Effect of Motor Control Exercise Combined With Laser Or TENS on Pain, Range of Motion, and Functional Disability on Obese Patients With Low Back Pain

NCT ID: NCT06545578

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-06
• Study Completion Date: 2023-07-30

Brief Summary

This randomized study aimed to assess the impact of MCE in conjunction with LLLT and MCE in conjunction with TENS on pain levels, ROM, and functional disability in obese patients with LBP.

Detailed Description

Sixty obese male and female patients with LBP participated in this study. After providing informed consent, they were randomly divided into two equal groups, with Group A receiving MCE combined with LLLT and Group B receiving MCE combined with TENS.

Conditions

Back Pain; Obesity; Motor Control Exercises; Laser Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group (A):

Group A received motor control exercises with low level laser therapy

Group Type: EXPERIMENTAL

low-level laser therapy

Intervention Type: OTHER

The Low-level laser (LLL) pain-relief instrument RG-300IB (code E22), manufactured in China, was utilized for low-level laser therapy (LLLT) in Group A . The therapy employed a wavelength of 830 nm (near infrared) and involved careful skin contact hygiene at specified positions, 2.5 and 3.5 cm laterally from the spinous process (L4, L5, or S1) and one distal level segment. The laser operated at a repetition rate of 5,000, with a power density of 300 mW/cm2 and a power output of 10 mW. Each point received 3 J of energy, resulting in a density of 3 J/cm2, with four points. The spot size was 1 cm, and each point received a 30-second treatment. The energy was administered three times per week for four weeks

motor control exercises

Intervention Type: OTHER

Training in coordinated trunk muscle action, including decreasing overactive superficial muscles and independent activation of deep muscles (such as transversus abdominis and multifidus). Exercises for the pelvic floor muscles, controlling respiration, and regulating the position and movement of the spine were added to these exercises.

Group (B):

Group B received motor control exercises with transcutaneous electrical nerve stimulation

Group Type: EXPERIMENTAL

TENS

Intervention Type: OTHER

TENS Intelect Advanced device (Chattanooga, Mouguerre, France). The parameters for TENS stimulation included a frequency range of 60-80 Hz, a pulse width of 50-80 ms, and an intensity of 10-30 mA. Before commencing therapy, patients were provided information regarding the therapeutic approach and any potential adverse effects. During the procedure, two channels (four electrodes) were employed, with one set placed on the right and one on the left paraspinal muscles at the level of L2-L4. Active electrodes from the other channels were affixed 1.5 cm laterally to the spine, while passive electrodes were positioned 3 cm away. TENS therapy was utilized for 30 minutes in Group B, and the intensity of the pain and discomfort was adjusted to the patient's tolerance level.

motor control exercises

Intervention Type: OTHER

Training in coordinated trunk muscle action, including decreasing overactive superficial muscles and independent activation of deep muscles (such as transversus abdominis and multifidus). Exercises for the pelvic floor muscles, controlling respiration, and regulating the position and movement of the spine were added to these exercises.

Interventions

low-level laser therapy

The Low-level laser (LLL) pain-relief instrument RG-300IB (code E22), manufactured in China, was utilized for low-level laser therapy (LLLT) in Group A . The therapy employed a wavelength of 830 nm (near infrared) and involved careful skin contact hygiene at specified positions, 2.5 and 3.5 cm laterally from the spinous process (L4, L5, or S1) and one distal level segment. The laser operated at a repetition rate of 5,000, with a power density of 300 mW/cm2 and a power output of 10 mW. Each point received 3 J of energy, resulting in a density of 3 J/cm2, with four points. The spot size was 1 cm, and each point received a 30-second treatment. The energy was administered three times per week for four weeks

Intervention Type: OTHER

TENS

TENS Intelect Advanced device (Chattanooga, Mouguerre, France). The parameters for TENS stimulation included a frequency range of 60-80 Hz, a pulse width of 50-80 ms, and an intensity of 10-30 mA. Before commencing therapy, patients were provided information regarding the therapeutic approach and any potential adverse effects. During the procedure, two channels (four electrodes) were employed, with one set placed on the right and one on the left paraspinal muscles at the level of L2-L4. Active electrodes from the other channels were affixed 1.5 cm laterally to the spine, while passive electrodes were positioned 3 cm away. TENS therapy was utilized for 30 minutes in Group B, and the intensity of the pain and discomfort was adjusted to the patient's tolerance level.

Intervention Type: OTHER

motor control exercises

Training in coordinated trunk muscle action, including decreasing overactive superficial muscles and independent activation of deep muscles (such as transversus abdominis and multifidus). Exercises for the pelvic floor muscles, controlling respiration, and regulating the position and movement of the spine were added to these exercises.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients aged 40 to 77 years
• non-athletic, have a BMI > 25
• complaining of LBP.

Exclusion Criteria

• vertebral fractures
• surgical spinal fixation
• rheumatic disorders
• any underlying medical condition that may be causing back pain, including:
• malignancy
• viscerogenic causes
• infection, systemic disease of the muscles and skeletal system,
• sensory dysfunction
• neuromuscular diseases like multiple sclerosis.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ababa

lecturer of internal physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ababa physical therapy center

Banī Suwayf, , Egypt

Countries

Egypt

Other Identifiers

P.T-ORTH-05/2023-511

Identifier Type: -

Identifier Source: org_study_id