Effect of Treatment on Connective Tissue in Low Back Pain

NCT04762563 | Completed

• 1 other identifier: 003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Low Back Pain; Connective Tissue Defect (Diagnosis)

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Experimental: Study Group

EXPERIMENTAL

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

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)

Interventions

IASTM application OTHER

IASTM application .

Experimental: Study Group

Kinesio Tape® Tex Gold) OTHER

Kinesio Tape® Tex Gold)

Active Comparator

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead
• Medical Park Hospital Istanbul: collaborator

Study Sites (1)

Emine Atıcı

Istanbul, None Selected, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

TU (1)