Lumbar Disc HerniationNCT06777095
Effects of Kinesio Taping on Pain, Endurance, Proprioception, Mobility and Disability in Lumbar Disc Herniation
A study testing Routine Treatment + I Taping, Routine Treatment + Star Taping and Routine Treatment in people with Lumbar Disc Herniation and Lumbar Disc Disease, run by Sevtap Günay at 1 site in Turkey (Türkiye).
Trial summary
In addition to the physical therapy program, taping was applied to 90 patients diagnosed with lumbar disc herniation. 90 patients were randomized into 3 groups. Group 1 received star-shaped taping to the lumbar region in addition to physical therapy, Group 2 received I-shaped taping to the erector spinae muscles in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Disc Disease, Chronic Pain
- What is being tested?
- Routine Treatment + I Taping, Routine Treatment + Star Taping and Routine Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 29 Mar 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having moderate to severe low back pain (Numeric Rating Scale>3) for at least 6 weeks
- Voluntariness to participate in the study
Who cannot join
- History of lumbar fracture or tumor
- Previous lumbosacral or abdominal surgery
- Ankylosing spondylitis, spondylolisthesis, fibromyalgia, peripheral neurogenic disease
- Pregnancy
- History of cancer
- Demonstrated allergy/intolerance to kinesiotaping during a test performed before the initial evaluation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Cigli Training and Research Hospital
Izmir
About this study
Official title: Effects of Different Kinesio Taping Treatments Added to the Physical Therapy Program on Pain, Endurance, Lumbar Proprioception, Mobility and Disability in Patients Diagnosed With Lumbar Disc Herniation: A Randomized Controlled Trial
In addition to the physical therapy program, taping was applied to 90 patients diagnosed with lumbar disc herniation. 90 patients were randomized into 3 groups. Group 1 received star-shaped taping to the lumbar region in addition to physical therapy, Group 2 received I-shaped taping to the erector spinae muscles in addition to physical therapy, and Group 3 was planned as the control group. In the first evaluation, sociodemographic information and disease duration (months) were questioned. Then, pain, muscle strength and endurance mobility, lumbar proprioception, functional level, and disability were evaluated. Evaluations were performed before treatment, after taping and at the end of the 12th week.
Read the detailed description
The study included 90 patients aged between 18-65 years who were diagnosed with LDH by magnetic resonance imaging (MRI), had moderate to severe low back pain (Numeric Rating Scale >4) for at least 6 weeks, and were planned to receive a physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks). The 90 patients included in the study were randomized into 3 groups using the computer-assisted randomization method. Group 1 received star-shaped taping to the lumbar region in addition to physical therapy (5 times in total every 3 days), Group 2 received I-shaped taping to the erector spinae muscles in addition to physical therapy (5 times in total every 3 days), and Group 3 was planned as the control group. In the first evaluation, sociodemographic information (age, gender, height (m), weight (kg), BMI (kg/m2)) and disease duration (months) were questioned. Then, pain (pain intensity and pressure pain threshold), muscle strength (lumbar extensor muscle strength) and endurance (trunk extensor muscle endurance), mobility (lumbar lordosis angle, joint range of motion), lumbar proprioception, functional level, disability evaluations were performed. Evaluations were performed before treatment, after the taping application and at the end of the 12th week. Post-treatment evaluations were performed the day after the tape was removed.
- Conditions
- Lumbar Disc Herniation, Lumbar Disc Disease, Chronic Pain
- Being tested
- Routine Treatment + I Taping, Routine Treatment + Star Taping, Routine Treatment
- Keywords
- Taping, Low back pain, Lumbar disc herniation, Muscular fitness, Proprioception, Mobility, Disability
- Medical subject headings
- Intervertebral Disc Displacement, Intervertebral disc disease, Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Treatment + I TapingOther
Routine physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks) was applied. In addition to routine treatment, I taping (a total of 5 times every 3 days) was performed. Two I-shaped kinesio tapings were applied on the paraspinal muscles from the posterior superior iliac spine to the T12 level. 50% tension was applied to the area of the tapes outside the anchor points.
Routine Treatment + Star TapingOther
Routine physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks) was applied. In addition to routine treatment, star taping (a total of 5 times every 3 days) was performed. Four I tapes, one vertical, one horizontal and two at a 45° angle to the vertical tape, were applied to the point of maximum pain in the lumbar region. 25% tension was applied to the midpoint of the tapes except for the ends.
Routine TreatmentOther
Routine physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks) was applied. No taping was applied.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | In addition to routine physical therapy sessions, I taping was applied to the paraspinal muscles. Receives: Other: Routine Treatment + I Taping |
| Group 2 | Active comparator | In addition to routine physical therapy sessions, star taping was applied to sensitive points. Receives: Other: Routine Treatment + Star Taping |
| Group 3 | Other | No application (no taping) was made outside of the routine physical therapy program. Receives: Other: Routine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessment
Pain intensity was measured using the Pain Intensity Numerical Rating Scale, which is most commonly used in the management of patients with chronic low back pain. The scale has 11 points ranging from no pain = 0 to worst possible pain = 10. Patients were asked to indicate their pain intensity during the "last 24 hours" or "average pain" at rest.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Pressure pain threshold assessment
The pressure pain threshold was determined in kg/cm2 using an algometer device. Measurements were made at 4 points, 5 cm lateral to the L3 and L5 spinous processes on the right and left. The patient was informed to give the command 'stop' when the pressure sensitivity became unbearable or turned into pain. The test was stopped as soon as the patient reported pain and the applied force was recorded. 2 measurements were made at 30-second intervals and the average of the measurements was used. If the participant did not report pain at a force equivalent to 100 N/s, the test was stopped and this value was accepted.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Muscle strength assessment
Lumbar extensor muscle strength was measured with a hand held dynamometer. Participants were positioned face down on a stretcher with their hands clasped. The base of the dynamometer was fixed to the center of the T4 spine and participants were asked to extend their trunks. The tests were repeated twice with at least a one-minute rest. The higher value was recorded as the result.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Endurance assessment
The measurement was made using the Biering-Sorensen test. The participant placed the upper half of his/her body on another examination table at a lower height. The participant was asked to hold his/her body isometrically in a horizontal position with hands clasped behind the head until fatigue or pain was felt. The test was terminated when any part of the participant's upper extremities touched the table. The tests were repeated twice with at least a one-minute rest break. The higher value was recorded as the result.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Lumbar lordosis angle assessment
Lumbar lordosis was measured using a digital inclinometer. The participant stood with their feet 15 cm apart and their arms at their sides while looking ahead. In this position, the T12-L1 and S1 spine levels were marked by the physiotherapist. Lumbar lordosis was calculated by placing one end of the inclinometer on T12-L1 and the other on the sacrum.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Lumbar joint range of motion assessment
Participants' lumbar flexion, extension and lateral flexion active joint range of motion measurements were evaluated angularly with a universal goniometer.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Proprioception assessment
Proprioception was assessed by having the participants attempt to reproduce the target position. Three different target positions were selected. The participants were asked to repeat two different trunk positions from upright posture to 45° and 60° flexion with the eyes looking forward, and one position to 15° extension. Each participant was positioned in 45° lumbar flexion for 10 seconds after a neutral starting position and was asked to remember this position. The participant then returned to the neutral position and was given verbal instructions to reproduce the target position as accurately as possible. The participant reported to the therapist that he had reached the target position as perceived. The participant was asked to maintain the final position for 3 seconds and this position was recorded. The same procedures were repeated for 60° lumbar flexion and 15° lumbar extension. Each trial was repeated three times with a 30-second rest; the mean was then calculated.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Functional level assessment
A 30-second stand-up-sit test was performed to determine the functional level. Participants were asked to sit in a back-supported chair without arm support, with their hands crossed on their shoulders. Participants were asked to sit immediately after coming to an upright standing position. A trial test was performed to learn the test. The individual who learned the test was asked to sit down and stand up for 30 seconds and the number of repetitions of the movement was recorded.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Disability assessment
The Roland Morris Disability Questionnaire was used to assess disability due to low back pain. The questionnaire consists of 24 items regarding physical activity, rest/sleep, psychosocial outcomes, home management, nutrition, and pain frequency. Higher scores indicate increasing disability.
Measured: Baseline, day after last taping application (week 2), 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Mar 2023
- Primary completion15 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevtap Günay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevtap Günay, Izmir Katip Celebi University
- Investigators
- Filiz Meryem SERTPOYRAZ, Assoc. Dr., Study director, Department of Physiotherapy and Rehabilitation, Bakircay University Training and Research HospitalHilal UZUNLAR, PhD(c), RA, Study chair, Izmir Katip Çelebi University, Department of Physiotherapy and RehabilitationEcem SAK, Ass.Dr., Study chair, Department of Physiotherapy and Rehabilitation, Bakircay University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777095
- Sponsor's protocol ID
- Izmir Katip Celebi
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.
PubMed 24239490Keles BY, Yalcinkaya EY, Gunduz B, Bardak AN, Erhan B. Kinesio Taping in patients with lumbar disc herniation: A randomised, controlled, double-blind study. J Back Musculoskelet Rehabil. 2017;30(3):543-550. doi: 10.3233/BMR-150491.
PubMed 27858685Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
PubMed 16034851Suzuki H, Aono S, Inoue S, Imajo Y, Nishida N, Funaba M, Harada H, Mori A, Matsumoto M, Higuchi F, Nakagawa S, Tahara S, Ikeda S, Izumi H, Taguchi T, Ushida T, Sakai T. Clinically significant changes in pain along the Pain Intensity Numerical Rating Scale in patients with chronic low back pain. PLoS One. 2020 Mar 3;15(3):e0229228. doi: 10.1371/journal.pone.0229228. eCollection 2020.
PubMed 32126108Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PubMed 22588748de Oliveira RF, Liebano RE, Costa Lda C, Rissato LL, Costa LO. Immediate effects of region-specific and non-region-specific spinal manipulative therapy in patients with chronic low back pain: a randomized controlled trial. Phys Ther. 2013 Jun;93(6):748-56. doi: 10.2522/ptj.20120256. Epub 2013 Feb 21.
PubMed 23431209Karthikbabu S, Chakrapani M. Hand-Held Dynamometer is a Reliable Tool to Measure Trunk Muscle Strength in Chronic Stroke. J Clin Diagn Res. 2017 Sep;11(9):YC09-YC12. doi: 10.7860/JCDR/2017/28105.10672. Epub 2017 Sep 1.
PubMed 29207821Latimer J, Maher CG, Refshauge K, Colaco I. The reliability and validity of the Biering-Sorensen test in asymptomatic subjects and subjects reporting current or previous nonspecific low back pain. Spine (Phila Pa 1976). 1999 Oct 15;24(20):2085-9; discussion 2090. doi: 10.1097/00007632-199910150-00004.
PubMed 10543003Chang NJ, Chou W, Hsiao PC, Chang WD, Lo YM. Acute effects of Kinesio taping on pain, disability and back extensor muscle endurance in patients with low back pain caused by magnetic resonance imaging-confirmed lumbar disc degeneration. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):85-93. doi: 10.3233/BMR-169681.
PubMed 28800306Abbasi S, Hadian Rasanani MR, Ghotbi N, Olyaei GR, Bozorgmehr A, Rasouli O. Short-term effect of kinesiology taping on pain, functional disability and lumbar proprioception in individuals with nonspecific chronic low back pain: a double-blinded, randomized trial. Chiropr Man Therap. 2020 Nov 20;28(1):63. doi: 10.1186/s12998-020-00349-y.
PubMed 33213492Lin YH, Sun MH. The effect of lifting and lowering an external load on repositioning error of trunk flexion-extension in subjects with and without low back pain. Clin Rehabil. 2006 Jul;20(7):603-8. doi: 10.1191/0269215506cr971oa.
PubMed 16894803Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
PubMed 10380242Kucukdeveci AA, Tennant A, Elhan AH, Niyazoglu H. Validation of the Turkish version of the Roland-Morris Disability Questionnaire for use in low back pain. Spine (Phila Pa 1976). 2001 Dec 15;26(24):2738-43. doi: 10.1097/00007632-200112150-00024.
PubMed 11740366Alahmari KA, Rengaramanujam K, Reddy RS, Samuel PS, Tedla JS, Kakaraparthi VN, Ahmad I. The immediate and short-term effects of dynamic taping on pain, endurance, disability, mobility and kinesiophobia in individuals with chronic non-specific low back pain: A randomized controlled trial. PLoS One. 2020 Sep 29;15(9):e0239505. doi: 10.1371/journal.pone.0239505. eCollection 2020.
PubMed 32991582
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Kinesio Taping Treatments Added to the Physical Therapy Program on Pain, Endurance, Lumbar Proprioception, Mobility and Disability in Patients Diagnosed With Lumbar Disc Herniation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06777095
- Acronym / sponsor ID
- Izmir Katip Celebi
- Conditions
- Lumbar Disc Herniation, Lumbar Disc Disease, Chronic Pain
- Keywords
- Taping, Low back pain, Lumbar disc herniation, Muscular fitness, Proprioception, Mobility, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sevtap GünayUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 15 Jan 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.
In addition to the physical therapy program, taping was applied to 90 patients diagnosed with lumbar disc herniation. 90 patients were randomized into 3 groups. Group 1 received star-shaped taping to the lumbar region in addition to physical therapy, Group 2 received I-shaped taping to the erector spinae muscles in addition to physical therapy, and Group 3 was planned as the control group. In the first evaluation, sociodemographic information and disease duration (months) were questioned. Then, pain, muscle strength and endurance mobility, lumbar proprioception, functional level, and disability were evaluated. Evaluations were performed before treatment, after taping and at the end of the 12th week.
Detailed description
The study included 90 patients aged between 18-65 years who were diagnosed with LDH by magnetic resonance imaging (MRI), had moderate to severe low back pain (Numeric Rating Scale >4) for at least 6 weeks, and were planned to receive a physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks). The 90 patients included in the study were randomized into 3 groups using the computer-assisted randomization method. Group 1 received star-shaped taping to the lumbar region in addition to physical therapy (5 times in total every 3 days), Group 2 received I-shaped taping to the erector spinae muscles in addition to physical therapy (5 times in total every 3 days), and Group 3 was planned as the control group. In the first evaluation, sociodemographic information (age, gender, height (m), weight (kg), BMI (kg/m2)) and disease duration (months) were questioned. Then, pain (pain intensity and pressure pain threshold), muscle strength (lumbar extensor muscle strength) and endurance (trunk extensor muscle endurance), mobility (lumbar lordosis angle, joint range of motion), lumbar proprioception, functional level, disability evaluations were performed. Evaluations were performed before treatment, after the taping application and at the end of the 12th week. Post-treatment evaluations were performed the day after the tape was removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Routine Treatment + I TapingIn addition to routine physical therapy sessions, I taping was applied to the paraspinal muscles. |
| Group 2 | Active comparator | Other: Routine Treatment + Star TapingIn addition to routine physical therapy sessions, star taping was applied to sensitive points. |
| Group 3 | Other | Other: Routine TreatmentNo application (no taping) was made outside of the routine physical therapy program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having moderate to severe low back pain (Numeric Rating Scale>3) for at least 6 weeks
- Voluntariness to participate in the study
Key exclusion criteria (6 listed)
- History of lumbar fracture or tumor
- Previous lumbosacral or abdominal surgery
- Ankylosing spondylitis, spondylolisthesis, fibromyalgia, peripheral neurogenic disease
- Pregnancy
- History of cancer
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 |
|---|---|---|
| Routine Treatment + I TapingRoutine physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks) was applied. In addition to routine treatment, I taping (a total of 5 times every 3 days) was performed. Two I-shaped kinesio tapings were applied on the paraspinal muscles from the posterior superior iliac spine to the T12 level. 50% tension was applied to the area of the tapes outside the anchor points. | Other | Group 1 |
| Routine Treatment + Star TapingRoutine physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks) was applied. In addition to routine treatment, star taping (a total of 5 times every 3 days) was performed. Four I tapes, one vertical, one horizontal and two at a 45° angle to the vertical tape, were applied to the point of maximum pain in the lumbar region. 25% tension was applied to the midpoint of the tapes except for the ends. | Other | Group 2 |
| Routine TreatmentRoutine physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks) was applied. No taping was applied. | Other | Group 3 |
Primary outcome
Pain intensity assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
Pain intensity was measured using the Pain Intensity Numerical Rating Scale, which is most commonly used in the management of patients with chronic low back pain. The scale has 11 points ranging from no pain = 0 to worst possible pain = 10. Patients were asked to indicate their pain intensity during the "last 24 hours" or "average pain" at rest.
Pressure pain threshold assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
The pressure pain threshold was determined in kg/cm2 using an algometer device. Measurements were made at 4 points, 5 cm lateral to the L3 and L5 spinous processes on the right and left. The patient was informed to give the command 'stop' when the pressure sensitivity became unbearable or turned into pain. The test was stopped as soon as the patient reported pain and the applied force was recorded. 2 measurements were made at 30-second intervals and the average of the measurements was used. If the participant did not report pain at a force equivalent to 100 N/s, the test was stopped and this value was accepted.
Muscle strength assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
Lumbar extensor muscle strength was measured with a hand held dynamometer. Participants were positioned face down on a stretcher with their hands clasped. The base of the dynamometer was fixed to the center of the T4 spine and participants were asked to extend their trunks. The tests were repeated twice with at least a one-minute rest. The higher value was recorded as the result.
Endurance assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
The measurement was made using the Biering-Sorensen test. The participant placed the upper half of his/her body on another examination table at a lower height. The participant was asked to hold his/her body isometrically in a horizontal position with hands clasped behind the head until fatigue or pain was felt. The test was terminated when any part of the participant's upper extremities touched the table. The tests were repeated twice with at least a one-minute rest break. The higher value was recorded as the result.
Lumbar lordosis angle assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
Lumbar lordosis was measured using a digital inclinometer. The participant stood with their feet 15 cm apart and their arms at their sides while looking ahead. In this position, the T12-L1 and S1 spine levels were marked by the physiotherapist. Lumbar lordosis was calculated by placing one end of the inclinometer on T12-L1 and the other on the sacrum.
Lumbar joint range of motion assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
Participants' lumbar flexion, extension and lateral flexion active joint range of motion measurements were evaluated angularly with a universal goniometer.
Proprioception assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
Proprioception was assessed by having the participants attempt to reproduce the target position. Three different target positions were selected. The participants were asked to repeat two different trunk positions from upright posture to 45° and 60° flexion with the eyes looking forward, and one position to 15° extension. Each participant was positioned in 45° lumbar flexion for 10 seconds after a neutral starting position and was asked to remember this position. The participant then returned to the neutral position and was given verbal instructions to reproduce the target position as accurately as possible. The participant reported to the therapist that he had reached the target position as perceived. The participant was asked to maintain the final position for 3 seconds and this position was recorded. The same procedures were repeated for 60° lumbar flexion and 15° lumbar extension. Each trial was repeated three times with a 30-second rest; the mean was then calculated.
Functional level assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
A 30-second stand-up-sit test was performed to determine the functional level. Participants were asked to sit in a back-supported chair without arm support, with their hands crossed on their shoulders. Participants were asked to sit immediately after coming to an upright standing position. A trial test was performed to learn the test. The individual who learned the test was asked to sit down and stand up for 30 seconds and the number of repetitions of the movement was recorded.
Disability assessment
Time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline
The Roland Morris Disability Questionnaire was used to assess disability due to low back pain. The questionnaire consists of 24 items regarding physical activity, rest/sleep, psychosocial outcomes, home management, nutrition, and pain frequency. Higher scores indicate increasing disability.
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 15 Jan 2025.
- Background: PubMed 24239490Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.
- Background: PubMed 27858685Keles BY, Yalcinkaya EY, Gunduz B, Bardak AN, Erhan B. Kinesio Taping in patients with lumbar disc herniation: A randomised, controlled, double-blind study. J Back Musculoskelet Rehabil. 2017;30(3):543-550. doi: 10.3233/BMR-150491.
- Background: PubMed 16034851Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
- Background: PubMed 32126108Suzuki H, Aono S, Inoue S, Imajo Y, Nishida N, Funaba M, Harada H, Mori A, Matsumoto M, Higuchi F, Nakagawa S, Tahara S, Ikeda S, Izumi H, Taguchi T, Ushida T, Sakai T. Clinically significant changes in pain along the Pain Intensity Numerical Rating Scale in patients with chronic low back pain. PLoS One. 2020 Mar 3;15(3):e0229228. doi: 10.1371/journal.pone.0229228. eCollection 2020.
- Background: PubMed 11690728Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
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- 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.
Filiz Meryem SERTPOYRAZ, Assoc. Dr. study director
Department of Physiotherapy and Rehabilitation, Bakircay University Training and Research Hospital
Hilal UZUNLAR, PhD(c), RA study chair
Izmir Katip Çelebi University, Department of Physiotherapy and Rehabilitation
Ecem SAK, Ass.Dr. study chair
Department of Physiotherapy and Rehabilitation, Bakircay University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Treatment + I Taping, Routine Treatment + Star Taping and Routine Treatment in people with Lumbar Disc Herniation and Lumbar Disc Disease, run by Sevtap Günay 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 2 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 15 Jan 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 assessment (time frame: Baseline, day after last taping application (week 2), 12 weeks after baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777095, which also lists 16 linked publications.
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 15 Jan 2025.