Biomechanical Taping on Low Back Pain With Increased Foot Pronation

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04776798
• Other study ID #: 05.SKHEK
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: February 2023

Study information

• Verified date: August 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: February 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Foot Posture
• Functional Mitral Regurgitation
• Low Back Pain
• Mitral Valve Insufficiency
• Taping

Intervention

Other:
• Taping
Tape applications will repeat twice per week, for 4 weeks.

Locations

Country	Name	City	State
Turkey	Ayse Alpözgen	Küçükçekmece	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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