Effect of Treatment on Connective Tissue in Low Back Pain

The Effect of Instrument Assisted Soft Tissue Mobilization and Kinesiology Taping on Connective Tissue Thickness in Patients With Chronic Low Back Pain

The purpose of the study is to investigate the effects of instrument assisted soft tissue mobilization (IASTM) and kinesiology taping (KT) that are additional treatment to the conservative treatment for the lumbar region and hamstrings and connective tissue thickness in patients with chronic non-specific low back pain (CNSLBP).

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Connective Tissue Defect (Diagnosis)
• Intervention / Treatment: Other: IASTM application; Other: Kinesio Tape® Tex Gold)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • None Selected
    • Istanbul, None Selected, Turkey, 34000
      • Emine Atıcı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between the ages of 30 and 50
• who had low back pain for at least 12 weeks,
• received no physical therapy in the last 6 months,
• received no IASTM or chemotherapy,
• had normal movement of the hip joint
• Visual Analog Scale value above 3

Exclusion Criteria:

• the presence of allergy and skin diseases,
• pregnancy,
• major structural spinal deformity (scoliosis, kyphosis, stenosis),
• inflammatory disease,
• presence of extruded and sequestered herniation, -signs of neurological disease, -
• presence of orthopedic diseases such as fracture
• a history of spinal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Study Group; Patients in the IASTM group were asked to lie face down on a stretcher, exposing the entire lumbar region. IASTM was applied to all paraspinal muscles for a total of 5 minutes after massage cream was applied. Immediately afterwards, the same application was performed for the right and left hamstring muscles from the gluteal line to the bottom of the popliteal fossa for 3 minutes after massage cream was applied. IASTM application was performed vertically, horizontally and diagonally using instruments of different sizes and shapes at an angle of 45 degrees to the skin surface.	Other: IASTM application; IASTM application .
Active Comparator: Active Comparator; KT application (Kinesio Tape® Tex Gold) was performed using the "muscle technique". In lumbar region application, while the patient was standing, the tape was cut as a Y-strip with a base of 5 cm.	Other: Kinesio Tape® Tex Gold); Kinesio Tape® Tex Gold)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
straight leg test	Straight leg raise (SLR) was used to determine hamstring shortness. For SLR application, while the patient was lying on the back, the leg was lifted by the researcher to the level where the pain began, and the flexion angle in the hip was recorded	4 weeks
sit and reach test	The sit and reach test (SRT) to measure the flexibility.During SRT application, the distance between the middle fingers of the hands and the feet was recorded while the patient was in the long sitting position in the bed and reached the toes with their hands without bending the knees	4 weeks
Modified Schober test	Modified Schober Test and finger-ground distance evaluation for the spinal mobility assessment. For the Modified Schober Test, after marking 5 cm below and 10 cm above the spinous process of the lumbar vertebra while the patient was standing, the patient was asked to bend forward without bending the knees, and the change in the same range was recorded	4 weeks
finger-ground distance measurement	While measuring "finger-ground distance", the patient was asked to touch the ground with both hands while standing with the knees in extension. The distance between the fingertip and the ground was recorded	4 weeks
Ultrasonography	In this study, Siemens Acuson S 3000 device and Siemens HD 10 MHz linear probe were used for subcutaneous and perimuscular zone measurements.2 cm lateral to the midpoint of the L2-3 interspinous ligament is the area where the fascia planes are most parallel to the skin. In this study, the probe was centered at this point, which was determined while the patient was lying face down on the stretcher, and measurements were made from the right and left. For the measurement location in the hamstring region, the point where the fascia planes were most parallel to the skin was determined, as in the lumbar region. Measurement was performed in the area where the zones were most clearly seen lateral to the popliteal fossa.	4 weeks

Collaborators and Investigators

• Sponsor: Okan University
• Collaborators: Medical Park Hospital Istanbul

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 003 (NuSkin International)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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