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Biomechanical Taping on Low Back Pain With Increased Foot Pronation

Primary Purpose

Low Back Pain, Foot Posture, Taping

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Taping
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring biomechanical-taping, mechanical low back pain, foot posture, function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mechanical low back pain for at least 6 months
  • Age between 18-65 years
  • Increased, bilateral, flexible pronation of the feet (Foot Posture Index-6 score> 0)

Exclusion Criteria:

  • Rigid pes planus, pes cavus, equinus deformity, hallux valgus, hallux rigid or calcaneal epin in the feet
  • Lower extremity injury or surgery in the last 6 months
  • Radicular type back pain (patients with leg pain> low back pain)
  • Body Mass Index (BMI)> 30,
  • Use of analgesics
  • Pregnancy
  • Presence of symptoms related to a history of spinal surgery in the last 5 years.
  • Neurological impairment or cognitive dysfunction (stroke, dementia, etc.)
  • Rheumatological diseases
  • Peripheral vascular diseases
  • Difference in length between extremities

Sites / Locations

  • Ayşe Alpözgen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Biomechanical Taping

Placebo Taping

Arm Description

Anti pronation taping will apply bilaterally with Dynamic Tape®. The tape will attach to the dorsal aspect of the foot. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w.

Placebo Taping will apply bilaterally to each individual in the control group by the same physiotherapist, without any effect on increased pronation. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
It is used to evaluate the level of pain.The activity, rest and night pain levels of the patients will be question.
Foot Posture Index (FPI-6)
FPI-6 examines foot posture under 6 headings: talar head palpation, supra and infra lateral malleoli curvature, calcaneal frontal plane position, prominence in region of talonavicular joint, congruence of medial longitudinal arch, abduction/adduction of forefoot on rearfoot. Each measure is scored from -2 to 2. A total score of 0 is considered a neutral foot; a positive score is for pronated foot, whereas a supinated foot is given a negative score.

Secondary Outcome Measures

6 Minute Walk Test (6MWT)
The 6MWT provides an indirect assessment of physical performance and endurance capacity.the person is asked to walk for 6 minutes as fast as possible in the 30-meter straight corridor, the patient does not speak during walking, but is supported with motivating sentences at the end of every 1 minute. After 6 minutes, the distance traveled (meters-m) is recorded.
Step-On-Stool Test
The person tested is asked to step up onto and down from a stool at a self-selected speed. The step height is 0.40 meters for women, 0.44 meters for men. The number of steps managed will be record.
PILE Lumbar Lifting Test
The lumbar Spine is tested by asking to lift the box with a weight of 76 cm shelf from the ground to waist level. The test starts with weights of 3.6 kg for women and 5.9 kg for men. It is asked to lift the box containing weight 4 times in 20 seconds. For each completed round, a weight of 2.25 kg for women and 4.5 kg for men are added to the box. If the patient reaches 85% of the maximum heart rate, lifts 55-60% of his body weight, shows pain or fatigue after a 20-second interval, and cannot complete 4 repetitions within 20 seconds, the test is terminated. The maximum weight lifted & the number of repetitions multiplied so total work done will calculate and record.
Revised Oswestry Disability Index
; It is a self-administered questionnaire and consists of 10 sections. Each section is scored between 1 and 5 (the highest score for the last question is 6), test scores range from 0 to 51. An increase in the score is interpreted as an increase in disability

Full Information

First Posted
February 27, 2021
Last Updated
August 3, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04776798
Brief Title
Biomechanical Taping on Low Back Pain With Increased Foot Pronation
Official Title
The Effects of Biomechanical Taping on Individuals With Mechanical Low Back Pain With Increased Foot Pronation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

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
It is stated that abnormal lower extremity posture and biomechanics are effective in the development and progression of Low Back Pain (LBP). Exercise, electrotherapy, insoles, and orthoses are used for the prevention and treatment of low back pain.The use of orthosis, insoles, and taping techniques stands out in the correction of foot posture and dysfunctions, which are stated to cause LBP. In studies examining the application of taping to improve foot posture and biomechanics, it is stated that taping is effective in improving foot posture and biomechanics in the short term. Biomechanical taping has been used in the treatment of musculoskeletal disorders in recent years. It is aimed to correct the impaired joint biomechanics by reducing the load on the joint, supporting strength, and providing movement modification.
Detailed Description
In this study, it is assumed that correction of "increased foot pronation" with dynamic taping will result in the recovery of increased internal rotation and decreased shock absorption during weight-bearing, which is stated to cause pain. The study aims to investigate the effects of biomechanical tapping in combination with a home exercise program on LBP. Participants with a diagnosis of LBP and bilateral increased flexible foot pronation will divide into two groups (Biomechanical Taping (BT) group or Placebo Taping (PT) group). Tape applications will repeat twice per week, for 4 weeks. And also a home-based exercise program will apply to both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Foot Posture, Taping, Functional Mitral Regurgitation
Keywords
biomechanical-taping, mechanical low back pain, foot posture, function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biomechanical Taping
Arm Type
Experimental
Arm Description
Anti pronation taping will apply bilaterally with Dynamic Tape®. The tape will attach to the dorsal aspect of the foot. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w.
Arm Title
Placebo Taping
Arm Type
Placebo Comparator
Arm Description
Placebo Taping will apply bilaterally to each individual in the control group by the same physiotherapist, without any effect on increased pronation. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w.
Intervention Type
Other
Intervention Name(s)
Taping
Intervention Description
Tape applications will repeat twice per week, for 4 weeks.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
It is used to evaluate the level of pain.The activity, rest and night pain levels of the patients will be question.
Time Frame
4 week
Title
Foot Posture Index (FPI-6)
Description
FPI-6 examines foot posture under 6 headings: talar head palpation, supra and infra lateral malleoli curvature, calcaneal frontal plane position, prominence in region of talonavicular joint, congruence of medial longitudinal arch, abduction/adduction of forefoot on rearfoot. Each measure is scored from -2 to 2. A total score of 0 is considered a neutral foot; a positive score is for pronated foot, whereas a supinated foot is given a negative score.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
6 Minute Walk Test (6MWT)
Description
The 6MWT provides an indirect assessment of physical performance and endurance capacity.the person is asked to walk for 6 minutes as fast as possible in the 30-meter straight corridor, the patient does not speak during walking, but is supported with motivating sentences at the end of every 1 minute. After 6 minutes, the distance traveled (meters-m) is recorded.
Time Frame
4 week
Title
Step-On-Stool Test
Description
The person tested is asked to step up onto and down from a stool at a self-selected speed. The step height is 0.40 meters for women, 0.44 meters for men. The number of steps managed will be record.
Time Frame
4 week
Title
PILE Lumbar Lifting Test
Description
The lumbar Spine is tested by asking to lift the box with a weight of 76 cm shelf from the ground to waist level. The test starts with weights of 3.6 kg for women and 5.9 kg for men. It is asked to lift the box containing weight 4 times in 20 seconds. For each completed round, a weight of 2.25 kg for women and 4.5 kg for men are added to the box. If the patient reaches 85% of the maximum heart rate, lifts 55-60% of his body weight, shows pain or fatigue after a 20-second interval, and cannot complete 4 repetitions within 20 seconds, the test is terminated. The maximum weight lifted & the number of repetitions multiplied so total work done will calculate and record.
Time Frame
4 week
Title
Revised Oswestry Disability Index
Description
; It is a self-administered questionnaire and consists of 10 sections. Each section is scored between 1 and 5 (the highest score for the last question is 6), test scores range from 0 to 51. An increase in the score is interpreted as an increase in disability
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mechanical low back pain for at least 6 months Age between 18-65 years Increased, bilateral, flexible pronation of the feet (Foot Posture Index-6 score> 0) Exclusion Criteria: Rigid pes planus, pes cavus, equinus deformity, hallux valgus, hallux rigid or calcaneal epin in the feet Lower extremity injury or surgery in the last 6 months Radicular type back pain (patients with leg pain> low back pain) Body Mass Index (BMI)> 30, Use of analgesics Pregnancy Presence of symptoms related to a history of spinal surgery in the last 5 years. Neurological impairment or cognitive dysfunction (stroke, dementia, etc.) Rheumatological diseases Peripheral vascular diseases Difference in length between extremities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Zengin Alpozgen, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayşe Alpözgen
City
Küçükçekmece
State/Province
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Biomechanical Taping on Low Back Pain With Increased Foot Pronation

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