- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05334394
The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
April 12, 2022 updated by: Kubra Bali, Medipol University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fındıkzade
-
Istanbul, Fındıkzade, Turkey, 34093
- Fındıkzade Medipol Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Control Group
|
Exercise is recommended by physical therapists for most chronic low back pain patients.
|
|
EXPERIMENTAL: Mulligan Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TecnoBody Static Balance Device Measurements
Time Frame: 5 Minutes
|
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
|
5 Minutes
|
|
Pressure Pain-Threshold Measurements with Algometer
Time Frame: 5 Minutes
|
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.
|
5 Minutes
|
|
Electrogoniometer
Time Frame: 5 Minutes
|
It is an evaluation tool used to record the objective measurement of joint range of motion.
|
5 Minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 1 Minutes
|
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.
|
1 Minutes
|
|
Oswestry Disability Index
Time Frame: 10 Minutes
|
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.
|
10 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kübra Bali, Licenced, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 10, 2021
Primary Completion (ACTUAL)
February 1, 2022
Study Completion (ACTUAL)
February 15, 2022
Study Registration Dates
First Submitted
April 4, 2022
First Submitted That Met QC Criteria
April 12, 2022
First Posted (ACTUAL)
April 19, 2022
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-2868
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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