Chronic Low Back Pain (Non-specific, Uncomplicated)NCT06961903
Effectiveness of Functional Taping, Manual Therapy and Stereodynamic Interference Current
A study testing physiotherapy programme, Functional Taping and Manual Therapy in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effects of functional taping, manual therapy, and stereodynamic interference current applications on pain, functional capacity, sleep quality, and kinesiophobia in individuals with chronic low back pain (LBP). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Chronic Low Back Pain (Non-specific, Uncomplicated)
- What is being tested?
- physiotherapy programme, Functional Taping and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Jan 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- participants had to be aged between 20 and 50 years,
- have a diagnosis of chronic low back pain (low back pain persisting for more than 12 weeks),
- have a Visual Analogue Scale (VAS) score of at least 4/10,
- be suitable for physical therapy, and sign a written informed consent form by voluntarily agreeing to participate in the study.
Who cannot join
- with a history of lumbar surgery,
- acute inflammatory diseases or signs of infection, rheumatological, neurological or cardiovascular system diseases,
- pregnancy status,
- history of invasive intervention in the lumbar region within the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Functional Taping, Manual Therapy and Stereodynamic Interference Current in Patients With Chronic Low Back Pain
This study aimed to compare the effects of functional taping, manual therapy, and stereodynamic interference current applications on pain, functional capacity, sleep quality, and kinesiophobia in individuals with chronic low back pain (LBP). Conducted with 88 participants, the study divided them into four groups: a control group (standard physiotherapy), a functional taping group, a manual therapy group, and a stereodynamic interference current group. All groups received 10 sessions of treatment, 3 days a week. The study evaluated pain intensity (VAS), fear of movement (FOM), functional disability (ODI), and sleep quality (PSQI) at three points: before treatment, after treatment, and one month later. Results showed that manual therapy significantly improved pain levels (p<0.05), while stereodynamic interference current also reduced pain. Functional taping was most effective in reducing kinesiophobia (p<0.05). No significant differences were observed between the groups in terms of the Oswestry Disability Index and Pittsburgh Sleep Quality Index scores (p>0.05). The study concluded that manual therapy was the most effective for pain control, and functional taping was superior for managing kinesiophobia, emphasizing the need for individualized and multidisciplinary approaches in treating musculoskeletal health issues.
Read the detailed description
This randomized controlled experimental study was designed to compare the effects of functional taping, manual therapy, and stereodynamic interference current applications on pain, functional capacity, sleep quality, and kinesiophobia in individuals with chronic low back pain (LBP). A total of 88 participants diagnosed with chronic LBP were recruited and randomly assigned into four groups: a control group receiving standard physiotherapy, a functional taping group, a manual therapy group, and a stereodynamic interference current group.
All participants underwent treatment for 10 sessions, administered three times per week. The interventions were standardized across the groups, and treatment adherence was carefully monitored. Assessments were conducted at three time points: baseline (before treatment), immediately after the treatment period, and one month following the completion of treatment.
The primary outcome measures included pain intensity, assessed with the Visual Analog Scale (VAS); fear of movement (kinesiophobia), assessed with the Tampa Scale of Kinesiophobia (TSK); functional disability, assessed with the Oswestry Disability Index (ODI); and sleep quality, assessed with the Pittsburgh Sleep Quality Index (PSQI).
The results indicated that the manual therapy group exhibited the greatest improvement in both resting and movement-related pain (p<0.05). Stereodynamic interference current application was also found to significantly reduce pain levels. The functional taping group demonstrated the most substantial improvement in reducing kinesiophobia scores (p<0.05). However, there were no statistically significant differences between the groups regarding functional disability (ODI) and sleep quality (PSQI) scores (p>0.05).
The findings highlight that manual therapy is particularly effective for managing pain in chronic LBP patients, while functional taping is especially beneficial for addressing fear of movement. These results underscore the importance of individualized treatment planning based on the specific needs of patients and support the integration of multidisciplinary approaches to effectively manage complex musculoskeletal conditions
- Being tested
- physiotherapy programme, Functional Taping, Manual Therapy, Stereodynamic Interference Current
- Keywords
- Chronic low back pain, manual therapy, functional taping, electrotherapy, kinesiophobia
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy programmeOther
A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.
Functional TapingOther
A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. In addition, the taping method applied in this study can be defined as a "Function-Oriented Taping Application to Preserve Extension: Lumbar Extension Taping," which was specifically designed to maintain lumbar extension.
Manual TherapyOther
A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.Manual Therapy (MT), which literally means "hands-on treatment," is an evidence-based therapeutic approach consisting of skilled hand movements and maneuvers applied to produce therapeutic effects and to treat musculoskeletal dysfunctions and pain. In addition to the standard program, manual therapy was also administered in this study.
Stereodynamic Interference CurrentOther
A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.In addition, the stereodynamic interference current method was applied in this study. A 'Y' electrode was used during the application. Due to the rapid development of accommodation, the current intensity was frequently increased during the session. The average treatment duration was 15 minutes, and a frequency of 50-100 Hz was used to achieve analgesic effects.
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy | Experimental | A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. Receives: Other: physiotherapy programme |
| Functional Taping | Experimental | A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. In addition, the taping method applied in this study can be defined as a "Function-Oriented Taping Application to Preserve Extension: Lumbar Extension Taping," which was specifically designed to maintain lumbar extension. Receives: Other: physiotherapy programme; Other: Functional Taping |
| Manual Therapy | Experimental | A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.Manual Therapy (MT), which literally means "hands-on treatment," is an evidence-based therapeutic approach consisting of skilled hand movements and maneuvers applied to produce therapeutic effects and to treat musculoskeletal dysfunctions and pain. In addition to the standard program, manual therapy was also administered in this study. Receives: Other: physiotherapy programme; Other: Manual Therapy |
| Stereodynamic Interference Current | Experimental | A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.In addition, the stereodynamic interference current method was applied in this study. A 'Y' electrode was used during the application. Due to the rapid development of accommodation, the current intensity was frequently increased during the session. The average treatment duration was 15 minutes, and a frequency of 50-100 Hz was used to achieve analgesic effects. Receives: Other: physiotherapy programme; Other: Stereodynamic Interference Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The VAS is a measurement tool that allows individuals to subjectively assess the intensity of pain they perceive. The VAS is usually located on a 10 cm long horizontal line between two extremes ranging from 'no pain' to 'unbearable pain'. Participants are asked to mark their current pain level on this line and the measurement is made by evaluating the distance from the marked point to the starting point in centimetres (cm). The VAS is a simple and reliable tool that is frequently preferred to quantitatively measure the severity of pain, especially in clinical research.
Measured: through study completion, an average of one month.
kinesiophobia level
The Tampa Kinesiophobia Scale (TSK) is a self-report form developed to measure the fear of movement that individuals develop due to pain. The TSK consists of a total of 17 items and each item is scored from 'strongly disagree' to 'strongly agree' on a 4-point Likert-type scale. High scores indicate a high level of movement avoidance and pain-related fear of movement. Especially in individuals with chronic pain, it is an important tool in terms of evaluating the fear of movement related to pain and making plans for treatment.
Measured: through study completion, an average of one month.
Low Back Disability Index
The Oswestry Low Back Disability Index (ODI) is a comprehensive scale developed to assess the level of functional disability in individuals with low back pain and measures the impact of low back pain on activities of daily living. This index, which consists of a total of 10 items, evaluates daily activities such as pain intensity, personal care, lifting, walking, sitting, sitting, standing, sleeping, social life, travelling and sex life. Each item is scored between 0 and 5 and the level of disability is determined by converting the total score into a percentage. Higher scores mean more disability. The ODI is one of the most widely used tools worldwide to measure functional status in individuals with chronic low back pain.
Measured: through study completion, an average of one month.
Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale developed to assess the sleep quality of individuals in the last month. The PSQI consists of a total of 19 items and assesses seven different components, including sleep duration, sleep latency, sleep efficiency, sleep disturbances, sleep medication use, and daytime sleepiness. The scores obtained from each component are included in the total scoring to determine the overall sleep quality. The total score obtained varies between 0 and 21; high scores indicate poor sleep quality. PSQI is a reliable measurement tool to detect sleep quality deterioration especially in chronic pain patients.
Measured: through study completion, an average of one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion31 Jan 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 Pain (Non-specific, Uncomplicated)Studies 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
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem Atakent University Hospital
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Muhammed Fatih Kavak, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961903
- Sponsor's protocol ID
- 2022/15
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Functional Taping, Manual Therapy and Stereodynamic Interference Current in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06961903
- Acronym / sponsor ID
- 2022/15
- Keywords
- Chronic low back pain, manual therapy, functional taping, electrotherapy, kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Acibadem Atakent University Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 8 May 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.
This study aimed to compare the effects of functional taping, manual therapy, and stereodynamic interference current applications on pain, functional capacity, sleep quality, and kinesiophobia in individuals with chronic low back pain (LBP). Conducted with 88 participants, the study divided them into four groups: a control group (standard physiotherapy), a functional taping group, a manual therapy group, and a stereodynamic interference current group. All groups received 10 sessions of treatment, 3 days a week. The study evaluated pain intensity (VAS), fear of movement (FOM), functional disability (ODI), and sleep quality (PSQI) at three points: before treatment, after treatment, and one month later. Results showed that manual therapy significantly improved pain levels (p<0.05), while stereodynamic interference current also reduced pain. Functional taping was most effective in reducing kinesiophobia (p<0.05). No significant differences were observed between the groups in terms of the Oswestry Disability Index and Pittsburgh Sleep Quality Index scores (p>0.05). The study concluded that manual therapy was the most effective for pain control, and functional taping was superior for managing kinesiophobia, emphasizing the need for individualized and multidisciplinary approaches in treating musculoskeletal health issues.
Detailed description
This randomized controlled experimental study was designed to compare the effects of functional taping, manual therapy, and stereodynamic interference current applications on pain, functional capacity, sleep quality, and kinesiophobia in individuals with chronic low back pain (LBP). A total of 88 participants diagnosed with chronic LBP were recruited and randomly assigned into four groups: a control group receiving standard physiotherapy, a functional taping group, a manual therapy group, and a stereodynamic interference current group.
All participants underwent treatment for 10 sessions, administered three times per week. The interventions were standardized across the groups, and treatment adherence was carefully monitored. Assessments were conducted at three time points: baseline (before treatment), immediately after the treatment period, and one month following the completion of treatment.
The primary outcome measures included pain intensity, assessed with the Visual Analog Scale (VAS); fear of movement (kinesiophobia), assessed with the Tampa Scale of Kinesiophobia (TSK); functional disability, assessed with the Oswestry Disability Index (ODI); and sleep quality, assessed with the Pittsburgh Sleep Quality Index (PSQI).
The results indicated that the manual therapy group exhibited the greatest improvement in both resting and movement-related pain (p<0.05). Stereodynamic interference current application was also found to significantly reduce pain levels. The functional taping group demonstrated the most substantial improvement in reducing kinesiophobia scores (p<0.05). However, there were no statistically significant differences between the groups regarding functional disability (ODI) and sleep quality (PSQI) scores (p>0.05).
The findings highlight that manual therapy is particularly effective for managing pain in chronic LBP patients, while functional taping is especially beneficial for addressing fear of movement. These results underscore the importance of individualized treatment planning based on the specific needs of patients and support the integration of multidisciplinary approaches to effectively manage complex musculoskeletal conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| physiotherapy | Experimental | Other: physiotherapy programmeA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. |
| Functional Taping | Experimental | Other: physiotherapy programme, Other: Functional TapingA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. In addition, the taping method applied in this study can be defined as a "Function-Oriented Taping Application to Preserve Extension: Lumbar Extension Taping," which was specifically designed to maintain lumbar extension. |
| Manual Therapy | Experimental | Other: physiotherapy programme, Other: Manual TherapyA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.Manual Therapy (MT), which literally means "hands-on treatment," is an evidence-based therapeutic approach consisting of skilled hand movements and maneuvers applied to produce therapeutic effects and to treat musculoskeletal dysfunctions and pain. In addition to the standard program, manual therapy was also administered in this study. |
| Stereodynamic Interference Current | Experimental | Other: physiotherapy programme, Other: Stereodynamic Interference CurrentA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.In addition, the stereodynamic interference current method was applied in this study. A 'Y' electrode was used during the application. Due to the rapid development of accommodation, the current intensity was frequently increased during the session. The average treatment duration was 15 minutes, and a frequency of 50-100 Hz was used to achieve analgesic effects. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- participants had to be aged between 20 and 50 years,
- have a diagnosis of chronic low back pain (low back pain persisting for more than 12 weeks),
- have a Visual Analogue Scale (VAS) score of at least 4/10,
- be suitable for physical therapy, and sign a written informed consent form by voluntarily agreeing to participate in the study.
Key exclusion criteria (4 listed)
- with a history of lumbar surgery,
- acute inflammatory diseases or signs of infection, rheumatological, neurological or cardiovascular system diseases,
- pregnancy status,
- history of invasive intervention in the lumbar region within the last six months
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 |
|---|---|---|
| physiotherapy programmeA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. | Other | Functional Taping, Manual Therapy, Stereodynamic Interference Current, physiotherapy |
| Functional TapingA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. In addition, the taping method applied in this study can be defined as a "Function-Oriented Taping Application to Preserve Extension: Lumbar Extension Taping," which was specifically designed to maintain lumbar extension. | Other | Functional Taping |
| Manual TherapyA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.Manual Therapy (MT), which literally means "hands-on treatment," is an evidence-based therapeutic approach consisting of skilled hand movements and maneuvers applied to produce therapeutic effects and to treat musculoskeletal dysfunctions and pain. In addition to the standard program, manual therapy was also administered in this study. | Other | Manual Therapy |
| Stereodynamic Interference CurrentA program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.In addition, the stereodynamic interference current method was applied in this study. A 'Y' electrode was used during the application. Due to the rapid development of accommodation, the current intensity was frequently increased during the session. The average treatment duration was 15 minutes, and a frequency of 50-100 Hz was used to achieve analgesic effects. | Other | Stereodynamic Interference Current |
Primary outcome
pain intensity
Time frame: through study completion, an average of one month.
The VAS is a measurement tool that allows individuals to subjectively assess the intensity of pain they perceive. The VAS is usually located on a 10 cm long horizontal line between two extremes ranging from 'no pain' to 'unbearable pain'. Participants are asked to mark their current pain level on this line and the measurement is made by evaluating the distance from the marked point to the starting point in centimetres (cm). The VAS is a simple and reliable tool that is frequently preferred to quantitatively measure the severity of pain, especially in clinical research.
kinesiophobia level
Time frame: through study completion, an average of one month.
The Tampa Kinesiophobia Scale (TSK) is a self-report form developed to measure the fear of movement that individuals develop due to pain. The TSK consists of a total of 17 items and each item is scored from 'strongly disagree' to 'strongly agree' on a 4-point Likert-type scale. High scores indicate a high level of movement avoidance and pain-related fear of movement. Especially in individuals with chronic pain, it is an important tool in terms of evaluating the fear of movement related to pain and making plans for treatment.
Low Back Disability Index
Time frame: through study completion, an average of one month.
The Oswestry Low Back Disability Index (ODI) is a comprehensive scale developed to assess the level of functional disability in individuals with low back pain and measures the impact of low back pain on activities of daily living. This index, which consists of a total of 10 items, evaluates daily activities such as pain intensity, personal care, lifting, walking, sitting, sitting, standing, sleeping, social life, travelling and sex life. Each item is scored between 0 and 5 and the level of disability is determined by converting the total score into a percentage. Higher scores mean more disability. The ODI is one of the most widely used tools worldwide to measure functional status in individuals with chronic low back pain.
Sleep Quality Index
Time frame: through study completion, an average of one month.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale developed to assess the sleep quality of individuals in the last month. The PSQI consists of a total of 19 items and assesses seven different components, including sleep duration, sleep latency, sleep efficiency, sleep disturbances, sleep medication use, and daytime sleepiness. The scores obtained from each component are included in the total scoring to determine the overall sleep quality. The total score obtained varies between 0 and 21; high scores indicate poor sleep quality. PSQI is a reliable measurement tool to detect sleep quality deterioration especially in chronic pain patients.
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 8 May 2025.
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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 physiotherapy programme, Functional Taping and Manual Therapy in people with Chronic Low Back Pain (Non-specific, Uncomplicated), 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 4 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 8 May 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?
pain intensity (time frame: through study completion, an average of one month.). 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 8 May 2025.