Low Back PainNCT06952205
Efficiency of Function-oriented Taping Application in Low Back Pain Patients
A study testing Experimental group and only exercises in people with Low Back Pain and Kinesiophobia, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of this study is to determine the efficiency of functional tape application to patients with acute or subacute low back pain. 40 patients with acute-subacute low back pain were divided into two groups: control and experimental group. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Low Back Pain, Kinesiophobia
- What is being tested?
- Experimental group and only exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 23 Jun 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 20 and 65
- Being literate in Turkish
- Having lower back pain for less than 3 months
- Informed Consent Form for taping application to have been signed
Who cannot join
- Allergic reaction on the skin
- Hypertension, Type 2 diabetes mellitus (DM) and Presence of accompanying systemic disease other than hypercholesterolemia
- Not being able to communicate
- Using corsets and similar supports
- Having a body mass index > 30
- Use of antidepressant and myorelexan medication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar Üniversity Physiotherapy and Rehabilitation Department
Istanbul, Ümraniye
About this study
Purpose of this study is to determine the efficiency of functional tape application to patients with acute or subacute low back pain. 40 patients with acute-subacute low back pain were divided into two groups: control and experimental group. To control group, McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied. To experimental group, functional taping were applied in addition of these treatments. Range of Motion (ROM), Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia (TSK) and The Oswestry Disability Index (ODI) were evaluated preand post-treatment and datas were analyzed with statistical methods. In analysis; p value was accepted p<0,05 for t test and Mann Whitney U test process. In the measurements that compared the improvement of both groups, based on pre- and post-treatment evaluations; improvement in the experimental group was significantly higher in all of these parameters of ROM, VAS, TSK and ODI than in the control group (p<0,05). The use of functional rigid taping in patients with acute and subacute low back pain provided a statistically significant improvement in all measured values of patients and provide better results than the control group. However, there is a need for comparative new studies in order to measure the effectiveness of rigid taping in a more accurate way.
- Conditions
- Low Back Pain, Kinesiophobia
- Being tested
- Experimental group, only exercises
- Keywords
- Rigid taping, Functional taping
- Medical subject headings
- Low Back Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied.To experimental group, functional taping were applied in addition of these treatments.
only exercisesOther
McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments
| Study group | Role | What they receive |
|---|---|---|
| functional taping | Experimental | McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied.To experimental group, functional taping were applied in addition of these treatments. Receives: Other: Experimental group; Other: only exercises |
| control group with only exercises | Active comparator | McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments Receives: Other: only exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
The flexion, extension, rotation, and lateral flexion range of motion of the lumbar region will be measured using a goniometer
Measured: through study completion, an average of 2 weeks.
Pain intensity
The Visual Analog Scale (VAS) will evaluate low back pain by asking participants to mark their pain level on a 10 cm scale, where 0 indicates no pain and 10 indicates severe pain, based on their experience over the past week.
Measured: through study completion, an average of 2 weeks.
Degree of kinesiophobia
The Tampa Kinesiophobia Scale measures an individual's level of fear related to movement. Participants complete a 17-item questionnaire, indicating their fear and anxiety levels towards specific physical activities or movements. The scale uses a scoring system from 1 to 4 for each item, with a total score of up to 68. Higher scores indicate a higher level of kinesiophobia, while lower scores indicate less fear.
Measured: through study completion, an average of 2 weeks
Disability Index
The Oswestry Disability Index (ODI) measures functional limitations in daily activities due to low back pain. The questionnaire consists of 10 sections, each assessing difficulties experienced by the participant due to pain. Participants rate each section from 0 to 5. The total score indicates the level of disability, with higher scores reflecting greater limitations in the individual's quality of life.
Measured: through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Feb 2017
- Primary completion1 Jun 2017
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Muhammed Fatih Kavak, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952205
- Sponsor's protocol ID
- MFKavak-01
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Function-oriented Taping Application in Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT06952205
- Acronym / sponsor ID
- MFKavak-01
- Conditions
- Low Back Pain, Kinesiophobia
- Keywords
- Rigid taping, Functional taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 30 Apr 2025 (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.
Purpose of this study is to determine the efficiency of functional tape application to patients with acute or subacute low back pain. 40 patients with acute-subacute low back pain were divided into two groups: control and experimental group. To control group, McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied. To experimental group, functional taping were applied in addition of these treatments. Range of Motion (ROM), Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia (TSK) and The Oswestry Disability Index (ODI) were evaluated preand post-treatment and datas were analyzed with statistical methods. In analysis; p value was accepted p<0,05 for t test and Mann Whitney U test process. In the measurements that compared the improvement of both groups, based on pre- and post-treatment evaluations; improvement in the experimental group was significantly higher in all of these parameters of ROM, VAS, TSK and ODI than in the control group (p<0,05). The use of functional rigid taping in patients with acute and subacute low back pain provided a statistically significant improvement in all measured values of patients and provide better results than the control group. However, there is a need for comparative new studies in order to measure the effectiveness of rigid taping in a more accurate way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional taping | Experimental | Other: Experimental group, Other: only exercisesMcKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied.To experimental group, functional taping were applied in addition of these treatments. |
| control group with only exercises | Active comparator | Other: only exercisesMcKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 20 and 65
- Being literate in Turkish
- Having lower back pain for less than 3 months
- Informed Consent Form for taping application to have been signed
Key exclusion criteria (6 listed)
- Allergic reaction on the skin
- Hypertension, Type 2 diabetes mellitus (DM) and Presence of accompanying systemic disease other than hypercholesterolemia
- Not being able to communicate
- Using corsets and similar supports
- Having a body mass index > 30
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 |
|---|---|---|
| Experimental groupMcKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied.To experimental group, functional taping were applied in addition of these treatments. | Other | functional taping |
| only exercisesMcKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments | Other | control group with only exercises, functional taping |
Primary outcome
Range of Motion
Time frame: through study completion, an average of 2 weeks.
The flexion, extension, rotation, and lateral flexion range of motion of the lumbar region will be measured using a goniometer
Pain intensity
Time frame: through study completion, an average of 2 weeks.
The Visual Analog Scale (VAS) will evaluate low back pain by asking participants to mark their pain level on a 10 cm scale, where 0 indicates no pain and 10 indicates severe pain, based on their experience over the past week.
Degree of kinesiophobia
Time frame: through study completion, an average of 2 weeks
The Tampa Kinesiophobia Scale measures an individual's level of fear related to movement. Participants complete a 17-item questionnaire, indicating their fear and anxiety levels towards specific physical activities or movements. The scale uses a scoring system from 1 to 4 for each item, with a total score of up to 68. Higher scores indicate a higher level of kinesiophobia, while lower scores indicate less fear.
Disability Index
Time frame: through study completion, an average of 2 weeks
The Oswestry Disability Index (ODI) measures functional limitations in daily activities due to low back pain. The questionnaire consists of 10 sections, each assessing difficulties experienced by the participant due to pain. Participants rate each section from 0 to 5. The total score indicates the level of disability, with higher scores reflecting greater limitations in the individual's quality of life.
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 30 Apr 2025.
- 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 Experimental group and only exercises in people with Low Back Pain and Kinesiophobia, run by Uskudar 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 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 30 Apr 2025. 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?
Range of Motion (time frame: through study completion, an average of 2 weeks.). 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 30 Apr 2025.