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Effect of Treatment on Connective Tissue in Low Back Pain

Primary Purpose

Low Back Pain, Connective Tissue Defect (Diagnosis)

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
IASTM application
Kinesio Tape® Tex Gold)
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emine Atıcı

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Study Group

Active Comparator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2021
Last Updated
February 18, 2021
Sponsor
Okan University
Collaborators
Medical Park Hospital Istanbul
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1. Study Identification

Unique Protocol Identification Number
NCT04762563
Brief Title
Effect of Treatment on Connective Tissue in Low Back Pain
Official Title
The Effect of Instrument Assisted Soft Tissue Mobilization and Kinesiology Taping on Connective Tissue Thickness in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
Collaborators
Medical Park Hospital Istanbul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Connective Tissue Defect (Diagnosis)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
IASTM application
Intervention Description
IASTM application .
Intervention Type
Other
Intervention Name(s)
Kinesio Tape® Tex Gold)
Intervention Description
Kinesio Tape® Tex Gold)
Primary Outcome Measure Information:
Title
straight leg test
Description
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
Time Frame
4 weeks
Title
sit and reach test
Description
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
Time Frame
4 weeks
Title
Modified Schober test
Description
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
Time Frame
4 weeks
Title
finger-ground distance measurement
Description
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
Time Frame
4 weeks
Title
Ultrasonography
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Emine Atıcı
City
Istanbul
State/Province
None Selected
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Treatment on Connective Tissue in Low Back Pain

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