Low Back Pain, MechanicalNCT06201286
Effect of Manual Therapy on Obese Individuals With Low Back Pain
A study testing Mulligan Concept and Stretching and strengthening exercises in people with Low Back Pain, Mechanical and Obesity, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study will investigate the effectiveness of Mulligan mobilisation techniques Sustained Natural Apophyseal Glides (SNAGS) and Natural Apophyseal Glides (NAGs) on pain, disability, and range of motion (ROM) in obese individuals with mechanical low back pain (LBP). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain, Mechanical, Obesity
- What is being tested?
- Mulligan Concept and Stretching and strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 Apr 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with mechanical low back pain, Body Mass Index (BMI) was between 30.00-39.99, 1.-2. Forty-six patients, aged 20-50 years, who were extremely obese and had pain radiating to the lower back and hips for at least 3 months,
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant İzzet Baysal University
Bolu, 14300
About this study
Official title: Pain, Function and Range of Motion Related Outcomes of Mulligan Concept Applications in Obese Individuals With Chronic Mechanical Low Back Pain: a Randomized Controlled Study
This study will investigate the effectiveness of Mulligan mobilisation techniques Sustained Natural Apophyseal Glides (SNAGS) and Natural Apophyseal Glides (NAGs) on pain, disability, and range of motion (ROM) in obese individuals with mechanical low back pain (LBP).
Read the detailed description
One of the most important methods in the treatment of LBP in recent years is manual therapy; manipulation, mobilisation and soft tissue techniques. With the manual techniques applied to the spine, the position and placement of the anatomical structures are changed and the tight and tense tissues are loosened. It has been observed that Mulligan techniques can correct the faults that cause pain in the spine and that the structures that cause pain return to their normal functions when released. In the literature, it has recently been observed that the number of studies examining manual therapy and Mulligan Concept methods has increased. Studies examining the effect of SNAG method on the lumbar region (12) and the effect of mobilisation and taping on chronic low back pain were found. However, no study was found in which SNAG and NAGS applications were applied on obese patients diagnosed with mechanical low back pain. Therefore, in this study, SNAG and NAGS in obese patients with LBP to investigate the effectiveness of the practices
- Conditions
- Low Back Pain, Mechanical, Obesity
- Being tested
- Mulligan Concept, Stretching and strengthening exercises
- Keywords
- Mulligan concept, Range of Motion, Low Back Pain, Obesity
- Medical subject headings
- Low Back Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan ConceptOther
Mulligan Concept was applied by the physiotherapist who received A-B module trainings. Mulligan techniques were performed with 3 sets of 10 repetitions and 15-20 seconds rest between sets. Mobilisations were applied to the spinous process of each vertebra of the lumbar region with 3 sets of 10 repetitions of SNAG and 3 sets of 10 repetitions of NAGS techniques. In the standing position, the physiotherapist took a position next to the patient and stabilised the patient by grasping the abdomen with one arm.
Strengthening exercises were applied to the rectus abdominis, internal and external obliquus, transversus abdominis muscles from flexor muscle groups in 3 sets of 10 repetitions. Stretching exercises were applied to the erector spinae and intertransversarii lumborum muscles from extensor muscle groups as 3 sets of 10 repetitions for 15-30 seconds.
Stretching and strengthening exercisesOther
Strengthening exercises were applied to the rectus abdominis, internal and external obliquus, transversus abdominis muscles from flexor muscle groups in 3 sets of 10 repetitions. Stretching exercises were applied to the erector spinae and intertransversarii lumborum muscles from extensor muscle groups as 3 sets of 10 repetitions for 15-30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan group (MG) | Experimental | Mulligan group underwent an exercise program planned as 6 sessions. A one-day gap separated each session, and the entire program spanned 11 days. In Mulligan group, they received SNAG and NAGS techniques as part of the Mulligan concept applications, utilizing tools like the Mulligan belt, sponge, and stretcher. Both groups participated in supervised stretching and strengthening exercises. Receives: Other: Mulligan Concept |
| Control group | Other | Control group underwent an exercise program planned as 6 sessions. A one-day gap separated each session, and the entire program spanned 11 days. Both groups participated in supervised stretching and strengthening exercises. Receives: Other: Stretching and strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
Visual analogue scale (VAS) was used to assess the severity of mechanical neck pain. Individuals were asked to mark the pain they felt on a 10 cm long VAS scale ("0" indicates no pain and "10" indicates unbearable pain).
Measured: Two times in 11 day (before intervention, immediately after last intervention)
The Oswestry Low Back Pain Disability Questionnaire
Evaluate back disability status a questionnaire consisting of 10 items. The items measure the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleeping, social life, travelling and the degree of change in pain, respectively. Under each item, the patient was asked six statements to be marked. The first statement is scored as "0" and the sixth statement is scored as "5". The higher the score, the higher the level of disability.
Measured: Two times in 11 day (before intervention, immediately after last intervention)
Joint Range of Motion Assessment (ROM)
Active flexion, extension, right/left lateral flexion and rotation of the cervical region were measured in the sitting position with a phone goniometer application.
Measured: Two times in 11 day (before intervention, immediately after last intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Nov 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Osman Pala, Abant Izzet Baysal University
- Investigators
- Ömer Osman PALA, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201286
- Sponsor's protocol ID
- AIBU-FTR-OOP-05
- Status last verified
- Dec 2023
- First submitted
- 30 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for data sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Function and Range of Motion Related Outcomes of Mulligan Concept Applications in Obese Individuals With Chronic Mechanical Low Back Pain: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06201286
- Acronym / sponsor ID
- AIBU-FTR-OOP-05
- Conditions
- Low Back Pain, Mechanical, Obesity
- Keywords
- Mulligan concept, Range of Motion, Low Back Pain, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 11 Jan 2024 (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 will investigate the effectiveness of Mulligan mobilisation techniques Sustained Natural Apophyseal Glides (SNAGS) and Natural Apophyseal Glides (NAGs) on pain, disability, and range of motion (ROM) in obese individuals with mechanical low back pain (LBP).
Detailed description
One of the most important methods in the treatment of LBP in recent years is manual therapy; manipulation, mobilisation and soft tissue techniques. With the manual techniques applied to the spine, the position and placement of the anatomical structures are changed and the tight and tense tissues are loosened. It has been observed that Mulligan techniques can correct the faults that cause pain in the spine and that the structures that cause pain return to their normal functions when released. In the literature, it has recently been observed that the number of studies examining manual therapy and Mulligan Concept methods has increased. Studies examining the effect of SNAG method on the lumbar region (12) and the effect of mobilisation and taping on chronic low back pain were found. However, no study was found in which SNAG and NAGS applications were applied on obese patients diagnosed with mechanical low back pain. Therefore, in this study, SNAG and NAGS in obese patients with LBP to investigate the effectiveness of the practices
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan group (MG) | Experimental | Other: Mulligan ConceptMulligan group underwent an exercise program planned as 6 sessions. A one-day gap separated each session, and the entire program spanned 11 days. In Mulligan group, they received SNAG and NAGS techniques as part of the Mulligan concept applications, utilizing tools like the Mulligan belt, sponge, and stretcher. Both groups participated in supervised stretching and strengthening exercises. |
| Control group | Other | Other: Stretching and strengthening exercisesControl group underwent an exercise program planned as 6 sessions. A one-day gap separated each session, and the entire program spanned 11 days. Both groups participated in supervised stretching and strengthening exercises. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosed with mechanical low back pain, Body Mass Index (BMI) was between 30.00-39.99, 1.-2. Forty-six patients, aged 20-50 years, who were extremely obese and had pain radiating to the lower back and hips for at least 3 months,
Key exclusion criteria (1 listed)
- -
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 ConceptMulligan Concept was applied by the physiotherapist who received A-B module trainings. Mulligan techniques were performed with 3 sets of 10 repetitions and 15-20 seconds rest between sets. Mobilisations were applied to the spinous process of each vertebra of the lumbar region with 3 sets of 10 repetitions of SNAG and 3 sets of 10 repetitions of NAGS techniques. In the standing position, the physiotherapist took a position next to the patient and stabilised the patient by grasping the abdomen with one arm. Strengthening exercises were applied to the rectus abdominis, internal and external obliquus, transversus abdominis muscles from flexor muscle groups in 3 sets of 10 repetitions. Stretching exercises were applied to the erector spinae and intertransversarii lumborum muscles from extensor muscle groups as 3 sets of 10 repetitions for 15-30 seconds. | Other | Mulligan group (MG) |
| Stretching and strengthening exercisesStrengthening exercises were applied to the rectus abdominis, internal and external obliquus, transversus abdominis muscles from flexor muscle groups in 3 sets of 10 repetitions. Stretching exercises were applied to the erector spinae and intertransversarii lumborum muscles from extensor muscle groups as 3 sets of 10 repetitions for 15-30 seconds. | Other | Control group |
Primary outcome
Pain Assessment
Time frame: Two times in 11 day (before intervention, immediately after last intervention)
Visual analogue scale (VAS) was used to assess the severity of mechanical neck pain. Individuals were asked to mark the pain they felt on a 10 cm long VAS scale ("0" indicates no pain and "10" indicates unbearable pain).
The Oswestry Low Back Pain Disability Questionnaire
Time frame: Two times in 11 day (before intervention, immediately after last intervention)
Evaluate back disability status a questionnaire consisting of 10 items. The items measure the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleeping, social life, travelling and the degree of change in pain, respectively. Under each item, the patient was asked six statements to be marked. The first statement is scored as "0" and the sixth statement is scored as "5". The higher the score, the higher the level of disability.
Joint Range of Motion Assessment (ROM)
Time frame: Two times in 11 day (before intervention, immediately after last intervention)
Active flexion, extension, right/left lateral flexion and rotation of the cervical region were measured in the sitting position with a phone goniometer application.
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 11 Jan 2024.
- Individual participant dataSharing planned: No. There is no plan for data sharing
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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.
Ömer Osman PALA, PhD principal investigator
Abant Izzet Baysal 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 Concept and Stretching and strengthening exercises in people with Low Back Pain, Mechanical and Obesity, run by Abant Izzet Baysal 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 1 inclusion and 1 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 11 Jan 2024. 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?
Pain Assessment (time frame: Two times in 11 day (before intervention, immediately after last intervention)). 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 11 Jan 2024.