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Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain

Primary Purpose

Low Back Pain, Young Adult, Therapy

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Dynamic tape
Sham tape
Sponsored by
John Paul II University of Applied Sciences in Biala Podlaska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • participants' age between 18 and 30,
  • the presence of pain in the lumbar region of the spine,
  • participants who have not been using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
  • no contraindications to the use of dynamic kinesiology taping patches,
  • informed, written consent to participate in the study.

Exclusion Criteria:

  • status of the post lumbar spine surgery,
  • subjects who have had a spinal injury within 6 months prior to the start of the study,
  • neoplastic diseases,
  • congenital structural pathologies of the spine,
  • allergy to the adhesive substance of kinesiology taping or paper patch,
  • being a physiotherapy student.

Sites / Locations

  • Pope John Paul II State School Of Higher Education in Biała Podlaska
  • Laboratory of Pope John Paul II State School Of Higher Education in Biala Podlaska

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dynamic tape

Paper tape

Arm Description

Experimental group will use a special dynamic tape on the lumbar extensor muscles

Control group will use a paper tape on the lumbar extensor muscles

Outcomes

Primary Outcome Measures

Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.

Secondary Outcome Measures

Modified Laitinen's pain questionnaire
The Laitinen questionnaire takes into account four indicators evaluated in a scale of 0 to 4: the intensity of pain, the frequency of its occurrence, the use of analgesic medications and limitation of the participant's motor activity. A research participant could be granted from 0 to 16 points, the maximum score meaning the highest level of pain.
Oswestry Disability Index
Oswestry Disability Index takes into account ten indicators evaluated in a scale of 0 to 5. A research participant could be granted from 0 to 50 points, the minimum score meaning the highest level of disability.

Full Information

First Posted
October 18, 2021
Last Updated
April 11, 2022
Sponsor
John Paul II University of Applied Sciences in Biala Podlaska
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1. Study Identification

Unique Protocol Identification Number
NCT05104957
Brief Title
Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain
Official Title
Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain in Subjects Under 30 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
John Paul II University of Applied Sciences in Biala Podlaska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lumbar spine pain syndromes are one of the most common pain conditions in our society. The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Today, this method is used in many fields of medicine. Its primary purpose is to support the musculoskeletal system by using various types of applications. There is a lack of publications in the global literature on the effect of kinesiotaping of the external oblique muscles on lumbar spine pain. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
Detailed Description
Back pain occurs in people of all ages, regardless of their job. Both blue-collar and white-collar workers are exposed to strain and pain in the lumbar spine. The presence of pain is also promoted by low physical activity, poor motor habits, as well as stress. There are numerous factors affecting the quality of life in patients with lower back pain. These include degree of pain, physical fitness, individual factors, degree of social support, and a potential for adapting forces to match constantly changing conditions. The contemporary functional model of lumbar spinal muscles divides them into local stabilizers, single-joint global stabilizers, and multi-joint global stabilizers. The abdominal external oblique muscles are classified as global stabilizers. They generate force to control range of motion and allow limitation of that range (eccentric control), and functionally control rotation in all movements, regardless of the load acting on the spine. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Young Adult, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study participants will be randomly qualified (allocated via a computer program) to the two groups: A - dynamic tape, B - sham (paper) tape
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Before commencing the tests, each participant was familiarized with their course, expressed their informed written consent for participation and random assignment to a specified tested group. The author of this paper had no influence on the categorization of the participants into individual treatment groups. During the studies, the physiotherapists performing the categorization were not informed about the results of the used treatment.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic tape
Arm Type
Experimental
Arm Description
Experimental group will use a special dynamic tape on the lumbar extensor muscles
Arm Title
Paper tape
Arm Type
Sham Comparator
Arm Description
Control group will use a paper tape on the lumbar extensor muscles
Intervention Type
Other
Intervention Name(s)
Dynamic tape
Intervention Description
The experimental group will use a special dynamic patch made of cotton, coated with a hypoallergenic acrylic heat-activated adhesive arranged in sinusoidal-shaped layers. The tape will be applied using the muscle technique with a Y-shaped cut patch directly to the dried and non-greased skin. The application will be performed in a standing position, with the participant's lower extremities straight. The therapist will place the beginning of the tape (the base) on the participant's sacrum and then, asking them to bend 45 degrees forward, tape the tails of the tape along the spine on the extensor muscles of the lumbar region, without changing the tension of the tape, keeping the base in the initial position.
Intervention Type
Other
Intervention Name(s)
Sham tape
Intervention Description
In the control group, a plain paper patch will be used to conduct the study, which, like the dynamic patch, will be applied using the same form of tape cutting and the same application technique. The entire method of applying the patch will also take place in the participant's standing position with forward bending. The paper patch will be placed at the levels from the L3 segment to the sacrum, along the spine on the lumbar extensor muscles.
Primary Outcome Measure Information:
Title
Visual analogue scale of pain (VAS)
Description
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Time Frame
Visual analogue pain scale (VAS) will be carried out before the start of the therapy.
Title
Visual analogue scale of pain (VAS)
Description
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Time Frame
Visual analogue pain scale (VAS) will be carried out 4 days of therapy, immediately after its completion.
Title
Visual analogue scale of pain (VAS)
Description
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Time Frame
Visual analogue pain scale (VAS) will be carried out four weeks after the end of the treatment.
Secondary Outcome Measure Information:
Title
Modified Laitinen's pain questionnaire
Description
The Laitinen questionnaire takes into account four indicators evaluated in a scale of 0 to 4: the intensity of pain, the frequency of its occurrence, the use of analgesic medications and limitation of the participant's motor activity. A research participant could be granted from 0 to 16 points, the maximum score meaning the highest level of pain.
Time Frame
Modified Laitinen's pain questionnaire will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
Title
Oswestry Disability Index
Description
Oswestry Disability Index takes into account ten indicators evaluated in a scale of 0 to 5. A research participant could be granted from 0 to 50 points, the minimum score meaning the highest level of disability.
Time Frame
Oswestry Disability Index will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participants' age between 18 and 30, the presence of pain in the lumbar region of the spine, participants who have not been using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry, no contraindications to the use of dynamic kinesiology taping patches, informed, written consent to participate in the study. Exclusion Criteria: status of the post lumbar spine surgery, subjects who have had a spinal injury within 6 months prior to the start of the study, neoplastic diseases, congenital structural pathologies of the spine, allergy to the adhesive substance of kinesiology taping or paper patch, being a physiotherapy student.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamil Zaworski, Ph.D.
Organizational Affiliation
John Paul II University of Applied Sciences in Biala Podlaska
Official's Role
Study Chair
Facility Information:
Facility Name
Pope John Paul II State School Of Higher Education in Biała Podlaska
City
Biała Podlaska
ZIP/Postal Code
21-500
Country
Poland
Facility Name
Laboratory of Pope John Paul II State School Of Higher Education in Biala Podlaska
City
Biała Podlaska
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain

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