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Completed

NCT Number: NCT05866159

Effects of Kinesio Tape on Chronic Low Back Pain

This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional disability, and physical activity. The hypothesis is that applying KT to the lumbar spine would improve back-specific body perception, reduce pain and functional disability, and increase physical activity in individuals with CLBP compared to the sham-taping group.

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

About this study

Low back pain (LBP) is prevalent and the leading cause of disability worldwide. In addition, it is often associated with psychological, social, and physical factors that can impact one's ability to function, participate in society, maintain job satisfaction, and socioeconomic status. Therefore, managing it requires a significant amount of healthcare resources. Maladaptive body image and maladaptive beliefs are among the conditions that can be targeted during treatment as they may contribute to the chronicity of LBP.

This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional disability, and physical activity. The hypothesis is that applying KT to the lumbar spine would improve back-specific body perception, reduce pain and functional disability, and increase physical activity in individuals with CLBP compared to the sham-taping group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ability to speak and write Turkish fluently
  • have been experiencing low back pain for at least 3 months
  • have a pain severity score of ≥4 on the visual analog scale

Exclusion criteria

  • had significant spinal surgery in the past (fusion or discectomy), spinal surgery within the last six months,
  • a diagnosis of a serious spinal condition (such as cancer, inflammatory arthropathy, or vertebral fracture),
  • skin allergy to KT or pre-existing skin lesion or infection
  • a neurological disease,
  • is currently pregnant,

Treatment and study plan

Kinesiotape using Rocktape®

Other

Kinesiotape using Rocktape® on day one by a physiotherapist who has experienced more than five years. If possible, the taping will be left for seven days.

Sham Taping

Other

sham taping with Rocktape®, with no tension.

Primary outcomes

  1. Change in The Fremantle Back Awareness Questionnaire (FreBAQ) on day 1 and day 7 (in points)

    Time frame: day 1 before the start of the kinesiotaping, day 3, and day 7

    The Fremantle Back Awareness Questionnaire (FreBAQ) is a tool used to measure a patient's perception of their back. It consists of nine questions rated on a five-point scale, ranging from "0=never" to "4=always".

Secondary outcomes

  1. Change in Pain Intensity (VAS) on day 0 and day 7 (in millimeters)

    Time frame: day 1 before the start of the kinesiotaping, day 3, and day 7

    Patients will score their low-back pain intensity over the past week on a horizontal 10 cm line with descriptive anchors at each end, such as on the right, "no pain" to the left, and "extreme pain."

  2. Change in The Roland-Morris Disability Questionnaire (RMDQ) on day 1 and day 7 (in points)

    Time frame: day 1 before the start of the kinesiotaping, day 3, and day 7

    The RMDQ evaluates self-reported physical disability resulting from low back pain. The RMDQ questionnaire consists of 24 items. Each item is scored as "0" if left blank or "1" if endorsed. The total RMQ score ranges from 0 to 24, with higher scores indicating more pain-related disability.

  3. Change in The International Physical Activity Questionnaire - Short Form (IPAQ-SF) on day 1 and day 7 (in MET min/wk)

    Time frame: day 1 before the start of the kinesiotaping, day 3, and day 7

    The IPAQ was developed to assess physical activity internationally. There are two versions of the International Physical Activity Questionnaire (IPAQ): the long form with 31 items (IPAQ-LF) and the short form with nine items (IPAQ-SF). The IPAQ-SF measures activity in four different intensity levels, including 1)vigorous activities, 2) moderate activities, 3) walking, and 4) sitting.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

The Effect of Kinesio Tape on Back-Specific Body Perception, Pain, Functional Status, and Physical Activity Level in Patients With Chronic Low Back Pain

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 19, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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