponsors and contacts
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Source ClinicalTrials.gov