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Biomechanical Taping on Low Back Pain With Increased Foot Pronation

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ClinicalTrials.gov Identifier: NCT04776798
Recruitment Status : Enrolling by invitation
First Posted : March 2, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ayse Zengin Alpozgen, Istanbul University-Cerrahpasa

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Foot Posture Taping Functional Mitral Regurgitation Other: Taping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Biomechanical Taping on Individuals With Mechanical Low Back Pain With Increased Foot Pronation
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 4 week ]
    It is used to evaluate the level of pain.The activity, rest and night pain levels of the patients will be question.

  2. Foot Posture Index (FPI-6) [ Time Frame: 4 week ]
    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 :
  1. 6 Minute Walk Test (6MWT) [ Time Frame: 4 week ]
    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.

  2. Step-On-Stool Test [ Time Frame: 4 week ]
    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.

  3. PILE Lumbar Lifting Test [ Time Frame: 4 week ]
    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. Revised Oswestry Disability Index [ Time Frame: 4 week ]
    ; 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776798


Locations
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Turkey
Ayşe Alpözgen
Küçükçekmece, İstanbul, Turkey
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: Ayse Zengin Alpozgen, PhD Istanbul University-Cerrahpasa
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Responsible Party: Ayse Zengin Alpozgen, Asst.Prof., Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04776798    
Other Study ID Numbers: 05.SKHEK
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayse Zengin Alpozgen, Istanbul University-Cerrahpasa:
biomechanical-taping
mechanical low back pain
foot posture
function
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases