Mechanical Low Back Pain Clinical Trial
Official title:
Efficiency of Muscle Energy Techniques In Female Patients Mechanical Lower Pain: A Randomised Control Trial A Randomised Control Trial
NCT number | NCT05573594 |
Other study ID # | PIR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 10, 2017 |
Est. completion date | February 10, 2018 |
Verified date | October 2022 |
Source | Bulent Ecevit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Purpose: The aim of this study is to investigate the efficiency of the Muscle Energy Technique in female patients with mechanical low back pain. Methods: A total of 40 female participants aged 30-45 were randomly divided into two groups (Study Group and Control Group). Control group participants were under 10 sessions conventional physical therapy and rehabilitation (TENS, US, hot pack) and performed standard home exercises. Study Group participants were under 8 sessions muscle energy technique in addition to conventional physical therapy and standard home exercises. Pain (Visual Analog Scale-VAS), spinal mobility (Modify Schober Test-MST), flexibility (Fingertip Floor Distance-FFD, Right and Left Lateral Flexion Floor Distance-LFFD), quality of life (Nottingham Health Profile-NHP), disability (Oswestry Disability Index-ODI), kinesiofobia (Tampa Kinesiofobia Scale-TKS) and depressive symptoms (Beck Depression Inventory-BDI) were measured at baseline, after the treatment and 3th months.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 10, 2018 |
Est. primary completion date | January 10, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 45 Years |
Eligibility | Inclusion Criteria: - being a volunteer female between the ages of 30 and 45 - having a complaint of low back pain for at least 3 months with the diagnosis of mechanical low back pain Exclusion Criteria: - having previous spinal surgery - having radicular type low back pain - having neuromuscular disease |
Country | Name | City | State |
---|---|---|---|
Turkey | Zonguldak Bülent Ecevit University | Zonguldak | Kozlu |
Lead Sponsor | Collaborator |
---|---|
Bulent Ecevit University |
Turkey,
Diamond S, Borenstein D. Chronic low back pain in a working-age adult. Best Pract Res Clin Rheumatol. 2006 Aug;20(4):707-20. Review. — View Citation
Fryer G, Pearce AJ. The effect of muscle energy technique on corticospinal and spinal reflex excitability in asymptomatic participants. J Bodyw Mov Ther. 2013 Oct;17(4):440-7. doi: 10.1016/j.jbmt.2013.05.006. Epub 2013 May 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Assessment | The pain severity felt by the participants in the lumbal region was evaluated with the Visual Analog Scale (VAS). VAS is the most appropriate tool for defining pain severity or intensity with its simplicity, reliability and validity as well as ratio scale features (Yakut and Kayihan 2002). The VAS is a 10cm horizontal scale with 0 as "no pain" and 10 "very severe pain". The participant was asked to mark the severity of low back pain on the line. The marked point was measured and recorded. | 8 week | |
Primary | Modified Shober Test | The participant's sacrum bases were combined with a line, the central point of this line was marked, 10 cm above and 5 cm below the central line were marked, and the participants were asked to bend fully forward without bending their knees. If the difference in this distance is less than 5 cm, the measurement was accepted as a decrease in spinal mobility (Tousignant 2005). | 8 week | |
Primary | Fingertip-Ground Distance | In this test, the participant measures 15 cm. height, while standing upright on a block, he was asked to bend forward without bending his knees, and the fingertip-to-floor distance was measured with a tape measure (Inanoglu and Baltaci 2014). | 8 week | |
Primary | Lumbal Lateral Flexion Distance | It was started with the participant's feet shoulder-width apart, while standing upright, arms parallel to each other and at the side of the trunk. The place of the distal end of the middle finger of the right and left hand of the participant on the thigh was marked, and he was asked to tilt his body to the side by sliding his hand down on the thigh. The end point was marked again and the distance between the Right and Left LuMLBPr Lateral Flexion Distance and the ground was measured with a tape measure and the value found was recorded in centimeters (Inanoglu and Baltaci 2014). | 8 week | |
Primary | Tampa Kinesiophobia Scale | It was used to evaluate the fear avoidance levels (kinesiophobia) of the participants. This scale, which is used in acute and chronic low back pain, fibromyalgia and musculoskeletal injuries and whiplash-related diseases, consists of 17 questions and a 4-point Likert score (1 = strongly disagree, 4 = completely agree) is used. Items 4, 8, 12, and 16 are reverse-scored, and the high score of the participant in the scale, which is calculated with a total score of 17-68, indicates that kinesiophobia is also high (Yilmaz 2011). | 8 week | |
Primary | Oswestry Disability Index | It was used to evaluate the disability level. The Turkish validity and reliability of this index was done by Yakut et al. (Yakut 2004). In the anMET, which questions the disability status in activities of daily living (pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travel, and the degree of change in pain), with an index consisting of 10 items, those who score 0-14 score mild, 15- Those with a score of 29 were considered to have moderate disability, and those with a score above 30 were considered to have advanced disability (Fairbank 2000). | 8 week | |
Primary | Nottingham Health Profile | The Turkish version of Küçükdeveci et al. was used to evaluate the health-related quality of life of the participants and to measure the extent to which the health problems perceived by the individual affect normal daily activities. In the questionnaire, which evaluates health status in 6 dimensions with 38 items, energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items) and consists of physical activity (8 items). When the scores obtained from the sub-scores for the total NSP score approach from 0 to 100, it is accepted that the quality of life decreases (Küçükdeveci 2000). | 8 week | |
Primary | Beck Depression Inventory | This questionnaire, the Turkish validity and reliability of which was conducted by Hisli et al. in 1988, was used to evaluate the depressive symptoms of the participants. Somatic, cognitive, motivational and emotional symptoms are scored with a total of 21 items. An increase in the total scores of the participants indicates an increase in their depressive symptoms (Beck et al. 1961). In our study, analysis was performed using the total scores of the scale. | 8 week |
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