## Protocol Section
### Identification Module
**NCT ID:** NCT06417255

**Brief Title:** Comparison Of The Effects Of Kinesiotape Application And Foam Roller Exercises

**Official Title:** Comparison Of The Effects Of Kinesiotape Application And Foam Roller Exercises in Individuals With Chronic Low Back Pain

#### Organization Study ID Info
**ID:** CHRONIC LOW BACK PAIN
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medipol University Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-26

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-11

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul Medipol University Hospital

#### Responsible Party

**Investigator Affiliation:** Istanbul Medipol University Hospital

**Investigator Full Name:** hazal genc

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Low back pain is an important health problem that is common worldwide, with a lifetime prevalence of up to 80%.

**Detailed Description:** Low back pain that lasts less than 6 weeks is called acute low back pain, if it continues for 6-12 weeks it is called subacute low back pain, and if it continues for more than 12 weeks it is called chronic low back pain. The majority of low back pain (97%) is of mechanical origin.

### Conditions Module

**Conditions:**

- Low Back Pain, Mechanical

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: kinesiotape application

**Label:** kinesiotape application

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: foam roller application

**Label:** foam roller application

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- kinesiotape application

**Description:** The strips used for kinesiological taping can be applied by giving different shapes. These shapes are I, Y, X, ring (donut), rake and net

**Name:** kinesiotape application

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- foam roller application

**Description:** In the foam roller group, "Actifoam" brand non-serrated foam rollers with a size of "15x90" cm were used.

**Name:** foam roller application

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The algometer, an effective way of measuring pressure pain threshold (PPT), is used to measure soft tissue pain associated with trigger points.

Pittsburgh Sleep Quality Scale The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21

Schober Flexibility Test With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion.

**Measure:** Pressure Pain Measurement with Algometer

**Time Frame:** 6 weeks

**Description:** The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21

**Measure:** Pittsburgh Sleep Quality Scale

**Time Frame:** 6 weeks

**Description:** With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion.

**Measure:** Schober Flexibility Test

**Time Frame:** 6 weeks

**Description:** The finger-to-floor distance test is a test that measures specific physical disability. This test is performed with the person standing upright with feet together. The patient is asked to lean as far forward as possible with knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the floor is measured with a flexible tape measure.

**Measure:** The finger-to-floor distance

**Time Frame:** 6 weeks

**Description:** The Tampa Kinesiophobia Scale measures fear of movement and fear of (re)injury during movement. High fear of movement and/or (re)injury, as measured by the Tampa Kinesiophobia Scale, has been found to be associated with poor performance on a number of physical tests.

The minimum and maximum values of the Tampa Kinesiophobia Fatigue Scale are between 17 and 68. The total score range of this scale is between 0 and 68.

**Measure:** Tampa Kinesiophobia Fatigue Scale

**Time Frame:** 6 weeks

**Description:** The Oswestry Disability Index, first introduced by Fairbank et al. in 1980, is considered close to the gold standard for measuring the severity of disability due to low back pain. The Oswestry scale is a self-administered, free, easy-to-use and easy-to-score questionnaire containing 10 questions on different functional domains.

The Oswestry Disability Index (ODI) is a widely used tool to assess disability related to low back pain. It consists of 10 sections addressing various daily activities, each scored on a scale of 0 to 5. The minimum score is 0, indicating no disability, while the maximum score is 50, indicating severe disability.

**Measure:** Oswestry Scale

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with chronic low back pain
* Individuals aged 18-60 years
* Patients without verbal communication barriers
* Patients without cognitive impairment (delirium, dementia, amnesia)

Exclusion Criteria:

* Exercise contraindication (uncontrolled medical conditions)
* Patients with previous spinal surgery
* Patients who develop an allergic reaction to the kinesiotape tape to be applied

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hazaloksuz@gmail.com

**Name:** Hazal GENÇ, PhD

**Phone:** 05413204291

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** hazaloksuz@gmail.com

- **Name:** Hazal GENÇ

- **Phone:** 05413204291

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Hazal GENÇ

**State:** None Selected

**Status:** RECRUITING

**Zip:** 34353

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Misc Info Module

- Version Holder: 2024-05-31
