The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain, Lumbal Disc Herniation, Imbalance
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mulligan Technique
Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Balance, Chronic Low Back Pain, Exercise, Lumbal Disc Herniation, Manual Therapy, Mulligan Mobilization
Eligibility Criteria
Inclusion Criteria:
- Experiencing non-specific chronic low back pain for more than 3 months
- The diagnosis has been confirmed by the Health Board Report
- Be over 18 years old
- Be younger than 65 years old
- Pain of at least 2 severity according to VAS
- Voluntarily agree to participate in the study
Exclusion Criteria:
- Previous lumbar trauma or operation
- Long-term use of corticosteroids
- Cancer
- Pregnancy
- Osteoporosis
- Systemic Diseases
- Spinal Deformities
- Lumbal Stenosis
- Ankylozone Spondylitis
- Spondylolisthesis
- Spinal Deformities
- Lumbal Stenosis
Sites / Locations
- Fındıkzade Medipol Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mulligan Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
TecnoBody Static Balance Device Measurements
TecnoBody Stability Easy is a stabilometric system consisting of three highly sensitive sensors. The system is based on continuous observation of the foot pressure center (COP). By recording the postural oscillations of the body as a function of time, detailed information about the postural system is obtained
Pressure Pain-Threshold Measurements with Algometer
It is a device used to evaluate the sensitivity to pain and to determine the perception of pressure. The pressure algometer has proven useful in evaluating fibrositis and hypersensitive spots, trigger points, arthritis activation, and visceral pain-pressure sensitivity.
Electrogoniometer
It is an evaluation tool used to record the objective measurement of joint range of motion.
Secondary Outcome Measures
Visual Analog Scale
Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his / her condition is appropriate by drawing a line or by placing a dot or marking.
Oswestry Disability Index
The Oswestry Disability Index is a commonly used outcome measure to detect perceived disability in patients with low back pain. It consists of 10 questions, each of which is scored between 0 and 5, assessing the degree of pain, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change in pain. The minimum score obtained from the scale is 0, and the maximum score is 50. 0-4 points as no disability, 5-14 points as mild, 15-24 points as moderate, 25-34 points as severe and 35-50 points as complete functional disability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334394
Brief Title
The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
Official Title
The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol 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
This study was aimed to investigate the effectiveness of mulligan mobilization technique on balance, pain and functionality in patients with chronic low back pain and to compare it with exercise.37 patients aged between 18-65 who applied to Fındıkzade Medipol Hospital were included in the study. The individuals participating in the study were divided into two groups, 18 control and 19 mulligan groups, according to the randomization table. The intervention was performed 3 times a week for 4 weeks. Conventional physiotherapy and exercise program accompanied by a physiotherapist were applied to the control group, and conventional physiotherapy and mulligan mobilization technique were applied to the mulligan group. Conventional physiotherapy methods included ultrasound (US), Transcutaneous Electrical Nerve Stimulation (TENS), and hotpack. The patients were evaluated with TecnoBody Static Balance Device, algometer, electrogoniometer, visual analog scale, Oswestry Low Back Pain Disability Questionnaire before and after the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Lumbal Disc Herniation, Imbalance
Keywords
Balance, Chronic Low Back Pain, Exercise, Lumbal Disc Herniation, Manual Therapy, Mulligan Mobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mulligan Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mulligan Technique
Intervention Description
Mulligan suggested that injuries or sprains can cause a minor positional error in a joint, thereby causing limitations in physiological movement. Unique to this concept is mobilization of the spine while weight bearing and directing the mobilization parallel to the spinal facet planes. Although it includes various mobilization techniques, one of the most important techniques, motion co-mobilization, is the SNAG's technique, which includes the application of accessory passive gliding to the lumbar vertebra while the patient performs active movement simultaneously.
Intervention Type
Other
Intervention Name(s)
Exercise Therapy
Intervention Description
Exercise is recommended by physical therapists for most chronic low back pain patients.
Primary Outcome Measure Information:
Title
TecnoBody Static Balance Device Measurements
Description
TecnoBody Stability Easy is a stabilometric system consisting of three highly sensitive sensors. The system is based on continuous observation of the foot pressure center (COP). By recording the postural oscillations of the body as a function of time, detailed information about the postural system is obtained
Time Frame
5 Minutes
Title
Pressure Pain-Threshold Measurements with Algometer
Description
It is a device used to evaluate the sensitivity to pain and to determine the perception of pressure. The pressure algometer has proven useful in evaluating fibrositis and hypersensitive spots, trigger points, arthritis activation, and visceral pain-pressure sensitivity.
Time Frame
5 Minutes
Title
Electrogoniometer
Description
It is an evaluation tool used to record the objective measurement of joint range of motion.
Time Frame
5 Minutes
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his / her condition is appropriate by drawing a line or by placing a dot or marking.
Time Frame
1 Minutes
Title
Oswestry Disability Index
Description
The Oswestry Disability Index is a commonly used outcome measure to detect perceived disability in patients with low back pain. It consists of 10 questions, each of which is scored between 0 and 5, assessing the degree of pain, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change in pain. The minimum score obtained from the scale is 0, and the maximum score is 50. 0-4 points as no disability, 5-14 points as mild, 15-24 points as moderate, 25-34 points as severe and 35-50 points as complete functional disability.
Time Frame
10 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Experiencing non-specific chronic low back pain for more than 3 months
The diagnosis has been confirmed by the Health Board Report
Be over 18 years old
Be younger than 65 years old
Pain of at least 2 severity according to VAS
Voluntarily agree to participate in the study
Exclusion Criteria:
Previous lumbar trauma or operation
Long-term use of corticosteroids
Cancer
Pregnancy
Osteoporosis
Systemic Diseases
Spinal Deformities
Lumbal Stenosis
Ankylozone Spondylitis
Spondylolisthesis
Spinal Deformities
Lumbal Stenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kübra Bali, Licenced
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fındıkzade Medipol Hospital
City
Istanbul
State/Province
Fındıkzade
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
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The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
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