The Effect of Kinesiotaping in Pregnant Women

NCT06709105 | Completed

• 1 other identifier: 192
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the effect of an exercise program combined with Kinesio Taping (KT) and sham KT on clinical parameters in pregnant women with low back pain. A total of 40 participants were included in the study, 20 in the experimental and 20 in the control groups. Visual Analog Scale (VAS), Roland Morris Quality of Life Questionnaire and Pittsburgh Sleep Quality Index were used as data collection tools. The experimental group received KT and an exercise program, while the control group received sham KT and exercise program.

Conditions

KINESIOTAPING

Keywords

Kinesiotaping; Low Back Pain; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  The Visual Analogue Scale (VAS) has been widely used in numerous studies to assess the intensity of pain and is considered a reliable and valid tool. It measures subjectively perceived pain on a scale resembling a 0-10 cm ruler, with one end representing no pain and the other indicating the most severe pain.

  up to 30 minutes

Secondary Outcomes (1)

• Pittsburgh sleep quality index

  up to 30 minutes

Study Arms (2)

Kinesiotape application

EXPERIMENTAL

The application was performed using 5 cm x 5 m kinesio tape material. After preparing the standing patient in terms of clothing and skin readiness, the patient was asked to lean forward. To adhere the tape to the right paravertebral region, the lower end of the tape was first adhered 7 cm below the sacroiliac joint at the level of the paravertebral muscles. Then, while the patient was leaning forward, a slight rotation to the left was requested, and in this position, the tape was adhered upwards along the paravertebral muscles without any tension. When applying the tape to the left paravertebral region, the same procedure was mirrored as on the right, with the tape again applied without any tension. The third tape was applied while the patient was standing upright and leaning slightly forward, placed over the sacroiliac joints and parallel to the floor, stretching the tape by 25%.

Other: Kinesiotape

Sham group

SHAM COMPARATOR

Sham Kinesio taping was applied to the patients in the control group. In this sham protocol, Kinesio bands were attached between the 12th rib on both sides and the corresponding sacroiliac joint, passing over the paravertebral muscles without employing any specific banding technique. The third tape was adhered between both sacroiliac joints, also without any adhesive technique. Patients were inquired about any discomfort and informed that the tapes would remain in place until the second session.

Other: Sham (no implant)

Interventions

Kinesiotape OTHER

The application was performed using 5 cm x 5 m kinesio tape material. After preparing the standing patient in terms of clothing and skin readiness, the patient was asked to lean forward. To adhere the tape to the right paravertebral region, the lower end of the tape was first adhered 7 cm below the sacroiliac joint at the level of the paravertebral muscles. Then, while the patient was leaning forward, a slight rotation to the left was requested, and in this position, the tape was adhered upwards along the paravertebral muscles without any tension. When applying the tape to the left paravertebral region, the same procedure was mirrored as on the right, with the tape again applied without any tension. The third tape was applied while the patient was standing upright and leaning slightly forward, placed over the sacroiliac joints and parallel to the floor, stretching the tape by 25%.

Kinesiotape application

Sham (no implant) OTHER

Sham Kinesio taping was applied to the patients in the control group. In this sham protocol, Kinesio bands were attached between the 12th rib on both sides and the corresponding sacroiliac joint, passing over the paravertebral muscles without employing any specific banding technique. The third tape was adhered between both sacroiliac joints, also without any adhesive technique. Patients were inquired about any discomfort and informed that the tapes would remain in place until the second session.

Sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• week pregnant women without neurologic deficits
• Females with mechanical low back pain
• VAS of at least 3

You may not qualify if:

• High-risk pregnant women with twin pregnancy
• Placenta previa
• Pre-eclampsia
• Threatened preterm delivery
• Orthopedic and rheumatologic diseases
• Radiculopathy

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Muhammet Şahin Elbastı

Elâzığ, Firat University, 23119, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Athletic Tape; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Medicine and Rehabilitation Departmant

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 29, 2024
• Study Start: April 10, 2024
• Primary Completion: July 20, 2024
• Study Completion: August 20, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

TU (1)