NCT04943640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 12, 2021

Last Update Submit

June 21, 2021

Conditions

Keywords

low back painkinesiotapequality of lifeskin temperaturephysiotherapy

Outcome Measures

Primary Outcomes (2)

  • Change from Roland-Morris Disability Questionnaire score at five weeks

    The Roland-Morris Disability Questionnaire is a 24-item survey designed to assess the degree of functional limitation in patients with low back pain. The questionnaire answers are Yes-No (Yes: 1 point, No: 0 points), and high scores indicate severe disability

    before and after five weeks of treatment (10 sessions)

  • Change from Tissue temperature at five weeks

    Regional tissue temperature was measured by digital electronic infrared thermography (FLIR-e63900, Wilsonville, OR, USA). This method is a non-invasive assessment tool that does not require intervention by the investigator. The investigator can see changes in the skin surface temperature of the patient and, the thermal differences of the measured point are shown on the monitor.

    before and after five weeks of treatment (10 sessions)

Secondary Outcomes (2)

  • Change from The Oswestry Low Pain Disability Questionnaire score at five weeks

    before and after five weeks of treatment (10 sessions)

  • Change from Pain severity at five weeks

    before and after each session( five weeks of treatmant)

Study Arms (3)

kinesio taping

EXPERIMENTAL

The patient was advised to clean the skin with alcohol and shave the hairy areas. The standing patient was asked to take off high heels if he/she was wearing them. The paravertebral technique was used with 5 cm x 5 m kinesio tape material. While the patient was standing in an upright position, two longitudinal pieces were cut by taking the tape and slightly rolling its corners. The patient was asked to lean forward. The lower end of the tape was attached 7 cm below the sacroiliac joint at the level of the paravertebral muscles and the patient was bent forward. The patient was asked to do a slight rotation to the left, and while in this position, the tape was attached to T11-T12 without stretching at all. Kinesio tape was attached to the opposite side of the vertebrae with the same procedure.

Other: kinesio taping

rigid taping

EXPERIMENTAL

The patient was asked to lean forward, and 5 cm x 5 m rigid tape material was used in the right paravertebral region. When bonding the tape, first, the lower end of the tape was attached 7 cm below the sacroiliac joint at the level of the paravertebral muscles and the patient was bent forward. Then, the patient was asked to do a slight rotation to the left, and while in this position, the hypoallergenic tape (beta fix) was applied with no tension \[23\]. Then, rigid tape was applied upward onto the paravertebral muscles. The left paravertebral region was taped with the same procedure as the right paravertebral region .

Other: rigid taping

placebo taping groups

PLACEBO COMPARATOR

Placebo taping was applied to patients in this group using betafix, an elastic stabilization tape, as material. A straight line of betafix was applied to the non-painful scapular inferior alignment of the spine, right and left, while the patient was standing upright. Treatment with taping was administered to all groups every 2 days by the same physiotherapist .

Other: placebo taping

Interventions

Kinesio tape was developed by Kenzo Kase in the 1970s. It is an elastic tape, and its adhesive face is sinusoidal wavy. This feature has been shown to increase daily living activities and functions, as it supports the tissue while also allowing movement \[12\]. Kinesio tape lifts the skin and subcutaneous soft tissues of the fascia, which are painful and inflamed regions upon contractions seen in the tissue after tense adhesion to the skin. Therefore, it has been reported to reduce oedema and inflammation by creating more space and providing blood and lymphatic fluid flow.

kinesio taping

The tape material used in rigid (athletic) tape application is hard. It is used to position and unite the soft tissue, to protect the tissue from impact and to prevent local swelling.There are studies in the literature supporting the sensorimotor and proprioceptive sensation-enhancing effect of the athletic band, which provides a very good sensory input through the skin.

rigid taping

Placebo taping was applied to the patients in this group, using betafix, an elastic fixation band, as the material. The patient was told that taping would be applied. A straight line betafix was applied to the non-painful scapular inferior level of the spine on the right and left sides of the standing patient.

placebo taping groups

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Ankara, 06760, Turkey (Türkiye)

Location

Departmant of Health Services Vocational School, Physical Thraphy and Rehablitation, Ufuk University

Ankara, Turkey (Türkiye)

Location

Faculty of Health Sciences, Departmant of Physiotherapy and Rehabilitation, Baskent University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • Silva Parreira Pdo C, Menezes Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta Silva T, da Luz Junior MA, Pena Costa LO. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. J Physiother. 2013 Mar;59(1):52; discussion 52. doi: 10.1016/S1836-9553(13)70147-4.

    PMID: 23419916BACKGROUND
  • 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.

    PMID: 15129077BACKGROUND
  • 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.

    PMID: 11740366BACKGROUND
  • 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.

    PMID: 6226917BACKGROUND
  • 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.

    PMID: 29489530BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tugce Bozkurt

    Ufuk University

    PRINCIPAL INVESTIGATOR
  • Rabia Tugba Kilic

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR
  • Hayri Baran Yosmaoğlu

    Baskent University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 29, 2021

Study Start

November 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations