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CompletedNCT05302882Updated Mar 31, 2022

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

An interventional study of Myofascial release and Classical massage in Chronic Low-back Pain, sponsored by Halic University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Halic University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

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".

Read the detailed description

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".

02

Conditions studied

  • Chronic Low-back Pain

Keywords

  • Myofascial release
  • Chronic low back pain
  • Flexibility
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Halic University is the lead sponsor of 80 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. problems of cooperation;
  2. malignancy or infection;
  3. acute fractures;
  4. occlusive edema;
  5. osteoporosis;
  6. advanced degenerative joint problems;
  7. acute rheumatologic conditions;
  8. cortisone therapy;
  9. use of blood thinners;
  10. skin problems.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Experimental Group

    Myofascial release was applied to the experimental group

    Behavioral: Myofascial release

  • Active comparator
    Control Group

    Classical massage was applied to the control group

    Behavioral: Classical massage

Interventions

  • BehavioralMyofascial release

    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.

  • BehavioralClassical massage

    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.

06

What researchers measure

Primary outcomes

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

    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

    Time frame: Baseline, immediately after the intervention

  2. Change in The Straight Leg Raise Test Score

    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.

    Time frame: Baseline, immediately after the intervention

  3. Change in The Modified Schober Test Score

    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.

    Time frame: Baseline, immediately after the intervention

  4. Change in Sit and Reach Test Score

    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

    Time frame: Baseline, immediately after the intervention

07

Study locations

1 site
  • Halic University
    Istanbul, Eyupsultan 2022, Turkey
08

References and documents

Publications

  • Boff TA, Pasinato F, Ben AJ, Bosmans JE, van Tulder M, Carregaro RL. Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial. Physiotherapy. 2020 Jun;107:71-80. doi: 10.1016/j.physio.2019.11.002. Epub 2019 Nov 18. PubMed 32026838 ↗
  • Lohr C, Medina-Porqueres I. Immediate effects of myofascial release on neuromechanical characteristics in female and male patients with low back pain and healthy controls as assessed by tensiomyography. A controlled matched-pair study. Clin Biomech (Bristol). 2021 Apr;84:105351. doi: 10.1016/j.clinbiomech.2021.105351. Epub 2021 Apr 5. PubMed 33848704 ↗
  • Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897. PubMed 28441294 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05302882
Lead sponsor
Halic University
Responsible party
Ayşenur Çetinkaya (Lecturer, Halic University) — Principal investigator
First posted
Mar 31, 2022
Start date
Mar 5, 2021
Primary completion
Apr 30, 2021
Completion
May 27, 2021
Last update
Mar 31, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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