Clinical trial NCT04943640: The Additional Effect of Different Taping Applications in Patients With Lumbar Radiculopathy
Official title: The Additional Effect of Different Taping Applications on Pain, Functionality, and Tissue Temperature in Patients With Lumbar Radiculopathy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Recurrent
Kinesiotape
Quality of Life
Physiotherapy
Keywords: low back pain
kinesiotape
quality of life
skin temperature
physiotherapy
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study aims to compare the therapeutic effects of different taping materials and techniques on pain, functionality, and tissue temperature in patients with lumbar radiculopathy.

Detailed description: Pain occurs due to the intervertebral disc; ligaments in the region; or degeneration, strain, and sprains in the muscles, neurogenic, inflammatory, infectious, or neoplastic problems caused by structures in and around the spine . Low back pain is a serious health problem, with a lifetime prevalence of 84% . According to the American Society of Pain's clinical practice guidelines, low back pain is classified into three categories: nonspecific low back pain, radiculopathy-induced low back pain, and low back pain associated with another specific cause. A multidisciplinary approach is recommended for the treatment of low back pain. Before pharmacological treatments, cognitive behavioral therapy, physiotherapy exercise programmes, electrical physical therapy modalities, manual therapy, and psychological therapy are frequently referenced treatment options. Taping is one of the conservative physical therapy methods that is often a preferred treatment in clinics. Rigid (athletic) taping and kinesiological taping are the most preferred taping techniques . Non-elastic taping material is used in the rigid taping application. It is used to position soft tissue and ensure that the tissues come together, are protected from contact, create compression, and prevent local swelling. Studies supporting the sensorimotor and proprioceptive sensory enhancing effects of rigid tape, which provides very good sensory input over the skin, are found in previous studies \[7-9\]. Unlike rigid tape, kinesio tape can be stretched up to 140% of its resting length due to its structure, which is the approximate stretching capacity of normal skin .

Although there are various studies related to this topic, there is still no consensus on the effectiveness of taping in patients with low back pain who have disc degeneration. The reason for this is that some studies show the positive effect of kinesio taping on the reduction of low back pain, but some cannot show the effect of taping or find any changes . The healing mechanisms of different taping treatments have not been fully clarified. Moreover, local temperature, which is one of the indicators of vascularization and tissue healing, has not been investigated widely. Our study aims to examine the effects of different taping materials and techniques on pain, functionality, and local tissue temperature in patients with lumbar radiculopathy.

Eligibility criteria: Inclusion Criteria:

* The criterion for inclusion in the study for volunteers was low back pain due to lumbar radiculopathy.

Exclusion Criteria:

* Exclusion criteria were skin disease, central nervous system damage, tumour in the spine, surgical operation of the spine, pregnancy, and rheumatic disease

Primary outcomes:
measure: Change from Roland-Morris Disability Questionnaire score at five weeks
timeFrame: before and after five weeks of treatment (10 sessions)
measure: Change from Tissue temperature at five weeks
timeFrame: before and after five weeks of treatment (10 sessions)
Secondary outcomes:
measure: Change from The Oswestry Low Pain Disability Questionnaire score at five weeks
timeFrame: before and after five weeks of treatment (10 sessions)
measure: Change from Pain severity at five weeks
timeFrame: before and after each session( five weeks of treatmant)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
city: Ankara
country: Turkey
facility: Departmant of Health Services Vocational School, Physical Thraphy and Rehablitation, Ufuk University
city: Ankara
country: Turkey
facility: Faculty of Health Sciences, Departmant of Physiotherapy and Rehabilitation, Baskent University
Study officials:
affiliation: Ufuk University
name: Tugce Bozkurt
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Yildirim Beyazıt University
name: Rabia Tugba Kilic
role: STUDY_DIRECTOR
affiliation: Baskent University
name: Hayri Baran Yosmaoğlu
role: STUDY_CHAIR
References:
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citation: Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
citation: Kucukdeveci 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.
citation: Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
citation: Xue EY, Chandler LK, Viviano SL, Keith JD. Use of FLIR ONE Smartphone Thermography in Burn Wound Assessment. Ann Plast Surg. 2018 Apr;80(4 Suppl 4):S236-S238. doi: 10.1097/SAP.0000000000001363.