Lumbar Disc HerniationNCT04049812
Effectiveness of PEMF in Patients With Chronic Radicular Pain Due to Lomber Disc Herniation
A study testing PEMF, Hot pack and TENS in people with Lumbar Disc Herniation, run by Birkan Sonel Tur.
Trial summary
The aim of this study is to investigate the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- PEMF, Hot pack and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 31 Mar 2018
- 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
- Age 18-65
- Unilateral radicular pain for at least 3 months
- Severity of radicular pain with Visual Analog Score of at least 4/10
- Written informed consent
Who cannot join
- Pregnancy or lactation
- Cardiac pacemaker, or any metal implants or electronic devices anywhere in the body
- History of surgery or algological procedure of the lumbar region
- Physical therapy within the last year due to back pain
- Previous PEMF treatment
- Malignancy or suspicion
Show all 16Show fewer
- Polyneuropathy (diabetic or other)
- Connective tissue disease
- Presence of inflammatory joint pain
- Fibromyalgia
- Presence of open surface wound
- Tuberculosis, mycosis, or viral disease
- Presence of pain in another region of the body with higher severity than radicular back pain
- Use of drugs other than paracetamol-derivative simple analgesics (Nonsteroidal Aanti inflammatuar, central effective, or narcotic analgesics), or less than three weeks since the discontinuation of these drugs
- Advanced mood disorder
- Radiographic evidence of Grade 2 spondylolisthesis, presence of spinal instability, and advanced degenerative spondylarthrosis
About this study
Official title: Effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on Pain, Functional Status, and Quality of Life in Patients With Chronic Radicular Pain Due to Lumbar Disc Herniation
The aim of this study is to investigate the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation.
Read the detailed description
Pulsed Electromagnetic Field Therapy (PEMF) is a non-invasive, painless treatment for various injuries, bone related conditions and pains. However, further studies on PEMF effects on low back and radicular pain is needed due to lack of studies in this area.
- Conditions
- Lumbar Disc Herniation
- Being tested
- PEMF, Hot pack, TENS, Sham PEMF
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMFDevice
Hot packDevice
TENSDevice
Sham PEMFDevice
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic field (PEMF) treatment Group | Active comparator | Group received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment. Receives: Device: PEMF; Device: Hot pack; Device: TENS |
| Sham PEMF treatment Group | Sham comparator | Group received routine hot pack, TENS and sham PEMF treatment. Receives: Device: Hot pack; Device: TENS; Device: Sham PEMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 cm Pain Visual Analogue Scale (VAS)
The patient is asked to indicate their perceived pain intensity along a 10cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.
Measured: 3 weeks
10 cm Pain Visual Analogue Scale (VAS)
The patient is asked to indicate their perceived pain intensity along a 10 cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.
Measured: one month after treatment
Secondary outcomes (4)
Disability; Roland-Morris Disability Questionnaire (RMDQ)
RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of >1 indicates disability.
Measured: 3 weeks
Disability; Roland-Morris Disability Questionnaire (RMDQ)
RMDQ has 24 yes/no questions. Scoring is between 0-24. A score of 0: no disability, score of >1 indicates disability.
Measured: One month after treatment
Nottingham Health Profile (NHP)
Nottingham Health Profile (NHP) is a questionnaire designed to measure a patient's view of their own health status, in a number of areas.
The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.
Measured: 3 weeks
Nottingham Health Profile (NHP)
Nottingham Health Profile (NHP) is a questionnaire designed to measure a patient's view of their own health status, in a number of areas.
The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation.All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.
Measured: One month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Mar 2016
- Primary completion28 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birkan Sonel Tur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Birkan Sonel Tur, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049812
- Sponsor's protocol ID
- 05-188-16
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2019
- Last updated
- 8 Aug 2019
- 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 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on Pain, Functional Status, and Quality of Life in Patients With Chronic Radicular Pain Due to Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT04049812
- Acronym / sponsor ID
- 05-188-16
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Birkan Sonel TurUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 8 Aug 2019 (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 the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation.
Detailed description
Pulsed Electromagnetic Field Therapy (PEMF) is a non-invasive, painless treatment for various injuries, bone related conditions and pains. However, further studies on PEMF effects on low back and radicular pain is needed due to lack of studies in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field (PEMF) treatment Group | Active comparator | Device: PEMF, Device: Hot pack, Device: TENSGroup received routine hot pack, Transcutaneous electrical nerve stimulation (TENS) and PEMF treatment. |
| Sham PEMF treatment Group | Sham comparator | Device: Hot pack, Device: TENS, Device: Sham PEMFGroup received routine hot pack, TENS and sham PEMF treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- Unilateral radicular pain for at least 3 months
- Severity of radicular pain with Visual Analog Score of at least 4/10
- Written informed consent
Key exclusion criteria (16 listed)
- Pregnancy or lactation
- Cardiac pacemaker, or any metal implants or electronic devices anywhere in the body
- History of surgery or algological procedure of the lumbar region
- Physical therapy within the last year due to back pain
- Previous PEMF treatment
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 |
|---|---|---|
| PEMF | Device | Pulsed electromagnetic field (PEMF) treatment Group |
| Hot pack | Device | Pulsed electromagnetic field (PEMF) treatment Group, Sham PEMF treatment Group |
| TENS | Device | Pulsed electromagnetic field (PEMF) treatment Group, Sham PEMF treatment Group |
| Sham PEMF | Device | Sham PEMF treatment Group |
Primary outcome
10 cm Pain Visual Analogue Scale (VAS)
Time frame: 3 weeks
The patient is asked to indicate their perceived pain intensity along a 10cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.
10 cm Pain Visual Analogue Scale (VAS)
Time frame: one month after treatment
The patient is asked to indicate their perceived pain intensity along a 10 cm horizontal line, where '0' represents 'no pain' and '10', 'unbearable pain'.
4 secondary outcomes
Disability; Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 3 weeks
Disability; Roland-Morris Disability Questionnaire (RMDQ)
Time frame: One month after treatment
Nottingham Health Profile (NHP)
Time frame: 3 weeks
Nottingham Health Profile (NHP)
Time frame: One month after treatment
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 8 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PEMF, Hot pack and TENS in people with Lumbar Disc Herniation, run by Birkan Sonel Tur.
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 4 inclusion and 16 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
10 cm Pain Visual Analogue Scale (VAS) (time frame: 3 weeks). 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 8 Aug 2019.