Biomechanical Taping on Low Back Pain With Increased Foot Pronation

The Effects of Biomechanical Taping on Individuals With Mechanical Low Back Pain With Increased Foot Pronation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain; Functional Mitral Regurgitation; Taping; Foot Posture
• Intervention / Treatment: Other: Taping

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Küçükçekmece, İstanbul, Turkey
      • Ayşe Alpözgen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biomechanical Taping; 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.	Other: Taping; Tape applications will repeat twice per week, for 4 weeks.
Placebo Comparator: Placebo Taping; 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.	Other: Taping; Tape applications will repeat twice per week, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 week
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.	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 week
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.	4 week
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.	4 week
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	4 week

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Principal Investigator: Ayse Zengin Alpozgen, PhD, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: function; mechanical low back pain; foot posture; biomechanical-taping
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Heart Valve Diseases; Back Pain; Low Back Pain; Mitral Valve Insufficiency
• Other Study ID Numbers: 05.SKHEK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No