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The Effectiveness of Kinesio Taping in Patients With Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Kinesio taping
Conventional physical therapy
Sponsored by
University of Tabuk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Low back pain, Chronic, Kinesio taping, TENS, Exercises

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pain caused by mechanical/nonspecific low back pain.
  • Degeneration of the spine and intervertebral disc.
  • The visual analog scale of pain 4 and above
  • Low back pain for at least three months

Exclusion Criteria:

  • Physical therapy treatment is taken in the past 6 months period
  • Previous spinal surgery with fixation
  • Structural anomalies
  • Spinal cord compression
  • Severe osteoporosis
  • Acute infections
  • Severe cardiovascular or metabolic diseases
  • Pregnant women

Sites / Locations

  • University of Tabuk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Kinesio taping and Conventional Physical therapy

Conventional Physical therapy

Arm Description

Kinesio taping with Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy

Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale
Pain, for the Average pain intensity over the last week was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible
Modified Oswestry low back pain disability questionnaire
Disability were measured using the Modified Oswestry Disability Index (MODI) which is a self-rating questionnaire used to evaluate functional physical disability
Lumbar range of motion-Modified Schober test
Lumbar flexion range of motion were measured by using modified Schober method

Secondary Outcome Measures

Full Information

First Posted
November 23, 2021
Last Updated
December 29, 2021
Sponsor
University of Tabuk
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1. Study Identification

Unique Protocol Identification Number
NCT05173948
Brief Title
The Effectiveness of Kinesio Taping in Patients With Chronic Low Back Pain
Official Title
Effectiveness of Kinesio Taping and Conventional Physical Therapy in the Management of Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tabuk

4. Oversight

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

5. Study Description

Brief Summary
The objective of this study is to determine the effectiveness of Kinesio taping (KT) with Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and Supervised Exercise therapy and CPT in the management of CLBP.
Detailed Description
Chronic low back pain (CLBP) is one of the most common causes of chronic disability which leads to major social and economic consequences. The role and effectiveness of the Kinesio taping (KT) and Conventional Physical therapy (CPT) are evident from the existing literature but no comparison was found on the combination of other physical therapy techniques such as supervised exercise therapy and Transcutaneous Electrical Nerve Stimulation (TENS) with CLBP in the Kingdom of Saudi Arabia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Low back pain, Chronic, Kinesio taping, TENS, Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio taping and Conventional Physical therapy
Arm Type
Experimental
Arm Description
Kinesio taping with Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy
Arm Title
Conventional Physical therapy
Arm Type
Experimental
Arm Description
Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy
Intervention Type
Other
Intervention Name(s)
Kinesio taping
Intervention Description
Kinesio taping: The tape is measured from the sacrum to the 12th thoracic vertebra with forwarding flexion of the trunk. The base is affixed to the insertion in the resting position. The muscle is elongated and the base anchored with skin displacement. The tape is then affixed with 10% stretch paravertebrally over the muscle bundles up to T12. The tape is rubbed with the muscle in the elongated state.
Intervention Type
Device
Intervention Name(s)
Conventional physical therapy
Intervention Description
Transcutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform. Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region. The current intensity was increased up to the patient's perception of paraesthesia. The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles. Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
Pain, for the Average pain intensity over the last week was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible
Time Frame
Six weeks
Title
Modified Oswestry low back pain disability questionnaire
Description
Disability were measured using the Modified Oswestry Disability Index (MODI) which is a self-rating questionnaire used to evaluate functional physical disability
Time Frame
Six weeks
Title
Lumbar range of motion-Modified Schober test
Description
Lumbar flexion range of motion were measured by using modified Schober method
Time Frame
Six weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain caused by mechanical/nonspecific low back pain. Degeneration of the spine and intervertebral disc. The visual analog scale of pain 4 and above Low back pain for at least three months Exclusion Criteria: Physical therapy treatment is taken in the past 6 months period Previous spinal surgery with fixation Structural anomalies Spinal cord compression Severe osteoporosis Acute infections Severe cardiovascular or metabolic diseases Pregnant women
Facility Information:
Facility Name
University of Tabuk
City
Tabuk
State/Province
North West
ZIP/Postal Code
71491
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36045306
Citation
Pakkir Mohamed SH, Al Amer HS, Nambi G. The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Clin Rheumatol. 2023 Jan;42(1):233-244. doi: 10.1007/s10067-022-06352-3. Epub 2022 Sep 1.
Results Reference
derived

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The Effectiveness of Kinesio Taping in Patients With Chronic Low Back Pain

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