Chronic Low Back PainNCT05680467
Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Individuals With Chronic Low Back Pain
A study testing Manual Therapy and Manual Therapy plus TECAR in people with Chronic Low Back Pain, run by International Hellenic University at 1 site in Greece.
Trial summary
Chronic low back pain is defined as back pain that lasts longer than 12 weeks. The aim of this clinical study is to investigate the efficacy of combining a program of manual techniques with the application of Capacitive and Resistive Electric Transfer (TECAR) therapy to treat chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Manual Therapy and Manual Therapy plus TECAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 15 Dec 2022to 15 Mar 2023
- 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
- Duration of symptoms 12 weeks
- Women - Men
- Age range between 20 and 60 years
- Written consent to participate in the study
Who cannot join
- Neuropathic pain extending along the lower limb due to nerve root compression
- Previous spine surgery
- History of spine trauma or fracture
- Implanted pacemakers
- Pregnancy
- Cancer
- Systemic musculoskeletal diseases, diagnosed neurodegenerative diseases (e.g., Parkinson's), epilepsy, and history of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
Thessaloniki, Sindos Thessaloníki, 57400
About this study
Official title: Short-term Effects of Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Pain Disability and Spinal Mobility in Individuals With Chronic Low Back Pain: A Randomized Clinical Trial Study
Chronic low back pain is defined as back pain that lasts longer than 12 weeks. The aim of this clinical study is to investigate the efficacy of combining a program of manual techniques with the application of Capacitive and Resistive Electric Transfer (TECAR) therapy to treat chronic low back pain. Sixty adults with chronic low back pain will be randomly divided into three groups of 20 each. In the participants of the first group, a therapeutic protocol of manual soft tissue mobilization in the lumbar region will be applied. To the participants of the second group, the same protocol of manual techniques will be applied in combination with TECAR therapy, which will be applied through a conventional capacitive electrode as well as an antistatic electrode bracelet (making the hand of the physical therapist an antistatic electrode). The third group participants will receive no treatment. Both programs will include six treatments over two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland-Morris Disability Questionnaire (RMDQ), Pressure Pain Threshold (PPT) in the lumbar region with an algometer, and lumbar flexion range of motion through fingertip-to-floor distance (FFD) test will be evaluated before and after the intervention with a follow-up one month later. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, while the statistical significance index will be set at p < .05.
Read the detailed description
Background: Chronic low back pain is defined as back pain that lasts longer than 12 weeks.
Aim: The purpose of this clinical study is to investigate the efficacy of combining a program of manual techniques with the application of Capacitive and Resistive Electric Transfer (TECAR) therapy in people with chronic low back pain.
Method: Sixty adults with chronic low back pain will be randomly divided into three groups of 20 people each. In the participants of the first group, a therapeutic protocol of manual soft tissue mobilization in the lumbar region will be applied. To the participants of the second group, the same protocol of manual techniques will be applied in combination with TECAR therapy, which will be applied through a conventional capacitive electrode as well as an antistatic electrode bracelet (making the hand of the physical therapist an antistatic electrode). The third group participants will receive no treatment. Both programs will include six treatments over two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland-Morris Disability Questionnaire (RMDQ), Pressure Pain Threshold (PPT) in the lumbar region with an algometer, and lumbar flexion range of motion through fingertip-to-floor distance (FFD) test will be evaluated before and after the intervention with a follow-up one month later. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, while the statistical significance index will be set at p < .05.
Expected results: The protocol proposed in this clinical study combines the beneficial effects of TECAR treatment with the benefits of applying manual techniques. Modern TECAR devices make it possible, through special resistive bracelet electrodes, to turn the hand of the therapist into a mobile electrode providing a simultaneous effect of the two therapeutic means through manual techniques and high-frequency current. For this reason, we expect the specific combination to be more effective than the individual application of manual techniques in improving the clinical picture of adults with chronic low back pain. For the statistical analysis of the results, a two-way ANOVA with repeated measurements will be applied.
- Conditions
- Chronic Low Back Pain
- Being tested
- Manual Therapy, Manual Therapy plus TECAR, Control
- Keywords
- Chronic Low back pain, Manual therapy, Capacitive and Resistive Electric Transfer Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
The protocol will last 30 minutes and will include the application of the following manual techniques:
- Lumbar soft tissue and joint cranial and lateral mobilization with the patient in the supine position
- Bilateral medial lumbar soft tissue mobilization
- Functional massage on the quadratus lumborum muscle with the patient in a lateral position on both sides
- Extension with coupled sidebending mobilization of the thoracic area with the patient in a lateral position on both sides
- Soft tissue lateral mobilization of the thoracic area with the patient in a lateral position on both sides
Manual Therapy plus TECAROther
The participants of this group will be given the same manual protocol as the first group in combination with the application of high frequency current. Soft tissue mobilization manipulations will be applied in combination with a capacitive conventional electrode and with a special electrode bracelet that makes the therapist's own hand as an antistatic electrode. The frequencies of the high frequency current will be 300khz, 500khz, and 1MHz, while as a reference electrode a flexible self-adhesive ground will be used placed on the abdomen
ControlOther
Participants in this group will only receive general instructions about managing their back pain and counseling about avoiding activities that may worsen their symptoms.
| Study group | Role | What they receive |
|---|---|---|
| "Soft Tissue Mobilization" | Experimental | Participants allocated to this group will receive six sessions of soft tissue mobilization technique accord to Kaltenborn (2018) . Receives: Other: Manual Therapy |
| "Soft Tissue Mobilization" and "TECAR" | Experimental | Participants allocated to this group will receive the same manual therapy protocol with Group 1 in combination with Capacitive and Resistive Electric Transfer Therapy (TECAR). Receives: Other: Manual Therapy plus TECAR |
| "Control" | Active comparator | Control Group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS)
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.
Measured: pre-treatment, week: 1, 2, 6
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the quadratus lumborum muscle, in the sacroiliac joints, and paravertebrally in the L4-L5 intervertebral space. The metal rod of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure at a rate of 1Kg/s. PPT is calculated in kg/cm2 (Imamura et al., 2016)
Measured: pre-treatment, week: 1, 2, 6
Changes in functional capacity with the Greek Version of Roland-Morris Disability Questionnaire (RMDQ)
The functional ability of the participants will be evaluated with the Greek version of the Roland-Morris questionnaire, which consists of 24 questions related to daily activities that patients often report difficulty performing due to low back pain. Each positive answer earns one point and the final score is calculated by adding all the points. Therefore, the higher the score, the greater the restriction. The Greek version of the questionnaire shows satisfactory reliability and validity (ICC: 0.44-0.92) (Boscainos et al., 2003).
Measured: pre-treatment, week: 1, 2, 6
Changes in lumbar spine flexion range of motion with the Fingertip-To-Floor Test
Range of trunk forward flexion will be assessed through the Fingertip-To-Floor Test. When performing the test, the examinee is asked to try to reach the ground with the fingers of their hands by leaning forward while keeping their knees and hips extended. The examiner measures with a tape the distance of the fingers from the ground. The test is widely used in clinical practice to measure spinal mobility and shows high reliability and validity indices (Ekedahl et al. 2010).
Measured: Time Frame: pre-treatment, week: 1, 2, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start15 Dec 2022
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty participants with chronic low back pain will be randomly assigned to three groups of 20 each. The allocation of the sample to the groups will be performed using a randomization program (https://www.randomizer.org/) by an independent researcher. In the first group, a manual protocol will be applied with the simultaneous application of a high-frequency current through TECAR, in the second group, the same manual protocol will be applied without the TECAR device, while the third group will not receive any treatment. Participants of the two intervention groups will follow a total of six treatments over a period of three weeks with a follow-up after one month.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680467
- Sponsor's protocol ID
- EC-06/2022
- Status last verified
- Mar 2023
- First submitted
- 24 Dec 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Pain Disability and Spinal Mobility in Individuals With Chronic Low Back Pain: A Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT05680467
- Acronym / sponsor ID
- EC-06/2022
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low back pain, Manual therapy, Capacitive and Resistive Electric Transfer Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 11 Jan 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.
Chronic low back pain is defined as back pain that lasts longer than 12 weeks. The aim of this clinical study is to investigate the efficacy of combining a program of manual techniques with the application of Capacitive and Resistive Electric Transfer (TECAR) therapy to treat chronic low back pain. Sixty adults with chronic low back pain will be randomly divided into three groups of 20 each. In the participants of the first group, a therapeutic protocol of manual soft tissue mobilization in the lumbar region will be applied. To the participants of the second group, the same protocol of manual techniques will be applied in combination with TECAR therapy, which will be applied through a conventional capacitive electrode as well as an antistatic electrode bracelet (making the hand of the physical therapist an antistatic electrode). The third group participants will receive no treatment. Both programs will include six treatments over two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland-Morris Disability Questionnaire (RMDQ), Pressure Pain Threshold (PPT) in the lumbar region with an algometer, and lumbar flexion range of motion through fingertip-to-floor distance (FFD) test will be evaluated before and after the intervention with a follow-up one month later. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, while the statistical significance index will be set at p < .05.
Detailed description
Background: Chronic low back pain is defined as back pain that lasts longer than 12 weeks.
Aim: The purpose of this clinical study is to investigate the efficacy of combining a program of manual techniques with the application of Capacitive and Resistive Electric Transfer (TECAR) therapy in people with chronic low back pain.
Method: Sixty adults with chronic low back pain will be randomly divided into three groups of 20 people each. In the participants of the first group, a therapeutic protocol of manual soft tissue mobilization in the lumbar region will be applied. To the participants of the second group, the same protocol of manual techniques will be applied in combination with TECAR therapy, which will be applied through a conventional capacitive electrode as well as an antistatic electrode bracelet (making the hand of the physical therapist an antistatic electrode). The third group participants will receive no treatment. Both programs will include six treatments over two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland-Morris Disability Questionnaire (RMDQ), Pressure Pain Threshold (PPT) in the lumbar region with an algometer, and lumbar flexion range of motion through fingertip-to-floor distance (FFD) test will be evaluated before and after the intervention with a follow-up one month later. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, while the statistical significance index will be set at p < .05.
Expected results: The protocol proposed in this clinical study combines the beneficial effects of TECAR treatment with the benefits of applying manual techniques. Modern TECAR devices make it possible, through special resistive bracelet electrodes, to turn the hand of the therapist into a mobile electrode providing a simultaneous effect of the two therapeutic means through manual techniques and high-frequency current. For this reason, we expect the specific combination to be more effective than the individual application of manual techniques in improving the clinical picture of adults with chronic low back pain. For the statistical analysis of the results, a two-way ANOVA with repeated measurements will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Sixty participants with chronic low back pain will be randomly assigned to three groups of 20 each. The allocation of the sample to the groups will be performed using a randomization program (https://www.randomizer.org/) by an independent researcher. In the first group, a manual protocol will be applied with the simultaneous application of a high-frequency current through TECAR, in the second group, the same manual protocol will be applied without the TECAR device, while the third group will not receive any treatment. Participants of the two intervention groups will follow a total of six treatments over a period of three weeks with a follow-up after one month.
| Arm | Type | Receives |
|---|---|---|
| "Soft Tissue Mobilization" | Experimental | Other: Manual TherapyParticipants allocated to this group will receive six sessions of soft tissue mobilization technique accord to Kaltenborn (2018) . |
| "Soft Tissue Mobilization" and "TECAR" | Experimental | Other: Manual Therapy plus TECARParticipants allocated to this group will receive the same manual therapy protocol with Group 1 in combination with Capacitive and Resistive Electric Transfer Therapy (TECAR). |
| "Control" | Active comparator | Other: ControlControl Group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Duration of symptoms 12 weeks
- Women - Men
- Age range between 20 and 60 years
- Written consent to participate in the study
Key exclusion criteria (7 listed)
- Neuropathic pain extending along the lower limb due to nerve root compression
- Previous spine surgery
- History of spine trauma or fracture
- Implanted pacemakers
- Pregnancy
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 |
|---|---|---|
| Manual TherapyThe protocol will last 30 minutes and will include the application of the following manual techniques: * Lumbar soft tissue and joint cranial and lateral mobilization with the patient in the supine position * Bilateral medial lumbar soft tissue mobilization * Functional massage on the quadratus lumborum muscle with the patient in a lateral position on both sides * Extension with coupled sidebending mobilization of the thoracic area with the patient in a lateral position on both sides * Soft tissue lateral mobilization of the thoracic area with the patient in a lateral position on both sides | Other | "Soft Tissue Mobilization" |
| Manual Therapy plus TECARThe participants of this group will be given the same manual protocol as the first group in combination with the application of high frequency current. Soft tissue mobilization manipulations will be applied in combination with a capacitive conventional electrode and with a special electrode bracelet that makes the therapist's own hand as an antistatic electrode. The frequencies of the high frequency current will be 300khz, 500khz, and 1MHz, while as a reference electrode a flexible self-adhesive ground will be used placed on the abdomen | Other | "Soft Tissue Mobilization" and "TECAR" |
| ControlParticipants in this group will only receive general instructions about managing their back pain and counseling about avoiding activities that may worsen their symptoms. | Other | "Control" |
Primary outcome
Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS)
Time frame: pre-treatment, week: 1, 2, 6
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Time frame: pre-treatment, week: 1, 2, 6
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the quadratus lumborum muscle, in the sacroiliac joints, and paravertebrally in the L4-L5 intervertebral space. The metal rod of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure at a rate of 1Kg/s. PPT is calculated in kg/cm2 (Imamura et al., 2016)
Changes in functional capacity with the Greek Version of Roland-Morris Disability Questionnaire (RMDQ)
Time frame: pre-treatment, week: 1, 2, 6
The functional ability of the participants will be evaluated with the Greek version of the Roland-Morris questionnaire, which consists of 24 questions related to daily activities that patients often report difficulty performing due to low back pain. Each positive answer earns one point and the final score is calculated by adding all the points. Therefore, the higher the score, the greater the restriction. The Greek version of the questionnaire shows satisfactory reliability and validity (ICC: 0.44-0.92) (Boscainos et al., 2003).
Changes in lumbar spine flexion range of motion with the Fingertip-To-Floor Test
Time frame: Time Frame: pre-treatment, week: 1, 2, 6
Range of trunk forward flexion will be assessed through the Fingertip-To-Floor Test. When performing the test, the examinee is asked to try to reach the ground with the fingers of their hands by leaning forward while keeping their knees and hips extended. The examiner measures with a tape the distance of the fingers from the ground. The test is widely used in clinical practice to measure spinal mobility and shows high reliability and validity indices (Ekedahl et al. 2010).
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 28 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Manual Therapy plus TECAR in people with Chronic Low Back Pain, run by International Hellenic University at 1 site in Greece.
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 7 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 28 Mar 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 Greece. 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?
Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS) (time frame: pre-treatment, week: 1, 2, 6). The study lists 4 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 28 Mar 2023.