Low Back PainNCT05617924
Efficacy of Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
An observational study of Low Back Pain and Lumbar Disc Disease, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Motorized traction and non-surgical spinal decompression treatments are relatively new treatments for which there is insufficient evidence in the literature. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Low Back Pain, Lumbar Disc Disease, Lumbar Disc Herniation
- What is being tested?
- Physical Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 Jan 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20-75 who underwent physical therapy with the diagnosis of Lumbar discopathy in Afyonkarahisar Health Sciences University, Department of Physical Medicine and Rehabilitation Physical Therapy Unit between 01.01.2019-10.11.2022.
Who may be able to join
- Patients diagnosed with lumbar disc disorders
- Patients diagnosed with lumbar vertical hernia
- Aged 20-75 years
Who cannot join
- Patients treated for acute low back pain
- Patients with a history of lumbar surgery
- Patients with Spondylolisthesis or Spinal Stenosis
- Those with inflammatory rheumatic diseases (Ankylosing spondylitis, spondylarthropathy etc.)
- Patients with sequestered hernia
- Patients with insufficient data in the records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Conventional Physiotherapy, Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
Motorized traction and non-surgical spinal decompression treatments are relatively new treatments for which there is insufficient evidence in the literature. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.
Read the detailed description
Low back pain is one of the leading causes of disability worldwide. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greater risk for low back pain. Anatomical structures that potentially nociceptive contributors to low back pain are intervertebral discs, facet joints, and vertebral end plates. It has been determined that nonsurgical treatments are clinically effective in reducing pain and functional improvement in patients with lumbar disc herniation. However, the level of evidence has generally not been highly evaluated, which can be attributed to the paucity of well designed randomized controlled trials. Despite moderate evidence, exercise and traction are recommended. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.
01.01.2019-10.11.2022. Investigators planned to examine the records of patients aged 20-75 years who underwent physical therapy with the diagnosis of lumbar discopathy in AFSU FTR Department Physical Therapy Unit. Investigators planned to examine the routine anamnesis examination, treatment card and control evaluation records of the patients made in the FTR outpatient clinic from the automation system of their hospital.
- Conditions
- Low Back Pain, Lumbar Disc Disease, Lumbar Disc Herniation, Lumbar Radiculopathy, Physical Therapy
- Being tested
- Physical Therapy
- Medical subject headings
- Low Back Pain, Intervertebral disc disease, Intervertebral Disc Displacement, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyProcedure or surgery
Therapy methods using physical agents in treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy | Treatment method using physical agents such as analgesic currents and superficial-deep heaters Receives: Procedure: Physical Therapy | |
| Mechanical Traction | It is a stretching process for the spine with a weight and pulling system for the spine. Receives: Procedure: Physical Therapy | |
| Nonsurgical Spinal Decompression | Non-surgical spinal decompression is a technique that uses a precision computerized mechanism and opens spinal nerve roots through segmental distraction. Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Pain Scale (VAS)
Visual Pain Scale (VAS), which is easy to understand, apply and interpret, provides valid and reliable data in a short time, is the most used method in clinics. With a visual linear scale of 100 mm, the patient is told that there is no pain at the 0 point, and the most severe pain ever felt in life at the 100 point, and the patient is asked to put a mark on the point corresponding to his or her pain.
Measured: 5 minutes
Oswestry Disability Index
The Oswestry Disability Index was first described in 1980. The questionnaire consists of 10 items addressing different aspects of the function. Each item was scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage. Turkish validity and reliability have been demonstrated.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start15 Dec 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Adar, Afyonkarahisar Health Sciences University
- Investigators
- SEVDA ADAR, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617924
- Sponsor's protocol ID
- SALBP
- Status last verified
- Jan 2023
- First submitted
- 8 Nov 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Conventional Physiotherapy, Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT05617924
- Acronym / sponsor ID
- SALBP
- Conditions
- Low Back Pain, Lumbar Disc Disease, Lumbar Disc Herniation, Lumbar Radiculopathy, Physical Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 16 Nov 2022 (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.
Motorized traction and non-surgical spinal decompression treatments are relatively new treatments for which there is insufficient evidence in the literature. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.
Detailed description
Low back pain is one of the leading causes of disability worldwide. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greater risk for low back pain. Anatomical structures that potentially nociceptive contributors to low back pain are intervertebral discs, facet joints, and vertebral end plates. It has been determined that nonsurgical treatments are clinically effective in reducing pain and functional improvement in patients with lumbar disc herniation. However, the level of evidence has generally not been highly evaluated, which can be attributed to the paucity of well designed randomized controlled trials. Despite moderate evidence, exercise and traction are recommended. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.
01.01.2019-10.11.2022. Investigators planned to examine the records of patients aged 20-75 years who underwent physical therapy with the diagnosis of lumbar discopathy in AFSU FTR Department Physical Therapy Unit. Investigators planned to examine the routine anamnesis examination, treatment card and control evaluation records of the patients made in the FTR outpatient clinic from the automation system of their hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | – | Procedure: Physical TherapyTreatment method using physical agents such as analgesic currents and superficial-deep heaters |
| Mechanical Traction | – | Procedure: Physical TherapyIt is a stretching process for the spine with a weight and pulling system for the spine. |
| Nonsurgical Spinal Decompression | – | Procedure: Physical TherapyNon-surgical spinal decompression is a technique that uses a precision computerized mechanism and opens spinal nerve roots through segmental distraction. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20-75 who underwent physical therapy with the diagnosis of Lumbar discopathy in Afyonkarahisar Health Sciences University, Department of Physical Medicine and Rehabilitation Physical Therapy Unit between 01.01.2019-10.11.2022.
Key inclusion criteria (3 listed)
- Patients diagnosed with lumbar disc disorders
- Patients diagnosed with lumbar vertical hernia
- Aged 20-75 years
Key exclusion criteria (6 listed)
- Patients treated for acute low back pain
- Patients with a history of lumbar surgery
- Patients with Spondylolisthesis or Spinal Stenosis
- Those with inflammatory rheumatic diseases (Ankylosing spondylitis, spondylarthropathy etc.)
- Patients with sequestered hernia
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 |
|---|---|---|
| Physical TherapyTherapy methods using physical agents in treatment | Procedure or surgery | Conventional Physiotherapy, Mechanical Traction, Nonsurgical Spinal Decompression |
Primary outcome
Visual Pain Scale (VAS)
Time frame: 5 minutes
Visual Pain Scale (VAS), which is easy to understand, apply and interpret, provides valid and reliable data in a short time, is the most used method in clinics. With a visual linear scale of 100 mm, the patient is told that there is no pain at the 0 point, and the most severe pain ever felt in life at the 100 point, and the patient is asked to put a mark on the point corresponding to his or her pain.
Oswestry Disability Index
Time frame: 20 minutes
The Oswestry Disability Index was first described in 1980. The questionnaire consists of 10 items addressing different aspects of the function. Each item was scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage. Turkish validity and reliability have been demonstrated.
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 1 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
SEVDA ADAR principal investigator
Afyonkarahisar Health Sciences University
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 and Lumbar Disc Disease, run by Afyonkarahisar Health Sciences 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 3 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 1 Feb 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 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 Pain Scale (VAS) (time frame: 5 minutes). The study lists 2 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 1 Feb 2023.