Metabolic SyndromeNCT02865200
The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia
A study testing Dry Needling Application and Classic Physiotherapy Program in people with Metabolic Syndrome and Physical Activity, run by Eastern Mediterranean University.
Trial summary
Aim: This study was planned for comparing physical activity levels, nutrition quality and quality of life of the individuals that are diagnosed with and without metabolic syndrome (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC). Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Physical Activity, Quality of Life
- What is being tested?
- Dry Needling Application and Classic Physiotherapy Program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2015
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients among the ages of 35-70,
- Suffering from LBP for at least 3 months,
- Diagnosed with LDH having at least 1 active trigger point that can be cooperated .
Who cannot join
- Those with LDH that show neurological symptom,
- Having any orthopaedic problem at lower extremity and lower back region,
- Having sacroiliac joint problem, diagnosed with lumbar spondylolisthesis,
- Having any neurologic, rheumatic, oncologic problem,
- Who received any physiotherapy program at least 6 months before, patients having any corticosteroid treatment or oral medication
- Those having needle phobia were not included in the trial.
About this study
Aim: This study was planned for comparing physical activity levels, nutrition quality and quality of life of the individuals that are diagnosed with and without metabolic syndrome (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).
Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic characteristics of the individuals that participated the study were registered with a survey form. The long form of the International Physical Activity Questionnaire was used for determining physical activity levels of the individuals; whereas total numbers of daily steps were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS) was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for the assessment of health-related qualities of life of individuals and Beck Depression Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis and anthropometric measurements of individuals were also taken.
- Conditions
- Metabolic Syndrome, Physical Activity, Quality of Life
- Being tested
- Dry Needling Application, Classic Physiotherapy Program
- Keywords
- Nutrition, Public Health
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needling ApplicationOther
Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique.
Classic Physiotherapy ProgramOther
Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again.
Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Application | Experimental | Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique. The needles were kept on the body for 20 minutes and at the 10th minute, the needle was rolled and re-stimulation was enabled. The treatment was applied twice a week, which is equal to 6 sessions in total. Receives: Other: Dry Needling Application |
| Classic Physiotherapy Program | Experimental | Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again. The period of treatment was 6 sessions in total with 25 minutes of each.
Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin. Receives: Other: Classic Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed using the Short Form of McGill Pain Questionnaire-Visual Analogue Scale
The Short Form of McGill Pain Questionnaire-Visual Analogue Scale (MPQ-SF-VAS) was used in order to determine the pain intensity that the investigators use as primary outcome measure in the investigators study.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ender Angın, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865200
- Sponsor's protocol ID
- EasternMU
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia
- ClinicalTrials.gov ID
- NCT02865200
- Acronym / sponsor ID
- EasternMU
- Conditions
- Metabolic Syndrome, Physical Activity, Quality of Life
- Keywords
- Nutrition, Public Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
Aim: This study was planned for comparing physical activity levels, nutrition quality and quality of life of the individuals that are diagnosed with and without metabolic syndrome (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).
Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic characteristics of the individuals that participated the study were registered with a survey form. The long form of the International Physical Activity Questionnaire was used for determining physical activity levels of the individuals; whereas total numbers of daily steps were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS) was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for the assessment of health-related qualities of life of individuals and Beck Depression Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis and anthropometric measurements of individuals were also taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Application | Experimental | Other: Dry Needling ApplicationDry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique. The needles were kept on the body for 20 minutes and at the 10th minute, the needle was rolled and re-stimulation was enabled. The treatment was applied twice a week, which is equal to 6 sessions in total. |
| Classic Physiotherapy Program | Experimental | Other: Classic Physiotherapy ProgramHot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again. The period of treatment was 6 sessions in total with 25 minutes of each. Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients among the ages of 35-70,
- Suffering from LBP for at least 3 months,
- Diagnosed with LDH having at least 1 active trigger point that can be cooperated .
Key exclusion criteria (6 listed)
- Those with LDH that show neurological symptom,
- Having any orthopaedic problem at lower extremity and lower back region,
- Having sacroiliac joint problem, diagnosed with lumbar spondylolisthesis,
- Having any neurologic, rheumatic, oncologic problem,
- Who received any physiotherapy program at least 6 months before, patients having any corticosteroid treatment or oral medication
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 |
|---|---|---|
| Dry Needling ApplicationDry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique. | Other | Dry Needling Application |
| Classic Physiotherapy ProgramHot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again. Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin. | Other | Classic Physiotherapy Program |
Primary outcome
Pain assessed using the Short Form of McGill Pain Questionnaire-Visual Analogue Scale
Time frame: 2 weeks
The Short Form of McGill Pain Questionnaire-Visual Analogue Scale (MPQ-SF-VAS) was used in order to determine the pain intensity that the investigators use as primary outcome measure in the investigators study.
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 12 Aug 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling Application and Classic Physiotherapy Program in people with Metabolic Syndrome and Physical Activity, run by Eastern Mediterranean University.
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 12 Aug 2016. 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. 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?
Pain assessed using the Short Form of McGill Pain Questionnaire-Visual Analogue Scale (time frame: 2 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 12 Aug 2016.