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

NCT05104957 | Completed

• 1 other identifier: PopeJohnPaulIIStateSchHigherE2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain; Young Adult; Therapy

Outcome Measures

Primary Outcomes (3)

• 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 pain scale (VAS) will be carried out before the start of the therapy.

• 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 pain scale (VAS) will be carried out 4 days of therapy, immediately after its completion.

• 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 pain scale (VAS) will be carried out four weeks after the end of the treatment.

Secondary Outcomes (2)

• Modified Laitinen's pain questionnaire

  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

• Oswestry Disability Index

  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

Study Arms (2)

Dynamic tape

EXPERIMENTAL

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

Other: Dynamic tape

Paper tape

SHAM COMPARATOR

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

Other: Sham tape

Interventions

Dynamic tape OTHER

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.

Dynamic tape

Sham tape OTHER

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.

Paper tape

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• John Paul II University in Biała Podlaska: lead

Study Sites (2)

Pope John Paul II State School Of Higher Education in Biała Podlaska

Biała Podlaska, 21-500, Poland

Location

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

Biała Podlaska, Poland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kamil Zaworski, Ph.D.

  John Paul II University in Biała Podlaska

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study participants will be randomly qualified (allocated via a computer program) to the two groups: A - dynamic tape, B - sham (paper) tape

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 3, 2021
• Study Start: November 15, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 30, 2022
• Last Updated: April 12, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)