Lumbar Spine DiseaseNCT06014645
Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery
A study testing Rehabilitation in people with Lumbar Spine Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted with volunteer patients who are followed up by Bursa Çekirge State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone lumbar decompression surgery and who meet the study criteria. The cases will be divided into 2 groups by randomization software. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Spine Disease
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2023to 15 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having undergone lumbar decompression surgery without fusion and 2 months of history
- Participate in all necessary follow-up assessments
- Being between 18-65 years old
- Understand simple commands
- Signing the consent form
Who cannot join
- Presence of a previous spinal fusion surgery
- Presence of malignancy
- Having undergone spine surgery before
- Have any other orthopedic or neurological problem that may affect treatment and assessments
- Situations that prevent communication
- Lack of cooperation during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Home Programs on Pain and Mobility Gain After Lumbar Spinal Decompression Surgery
The study will be conducted with volunteer patients who are followed up by Bursa Çekirge State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone lumbar decompression surgery and who meet the study criteria. The cases will be divided into 2 groups by randomization software. The control group will receive post-operative exercise training and will be encouraged to move. The study group will receive a core stabilization program in addition to education via telerehabilitation. The first evaluation will be performed 2 months post-operatively and the second evaluation will be performed 2 months after treatment.
- Conditions
- Lumbar Spine Disease
- Being tested
- Rehabilitation, Control
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
The study group will be given a core stabilization program in addition to education.
ControlOther
The control group will receive post-operative cognitive training and will be encouraged to move.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This program will include reeducation isometric contraction exercises for transversus obdominus, oblique abdominals, multifidus lumborum muscles and strengthening stretching exercises for other extremities. These interventions will be sent to the patients via telerehabitation method and the patients will always have access to the programs and training. Receives: Other: Rehabilitation |
| Control Group | Active comparator | The control group will receive post-operative exercise training and will be encouraged to move as described by Moseley et al., 2004. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Measured: Change from Baseline VAS at 8 weeks
Tampa Scale for Kinesiophobia (TSK)
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Measured: Change from Baseline TSK at 8 weeks
Pain Catastrophising Scale (PCS)
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Measured: Change from Baseline PCS at 8 weeks
Roland Morris Disability Questionnaire (RMDQ)
The RMDQ is a self-administered questionnaire consisting of 24 items reflecting various activities of daily living. Each item is scored 1 if it is declared applicable to the participant and 0 otherwise, so that the total score can range from 0 (no disability) to 24 (severe disability).
Measured: Change from Baseline RMDQ at 8 weeks
Lumbar region flexibility in flexion extension lateral flexion directions
The subject stands on a block and then performs lumlal flexion with knees straight. The distance above the block with the finger is recorded with a negative sign and the distance below the block is recorded with a positive sign. The subject stands in front of a wall. The pelvis and trunk should be in contact with the wall. The subject is asked to perform lumbar extension. The distance between the sternal notch and the wall is measured and noted. The subject stands in front of a wall with hands next to the trunk. The subject is asked to perform lumbar lateral flexion. The distance from the first position to the last position is measured using the middle finger as a base and noted.
Measured: Change from Baseline flexibilty tests at 8 weeks
Lumbar region endurance flexor and extensor
The participant is placed prone on a treatment bed with the upper edge of the iliac crests flush with the edge of the bed. The lower body is secured to the bed with two straps. At the beginning of the test, participants cross their arms over their chest and remain in a neutral position for as long as possible. The time the position can be maintained is measured using a stopwatch. Participants are held in a supine position with both hips and knees flexed 90 degrees and the trunk flexed 60 degrees on a wedge. Stabilization is achieved with support from the back of the foot. After the wedge is moved back 10 cm, the participants maintain their body position for as long as possible. The time from the moment the wedge is moved back to the moment the participant re-establishes contact with the wedge is measured.
Measured: Change from Baseline endurance tests at 8 weeks
Functional Reach Test (FRT)
The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.
Measured: Change from Baseline FRT at 8 weeks
Stair Climbing Test (SCT)
The time (in seconds) taken to ascend and descend one flight of stairs is noted. A 9-step ladder with a 20 cm step height and a handrail is used. You are instructed to ascend and descend the stairs as quickly but safely as possible. The use of a handrail and walking aid is allowed if necessary. Timing starts with the start signal and ends when the participant has lowered both feet to ground level. The participant can stop and rest if necessary, but the timing continues.
Measured: Change from Baseline SCT at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start14 Jun 2023
- Primary completion10 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DiseaseStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Fatih Özden, PhD, Study director, Muğla Sıtkı Koçman UniversityMustafa Yalçın, MSc, Principal investigator, Bursa Çekirge State HospitalBaki Umut Tuğay, PhD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014645
- Sponsor's protocol ID
- Bursa NRŞ RKÇ
- Status last verified
- May 2024
- First submitted
- 17 Aug 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Home Programs on Pain and Mobility Gain After Lumbar Spinal Decompression Surgery
- ClinicalTrials.gov ID
- NCT06014645
- Acronym / sponsor ID
- Bursa NRŞ RKÇ
- Conditions
- Lumbar Spine Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 28 Aug 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 study will be conducted with volunteer patients who are followed up by Bursa Çekirge State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone lumbar decompression surgery and who meet the study criteria. The cases will be divided into 2 groups by randomization software. The control group will receive post-operative exercise training and will be encouraged to move. The study group will receive a core stabilization program in addition to education via telerehabilitation. The first evaluation will be performed 2 months post-operatively and the second evaluation will be performed 2 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RehabilitationThis program will include reeducation isometric contraction exercises for transversus obdominus, oblique abdominals, multifidus lumborum muscles and strengthening stretching exercises for other extremities. These interventions will be sent to the patients via telerehabitation method and the patients will always have access to the programs and training. |
| Control Group | Active comparator | Other: ControlThe control group will receive post-operative exercise training and will be encouraged to move as described by Moseley et al., 2004. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having undergone lumbar decompression surgery without fusion and 2 months of history
- Participate in all necessary follow-up assessments
- Being between 18-65 years old
- Understand simple commands
- Signing the consent form
Key exclusion criteria (6 listed)
- Presence of a previous spinal fusion surgery
- Presence of malignancy
- Having undergone spine surgery before
- Have any other orthopedic or neurological problem that may affect treatment and assessments
- Situations that prevent communication
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 |
|---|---|---|
| RehabilitationThe study group will be given a core stabilization program in addition to education. | Other | Intervention Group |
| ControlThe control group will receive post-operative cognitive training and will be encouraged to move. | Other | Control Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Change from Baseline VAS at 8 weeks
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Tampa Scale for Kinesiophobia (TSK)
Time frame: Change from Baseline TSK at 8 weeks
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Pain Catastrophising Scale (PCS)
Time frame: Change from Baseline PCS at 8 weeks
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Roland Morris Disability Questionnaire (RMDQ)
Time frame: Change from Baseline RMDQ at 8 weeks
The RMDQ is a self-administered questionnaire consisting of 24 items reflecting various activities of daily living. Each item is scored 1 if it is declared applicable to the participant and 0 otherwise, so that the total score can range from 0 (no disability) to 24 (severe disability).
Lumbar region flexibility in flexion extension lateral flexion directions
Time frame: Change from Baseline flexibilty tests at 8 weeks
The subject stands on a block and then performs lumlal flexion with knees straight. The distance above the block with the finger is recorded with a negative sign and the distance below the block is recorded with a positive sign. The subject stands in front of a wall. The pelvis and trunk should be in contact with the wall. The subject is asked to perform lumbar extension. The distance between the sternal notch and the wall is measured and noted. The subject stands in front of a wall with hands next to the trunk. The subject is asked to perform lumbar lateral flexion. The distance from the first position to the last position is measured using the middle finger as a base and noted.
Lumbar region endurance flexor and extensor
Time frame: Change from Baseline endurance tests at 8 weeks
The participant is placed prone on a treatment bed with the upper edge of the iliac crests flush with the edge of the bed. The lower body is secured to the bed with two straps. At the beginning of the test, participants cross their arms over their chest and remain in a neutral position for as long as possible. The time the position can be maintained is measured using a stopwatch. Participants are held in a supine position with both hips and knees flexed 90 degrees and the trunk flexed 60 degrees on a wedge. Stabilization is achieved with support from the back of the foot. After the wedge is moved back 10 cm, the participants maintain their body position for as long as possible. The time from the moment the wedge is moved back to the moment the participant re-establishes contact with the wedge is measured.
Functional Reach Test (FRT)
Time frame: Change from Baseline FRT at 8 weeks
The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.
Stair Climbing Test (SCT)
Time frame: Change from Baseline SCT at 8 weeks
The time (in seconds) taken to ascend and descend one flight of stairs is noted. A 9-step ladder with a 20 cm step height and a handrail is used. You are instructed to ascend and descend the stairs as quickly but safely as possible. The use of a handrail and walking aid is allowed if necessary. Timing starts with the start signal and ends when the participant has lowered both feet to ground level. The participant can stop and rest if necessary, but the timing continues.
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 7 May 2024.
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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.
Fatih Özden, PhD study director
Muğla Sıtkı Koçman University
Mustafa Yalçın, MSc principal investigator
Bursa Çekirge State Hospital
Baki Umut Tuğay, PhD principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Lumbar Spine Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 7 May 2024. 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 Turkey (Türkiye). 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?
Visual Analog Scale (VAS) (time frame: Change from Baseline VAS at 8 weeks). The study lists 8 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 7 May 2024.