Telerehabilitation After Spine Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-85
SponsorKuopio University Hospital
About this trial
The goal of this randomized clinical trial is to assess how different methods of delivering post-operative instructions affect the participants' recovery after spinal decompression surgery. In addition, the investigators evaluate the related healthcare costs and the use of healthcare services in both working-age and elderly populations. The main research questions of the study are:
1. Does the method or timing of post-operative information influence healthcare utilization or recovery after surgery? 2. Are telerehabilitation methods easily accessible and usable for the elderly population? 3. Does early intervention provided in the hospital lead to different recovery times after surgery?
The outcome measures include pain levels, daily activity levels, and healthcare utilization. The results will be compared between study groups based on the information delivery method and age group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
One-level spinal condition requiring decompression surgery
Working-age group: 20-65 years; Elderly group 65-85 years
Willing to participate
Disqualifiers
Malignant disease under active treatment
Other disease affecting spine (for example ankylosing disease or vertebral fracture)
Opioid or other substance dependancy
Trial design
Design model
Parallel
Treatments tested in this trial
Telerehabilitation method
Procedure/SurgeryRehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method
Nurse instructions
Procedure/SurgeryNurse gives the patient rehabilitation instructions after surgery when the subject leaves hospital
Physiotherapy after surgery, personal
Procedure/SurgeryPhysiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital
Hospital physioterapy
Procedure/SurgeryPhysiotherapist gives the patient rehabilitation instructions at the hospital outpatient clinic after 4-7 days post-operatively
Treatment groups
300 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Working-aged spinal decompression, one-level, pptActive comparator 1 intervention
Group B: Working-aged spinal decompression, one-level, teleExperimental treatment 1 intervention
Group C: Working-aged spinal decompression, one-level, nursePlacebo comparator 1 intervention
Group D: Elderly spinal decompression, one-level, teleExperimental treatment 1 intervention
Group E: Elderly spinal decompression patient, one-level, hptExperimental treatment 1 intervention
Group F: Elderly spinal decompression patient, one-level, pptActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain after surgery
Pain level / numerical rating scale, range 0-10 where 0 is no pain and 10 is most severe pain imaginable
Time frame
From enrollment to 1 year2
Function after surgery
Function/disability after surgery: investigators assess participants' function and disability by Roland-Morris Disability Questionnaire (RMDQ). RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).
Time frame
From enrollment and surgery to 12months after surgery3
Disability after surgery (Oswestry Disability Index, ODI)
Oswestry Disability Index (ODI) is a tool used to assess the impact of low back pain on daily functioning. It consists of a questionnaire with 10 questions that evaluate various aspects of daily activities, such as movement, sitting, standing, and sleeping. Each question is scored on a scale from 0 to 5, where 0 indicates no restrictions and 5 indicates significant restrictions. The total score is calculated by summing the scores from the questions, and the higher the score, the greater the impact of the condition on daily life. Common interpretation ranges include: 0-20 Normal or minimal disability; 21-40 Moderate disability; 41-60 Severe disability; 61-80 Disability that significantly restricts daily activities; 81-100 Bed bound or symptoms may be exaggerated
Time frame
From enrollment to 12 months after surgerySecondary outcomes
1
Daily activity level after surgery
Daily amount of steps, as measured with Garmin wearable activity tracker. Investigatos get the steps taken per day from the device as well as activity index measured by the device.
Time frame
From enrollment to 1 year after operation2
Overall health
Overall health EuroQol 5D questionnaire: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: (1) no problems, (2) slight problems, (3) moderate problems, (4) severe problems and (5) extreme problems. Each category is measured by above levels independently. The 5 dimensions' points do not combine as a sum score.
Time frame
From enrollment to surgery and 12 months post-op3
Overall Health / EuroQol VAS
The EuroQol Visual Analog Scale (EQ VAS) records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. EQ VAS range is 0-100 where 0 represents worst health the participant can imagine and 100 best health imaginable
Time frame
From enrollment to 12 months post-operative4
Contacts to healthcare provider
How many times a participant needs to contact a healthcare provider
Time frame
From enrollment and surgery to 12months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov