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NCT Number: NCT05302882

Evaluation of The Immediate Effect of Myofascial Release Application in Patients With Chronic Low Back Pain

Purpose: To determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP).

Materials and methods: Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".

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Key information

Conditions

Chronic Low-back Pain

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Halic University

Istanbul, Eyupsultan, 2022, Turkey (Türkiye)

About this study

It was aimed to determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP). Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 20 and 55 years;
  • low back pain lasting more than 3 months;
  • stable clinical status;
  • no cognitive and mental problems;
  • self-expression ability;
  • volunteering to participate in the study.

Exclusion criteria

  • problems of cooperation;
  • malignancy or infection;
  • acute fractures;
  • occlusive edema;
  • osteoporosis;
  • advanced degenerative joint problems;
  • acute rheumatologic conditions;
  • cortisone therapy;
  • use of blood thinners;
  • skin problems.

Treatment and study plan

Myofascial release

Behavioral

The physiotherapist placed both palms on the two right and left ribs at the T12 level and applied continuous stretching to the superior for 2 minutes. After this application, the physiotherapist placed one hand on the sacrum with the other hand on T12 with his hands crossed, and applied rhythmically 2 seconds of stretching and 2 seconds of relaxation for a total of 2 minutes. Then, myofascial release was terminated by applying deep compression to the paraspinal muscles with palms for 2 minutes on the right and 2 minutes on the left side, respectively.

Classical massage

Behavioral

Classical massage was applied to the lumbar region for 9 minutes. Classical massage was applied with the patient in the prone position. A small amount of solid vaseline was taken and a gentle stroke was applied for 1 minute to spread it sufficiently to the lumbar region. Then, superficial stroking was applied to the right paraspinal region for 1 minute from distal to proximal by the physiotherapist. After the same procedure was performed on the right paraspinal region for 1 minute. Then, both hands were placed on the right and left paraspinal region and friction was applied for 2 minutes. Afterwards, the patient's right paraspinal region was kneeding for 1 minute and then the same procedure was applied to the left paraspinal region for 1 minute. As the last procedure, the fingertips of both hands were placed on the right and left paraspinal region and the classical massage was completed by performing 2 minutes of deep euphlorage from the L5-S1 level to the T12 level.

Primary outcomes

  1. Change in Visual Analog Scale (VAS) Pain Score

    Time frame: Baseline, immediately after the intervention

    The VAS is a widely used scale for pain assessment in daily practice. VAS, with 0-10 numbers on it and they are asked to give a value between these numbers. 0: I have no pain, 10: I have very severe pain

  2. Change in The Straight Leg Raise Test Score

    Time frame: Baseline, immediately after the intervention

    test was used to assess hamstring flexibility. While the patient is in the supine position, the physiotherapist makes passive hip flexion with the knee straight and the measurement is made with a goniometer.

  3. Change in The Modified Schober Test Score

    Time frame: Baseline, immediately after the intervention

    Test is an assessment method that measures lumbar flexion flexibility. The lumbosacral junction and 10 cm above were marked when the person was in an upright position. Then third mark was placed 5 cm below the lumbosacral junction. After anterior flexion as far forward as possible, the distance between the highest and lowest marks was measured.

  4. Change in Sit and Reach Test Score

    Time frame: Baseline, immediately after the intervention

    test was used for flexibility evaluation. While the patient was performing maximum trunk flexion in the knee extension, the distance between the fingertip and the box aganist the sole of the foot was measured as +/- centimeters

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Official study title

Evaluation of The Immediate Effect of Myofascial Release Application on Pain, Flexibility and Trunk Mobility in Patients With Chronic Low Back Pain

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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