Low Back Pain, Spine Surgery, Telerehabilitation
Conditions
Keywords
Spine decompression, telerehabilitation, daily activity
Brief summary
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.
Interventions
PROCEDURETelerehabilitation method
Rehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method
PROCEDURENurse instructions
Nurse gives the patient rehabilitation instructions after surgery when the subject leaves hospital
PROCEDUREPhysiotherapy after surgery, personal
Physiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital
PROCEDUREHospital physioterapy
Physiotherapist gives the patient rehabilitation instructions at the hospital outpatient clinic after 4-7 days post-operatively
Sponsors
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* One-level spinal condition requiring decompression surgery * Working-age group: 20-65 years; Elderly group 65-85 years * Willing to participate
Exclusion criteria
* Malignant disease under active treatment * Other disease affecting spine (for example ankylosing disease or vertebral fracture) * Opioid or other substance dependancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain after surgery | From enrollment to 1 year | Pain level / numerical rating scale, range 0-10 where 0 is no pain and 10 is most severe pain imaginable |
| Function after surgery | From enrollment and surgery to 12months 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). |
| Disability after surgery (Oswestry Disability Index, ODI) | From enrollment to 12 months after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily activity level after surgery | From enrollment to 1 year after operation | 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. |
| Overall health | From enrollment to surgery and 12 months post-op | 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. |
| Overall Health / EuroQol VAS | From enrollment to 12 months post-operative | 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 |
| Contacts to healthcare provider | From enrollment and surgery to 12months after surgery | How many times a participant needs to contact a healthcare provider |
| Satisfaction to treatment and post-op rehabilitation | From enrollment to 12 months post-op | Satisfaction to post-op rehabilitation, asked by questionnaire by multiple YES/NO questions about the surgery and recovery period. The questions include "I am satisfied to the outcome of the operation", "I would still undergo the operation if I was able to decide now", "The operation helped to my radiculopathy", "I am happy for the rehabilitation I received after the surgery", "The physiotherapy and rehabilitation advice has been sufficient after the surgery", ... |
| Function after operation | From enrollment to 12 months post-operative | Oswestry Disability Index (ODI) |
| 6-minute walking test | From enrollment and surgery to 12months after post-op | On elderly people's research arm, investigators assess participants' physical fitness with 6-minute walking test. Investigators observes and takes time when patient walks 6 minutes in a controlled setting and the total distance covered is measured (meters). |
| Timed up and go test (3 meters distance) | From enrollment and surgery to 12months after post-op | A 3-meter distance is marked on the floor, with sufficient free space at the end to allow the person to turn around with an assistive device (e.g. a rollator). The front legs of the chair are positioned immediately behind the starting line. The test is performed while wearing shoes. The person being tested sits in the chair with their back against the backrest and their arms resting on the armrests. If necessary, a mobility aid may be kept within reach and ready for use. When the tester gives the starting command ("Ready - go"), the person stands up, walks at a comfortable and safe pace beyond the line marking the 3-meter distance, ensuring that both feet cross the line, turns around, walks back, and sits down in the chair. The time is measured to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped when the person being tested has sat back down in the chair, with their buttocks touching the seat. |
| Walking speed | From enrollment and surgery to 12 months postoperatively | Tested on elderly participants' arm. A 4-meter starting line and finish line are marked on the floor with tape. The test begins from a standing position behind the starting line and ends when the participant's body crosses the finish line. After the command "Go," the participant walks the marked distance twice at their usual pace, and the third time the participant walks the distance more as quickly as possible. The walking time is measured for all three trials to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped when the participant's body crosses the finish line. From these the average is calclulated (m/s) |
| Grip strength | From enrollment and surgery through 12 months postoperatively | On elderly participants' arm, maximum grip strength is measured using a hand dynamometer. During the test, the participant grips the dynamometer handle firmly, gradually increasing the force throughout the trial until maximum grip strength is reached. Each grip is maintained for 3-5 seconds. The position of the shoulder, elbow, and wrist joints must remain unchanged throughout the trial. The measurement unit is kilograms (kg), as indicated on the outermost scale of the dynamometer display. After the grip is released, the needle remains at the maximum value reached during the trial. Before each subsequent grip, the display is reset to zero using the screw located in the center of the display. |
| Balance | From enrollment and surgery through 12 months postoperatively | Measured on elderly participants' arm: Balance is assessed in three different positions: feet together, in a semi-tandem stance, and in a tandem stance. The participant may use a nearby table for support while positioning their feet into the required test position. Once the position has been achieved, the participant is instructed to release their hands from the support, after which the tester starts the timer. The time is measured to the nearest 0.01 seconds. The tester starts the timer with the command "Go." The timer is stopped after 10 seconds have elapsed or if the participant's feet move out of the required test position or if they use their hands for support. |
Countries
Finland
Contacts
CONTACTJanne Pesonen, MD, PhD
STUDY_DIRECTORJanne Pesonen, MD, PhD
Kuopio University Hospital; Department of Rehabilitation
Outcome results
None listed