Chronic Low-back PainNCT05334394
The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
A study testing Mulligan Technique and Exercise Therapy in people with Chronic Low-back Pain and Lumbal Disc Herniation, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain, Lumbal Disc Herniation, Imbalance
- What is being tested?
- Mulligan Technique and Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2021to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous lumbar trauma or operation
- Long-term use of corticosteroids
- Cancer
- Pregnancy
- Osteoporosis
- Systemic Diseases
Show all 12Show fewer
- Spinal Deformities
- Lumbal Stenosis
- Ankylozone Spondylitis
- Spondylolisthesis
- Spinal Deformities
- Lumbal Stenosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fındıkzade Medipol Hospital
Istanbul, Fındıkzade, 34093
About this study
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.
- Conditions
- Chronic Low-back Pain, Lumbal Disc Herniation, Imbalance
- Being tested
- Mulligan Technique, Exercise Therapy
- Keywords
- Balance, Chronic Low Back Pain, Exercise, Lumbal Disc Herniation, Manual Therapy, Mulligan Mobilization
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan TechniqueOther
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.
Exercise TherapyOther
Exercise is recommended by physical therapists for most chronic low back pain patients.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan Group | Experimental | Not described Receives: Other: Mulligan Technique |
| Control Group | Experimental | Not described Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 Minutes
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.
Measured: 5 Minutes
Electrogoniometer
It is an evaluation tool used to record the objective measurement of joint range of motion.
Measured: 5 Minutes
Secondary outcomes (2)
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.
Measured: 1 Minutes
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.
Measured: 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start10 Jul 2021
- Primary completion1 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Bali, Medipol University
- Investigators
- Kübra Bali, Licenced, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334394
- Sponsor's protocol ID
- E-10840098-772.02-2868
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05334394
- Acronym / sponsor ID
- E-10840098-772.02-2868
- Conditions
- Chronic Low-back Pain, Lumbal Disc Herniation, Imbalance
- Keywords
- Balance, Chronic Low Back Pain, Exercise, Lumbal Disc Herniation, Manual Therapy, Mulligan Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan Group | Experimental | Other: Mulligan Technique |
| Control Group | Experimental | Other: Exercise Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Previous lumbar trauma or operation
- Long-term use of corticosteroids
- Cancer
- Pregnancy
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan TechniqueMulligan 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. | Other | Mulligan Group |
| Exercise TherapyExercise is recommended by physical therapists for most chronic low back pain patients. | Other | Control Group |
Primary outcome
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
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.
Electrogoniometer
Time frame: 5 Minutes
It is an evaluation tool used to record the objective measurement of joint range of motion.
2 secondary outcomes
Visual Analog Scale
Time frame: 1 Minutes
Oswestry Disability Index
Time frame: 10 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kübra Bali, Licenced principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Technique and Exercise Therapy in people with Chronic Low-back Pain and Lumbal Disc Herniation, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TecnoBody Static Balance Device Measurements (time frame: 5 Minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.