Comparison of the Effect of Classical Physical Therapy Agents and Extracorporeal Shock Wave Therapy (ESWT) on Pain, Disability, Functional Status and Depression in Patients with Chronic Low Back Pain; Prospective randomized controlled trial
The aim of this study is to compare the effectiveness of classical physical therapy agents and extracorporeal shock wave therapy (ESWT) on pain, disability, functional status and depression in patients with chronic low back pain.
Design
Two arm parallel group randomised trial
Settings and conduct
It was decided to study with 80 patients with G-power program. Patients will be divided into two groups randomly. Randomization will be done with closed envelope. Evaluations will be repeated before treatment, after treatment and at 3rd month.
Participants/Inclusion and exclusion criteria
Participants/Inclusion criteria :Patients with low back pain who have been diagnosed with chronic low back pain for at least 3 months between 18- 65 years old.
Exclusion criteria:
Operational history of lumbar spine region.
Vertebral compression fracture.
Spinal tumors.
Intervertebral disc infections.
Inflammatory rheumatic disease.
Pregnant patients.
Heart disease.
Structural abnormalities.
Whether the patient is unwilling or unable to participate for any reason.
Deciding whether the clinician does not benefit the patient.
Intervention groups
For Group 1, classic physical therapy agents (Transcutaneous Electrical Nerve Stimulation 20 minutes, hot pack 20 min, ultrasound 5 min) to be applied. Group 2 will be applied at least 2 days apart and 5 sessions will be done in 2-3 weeks. The shock wave probe will be applied vertically to the quadratus lumborum, sacroiliac joint and the patient's pain after application of the joining gel, and the 20mm applicator will be applied at 2600 shots at a pressure of 2.8 bar and at a frequency of 10 Hz eswt.
Main outcome variables
The Beck Depression Scale will be used to determine the levels of depression, and Oswestry, Health Assessment Questionnaire (Haq). Visual analogue scale (VAS) and Algometer will be used to question the pain status in individuals.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190411043240N1
Registration date:2019-05-23, 1398/03/02
Registration timing:prospective
Last update:2019-05-23, 1398/03/02
Update count:0
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
mehmet okcu
Name of organization / entity
Ahi evran university
Country
Turkey
Phone
+90 386 441 02 44
Email address
mehmet.okcu@ahievran.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-20, 1398/04/29
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Classical Physical Therapy Agents and Extracorporeal Shock Wave Therapy (ESWT) on Pain, Disability, Functional Status and Depression in Patients with Chronic Low Back Pain; Prospective randomized controlled trial
Public title
Effect of the Extracorporeal Shock Wave Therapy (ESWT) in Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients with low back pain who have been diagnosed with chronic low back pain for at least 3 months between 18- 65 years old
Patients who are able to understand correctly the patient information form and cooperate
Patients consenting to participate in the study according to the informed consent form
Exclusion criteria:
Operational history of lumbar spine region.
Vertebral compression fracture
Spinal tumors
Intervertebral disc infections
Inflammatory rheumatic disease
Pregnant patients
Heart disease
Structural abnormalities
Whether the patient is unwilling or unable to participate for any reason
Deciding whether the clinician does not benefit the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
simple, individual, sealed envelopes
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kirsehir Ahi Evran University Faculty of Medicine
Street address
Ahi Evran Üniversitesi Tıp Fakültesi Bağbaşı Yerleşkesi Merkez / Kirsehir/Turkey
City
Kirsehir
Postal code
40100
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
2018-21/173
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
The Beck Depression Scale will be used to determine the levels of depression, and Oswestry, Health Assessment Questionnaire (Haq). Visual analogue scale (VAS) and Algometer will be used to question the pain status in individuals.
Timepoint
before treatment, after treatment and at 3rd month.
Method of measurement
The Beck Depression Scale will be used to determine the levels of depression, and Oswestry, Health Assessment Questionnaire (Haq). Visual analogue scale (VAS) and Algometer will be used to question the pain status in individuals.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: extracorporeal shock wave therapy. The model name of the device is Modus ESWT. Device has CE ("Conformité Européene") mark. The global product (barcode) number is 8680050920224. The device is registered in Turkey Pharmaceuticals and Medical Devices National Data Bank (TİTUBB). Extracorporeal shock wave therapy (ESWT) is a noninvasive procedure using single-pulse acoustic waves produced outside the body and focused on a specific area in the body.Studies have shown that ESWT is an effective and long-term pain-reducing method for soft tissue diseases such as plantar fasciitis and achilles tendinopathy; ESWT is routinely applied in achilles tendinopathy and plantar fasciitis.Shock waves promote axonal regeneration of peripheral nerves by various molecular reactions.ESWT has been reported to induce analgesia by biochemical changes in the nerve fiber itself and to reduce inflammation of soft tissues. It has also been shown that ESWT promotes revascularization, stimulates or re-activates the healing process of connective tissues, including tendons and bones, thereby alleviating pain and improving function.ESWT can be used to relieve pain as well as to improve muscle strength through proper motor stimulation by shock waves of muscles and tendons.ESWT device user's manual also includes low back pain in the ESWT indication list, but ESWT; There are few studies on the effects of low back pain on pain, disability and depression.ESWT will be applied in a total of 5 sessions 2-3 weeks after a minimum of 2 days. After the application of the joining gel, the shock wave probe will be placed perpendicular to the areas of the Quadratus Lumborum, Sacroiliac joint and the patient's pain, and the 20mm applicator will be applied at a pressure of 2.8 bar and at a frequency of 10 Hz with 2600 shots.
Category
Treatment - Devices
2
Description
Intervention group: Classical Physical Therapy Agents. Classic physical therapy agents TENS 20 minutes, Hot pack 20 min, ultrasound 5 min to be applied for 15 days.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparison of the Effect of Classical Physical Therapy Agents and Extracorporeal Shock Wave Therapy (ESWT) on Pain, Disability, Functional Status and Depression in Patients with Chronic Low Back Pain; Prospective randomized controlled trial
When the data will become available and for how long
When the study starts, study will become available and it will ends after 1 year after the end of study
To whom data/document is available
For medical doctors, physiotherapists
Under which criteria data/document could be used
Data/documents could be used after taking permission
From where data/document is obtainable
From researcher
What processes are involved for a request to access data/document
People which want to access data/document can write via e-mail.