RadiculopathyNCT03835182
Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of a Slipped Disc of the Lower Back
A study testing Ultrasound group and Short wave diathermy group in people with Radiculopathy and Low Back Pain, Mechanical, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Chronic low back pain is a common problem which results in reduced functionality, quality of life and general well being. Conservative treatment includes patient education, exercise, maintaining a healthy body mass index and appropriate modifications to activities of daily living. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Radiculopathy, Low Back Pain, Mechanical, Herniated Disk Lumbar
- What is being tested?
- Ultrasound group and Short wave diathermy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2018to 31 Dec 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1)Age 20-60
- 2)Presenting to the Baskent University Faculty of Medicine Physical Medicine and Rehabilitation Department outpatient clinic
- 3) history of low back pain for greater than three months
- 4) Aetiology of back pain lumbar disc herniation based on history, examination and computed tomography/ magnetic resonance imaging (protruded, extruded disc)
Who cannot join
- 1)lower extremity neurological deficit, 2) infectious, inflammatory, metabolic, neoplastic, abdominal, pelvic aetiology of back pain. 3) a history of vertebral fracture, spinal surgery, spondylolisthesis 4) heat intolerance/medical contraindication to thermal treatment 5) presence of metal prosthesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Medicine, Ankara Hospital
Ankara, 06800
About this study
Official title: Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of Lumbar Disc Herniation: a Randomised Control Study
Chronic low back pain is a common problem which results in reduced functionality, quality of life and general well being. Conservative treatment includes patient education, exercise, maintaining a healthy body mass index and appropriate modifications to activities of daily living. Physical modalities are used to support the mainstay of treatment and include superficial heat, transcutaneous electrical nerve stimulation (TENS), ultrasound, short wave diathermy , traction, and complimentary therapies.
In the clinical practice of the investigators, diathermy, in the form of ultrasound and short wave, is used to heat deeper tissues, increase tissue elasticity and metabolic rate and reduce pain and muscle spasm. The medical literature to date states that further studies are required to compare the efficacy of different diathermy modalities in the treatment of lower back pain.
The aim of this study was to compare the efficacy of ultrasound to that of short wave diathermy and a treatment program which does not include diathermy in the treatment of a slipped disc.
Read the detailed description
Chronic lumbar pain is a common problem which results in reduced functionality, quality of life and well being. Chronic low back pain also results in many missed days of work and so is an economic burden as well as a social one. Subacute and chronic conservative treatment of low back pain secondary to a herniated disc of the lower back includes education, lifestyle modifications, and maintenance of a normal body mass index. Physical therapy includes range of motion, strengthening and aerobic exercises alongside use of physical therapy modalities such as superficial heating, low frequency analgesic modalities such as TENS and deep heating modalities such as ultrasonic waves and short wave diathermy.
In Physical Medicine and Rehabilitation departments in Turkey, diathermy is commonly used as an adjunct to exercise in the inpatient treatment of disc herniation of the lumbar region. However, systematic reviews of the effects of diathermy in the form of ultrasound and short wave emphasise the necessity for further studies of their efficacy in the treatment of pain and impact on functionality and quality of life.
Therefore, in this study the investigators aim to compare the efficacy of ultrasound and short wave diathermy in treating pain, improving disability and quality of life in patients with chronic low back pain secondary to disc herniation of the lumbar vertebrae.
- Being tested
- Ultrasound group, Short wave diathermy group, Control group
- Keywords
- lumbar vertebrae, herniated disc, radiculopathy, low back pain, short wave therapy, diathermy, ultrasonic waves
- Medical subject headings
- Radiculopathy, Low Back Pain, Intervertebral Disc Displacement, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound groupDevice
Also called TENS, hotpack, exercise
Ultrasound 1 MHz, 1.5 W/cm2 for a total of 10 min applied to the lower back
Short wave diathermy groupDevice
Also called Curapuls 419 SWD (Enraf-Nonius, Delft, The Netherlands), TENS, hotpack, exercise
SWD frequency of 27.12MHz applied in continuous mode (thermic) applied to the lower back for twenty minutes
Control groupOther
Also called TENS, hotpack, exercise
superficial heat, analgesic physical modality and exercise only
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Active comparator | Thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The ultrasound group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) and ultrasound 1MHz frequency (ten minutes) applied to the lower back, abdominal and lower back muscle strengthening exercises. Receives: Device: Ultrasound group |
| Short wave diathermy group | Active comparator | The short wave diathermy group will consist of thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The short wave diathermy group will be treated with a hotpack (20minutes), transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) and short wave diathermy at a frequency of 27.12MHz (twenty minutes) applied to the lower back , abdominal and lower back muscle strengthening exercises. Receives: Device: Short wave diathermy group |
| Control group | Other | The control group will consist of thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The control group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) applied to the lower back , abdominal and lower back muscle strengthening exercises. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of pain
visual analogue scale (VAS) score from 0 to 10cm for current pain. 0= no pain 10= the worst pain imaginable
Measured: Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
Secondary outcomes (2)
Change in level of Disability
Modified Oswestry Low Back Pain Disability Questionnaire. The Revised Oswestry Disability Index is a condition specific outcome measure for low back pain. The index consists of ten questions with six possible responses regarding the patient's back pain, (scored from 0-5), including the severity of pain and impact on activities of daily living. The minimum obtainable score is 0, the maximum obtainable score is 50. This score is then used to calculate the index percentage using the formula: [total score/(no. of questions answered x 5)]100. The higher the percentage, the greater the level of disability due to low back pain. The minimal detectable change (90% confidence interval)is 10%, change of less than 10% maybe attributed to measurement error.
Measured: Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
Change in health related quality of life
Short Form 36 (SF-36).The SF 36 is a generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitations due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, emotional role, physical role, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100
Measured: Before treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start14 Sep 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies 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
- Factorial
- Model description
- Three groups of patients, each containing 31 patients, will be included in the study. Patients in each group will receive a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five sessions of physical therapy on consecutive days. The first group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation applied to the lower back (frequency, ultrasound 1MHz frequency (ten minutes), abdominal and lower back muscle strengthening exercises. The second group will be treated with hotpack, TENS and exercises as previously described plus short wave diathermy at 27.12MHz frequency for ten minutes applied to the lower back. The third group will receive hotpack, TENS applied to the lower back and strengthening exercises as previously described.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Ozen, Baskent University
- Investigators
- Sacide N Saracgil Cosar, MD, Study director, Baskent University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835182
- Sponsor's protocol ID
- KA13/236
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.
PubMed 25694111Oral A, Ketenci A. Physical Medicine and Rehabilitation Approaches in the Management of Radicular Low Back Pain. A review of the Evidence and Current Recommendations. Turkish Journal of Physlcai and Rehabilitation Medicine 59:57-68, 2013
Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
PubMed 17909209Jegede KA, Ndu A, Grauer JN. Contemporary management of symptomatic lumbar disc herniations. Orthop Clin North Am. 2010 Apr;41(2):217-24. doi: 10.1016/j.ocl.2010.01.003.
PubMed 20399360Fiore P, Panza F, Cassatella G, Russo A, Frisardi V, Solfrizzi V, Ranieri M, Di Teo L, Santamato A. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2011 Sep;47(3):367-73. Epub 2011 Jun 8.
PubMed 21654616Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.
PubMed 17909210Ahmed MS, Shakoor MA, Khan AA. Evaluation of the effects of shortwave diathermy in patients with chronic low back pain. Bangladesh Med Res Counc Bull. 2009 Apr;35(1):18-20. doi: 10.3329/bmrcb.v35i1.2320.
PubMed 19637541Ozen S, Guzel S, Senlikci HB, Cosar SNS, Selcuk ES. Efficacy of ultrasound versus short wave diathermy in the treatment of chronic low back pain in patients with lumbar disk herniation: a prospective randomized control study. BMC Sports Sci Med Rehabil. 2023 Nov 20;15(1):157. doi: 10.1186/s13102-023-00769-2.
PubMed 37986090Ebadi S, Henschke N, Forogh B, Nakhostin Ansari N, van Tulder MW, Babaei-Ghazani A, Fallah E. Therapeutic ultrasound for chronic low back pain. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD009169. doi: 10.1002/14651858.CD009169.pub3.
PubMed 32623724
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of Lumbar Disc Herniation: a Randomised Control Study
- ClinicalTrials.gov ID
- NCT03835182
- Acronym / sponsor ID
- KA13/236
- Keywords
- lumbar vertebrae, herniated disc, radiculopathy, low back pain, short wave therapy, diathermy, ultrasonic waves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Feb 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.
Chronic low back pain is a common problem which results in reduced functionality, quality of life and general well being. Conservative treatment includes patient education, exercise, maintaining a healthy body mass index and appropriate modifications to activities of daily living. Physical modalities are used to support the mainstay of treatment and include superficial heat, transcutaneous electrical nerve stimulation (TENS), ultrasound, short wave diathermy , traction, and complimentary therapies.
In the clinical practice of the investigators, diathermy, in the form of ultrasound and short wave, is used to heat deeper tissues, increase tissue elasticity and metabolic rate and reduce pain and muscle spasm. The medical literature to date states that further studies are required to compare the efficacy of different diathermy modalities in the treatment of lower back pain.
The aim of this study was to compare the efficacy of ultrasound to that of short wave diathermy and a treatment program which does not include diathermy in the treatment of a slipped disc.
Detailed description
Chronic lumbar pain is a common problem which results in reduced functionality, quality of life and well being. Chronic low back pain also results in many missed days of work and so is an economic burden as well as a social one. Subacute and chronic conservative treatment of low back pain secondary to a herniated disc of the lower back includes education, lifestyle modifications, and maintenance of a normal body mass index. Physical therapy includes range of motion, strengthening and aerobic exercises alongside use of physical therapy modalities such as superficial heating, low frequency analgesic modalities such as TENS and deep heating modalities such as ultrasonic waves and short wave diathermy.
In Physical Medicine and Rehabilitation departments in Turkey, diathermy is commonly used as an adjunct to exercise in the inpatient treatment of disc herniation of the lumbar region. However, systematic reviews of the effects of diathermy in the form of ultrasound and short wave emphasise the necessity for further studies of their efficacy in the treatment of pain and impact on functionality and quality of life.
Therefore, in this study the investigators aim to compare the efficacy of ultrasound and short wave diathermy in treating pain, improving disability and quality of life in patients with chronic low back pain secondary to disc herniation of the lumbar vertebrae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Three groups of patients, each containing 31 patients, will be included in the study. Patients in each group will receive a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five sessions of physical therapy on consecutive days. The first group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation applied to the lower back (frequency, ultrasound 1MHz frequency (ten minutes), abdominal and lower back muscle strengthening exercises. The second group will be treated with hotpack, TENS and exercises as previously described plus short wave diathermy at 27.12MHz frequency for ten minutes applied to the lower back. The third group will receive hotpack, TENS applied to the lower back and strengthening exercises as previously described.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Active comparator | Device: Ultrasound groupThirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The ultrasound group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) and ultrasound 1MHz frequency (ten minutes) applied to the lower back, abdominal and lower back muscle strengthening exercises. |
| Short wave diathermy group | Active comparator | Device: Short wave diathermy groupThe short wave diathermy group will consist of thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The short wave diathermy group will be treated with a hotpack (20minutes), transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) and short wave diathermy at a frequency of 27.12MHz (twenty minutes) applied to the lower back , abdominal and lower back muscle strengthening exercises. |
| Control group | Other | Other: Control groupThe control group will consist of thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The control group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) applied to the lower back , abdominal and lower back muscle strengthening exercises. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1)Age 20-60
- 2)Presenting to the Baskent University Faculty of Medicine Physical Medicine and Rehabilitation Department outpatient clinic
- 3) history of low back pain for greater than three months
- 4) Aetiology of back pain lumbar disc herniation based on history, examination and computed tomography/ magnetic resonance imaging (protruded, extruded disc)
Key exclusion criteria (1 listed)
- 1)lower extremity neurological deficit, 2) infectious, inflammatory, metabolic, neoplastic, abdominal, pelvic aetiology of back pain. 3) a history of vertebral fracture, spinal surgery, spondylolisthesis 4) heat intolerance/medical contraindication to thermal treatment 5) presence of metal prosthesis
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 |
|---|---|---|
| Ultrasound groupAlso: TENS, hotpack, exerciseUltrasound 1 MHz, 1.5 W/cm2 for a total of 10 min applied to the lower back | Device | Ultrasound group |
| Short wave diathermy groupAlso: Curapuls 419 SWD (Enraf-Nonius, Delft, The Netherlands), TENS, hotpack, exerciseSWD frequency of 27.12MHz applied in continuous mode (thermic) applied to the lower back for twenty minutes | Device | Short wave diathermy group |
| Control groupAlso: TENS, hotpack, exercisesuperficial heat, analgesic physical modality and exercise only | Other | Control group |
Primary outcome
Change in level of pain
Time frame: Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
visual analogue scale (VAS) score from 0 to 10cm for current pain. 0= no pain 10= the worst pain imaginable
2 secondary outcomes
Change in level of Disability
Time frame: Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
Change in health related quality of life
Time frame: Before treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of 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 21 Nov 2023.
- Background: PubMed 25694111Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.
- BackgroundOral A, Ketenci A. Physical Medicine and Rehabilitation Approaches in the Management of Radicular Low Back Pain. A review of the Evidence and Current Recommendations. Turkish Journal of Physlcai and Rehabilitation Medicine 59:57-68, 2013
- Background: PubMed 17909209Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
- Background: PubMed 20399360Jegede KA, Ndu A, Grauer JN. Contemporary management of symptomatic lumbar disc herniations. Orthop Clin North Am. 2010 Apr;41(2):217-24. doi: 10.1016/j.ocl.2010.01.003.
- Background: PubMed 21654616Fiore P, Panza F, Cassatella G, Russo A, Frisardi V, Solfrizzi V, Ranieri M, Di Teo L, Santamato A. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2011 Sep;47(3):367-73. Epub 2011 Jun 8.
- Background: PubMed 17909210Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.
- Background: PubMed 19637541Ahmed MS, Shakoor MA, Khan AA. Evaluation of the effects of shortwave diathermy in patients with chronic low back pain. Bangladesh Med Res Counc Bull. 2009 Apr;35(1):18-20. doi: 10.3329/bmrcb.v35i1.2320.
- Derived from this study: PubMed 37986090Ozen S, Guzel S, Senlikci HB, Cosar SNS, Selcuk ES. Efficacy of ultrasound versus short wave diathermy in the treatment of chronic low back pain in patients with lumbar disk herniation: a prospective randomized control study. BMC Sports Sci Med Rehabil. 2023 Nov 20;15(1):157. doi: 10.1186/s13102-023-00769-2.
- Derived from this study: PubMed 32623724Ebadi S, Henschke N, Forogh B, Nakhostin Ansari N, van Tulder MW, Babaei-Ghazani A, Fallah E. Therapeutic ultrasound for chronic low back pain. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD009169. doi: 10.1002/14651858.CD009169.pub3.
- Individual participant dataSharing planned: No
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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.
Sacide N Saracgil Cosar, MD study director
Baskent University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound group and Short wave diathermy group in people with Radiculopathy and Low Back Pain, Mechanical, run by Baskent 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 4 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 21 Nov 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?
Change in level of pain (time frame: Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment). 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 NCT03835182, which also lists 9 linked publications.
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 21 Nov 2023.