Low Back PainNCT07173413
Assessing the Quality of Telephone Follow-Up After Spine Surgery
An observational study of Low Back Pain, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate whether the quality of physiotherapy follow-up after spinal surgery can be maintained when conducted by telephone rather than in-person. The study is motivated by the desire to save healthcare resources and reduce the environmental impact of patient travel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Telephone post-surgery physiotherapy follow-up and In person post-operative physiotherapy follow-up
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jun 2025to 1 Feb 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing lumbar spine surgery at Aalborg University Hospital, Neurosurgical Department, who are able to read and understand Danish and consent to participate in the study.
Who may be able to join
- Patients who have undergone lumbar spine surgery at the Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark.
- Able to read and understand Danish.
Who cannot join
- Withdrawel of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark.
Aalborg, Aalborg, 9000
Thorvaldur Palsson, PhD, 97664217
About this study
Official title: Evaluating the Quality of Telephone Follow-Up After Spine Surgery: A Non-Inferiority Study
The aim of this study is to investigate whether the quality of physiotherapy follow-up after spinal surgery can be maintained when conducted by telephone rather than in-person. The study is motivated by the desire to save healthcare resources and reduce the environmental impact of patient travel. Data from patient records, including age, sex, surgery procedure, use of pain medication, and time spent on either phone or in-person follow-ups, will be collected to evaluate whether telephone-based follow-up is an effective and sustainable alternative for post-operative care.
Read the detailed description
This study aims to evaluate the effectiveness and patient experience of telephone-based versus in-person physiotherapy follow-up after spinal surgery. Patients are allocated to one of two groups based on the day of the week they undergo surgery. This allocation determines whether the patient receives a follow-up assessment by telephone or in-person with a physiotherapist.
Following their assigned follow-up, patients are asked to complete questionnaires via REDCap regarding their satisfaction with the follow-up, regardless of the modality. These questionnaires also collect information on pain, physical function, and health-related quality of life. In addition to the initial assessment immediately after the follow-up, patients are sent the same questionnaires again at one and three months post-surgery.
The primary objective of the study is to compare outcomes between the two groups, evaluating whether telephone-based follow-up provides a comparable level of satisfaction, pain management, functional recovery, and quality of life to traditional in-person follow-up. The results will inform whether telephone follow-up is a viable and resource-efficient alternative to in-person assessments while maintaining high standards of post-operative care.
- Conditions
- Low Back Pain
- Being tested
- Telephone post-surgery physiotherapy follow-up, In person post-operative physiotherapy follow-up
- Keywords
- low back pain, surgery
- 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.
Telephone post-surgery physiotherapy follow-upOther
Also called Telephone physiotherapy follow-up
Post-operative physiotherapy follow-up delivered via a structured telephone consultation. The session focuses on recovery after lumbar spine surgery, addressing pain management, mobility, exercise recommendations, and guidance on daily activities. The physiotherapist evaluates the patient's status verbally, answers questions, and provides tailored advice to support safe rehabilitation without requiring the patient to attend the hospital physically.
In person post-operative physiotherapy follow-upOther
Post-operative physiotherapy follow-up delivered as an in-person consultation at the hospital. The session includes assessment of recovery after lumbar spine surgery, hands-on evaluation if needed, and tailored advice on pain management, mobility, exercise progression, and daily activity. This format allows the physiotherapist to physically observe and, if relevant, demonstrate exercises to ensure correct performance and safe rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing surgery for low back pain receiving in-person physiotherapy follow-up | Patients undergoing surgery for low back pain receiving in-person physiotherapy follow-up Receives: Other: In person post-operative physiotherapy follow-up | |
| Patients undergoing surgery for low back pain receiving telephone physiotherapy follow-up | Patients undergoing surgery for low back pain receiving telephone physiotherapy follow-up Receives: Other: Telephone post-surgery physiotherapy follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
The ODI is a validated questionnaire assessing disability related to low back pain. It includes 10 items covering pain and daily functional limitations. Each item is scored from 0 to 5, where 0 represents minimal limitation and 5 represents severe limitation. The total score ranges from 0 to 50, with higher scores indicating greater disability.
Measured: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
Secondary outcomes (3)
Health related quality of life
The EQ-5D-5L questionnaire is a standardized measure of health-related quality of life recommended for multimorbidity research. The EQ-5D-5L assesses health status across five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-point ordinal scale ranging from 1 (indicating no problems) to 5 (indicating extreme difficulties) The EQ-5D index score can be regarded as a continuous outcome and ranges from -0.624 to 1, with higher scores indicating better general health and quality of life.
Measured: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
Patient Satisfaction with Follow-up (Modified CSQ-8)
Patient satisfaction will be assessed using a modified version of the validated Client Satisfaction Questionnaire-8 (CSQ-8). The original 8-item instrument measures overall satisfaction with healthcare services. For this study, the questionnaire has been adapted to specifically reflect the follow-up consultation with the physiotherapist, ensuring that responses relate to the guidance and instruction provided during the post-operative follow-up. Modifications include context-specific wording, such as "...based on the follow-up consultation with the physiotherapist," while maintaining the original structure and response options. Higher scores indicate greater satisfaction.
Measured: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
Back and leg pain (VAS, 0-100 mm)
Leg pain and back pain will be assessed using a 0-100 mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "worst imaginable pain."
Measured: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start12 Jun 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Christiansen Gandløse, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173413
- Sponsor's protocol ID
- K2025-124
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including questionnaire responses, pain scores, and functional outcomes) will be made available upon reasonable request to qualified researchers. Data will be shared after publication of the main study results. Requests must include a research proposal and be approved by the study investigators. Data will be shared under a data use agreement to ensure confidentiality and compliance with Danish data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Quality of Telephone Follow-Up After Spine Surgery: A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT07173413
- Acronym / sponsor ID
- K2025-124
- Conditions
- Low Back Pain
- Keywords
- low back pain, surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 15 Sep 2025 (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 aim of this study is to investigate whether the quality of physiotherapy follow-up after spinal surgery can be maintained when conducted by telephone rather than in-person. The study is motivated by the desire to save healthcare resources and reduce the environmental impact of patient travel. Data from patient records, including age, sex, surgery procedure, use of pain medication, and time spent on either phone or in-person follow-ups, will be collected to evaluate whether telephone-based follow-up is an effective and sustainable alternative for post-operative care.
Detailed description
This study aims to evaluate the effectiveness and patient experience of telephone-based versus in-person physiotherapy follow-up after spinal surgery. Patients are allocated to one of two groups based on the day of the week they undergo surgery. This allocation determines whether the patient receives a follow-up assessment by telephone or in-person with a physiotherapist.
Following their assigned follow-up, patients are asked to complete questionnaires via REDCap regarding their satisfaction with the follow-up, regardless of the modality. These questionnaires also collect information on pain, physical function, and health-related quality of life. In addition to the initial assessment immediately after the follow-up, patients are sent the same questionnaires again at one and three months post-surgery.
The primary objective of the study is to compare outcomes between the two groups, evaluating whether telephone-based follow-up provides a comparable level of satisfaction, pain management, functional recovery, and quality of life to traditional in-person follow-up. The results will inform whether telephone follow-up is a viable and resource-efficient alternative to in-person assessments while maintaining high standards of post-operative care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery for low back pain receiving in-person physiotherapy follow-up | – | Other: In person post-operative physiotherapy follow-upPatients undergoing surgery for low back pain receiving in-person physiotherapy follow-up |
| Patients undergoing surgery for low back pain receiving telephone physiotherapy follow-up | – | Other: Telephone post-surgery physiotherapy follow-upPatients undergoing surgery for low back pain receiving telephone physiotherapy follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing lumbar spine surgery at Aalborg University Hospital, Neurosurgical Department, who are able to read and understand Danish and consent to participate in the study.
Key inclusion criteria (2 listed)
- Patients who have undergone lumbar spine surgery at the Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark.
- Able to read and understand Danish.
Key exclusion criteria (1 listed)
- Withdrawel of consent
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 |
|---|---|---|
| Telephone post-surgery physiotherapy follow-upAlso: Telephone physiotherapy follow-upPost-operative physiotherapy follow-up delivered via a structured telephone consultation. The session focuses on recovery after lumbar spine surgery, addressing pain management, mobility, exercise recommendations, and guidance on daily activities. The physiotherapist evaluates the patient's status verbally, answers questions, and provides tailored advice to support safe rehabilitation without requiring the patient to attend the hospital physically. | Other | Patients undergoing surgery for low back pain receiving telephone physiotherapy follow-up |
| In person post-operative physiotherapy follow-upPost-operative physiotherapy follow-up delivered as an in-person consultation at the hospital. The session includes assessment of recovery after lumbar spine surgery, hands-on evaluation if needed, and tailored advice on pain management, mobility, exercise progression, and daily activity. This format allows the physiotherapist to physically observe and, if relevant, demonstrate exercises to ensure correct performance and safe rehabilitation. | Other | Patients undergoing surgery for low back pain receiving in-person physiotherapy follow-up |
Primary outcome
Oswestry Disability Index
Time frame: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
The ODI is a validated questionnaire assessing disability related to low back pain. It includes 10 items covering pain and daily functional limitations. Each item is scored from 0 to 5, where 0 represents minimal limitation and 5 represents severe limitation. The total score ranges from 0 to 50, with higher scores indicating greater disability.
3 secondary outcomes
Health related quality of life
Time frame: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
Patient Satisfaction with Follow-up (Modified CSQ-8)
Time frame: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
Back and leg pain (VAS, 0-100 mm)
Time frame: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.
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 15 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including questionnaire responses, pain scores, and functional outcomes) will be made available upon reasonable request to qualified researchers. Data will be shared after publication of the main study results. Requests must include a research proposal and be approved by the study investigators. Data will be shared under a data use agreement to ensure confidentiality and compliance with Danish data protection regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Aalborg University Hospital at 1 site in Denmark.
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 2 inclusion and 1 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 15 Sep 2025. 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 Denmark. 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. 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 Jacob Gandløse, PhD student (+4550998483, j.gandloese@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.). 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 15 Sep 2025.