Comparison of Kinesio Taping and Local Injection in Chronic Low Back Pain

NCT ID: NCT03895307

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-08-01

Brief Summary

Low back pain can be seen in every period of life. More than 80 percent of the society complain of low back pain at any time of life. Although the frequency of applying to a health institution due to low back pain varies from one society to the other, it takes place in the first three places in each community. Low back pain should be differentiated as new (acute) and long-term (chronic). In the treatment of chronic low back pain, rest, education, pharmacological treatment, physical therapy, painful point injections, surgical interventions, kinesio taping can be applied. The most frequently used physical therapy modalities for treatment of chronic low back pain are superficial and deep heat modalities (hot pack, infrared, ultrasound, microwave diathermy radar) and analgesic effective electrotherapy (TENS, interferential flows) modalities. One of the most important treatments is exercise therapy. In cases where conventional treatment of chronic low back pain is insufficient, that is, the patient's pain is still ongoing and functional recovery is insufficient, some alternative methods are also applied. These treatments include ozone, prolotherapy injection applications, dry needling, acupuncture, phytotherapy, balneotherapy, kinesio taping and so on. The aim of this study is to compare the efficacy of painful point injection and kinesio taping treatments in lumbar region in patients with chronic low back pain.

Detailed Description

Approximately 84 volunteer patients will be included in the study, patients older than 18 years, under 75 years of age, with a minimum of 3 months of mechanical back pain, Visual Analog Scale score of at least 60 patients will be included. Who are older than 18 years of age, having mental problems, having peripheral problems affecting the central nervous system, having received physical therapy to the lumbar region in the last 3 months, having been applied to the lumbar region within the last 3 months, having a history of lumbar region surgery, having a history of patients with motor deficit in the extremity, needle phobia, lidocaine and / or kinesio tape allergy, patients with wound, infection, burn, allergic lesions in the application area will not be included.

Patients included in the study will be included in the first (first), second (second), third (third) or fourth (fourth) treatment group by random number generator method.

The first group will be given the hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16. days.

The second group will be given a hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16 days.

The third group hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16. days, kinesio tape will be applied to the determined areas.

the fourth group hot package (20 minutes / day) + exercise + 1. 4. 7. 10. 13. 16. days sham tape application will be made in the regions determined. ****

• Patients in all groups will continue to use the hotpack and exercises until the 3rd month after the first day of their study. First session exercises with the same physiotherapist (stretching for back-waist, iliopsoas and hamstring muscles; exercise range of hip and waist; hip and waist isometric exercises). Each patient will do the exercises 20 minutes after the hot package application.

• saline and local anesthetic injection points to be applied to the lumbar region:

1. Future points on spinous projections from L1 to L5

2. Lumbar region 2 from the middle point of the spinous output bilateral and 2 cm to 4 cm lateral points

3. To each point of the iliac lobe of iliac crest will be injected subcutaneously with 0.5 ml 0.5% lidocaine-containing local anesthetic.

4. 6 mm 30 gauge needle tip will be used for injection.

5. For each patient who underwent subcutaneous local anesthetic, an average of 18-20 ml of 0.5% lidocaine-containing local anesthetic and 18-20 ml of 0.09% NaCl-containing isotonic saline will be used for each patient.

6. These points are the points of quadle technique applied in neural therapy.

• Kinesio taping will use 2 cut-to-length I-bands with a length of about 15 cm long for one patient. Space correction technique will be used for patients. The lumbar region of the patients will be glued vertically to the paravertebral muscles vertically 3-4 cm lateral to the spinous projections. As a starting point for patients, S1 will be adhered to the vertebra without tension, then the patient will be asked to come with maximum lumbar flexion posterior.

• For a patient in the treatment of sham kinesio taping, 2 pieces of approximately 15 cm long ends will be used to cut the curved I bands. The lumbar region of the patients will be glued vertically to the paravertebral muscles vertically 3-4 cm lateral to the spinous projections. Patients in the upright posture, kinesio tape S1 applied from the vertebra without stretching will be glued upwards and taped upwards.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

kinesio taping

two 15 cm I type kinesio tape applied longitudinally

Group Type: EXPERIMENTAL

kinesio tape

Intervention Type: OTHER

two 15 cm I type kinesio tape applied longitudinally

sham kinesio taping

two 15 cm I type kinesio tape applied longitudinally but without stretching

Group Type: PLACEBO_COMPARATOR

kinesio tape

Intervention Type: OTHER

two 15 cm I type kinesio tape applied longitudinally

local anesthetic

18-20 cc %0.5 lidocaine subcutaneous injection

Group Type: EXPERIMENTAL

local anesthetic

Intervention Type: OTHER

local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection

local serum physiologic

18-20 cc % 0.09 NaCl subcutaneous injection

Group Type: PLACEBO_COMPARATOR

local serum physiologic

Intervention Type: OTHER

serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection

Interventions

kinesio tape

two 15 cm I type kinesio tape applied longitudinally

Intervention Type: OTHER

local anesthetic

local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection

Intervention Type: OTHER

local serum physiologic

serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Under 18 years of age under 75 years

2. Chronic mechanic (decreased with resting and resting) for at least 3 months

3. Visual Analogue Scale score of at least 60-

Exclusion Criteria

1. Having mental problems

2. Having the disease affecting the peripheral and central nervous system

3. Have received physical therapy in the lumbar region within the last 3 months

4. Injection into the lumbar region within the last 3 months

5. Having a history of waist region surgery

6. Low motor dysfunction in lower extremity in physical examination

7. Needle phobia

8. Is allergic to lidocaine

9. Kinesio tape allergy

10. Wound, infection, burn, allergic lesions in the application area

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ADEM ERBİROL

Role: STUDY_DIRECTOR

sultan abdulhamid han

Locations

Sultan 2.Abdülhamid Han Training and Research Hospital

Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ademerbirol

Identifier Type: -

Identifier Source: org_study_id