Spine SurgeryNCT07795697
Telerehabilitation After Spine Surgery
A study testing Telerehabilitation method, Nurse instructions and Physiotherapy after surgery, personal in people with Spine Surgery and Telerehabilitation, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Spine Surgery, Telerehabilitation, Low Back Pain
- What is being tested?
- Telerehabilitation method, Nurse instructions and Physiotherapy after surgery, personal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One-level spinal condition requiring decompression surgery
- Working-age group: 20-65 years; Elderly group 65-85 years
- Willing to participate
Who cannot join
- Malignant disease under active treatment
- Other disease affecting spine (for example ankylosing disease or vertebral fracture)
- Opioid or other substance dependancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio
Janne Pesonen, +358447179703, janne.pesonen@pshyvinvointialue.fi
Jannina Koponen
About this study
Official title: Telerehabilitation as a Method of Rehabilitation Instructions After Spinal Decompression Surgery
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:
- Does the method or timing of post-operative information influence healthcare utilization or recovery after surgery?
- Are telerehabilitation methods easily accessible and usable for the elderly population?
- 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.
- Conditions
- Spine Surgery, Telerehabilitation, Low Back Pain
- Being tested
- Telerehabilitation method, Nurse instructions, Physiotherapy after surgery, personal, Hospital physioterapy
- Keywords
- Spine decompression, telerehabilitation, daily activity
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation methodProcedure or surgery
Rehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method
Nurse instructionsProcedure or surgery
Nurse gives the patient rehabilitation instructions after surgery when the subject leaves hospital
Physiotherapy after surgery, personalProcedure or surgery
Physiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital
Hospital physioterapyProcedure or surgery
Physiotherapist gives the patient rehabilitation instructions at the hospital outpatient clinic after 4-7 days post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Working-aged spinal decompression, one-level, ppt | Active comparator | Patient receives physiotherapy personally after surgery while leaving hospital Receives: Procedure: Physiotherapy after surgery, personal |
| Working-aged spinal decompression, one-level, tele | Experimental | Patient receives telerehabilitation personally after surgery 5-7 days Receives: Procedure: Telerehabilitation method |
| Working-aged spinal decompression, one-level, nurse | Placebo comparator | Patient receives nurse's instructions personally after surgery while leaving hospital Receives: Procedure: Nurse instructions |
| Elderly spinal decompression, one-level, tele | Experimental | Patient receives telerehabilitation personally after surgery 5-7 days Receives: Procedure: Telerehabilitation method |
| Elderly spinal decompression patient, one-level, hpt | Experimental | Patient receives physiotherapy personally after surgery at hospital outpatient clinic Receives: Procedure: Hospital physioterapy |
| Elderly spinal decompression patient, one-level, ppt | Active comparator | Patient receives physiotherapy personally after surgery when leaving the Receives: Procedure: Physiotherapy after surgery, personal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after surgery
Pain level / numerical rating scale, range 0-10 where 0 is no pain and 10 is most severe pain imaginable
Measured: From enrollment to 1 year
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).
Measured: From enrollment and surgery to 12months after surgery
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
Measured: From enrollment to 12 months after surgery
Secondary outcomes (11)
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.
Measured: From enrollment to 1 year after operation
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.
Measured: From enrollment to surgery and 12 months post-op
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
Measured: From enrollment to 12 months post-operative
Contacts to healthcare provider
How many times a participant needs to contact a healthcare provider
Measured: From enrollment and surgery to 12months after surgery
Satisfaction to treatment and post-op rehabilitation
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", ...
Measured: From enrollment to 12 months post-op
Function after operation
Oswestry Disability Index (ODI)
Measured: From enrollment to 12 months post-operative
6-minute walking test
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).
Measured: From enrollment and surgery to 12months after post-op
Timed up and go test (3 meters distance)
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.
Measured: From enrollment and surgery to 12months after post-op
Walking speed
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)
Measured: From enrollment and surgery to 12 months postoperatively
Grip strength
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.
Measured: From enrollment and surgery through 12 months postoperatively
Balance
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.
Measured: From enrollment and surgery through 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Nov 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janne Pesonen, MD, PhD, Study director, Kuopio University Hospital; Department of Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795697
- Sponsor's protocol ID
- KUH5960456
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: European Union Data Protection Regulations are very strict. Also, ethical committee prevents the data sharing unless absolutely necessary, and on which occasion the data request must be independently assessed
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation as a Method of Rehabilitation Instructions After Spinal Decompression Surgery
- ClinicalTrials.gov ID
- NCT07795697
- Acronym / sponsor ID
- KUH5960456
- Conditions
- Spine Surgery, Telerehabilitation, Low Back Pain
- Keywords
- Spine decompression, telerehabilitation, daily activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the method or timing of post-operative information influence healthcare utilization or recovery after surgery?
- Are telerehabilitation methods easily accessible and usable for the elderly population?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Working-aged spinal decompression, one-level, ppt | Active comparator | Procedure: Physiotherapy after surgery, personalPatient receives physiotherapy personally after surgery while leaving hospital |
| Working-aged spinal decompression, one-level, tele | Experimental | Procedure: Telerehabilitation methodPatient receives telerehabilitation personally after surgery 5-7 days |
| Working-aged spinal decompression, one-level, nurse | Placebo comparator | Procedure: Nurse instructionsPatient receives nurse's instructions personally after surgery while leaving hospital |
| Elderly spinal decompression, one-level, tele | Experimental | Procedure: Telerehabilitation methodPatient receives telerehabilitation personally after surgery 5-7 days |
| Elderly spinal decompression patient, one-level, hpt | Experimental | Procedure: Hospital physioterapyPatient receives physiotherapy personally after surgery at hospital outpatient clinic |
| Elderly spinal decompression patient, one-level, ppt | Active comparator | Procedure: Physiotherapy after surgery, personalPatient receives physiotherapy personally after surgery when leaving the |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- One-level spinal condition requiring decompression surgery
- Working-age group: 20-65 years; Elderly group 65-85 years
- Willing to participate
Key exclusion criteria (3 listed)
- Malignant disease under active treatment
- Other disease affecting spine (for example ankylosing disease or vertebral fracture)
- Opioid or other substance dependancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation methodRehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method | Procedure or surgery | Elderly spinal decompression, one-level, tele, Working-aged spinal decompression, one-level, tele |
| Nurse instructionsNurse gives the patient rehabilitation instructions after surgery when the subject leaves hospital | Procedure or surgery | Working-aged spinal decompression, one-level, nurse |
| Physiotherapy after surgery, personalPhysiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital | Procedure or surgery | Elderly spinal decompression patient, one-level, ppt, Working-aged spinal decompression, one-level, ppt |
| Hospital physioterapyPhysiotherapist gives the patient rehabilitation instructions at the hospital outpatient clinic after 4-7 days post-operatively | Procedure or surgery | Elderly spinal decompression patient, one-level, hpt |
Primary outcome
Pain after surgery
Time frame: 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
Time frame: 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)
Time frame: 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
11 secondary outcomes
Daily activity level after surgery
Time frame: From enrollment to 1 year after operation
Overall health
Time frame: From enrollment to surgery and 12 months post-op
Overall Health / EuroQol VAS
Time frame: From enrollment to 12 months post-operative
Contacts to healthcare provider
Time frame: From enrollment and surgery to 12months after surgery
Satisfaction to treatment and post-op rehabilitation
Time frame: From enrollment to 12 months post-op
Function after operation
Time frame: From enrollment to 12 months post-operative
6-minute walking test
Time frame: From enrollment and surgery to 12months after post-op
Timed up and go test (3 meters distance)
Time frame: From enrollment and surgery to 12months after post-op
Walking speed
Time frame: From enrollment and surgery to 12 months postoperatively
Grip strength
Time frame: From enrollment and surgery through 12 months postoperatively
Balance
Time frame: From enrollment and surgery through 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. European Union Data Protection Regulations are very strict. Also, ethical committee prevents the data sharing unless absolutely necessary, and on which occasion the data request must be independently assessed
Related trials for Spine Surgery
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Recruiting
Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring
Spine Surgery, Intraoperative Neurophysiological Monitoring
Enrolling by invitation
SpinePal Open Pilot
Spine Surgery
Recruiting
Surgical Recovery Support Pillow for Spine Surgeries
Spine Surgery Complications, Infection
RecruitingObservational study
ACSS Approach on Dysphagia
Anterior Cervical Spine Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janne Pesonen, MD, PhD study director
Kuopio University Hospital; Department of Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation method, Nurse instructions and Physiotherapy after surgery, personal in people with Spine Surgery and Telerehabilitation, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janne Pesonen, MD, PhD (+358 447179703, janne.pesonen@pshyvinvointialue.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after surgery (time frame: From enrollment to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.