Low Back PainNCT04912388
Serum Cytokine Levels in Patients with Lumbal Disc Herniation and Effectiveness of Exercise
A study testing Lumbal stabilization excercises and Conventional exercises in people with Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbal stabilization excercises and Conventional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2021to 30 Jul 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of disc herniation (protrusion, extrusion, sequestered disc)
- not an indication for lumbar disc herniation surgery
- for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain
- pain intensity of VAS ≥ 3
- male and female patients between the ages of 20-55
- not having low back pain complaints in the past
- female and male healthy individuals between the ages of 20-55
Who cannot join
- systemic or inflammatory disease
- pregnant or breastfeeding women
- surgery of lumbar region
- fracture of lumbar vertebrae
- lumbar scoliosis
- medication use for psychiatric disorders
Show all 11Show fewer
- tumor
- allergy
- neurological disease
- alcohol-drug use
- generalized musculoskeletal pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Physiotherapy and rehabilitation
Ankara, Altındağ, 06030
About this study
Official title: Serum Cytokine Levels in Patients with Lumbal Disc Herniation with and Without Neurological Deficits and Effectiveness of Exercise
The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study.
Read the detailed description
The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Healthy individuals of similar age, height and weight will also be included for references to normal serum cytokine levels. All patients will be evaluated twice, before and 6 weeks after treatment. The treatment program will be applied 3 times a week for 6 weeks under the supervision of a physiotherapist.
- Conditions
- Low Back Pain
- Being tested
- Lumbal stabilization excercises, Conventional exercises
- Keywords
- Low back pain, Disc herniation, Stabilization exercises, General exercises, Cytokines, Inflammation
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbal stabilization excercisesOther
The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
Conventional exercisesOther
The general exercise group will perform conventional exercises 3 times a week during 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The stabilization group | Experimental | The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks. Receives: Other: Lumbal stabilization excercises |
| The general exercise group | Experimental | The general exercise group will perform conventional exercises 3 times a week during 6 weeks. Receives: Other: Conventional exercises |
| The control group | No intervention | Individuals in the control group will not be treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory cytokines
Tnf-alfa , IL-6, IL-4, IL-1β, Beta-endorphins, Anandamide, Arachidonoylgylycerol will be evaluated with ELISA kit.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start30 Jul 2021
- Primary completion23 Feb 2024
- Study completion30 Jul 2024
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 Hacettepe UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, birgül morkoç, Hacettepe University
- Investigators
- Birgül Morkoç, PhD student, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912388
- Sponsor's protocol ID
- KA-20040
- Status last verified
- Mar 2024
- First submitted
- 28 May 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non are planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Cytokine Levels in Patients with Lumbal Disc Herniation with and Without Neurological Deficits and Effectiveness of Exercise
- ClinicalTrials.gov ID
- NCT04912388
- Acronym / sponsor ID
- KA-20040
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Disc herniation, Stabilization exercises, General exercises, Cytokines, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 3 Jun 2021 (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 the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study.
Detailed description
The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Healthy individuals of similar age, height and weight will also be included for references to normal serum cytokine levels. All patients will be evaluated twice, before and 6 weeks after treatment. The treatment program will be applied 3 times a week for 6 weeks under the supervision of a physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The stabilization group | Experimental | Other: Lumbal stabilization excercisesThe stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks. |
| The general exercise group | Experimental | Other: Conventional exercisesThe general exercise group will perform conventional exercises 3 times a week during 6 weeks. |
| The control group | No intervention | –Individuals in the control group will not be treated. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of disc herniation (protrusion, extrusion, sequestered disc)
- not an indication for lumbar disc herniation surgery
- for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain
- pain intensity of VAS ≥ 3
- male and female patients between the ages of 20-55
Key exclusion criteria (11 listed)
- systemic or inflammatory disease
- pregnant or breastfeeding women
- surgery of lumbar region
- fracture of lumbar vertebrae
- lumbar scoliosis
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 |
|---|---|---|
| Lumbal stabilization excercisesThe stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks. | Other | The stabilization group |
| Conventional exercisesThe general exercise group will perform conventional exercises 3 times a week during 6 weeks. | Other | The general exercise group |
Primary outcome
inflammatory cytokines
Time frame: 6 weeks
Tnf-alfa , IL-6, IL-4, IL-1β, Beta-endorphins, Anandamide, Arachidonoylgylycerol will be evaluated with ELISA kit.
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 2 Oct 2024.
- Individual participant dataSharing planned: No. Non are planned to be shared
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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.
Birgül Morkoç, PhD student principal investigator
Hacettepe 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 Lumbal stabilization excercises and Conventional exercises in people with Low Back Pain, run by Hacettepe 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 7 inclusion and 11 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 2 Oct 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?
inflammatory cytokines (time frame: 6 weeks). 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 2 Oct 2024.