The Effect of Deep Oscillation and Myofascial Relaxation With Chronic Nonspecific Low Back Pain

NCT04759404 | Completed DMC

• 1 other identifier: 1505183
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

In our study, it was aimed to investigate the effects of deep oscillation and myofascial release on pain, functionality and quality of life in individuals with chronic nonspecific low back pain. 72 individuals who voluntarily agree to participate in the study will be included. Participants will be randomly divided into three groups, the deep oscillation group, myofascial release and the control group. Home exercises including stretching and strengthening for waist, back and abdominals will be given to all groups. However, in addition to the deep oscillation group, deep oscillation will be applied to the lumbar region and myofascial relaxation will be applied to the lumbar region for the myofascial group. Individuals will be asked to come to the center where the research will be conducted for a total of six sessions for two weeks, three times a week. Participants' pain will be evaluated with Visual Analog Scale, disability status with Oswestry Disability Index, sleep quality with Pittsburgh Sleep Quality Index, and quality of life with Short Form-36 before and after the first treatment in the first treatment. Statistical analysis to be used in our research will be done with the Statistical Package for the Social Sciences 20.0 package program.

Conditions

Low Back Pain

Keywords

low back pain; muscle relaxation; quality of life; vibration; sleep

Outcome Measures

Primary Outcomes (5)

• Roland Morris Disability Questionnaire

  the total score is between 0 and 24, and the higher the score, the more disability

  change between baseline and first and 2 weeks

• Visual Analog Scale

  pain sensation is determined from 0 to 10. 0 is low pain, 10 is high pain

  change between baseline and first and 2 weeks

• Oswestry Disability Index

  The highest score is "100", the lowest is "0". The higher the total score, the higher the disability value.

  change between baseline and first and 2 weeks

• The Pittsburgh Sleep Quality Index

  A total score higher than five indicates a poor sleep quality.

  change between baseline and first and 2 weeks

• Short Form-36

  Scores for each subtitle are coded and converted into a scale between 0-100 points. The best health indicator is 100 points.

  change between baseline and first and 2 weeks

Study Arms (3)

Deep Oscillation Group

ACTIVE COMPARATOR

Individuals in the deep oscillation group will be treated by the researcher. During the application, individuals will be positioned face down on the stretcher. After the powder is applied to the lumbar region, deep oscillation treatment with a frequency of 80% -100% with a frequency of 145-150 Hz for the first 10 minutes and 55-60 Hz for 5 minutes will be applied with the Physiomed Deep Oscilation device. Each individual will be given a home exercise program (stretching and strengthening for waist, back and abdominal) consisting of stretching and strengthening. Individuals will be asked to come to the center where the research will take place, for a total of six sessions for two weeks, three times a week.

Other: Deep Oscillation Treatment

Myofascial Release Group

ACTIVE COMPARATOR

Individuals in the myofascial relaxation group will be treated by the researcher. During the application, individuals will lie face down on the stretcher. Myofascial release therapy will be applied in the lumbar region and each individual will be given home exercise (stretching and strengthening for waist, back and abdominal). Individuals will be asked to come to the center where the research will be conducted for a total of six sessions for two weeks, three times a week.

Other: Myofascial Release Treatment

Control Group

NO INTERVENTION

Interventions

Deep Oscillation Treatment OTHER

Deep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal

Deep Oscillation Group

Myofascial Release Treatment OTHER

Myofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal

Myofascial Release Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with Chronic Low Back Pain
• Getting 4 and above in the Roland Morris Disability Questionnaire
• Being 18 years or older
• Agree to voluntarily participate in the study

You may not qualify if:

• Having an acute infection
• Having a heart disease or pacemaker
• Hypersensitivity to electrostatic waves
• Having an infectious skin condition
• Having vertebrobasilar insufficiency
• Having knee pain complaints
• Being diagnosed with coronavirus
• Physical therapy for back pain in the last 6 months

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Private Mediworld Medical Center

Istanbul, Bayrampaşa, 34040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Leyla Ataş Balcı, Assist Prof

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

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

Model Details: The individuals are randomly allocated into deep oscillation, myofascial relaxation and control groups

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: February 15, 2021
• Primary Completion: March 8, 2021
• Study Completion: May 15, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)