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Different Physiotherapy Interventions on Chronic Low Back Pain

Primary Purpose

Exercise Training

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • inclusion criteria;

    1. Patients had to have LBP for at least 3 months,
    2. Patients who reported osteoarthritis or disk lesions (without neurologic compromise) with or without leg pain,
    3. Patients between 18 and 65 years of age,

Exclusion Criteria:

  • Patients were excluded if they demonstrated any of the following;

    1. They had neurologic signs, specific spinal pathology (eg, malignancy, inflammatory joint disease, bone disease),
    2. They had undergone back and lower extremity surgery.

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Relaxation Group

Proprioceptive Neuromuscular Facilitation Group

Core stabilization group

control group

Arm Description

Patients performed Jacobson relaxation technique in supine position. Respiration control and various visual imaging techniques were used during the technique. Relaxation exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.

Patients exercised with proprioceptive neuromuscular facilitation technique for trunk muscles using chopping and lifting patterns with ritmic initiation PNF exercises were made by the physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.

Patients had core stabilization exercises that involved spinal mobility. The patients performed the drawing-in maneuver within various visual imaging techniques during all exercises, especially with respiratory control. Exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.

Patients in the control group were told the importance of a single session exercise

Outcomes

Primary Outcome Measures

Pain Intensity
Pain intensity was measured with visual analog scale (VAS). For VAS, it is desirable that patients express their pain with a (X) mark on a scale of 100 mm. According to this, "0" means that the patients have no pain and "100" means that they have worst pain. The distance between the marking point and the start of the line is measured in millimeters and the numerical value found determines the pain intensity of patients. The total pain intensity is measured with the scale of Likert type of 6 points. In this scale "0" indicates no pain and "5" indicates worst pain.
Functionality
The Oswestry Low Back Pain Questionnaire was used to assess the functioning of daily living activities in low back pain. There are 10 questions in the questionnaire, 6 options in each question, ranging from 0 to 5 points. The patient is asked to choose the expression that best describes the situation. The highest score was 50, with mild functional impairment between 1-10 points, moderate functional impairment between 11-30 points, and severe functional impairment between 31-50 points. The Turkish version of the questionnaire was validated and reliable.
Kinesiophobia
Individuals' kinesiophobia were assessed by using the Tampa Kinesiophobia Scale. The questionnaire is a 17-item measure designed to measure fear of movement / re-injury. The scale includes injury / re-injury and fear-avoidance parameters in work-related activities. A 4-point Likert Scale (1 = strongly disagree, 4 = fully agree) is used on the scale. A total score is calculated after the reversal of 4, 8, 12, and 16 questions. The patient has a total score between 17-68. The high score on the scale indicates that the kinesophobia is also high. The Turkish version of the questionnaire was validated and reliable
core stability
Core stability was assessed with the pressure device (Stabilizer Pressure Biofeedback, USA, Chattanooga Group, Hixson, TN). For transversus abdominus (TrA) and multifidus (MF) muscle strength the patients performed the drawing-in maneuver in a supine position, with their knees flexed at 90°. To perform abdominal drawing-in maneuver, all the subjects were instructed to slowly draw in their lower abdomen as if they were holding their urine and then draw up their pelvic floor muscle so that it could contract, together with their lower abdomen, while continuing normal breathing. The end part of the pressure device was placed on the posterior superior iliac spine. The pressure gauge was set to indicate 40 mmHg before the drawing-in maneuver began. The subjects were told to increase the pressure by 10 mmHg using the drawing-in maneuver on the verbal instruction, "start", and to maintain the state for 5 seconds. Pressure changes were recorded as mmHg.

Secondary Outcome Measures

patient satisfaction
Patient satisfaction was measured with VAS for pain and functionality. The patients asked to express their satisfaction with a (X) mark on a scale of 10 cm. According to this, "0" means that the patients have worst satisfaction and "100" means that they greatest satisfaction. The distance between the marking point and the start of the line is measured and numerical value taken as a satisfaction level of patients.

Full Information

First Posted
April 4, 2018
Last Updated
July 7, 2020
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT03493438
Brief Title
Different Physiotherapy Interventions on Chronic Low Back Pain
Official Title
The Effect of Different Physiotherapy Interventions on Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

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
Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. ) The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.
Detailed Description
Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. Low back pain is a symptom rather than a disease. Non-specific low back pain term is used when the pathoanatomical cause of the pain cannot be determined. Most patients had pain that caused interference with daily function. Low back pain can be triggered by physical factors (eg, lifting awkwardly) or psychosocial factors (eg, being fatigued or tired), or by a combination of the two (eg, being distracted while lifting). There are several nonpharmacologic treatment options that include analgesics, muscle relaxants, physical therapy modalities, spinal manipulative therapy, psychological therapies and others for back pain. Unfortunately, none of the therapies has been established as superior to others. Controversly some of the investigators suggest individuals with chronic LBP can more benefit from exercise therapy interventions but still evidence on the effectiveness of nonpharmacologic therapies was very limited. The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain. Female patients with chronic, nonspecific LBP who were either undergoing or initiating physical therapy treatment at the Baskent University Ankara Hospital Physical Therapy and Rehabilitation outpatient clinic participated in the study. Before the study began patients were randomized into four groups: Relaxation, Proprioceptive Neuromuscular Facilitation (PNF), core stability and control groups. Descriptive characteristic of patients was evaluated at the beginning of the study. Pain, functionality, kinesiophobia and core stability was evaluated before and after the treatments. Pain and functionality were the primer outcome measures of this study, kinesiophobia, core stability and satisfaction were seconder. Patient satisfaction was assessed after the treatments. A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups. The program was involved one of the following techniques of relaxation: proprioceptive neuromuscular facilitation: core stability or control. At the end of the treatments, the individuals in each group were given exercise as home brochure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation Group
Arm Type
Experimental
Arm Description
Patients performed Jacobson relaxation technique in supine position. Respiration control and various visual imaging techniques were used during the technique. Relaxation exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.
Arm Title
Proprioceptive Neuromuscular Facilitation Group
Arm Type
Experimental
Arm Description
Patients exercised with proprioceptive neuromuscular facilitation technique for trunk muscles using chopping and lifting patterns with ritmic initiation PNF exercises were made by the physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.
Arm Title
Core stabilization group
Arm Type
Experimental
Arm Description
Patients had core stabilization exercises that involved spinal mobility. The patients performed the drawing-in maneuver within various visual imaging techniques during all exercises, especially with respiratory control. Exercises were made within the supervision of a physiotherapist. The application period was 20 minutes for one session, 3 days a week and totally six weeks.
Arm Title
control group
Arm Type
Other
Arm Description
Patients in the control group were told the importance of a single session exercise
Intervention Type
Other
Intervention Name(s)
exercise
Other Intervention Name(s)
A hot pack, conventional transcutaneous electrical stimulation (TENS) and exersice
Intervention Description
A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity was measured with visual analog scale (VAS). For VAS, it is desirable that patients express their pain with a (X) mark on a scale of 100 mm. According to this, "0" means that the patients have no pain and "100" means that they have worst pain. The distance between the marking point and the start of the line is measured in millimeters and the numerical value found determines the pain intensity of patients. The total pain intensity is measured with the scale of Likert type of 6 points. In this scale "0" indicates no pain and "5" indicates worst pain.
Time Frame
6 weeks
Title
Functionality
Description
The Oswestry Low Back Pain Questionnaire was used to assess the functioning of daily living activities in low back pain. There are 10 questions in the questionnaire, 6 options in each question, ranging from 0 to 5 points. The patient is asked to choose the expression that best describes the situation. The highest score was 50, with mild functional impairment between 1-10 points, moderate functional impairment between 11-30 points, and severe functional impairment between 31-50 points. The Turkish version of the questionnaire was validated and reliable.
Time Frame
6 weeks
Title
Kinesiophobia
Description
Individuals' kinesiophobia were assessed by using the Tampa Kinesiophobia Scale. The questionnaire is a 17-item measure designed to measure fear of movement / re-injury. The scale includes injury / re-injury and fear-avoidance parameters in work-related activities. A 4-point Likert Scale (1 = strongly disagree, 4 = fully agree) is used on the scale. A total score is calculated after the reversal of 4, 8, 12, and 16 questions. The patient has a total score between 17-68. The high score on the scale indicates that the kinesophobia is also high. The Turkish version of the questionnaire was validated and reliable
Time Frame
6 weeks
Title
core stability
Description
Core stability was assessed with the pressure device (Stabilizer Pressure Biofeedback, USA, Chattanooga Group, Hixson, TN). For transversus abdominus (TrA) and multifidus (MF) muscle strength the patients performed the drawing-in maneuver in a supine position, with their knees flexed at 90°. To perform abdominal drawing-in maneuver, all the subjects were instructed to slowly draw in their lower abdomen as if they were holding their urine and then draw up their pelvic floor muscle so that it could contract, together with their lower abdomen, while continuing normal breathing. The end part of the pressure device was placed on the posterior superior iliac spine. The pressure gauge was set to indicate 40 mmHg before the drawing-in maneuver began. The subjects were told to increase the pressure by 10 mmHg using the drawing-in maneuver on the verbal instruction, "start", and to maintain the state for 5 seconds. Pressure changes were recorded as mmHg.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
Patient satisfaction was measured with VAS for pain and functionality. The patients asked to express their satisfaction with a (X) mark on a scale of 10 cm. According to this, "0" means that the patients have worst satisfaction and "100" means that they greatest satisfaction. The distance between the marking point and the start of the line is measured and numerical value taken as a satisfaction level of patients.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: inclusion criteria; Patients had to have LBP for at least 3 months, Patients who reported osteoarthritis or disk lesions (without neurologic compromise) with or without leg pain, Patients between 18 and 65 years of age, Exclusion Criteria: Patients were excluded if they demonstrated any of the following; They had neurologic signs, specific spinal pathology (eg, malignancy, inflammatory joint disease, bone disease), They had undergone back and lower extremity surgery.
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06790
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Different Physiotherapy Interventions on Chronic Low Back Pain

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