NCT05573594

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2018

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

October 5, 2022

Last Update Submit

October 7, 2022

Conditions

Keywords

EfficiencyMechanical Low Back PainMuscle Energy Techniques

Outcome Measures

Primary Outcomes (8)

  • 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 Kayıhan 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

  • 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

  • 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 (İnanoğlu and Baltacı 2014).

    8 week

  • 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 (İnanoğlu and Baltacı 2014).

    8 week

  • 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 (Yılmaz 2011).

    8 week

  • 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

  • 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

  • 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

Study Arms (2)

MET Group

EXPERIMENTAL

the participants in the study group were under 8 sessions of MET, 2 times a week, in addition to the conventional physiotherapy program. In the content of conventional physiotherapy program for both groups; Hot Pack (20 min), Ultrasound (ITO brand 1 MHz and 1.5 W/cm2, 5 min), Transcutaneous Electrical Nerve Stimulation (TENS, 50-100 Hz, 20 min) and standard home exercises were included. The program went 5 times a week, 10 consecutive sessions. Each session lasted an average of 45 minutes.

Other: Muscle Energy TechniqueOther: conventional physical therapy and rehabilitation

Control Group

EXPERIMENTAL

In this study, the participants in the control group were under conventional physiotherapy program for 5 times a week, a total of 10 sessions In the content of conventional physiotherapy program for both groups; Hot Pack (20 min), Ultrasound (ITO brand 1 MHz and 1.5 W/cm2, 5 min), Transcutaneous Electrical Nerve Stimulation (TENS, 50-100 Hz, 20 min) and standard home exercises were included. The program went 5 times a week, 10 consecutive sessions. Each session lasted an average of 45 minutes

Other: conventional physical therapy and rehabilitation

Interventions

The Janda method (Post isometric relaxation PIR Technique), one of the Muscle Energy Techniques, was used on m.piriformis, m.quadratus lumborum, m.hamstring, m.psoas major muscles in the study group. First, the dysfunctional muscle was stretched passively by the physiotherapist up to the movement barrier, and 5-7 seconds of isometric muscle contraction in the opposite direction was requested from the patient at the barrier. This practice was continued until muscle tension or joint dysfunction disappeared. All participants performed standard home exercises consisting of stretching and strengthening. These exercises were taught to the participants by the physiotherapist in the first treatment session, and when they came to each treatment session, it was questioned whether they did it or not, and a control chart was created for exercise follow-up.

MET Group

In the content of conventional physiotherapy program for both groups; Hot Pack (20 min), Ultrasound (ITO brand 1 MHz and 1.5 W/cm2, 5 min), Transcutaneous Electrical Nerve Stimulation (TENS, 50-100 Hz, 20 min) and standard home exercises were included. The program went 5 times a week, 10 consecutive sessions. Each session lasted an average of 45 minutes.

Control GroupMET Group

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • having previous spinal surgery
  • having radicular type low back pain
  • having neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (2)

  • Diamond S, Borenstein D. Chronic low back pain in a working-age adult. Best Pract Res Clin Rheumatol. 2006 Aug;20(4):707-20. doi: 10.1016/j.berh.2006.04.002.

    PMID: 16979534BACKGROUND
  • 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.

    PMID: 24139001BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 10, 2022

Study Start

February 10, 2017

Primary Completion

January 10, 2018

Study Completion

February 10, 2018

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations