Effect of Manual Therapy on Obese Individuals With Low Back Pain

NCT06201286 | Completed

• 1 other identifier: AIBU-FTR-OOP-05
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Low Back Pain, Mechanical; Obesity

Keywords

Mulligan concept; Range of Motion; Low Back Pain; Obesity

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  Two times in 11 day (before intervention, immediately after last intervention)

Study Arms (2)

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.

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.

Other: Stretching and strengthening exercises

Interventions

Mulligan Concept OTHER

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.

Mulligan group (MG)

Stretching and strengthening exercises OTHER

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.

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Faculty of Health Sciences Bolu Abant İzzet Baysal University

Bolu, 14300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Obesity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Ömer Osman PALA, PhD

  Bolu Abant İzzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: November 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)