Lumbar Pain SyndromeNCT05937997
Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
A study testing high intensity physiotherapy, moderate intensity physiotherapy and low intensity physiotherapy in people with Lumbar Pain Syndrome, run by Median at 1 site in Germany.
Trial summary
The goal of this clinical trial is to investigate the safety of early inpatient rehabilitation after lumbar spine surgery. Participants are assigned to therapy groups C (low) - A (high) intensity and receive standardized multimodal rehabilitation for 3 weeks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Pain Syndrome
- What is being tested?
- high intensity physiotherapy, moderate intensity physiotherapy and low intensity physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteGermany
- Study dates
- 29 Dec 2014to 21 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients admitted to inpatient rehabilitation facility after lumbar spine surgery
Who cannot join
- non-German speakers
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to investigate the safety of early inpatient rehabilitation after lumbar spine surgery.
Participants are assigned to therapy groups C (low) - A (high) intensity and receive standardized multimodal rehabilitation for 3 weeks. Groups are compared in terms of safety, disability impairment as well as pain. Timing of rehabilitation is considered.
Read the detailed description
Purpose Literature on early rehabilitation after lumbar spine surgery trends towards a structurized program beginning in the post-acute phase, but publications are rare. Therefore, this study was conducted to investigate the safety of early rehabilitation according to ERAS® principles after different lumbar spine surgeries with regard to training intensity and timing of rehabilitation.
Methods Study design was prospective, non-randomized, and multicentric (3 inpatient rehabilitation facilities in Germany). Based on the senior rehabilitation physician's assessment for patient's physical capacity, patients were assigned to therapy groups C - A (low - high intensity). For statistical analysis patients were also grouped in 3 different time intervals depending on days past surgery until rehabilitation start and. Safety (recurrence rates), disability (Oswestry Disability Index (ODI)), and pain (Visual Analogue Scale (VAS)), were measured at the beginning and at the end of rehabilitation stay. Scores were compared between 3 therapy groups and 3 time intervals for within- and between-group differences. Analgesics and back orthesis use was assessed and analysed as well.
- Conditions
- Lumbar Pain Syndrome
- Being tested
- high intensity physiotherapy, moderate intensity physiotherapy, low intensity physiotherapy
- Keywords
- Enhanced recovery after surgery, spinal injuries, rehabilitation, recurrence, low back pain
- Medical subject headings
- Somatoform Disorders, Spinal Injuries, Recurrence, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity physiotherapyProcedure or surgery
high intensity exercises for 3 weeks inpatient rehabilitation
moderate intensity physiotherapyProcedure or surgery
moderate intensity exercises for 3 weeks inpatient rehabilitation
low intensity physiotherapyProcedure or surgery
low intensity exercises for 3 weeks inpatient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Group A high intensity | Active comparator | Physiotherapy with high intensity and no restrictions Receives: Procedure: high intensity physiotherapy |
| Group B moderate intensity | Active comparator | Physiotherapy with medium intensity and some restrictions Receives: Procedure: moderate intensity physiotherapy |
| Group C low intensity | Active comparator | Physiotherapy with low intensity and many restrictions Receives: Procedure: low intensity physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Oswestry Disability Index
Questionnaire with 10 items to evaluate the disability from back pain, results presented in precentage with 0 % experiencing no disability because of back issues and with 100 % experiencing the most disability because of back issues
Measured: at admission to rehabilitation clinic and at about 3 weeks at discharge
Secondary outcomes (2)
Change of Visual Analogue Scale
Standardized tool to measure subjective pain with 0 points meaning no pain and 10 points meaning the most imaginable pain
Measured: at admission to rehabilitation clinic and at about 3 weeks at discharge
Recurrence rate
Recurrence rate of lumbar spine injuries happening throughout the interventional phase
Measured: at admission to rehabilitation clinic and at about 3 weeks at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start29 Dec 2014
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Pain SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 therapy groups receiving different intensity of training
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Median
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Johannes Schroeter, Median
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937997
- Sponsor's protocol ID
- WS2017
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data available on reasonable request
Publications
Schroter J, Lechterbeck M, Hartmann F, Gercek E. [Structured rehabilitation after lumbar spine surgery : subacute treatment phase]. Orthopade. 2014 Dec;43(12):1089-95. doi: 10.1007/s00132-014-3051-2. German.
PubMed 25413281
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Timing in an ERAS-like Structured Rehabilitation Program After Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT05937997
- Acronym / sponsor ID
- WS2017
- Conditions
- Lumbar Pain Syndrome
- Keywords
- Enhanced recovery after surgery, spinal injuries, rehabilitation, recurrence, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- MedianUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- 29 Dec 2014 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 10 Jul 2023 (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 clinical trial is to investigate the safety of early inpatient rehabilitation after lumbar spine surgery.
Participants are assigned to therapy groups C (low) - A (high) intensity and receive standardized multimodal rehabilitation for 3 weeks. Groups are compared in terms of safety, disability impairment as well as pain. Timing of rehabilitation is considered.
Detailed description
Purpose Literature on early rehabilitation after lumbar spine surgery trends towards a structurized program beginning in the post-acute phase, but publications are rare. Therefore, this study was conducted to investigate the safety of early rehabilitation according to ERAS® principles after different lumbar spine surgeries with regard to training intensity and timing of rehabilitation.
Methods Study design was prospective, non-randomized, and multicentric (3 inpatient rehabilitation facilities in Germany). Based on the senior rehabilitation physician's assessment for patient's physical capacity, patients were assigned to therapy groups C - A (low - high intensity). For statistical analysis patients were also grouped in 3 different time intervals depending on days past surgery until rehabilitation start and. Safety (recurrence rates), disability (Oswestry Disability Index (ODI)), and pain (Visual Analogue Scale (VAS)), were measured at the beginning and at the end of rehabilitation stay. Scores were compared between 3 therapy groups and 3 time intervals for within- and between-group differences. Analgesics and back orthesis use was assessed and analysed as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 therapy groups receiving different intensity of training
| Arm | Type | Receives |
|---|---|---|
| Group A high intensity | Active comparator | Procedure: high intensity physiotherapyPhysiotherapy with high intensity and no restrictions |
| Group B moderate intensity | Active comparator | Procedure: moderate intensity physiotherapyPhysiotherapy with medium intensity and some restrictions |
| Group C low intensity | Active comparator | Procedure: low intensity physiotherapyPhysiotherapy with low intensity and many restrictions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients admitted to inpatient rehabilitation facility after lumbar spine surgery
Key exclusion criteria (1 listed)
- non-German speakers
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 |
|---|---|---|
| high intensity physiotherapyhigh intensity exercises for 3 weeks inpatient rehabilitation | Procedure or surgery | Group A high intensity |
| moderate intensity physiotherapymoderate intensity exercises for 3 weeks inpatient rehabilitation | Procedure or surgery | Group B moderate intensity |
| low intensity physiotherapylow intensity exercises for 3 weeks inpatient rehabilitation | Procedure or surgery | Group C low intensity |
Primary outcome
Change of Oswestry Disability Index
Time frame: at admission to rehabilitation clinic and at about 3 weeks at discharge
Questionnaire with 10 items to evaluate the disability from back pain, results presented in precentage with 0 % experiencing no disability because of back issues and with 100 % experiencing the most disability because of back issues
2 secondary outcomes
Change of Visual Analogue Scale
Time frame: at admission to rehabilitation clinic and at about 3 weeks at discharge
Recurrence rate
Time frame: at admission to rehabilitation clinic and at about 3 weeks at discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Results publication: PubMed 25413281Schroter J, Lechterbeck M, Hartmann F, Gercek E. [Structured rehabilitation after lumbar spine surgery : subacute treatment phase]. Orthopade. 2014 Dec;43(12):1089-95. doi: 10.1007/s00132-014-3051-2. German.
- Individual participant dataSharing planned: Undecided. data available on reasonable request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity physiotherapy, moderate intensity physiotherapy and low intensity physiotherapy in people with Lumbar Pain Syndrome, run by Median at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 10 Jul 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Oswestry Disability Index (time frame: at admission to rehabilitation clinic and at about 3 weeks at discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937997, which also lists 1 linked publication.
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 10 Jul 2023.