Non-Spesific Chronic Low Back PainNCT04170816
Dry Needling With And Without Kinesio Taping® in The Non-Specific Chronic Low Back Pain
A study testing Dry needling in people with Non-Spesific Chronic Low Back Pain, run by Kars State Hospital.
Trial summary
We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Spesific Chronic Low Back Pain
- What is being tested?
- Dry needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having no abnormal results in routine blood tests
- having no known acute or chronic inflammatory disease
- an education level required for understanding the applied treatment, interventions
Who cannot join
- malignancies
- active infection
- history of common inflammatory rheumatic disease
- trauma in spinal area, skin lesion, presence of infection or open wounds
- radiculopathy
- peripheral circulation disorder
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- use of warfarin due to coagulopathy
- arthropathy
- congenital or acquired spinal pathology
- pregnancy
About this study
Official title: Comparing Dry Needling With And Without Kinesio Taping® in The Treatment of Non-Specific Chronic Low Back Pain
We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP).
Read the detailed description
A total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. Both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in DN therapy. KT application will be performed after every DN session in the study group. Pain will evaluate with visual analog scale, functionality was evaluated with Oswestry Disability Index and the status of depression will be evaluated with Beck Depression Index before the treatment and at the first month.
- Conditions
- Non-Spesific Chronic Low Back Pain
- Being tested
- Dry needling
- Keywords
- Dry needling, Kinesiotape, Low-back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
Also called Kinesiotape
DN and KT therapy will be applied 3 sessions in 1-week intervals
| Study group | Role | What they receive |
|---|---|---|
| DN plus KT group | Active comparator | DN plus KT therapy is going to be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy is going to be applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles.
Kinesio Taping Application: Tapes is going to be left on the patient's body for 5 days. Receives: Device: Dry needling |
| DN group | Active comparator | DN will be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy was applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles. Receives: Device: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Amount of pressure (Kg/cm2) applied at the lomber multifidus muscle, quadratus lumborum and gluteus medius muscle myofascial trigger point site that elicit pain for the patient will be reported
Measured: 3 week
Pain by visual analog scale (VAS)
Visual analog scale (VAS,0-10) will be used to assess resting, activity and night pain.
Measured: 3 week
Oswestry disability Index (ODI)
Changes from the Baseline, ODI is an effective tool to provide information on the extent of backache affecting the patient ability to cope with tasks of everyday life. Ten sections are included in the ODI tool with a total possible score of 5 for each section. The first statement carries a score of 0, and the last has a score of 5.
Measured: 3 week
Beck Depression Inventory
This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Spesific 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kars State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Bagcier, Kars State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170816
- Sponsor's protocol ID
- 80576354-050-99/167
- Status last verified
- Nov 2019
- First submitted
- 15 Sep 2019
- Last updated
- 20 Nov 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Dry Needling With And Without Kinesio Taping® in The Treatment of Non-Specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04170816
- Acronym / sponsor ID
- 80576354-050-99/167
- Conditions
- Non-Spesific Chronic Low Back Pain
- Keywords
- Dry needling, Kinesiotape, Low-back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kars State HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 20 Nov 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.
We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP).
Detailed description
A total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. Both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in DN therapy. KT application will be performed after every DN session in the study group. Pain will evaluate with visual analog scale, functionality was evaluated with Oswestry Disability Index and the status of depression will be evaluated with Beck Depression Index before the treatment and at the first month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DN plus KT group | Active comparator | Device: Dry needlingDN plus KT therapy is going to be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy is going to be applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles. Kinesio Taping Application: Tapes is going to be left on the patient's body for 5 days. |
| DN group | Active comparator | Device: Dry needlingDN will be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy was applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having no abnormal results in routine blood tests
- having no known acute or chronic inflammatory disease
- an education level required for understanding the applied treatment, interventions
Key exclusion criteria (10 listed)
- malignancies
- active infection
- history of common inflammatory rheumatic disease
- trauma in spinal area, skin lesion, presence of infection or open wounds
- radiculopathy
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 needlingAlso: KinesiotapeDN and KT therapy will be applied 3 sessions in 1-week intervals | Device | DN group, DN plus KT group |
Primary outcome
Pain pressure threshold
Time frame: 3 week
Amount of pressure (Kg/cm2) applied at the lomber multifidus muscle, quadratus lumborum and gluteus medius muscle myofascial trigger point site that elicit pain for the patient will be reported
Pain by visual analog scale (VAS)
Time frame: 3 week
Visual analog scale (VAS,0-10) will be used to assess resting, activity and night pain.
Oswestry disability Index (ODI)
Time frame: 3 week
Changes from the Baseline, ODI is an effective tool to provide information on the extent of backache affecting the patient ability to cope with tasks of everyday life. Ten sections are included in the ODI tool with a total possible score of 5 for each section. The first statement carries a score of 0, and the last has a score of 5.
Beck Depression Inventory
Time frame: 3 week
This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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 in people with Non-Spesific Chronic Low Back Pain, run by Kars State Hospital.
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 10 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: status not confirmed, as of the sponsor's last update on 20 Nov 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. 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?
Results are not available in the source record.
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 pressure threshold (time frame: 3 week). 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 20 Nov 2019.