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Mechanical Low Back PainNCT05573594

Efficiency of Muscle Energy Techniques

A study testing Muscle Energy Technique and conventional physical therapy and rehabilitation in people with Mechanical Low Back Pain, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 45 years, women only
Conditions the study is for
Mechanical Low Back Pain
What is being tested?
Muscle Energy Technique and conventional physical therapy and rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Feb 2017to 10 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Zonguldak Bülent Ecevit University

    Zonguldak, Kozlu, 67600

Other trials in Turkey (Türkiye)

About this study

Official title: Efficiency of Muscle Energy Techniques In Female Patients Mechanical Lower Pain: A Randomised Control Trial A Randomised Control Trial

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.

Read the detailed description

There are many epidemiological and statistical studies showing the high incidence and prevalence of low back pain, which is a common problem all over the world (Manga et al 1993). Mechanical causes constitute 90% of the factors that cause low back pain (Diamond and Borenstein 2006).

Mechanical Low Back Pain (MLBP) is musculoskeletal pain of soft tissue origin that can be seen in the posterior lumbal region, sacral region or paraspinal region. MLBP, which is characterized by tendonitis, trigger points and muscle spasms, increases with movement and decreases with rest.

Muscle Energy Technique (MET) is a manual therapeutic procedure that creates voluntary contractions in skeletal muscles by creating force against the practitioner by the patient. MET is used to lengthen shortened muscles, mobilize restricted joints, and strengthen physiologically weakened muscles (Chaitow 2013).

Treatment methods generally applied to patients diagnosed with MLBP; physical therapy modalities, manual techniques, exercise therapy, medical therapy, psychological therapy and patient education. It is recommended that MET be used to reduce pain when administered to the spine (Wilson 2003) or muscles (Ballantyne et al. 2003).

The aim of our study is to investigate the efficiency of Muscle Energy Technique on spinal mobility, flexibility, pain, disability, fear avoidance behavior, quality of life and depressive symptoms in female patients with mechanical low back pain.

Being tested
Muscle Energy Technique, conventional physical therapy and rehabilitation
Keywords
Efficiency, Mechanical Low Back Pain, Muscle Energy Techniques
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Muscle Energy TechniqueOther

    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.

  • conventional physical therapy and rehabilitationOther

    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.

Study groups in NCT05573594
Study groupRoleWhat they receive
MET GroupExperimentalthe 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.
Receives: Other: Muscle Energy Technique; Other: conventional physical therapy and rehabilitation
Control GroupExperimentalIn 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
Receives: Other: conventional physical therapy and rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 week

  2. 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).

    Measured: 8 week

  3. 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).

    Measured: 8 week

  4. 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).

    Measured: 8 week

  5. 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).

    Measured: 8 week

  6. 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).

    Measured: 8 week

  7. 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).

    Measured: 8 week

  8. 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.

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start10 Feb 2017
  3. Primary completion10 Jan 2018
  4. Study completion10 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573594
Sponsor's protocol ID
PIR
Status last verified
Oct 2022
First submitted
5 Oct 2022
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16979534
  • 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.

    PubMed 24139001

Questions about this trial

What is this clinical trial studying?

A study testing Muscle Energy Technique and conventional physical therapy and rehabilitation in people with Mechanical Low Back Pain, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Assessment (time frame: 8 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05573594, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.

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