Effect of Manual Therapy on Obese Individuals With Low Back Pain

December 30, 2023 updated by: Ömer Osman Pala, Abant Izzet Baysal University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Bolu, Turkey, 14300
        • Faculty of Health Sciences Bolu Abant Izzet Baysal University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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,

Exclusion Criteria:

-

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mulligan group (MG)
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.
Other: Mulligan Concept

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.
Other: Control group
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.
Other: Stretching and strengthening exercises
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Two times in 11 day (before intervention, immediately after last intervention)
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.
Two times in 11 day (before intervention, immediately after last intervention)
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.
Two times in 11 day (before intervention, immediately after last intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ömer Osman PALA, PhD, Bolu abant Izzet Baysal 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIBU-FTR-OOP-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan for data sharing

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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