Clinical trial NCT05302882: Evaluation of The Immediate Effect of Myofascial Release Application in Patients With Chronic Low Back Pain
Official title: Evaluation of The Immediate Effect of Myofascial Release Application on Pain, Flexibility and Trunk Mobility in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Myofascial release
Chronic low back pain
Flexibility
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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".

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".

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Pain Score
timeFrame: Baseline, immediately after the intervention
measure: Change in The Straight Leg Raise Test Score
timeFrame: Baseline, immediately after the intervention
measure: Change in The Modified Schober Test Score
timeFrame: Baseline, immediately after the intervention
measure: Change in Sit and Reach Test Score
timeFrame: Baseline, immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Halic University
state: Eyupsultan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.