NCT07795697

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. 1.Does the method or timing of post-operative information influence healthcare utilization or recovery after surgery?
  2. 2.Are telerehabilitation methods easily accessible and usable for the elderly population?
  3. 3.Does early intervention provided in the hospital lead to different recovery times after surgery?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Nov 2025Dec 2029

Study Start

First participant enrolled

November 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

4.1 years

First QC Date

March 5, 2026

Last Update Submit

August 27, 2026

Conditions

Low Back PainTelerehabilitationSpine Surgery

Keywords

Spine decompressiontelerehabilitationdaily activity

Outcome Measures

Primary Outcomes (3)

  • Pain after surgery

    Pain level / numerical rating scale, range 0-10 where 0 is no pain and 10 is most severe pain imaginable

    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).

    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

    From enrollment to 12 months after surgery

Secondary Outcomes (11)

  • Daily activity level after surgery

    From enrollment to 1 year after operation

  • Overall health

    From enrollment to surgery and 12 months post-op

  • Overall Health / EuroQol VAS

    From enrollment to 12 months post-operative

  • Contacts to healthcare provider

    From enrollment and surgery to 12months after surgery

  • Satisfaction to treatment and post-op rehabilitation

    From enrollment to 12 months post-op

  • +6 more secondary outcomes

Study Arms (6)

Working-aged spinal decompression, one-level, ppt

ACTIVE COMPARATOR

Patient receives physiotherapy personally after surgery while leaving hospital

Procedure: Physiotherapy after surgery, personal

Working-aged spinal decompression, one-level, tele

EXPERIMENTAL

Patient receives telerehabilitation personally after surgery 5-7 days

Procedure: Telerehabilitation method

Working-aged spinal decompression, one-level, nurse

PLACEBO COMPARATOR

Patient receives nurse's instructions personally after surgery while leaving hospital

Procedure: Nurse instructions

Elderly spinal decompression, one-level, tele

EXPERIMENTAL

Patient receives telerehabilitation personally after surgery 5-7 days

Procedure: Telerehabilitation method

Elderly spinal decompression patient, one-level, hpt

EXPERIMENTAL

Patient receives physiotherapy personally after surgery at hospital outpatient clinic

Procedure: Hospital physioterapy

Elderly spinal decompression patient, one-level, ppt

ACTIVE COMPARATOR

Patient receives physiotherapy personally after surgery when leaving the

Procedure: Physiotherapy after surgery, personal

Interventions

Nurse instructionsPROCEDURE

Nurse gives the patient rehabilitation instructions after surgery when the subject leaves hospital

Working-aged spinal decompression, one-level, nurse
Physiotherapy after surgery, personalPROCEDURE

Physiotherapist gives the patient rehabilitation instructions after surgery when the subject leaves hospital

Elderly spinal decompression patient, one-level, pptWorking-aged spinal decompression, one-level, ppt
Hospital physioterapyPROCEDURE

Physiotherapist gives the patient rehabilitation instructions at the hospital outpatient clinic after 4-7 days post-operatively

Elderly spinal decompression patient, one-level, hpt
Telerehabilitation methodPROCEDURE

Rehabilitation instrucions given by physiotherapist 4-7 days after surgery with remote telerehabilitation method

Elderly spinal decompression, one-level, teleWorking-aged spinal decompression, one-level, tele

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One-level spinal condition requiring decompression surgery
  • Working-age group: 20-65 years; Elderly group 65-85 years
  • Willing to participate

You may not qualify if:

  • Malignant disease under active treatment
  • Other disease affecting spine (for example ankylosing disease or vertebral fracture)
  • Opioid or other substance dependancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janne Pesonen, MD, PhD

    Kuopio University Hospital; Department of Rehabilitation

    STUDY DIRECTOR

Central Study Contacts

Janne Pesonen, MD, PhD

CONTACT

+358 447179703janne.pesonen@pshyvinvointialue.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

August 31, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

August 31, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations

FI(1)