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Dynamic Knee ValgusNCT04660604

Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique in Individuals With Asymptomatic Dynamic Knee Valgus

A study testing Graston Technique® in people with Dynamic Knee Valgus and Force Production, run by Bahçeşehir 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

STUDY DESIGN: Randomized controlled study OBJECTIVES: To investigate the contribution of instrument assisted soft tissue mobilization (IASTM) applied to gluteus medius (GMed) to isokinetic strength, femoral internal rotation (FIR), frontal plan projection angle (FPPA) and postural stability (PS) in individuals with… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
What is being tested?
Graston Technique®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2019to 30 Dec 2020
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 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • to be a female between ages of 18 and 35,
  • to have an increase of more than 10 ° in FPPA in landing phase of single leg squat test (SLST),
  • not to have pain complaints
  • to be recreatively active.

Who cannot join

  • body mass index of 30 kg/m² and above,
  • to have previous lower extremity surgery and joint,
  • meniscus or ligament injury,
  • chronic knee instability,
  • leg length inequality,
  • joint degeneration detected by radiography,
Show all 9Show fewer
  • cardiac, musculoskeletal system, vestibular and neurological problems,
  • using corticosteroids for a long time
  • being pregnant.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Pelin Pişirici

    Istanbul, Besiktas/Istanbul, 34353

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Functional and Biomechanical Effect of Instrument Assisted Soft Tissue Mobilization Technique in Individuals With Asymptomatic Dynamic Knee Valgus - Randomized Controlled Trial

STUDY DESIGN: Randomized controlled study OBJECTIVES: To investigate the contribution of instrument assisted soft tissue mobilization (IASTM) applied to gluteus medius (GMed) to isokinetic strength, femoral internal rotation (FIR), frontal plan projection angle (FPPA) and postural stability (PS) in individuals with asymptomatic dynamic knee valgus (DDV).

BACKGROUND: In the literature effect of IASTM on force production and performance has been examined with exercise, and results of the studies are contradictory. Studies investigating the effects of IASTM without exercise and at recommended dose are needed.

METHODS: 44 participants with DDV (21,39±1,79) were randomized to be control group (CG=22) and graston group (GG=22). First day, participants' FIR, FPPA with single leg squat test, dynamic and static PS on involved leg evaluations were completed. Second day, eccentric strength of GMed was measured by isokinetic test. IASTM application was applied 6 weeks, twice a week, 5 minutes, using Graston Technique® instruments. CG has not been attempted. Evaluations were repeated at the end of treatment.

Read the detailed description

Introduction Dynamic knee valgus (DDV), one of the lower extremity faulty movement patterns, is a biomechanical deviation that occurs in 3 motion plans, involving femoral internal rotation (FIR) and contralateral pelvis fall simultaneously with hip adduction.1 Hip flexion, adduction and FIR moments occur simultaneously during loading phase of walking, running or landing after jumping. Combination of these moments also forms DDV. These moments are resisted by intrinsic moments caused by eccentric contractions of hip extensor, abductor and external rotator muscles. Strength deficiency of these muscles in weight transfer activities causes an increase in hip adduction, and FIR, changes whole lower extremity kinematics.2,3 The valgus alignment also increases the risk of injury.4 In the review examining relationship between hip muscle strength and DDV, it was determined that decrease in gluteus medius (GMed) strength in functional activities on single leg was associated with DDV.2 Abduction torque produced by hip abductors stabilizes pelvis on relatively fixed femur by controlling pelvis in frontal and horizontal planes during stance phase of walking and most of stance and GMed produces most of the compression forces in hip.3,5 Therefore, GMed strength is also very important for postural stability (PS). In individuals with DDV, strength of hip muscles, especially GMed, should be focused on increasing PS during the tests performed on single leg and in injury prevention programs.4,6 Anatomical features of women increase the risk of DDV. In addition, when gender comparison was made, it was seen that women needed more eccentric contraction in the hip abductor muscles during the stance phase of running.7, and strength deficiency in proximal hip stabilizers of females could cause a greater decrease in athletic performance compared to men.8 Therefore, evaluation of eccentric strength of GMed muscle should be evaluated specific to gender.2 Thus, a more precise conclusion can be found in terms of abductor muscle strength, DDV and lower extremity alignment.

Effect of soft tissue mobilization techniques on force production and performance is a remarkable topic. Instrument-assisted soft tissue mobilization (IASTM) technique, one of the soft tissue mobilization techniques, has also been found to be effective method that affects muscle strength, performance and endurance through activation of muscle and nervous systems.9-11 However, in studies IASTM technique was applied with an exercise protocol, and contribution of IASTM in force generation and performance increase is not understood.

According to our knowledge, in the literature there is no randomized controlled study examining the effect of IASTM applied without exercise. Aim of our study is to investigate changes caused by IASTM applied to GMed muscle on eccentric force production of GMed, FIR, frontal plane projection angle (FPPA) and PS.

Being tested
Graston Technique®

What participants receive

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

  • Graston Technique®Device

    Graston technique, one of the soft tissue mobilization techniques, has also been found to be effective method that affects muscle strength, performance and endurance through activation of muscle and nervous systems.

Study groups in NCT04660604
Study groupRoleWhat they receive
Graston Technique® GroupExperimentalParticipants were asked to warm up at a speed that they felt comfortable for 5 minutes at a gentle tempo with an ergometer. Time was followed by a stopwatch. Participants who completed warm-up were taken to GT® application. Application was implemented by a GT® certified therapist with 13 years of experience in orthopedic rehabilitation. Intervention dosage was determined as 2 times a week, 12 sessions over 6 weeks. GMed muscle was scanned between crista iliaca and trochanter major, and a fascial release was applied. Each session lasted 5 minutes. At the end of sessions, iliotibial band stretching exercises (30 seconds, 3 repetitions) was given to the treated side. Application protocol has been determined with reference to GT® manual
Receives: Device: Graston Technique®
Control GroupNo interventionControl group is followed up for 6 weeks without intervention.

What is being measured

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

  1. Change in isokinetic strength measurement

    gluteus medius eccentric strength evaluated with Cybex® Norm isokinetic dynamometer

    Measured: Pre evaluation before the intervention, 1 day after the intervention

Secondary outcomes (3)
  1. Change in postural stability evaluation

    static and dynamic single leg postural stability

    Measured: Pre evaluation before the intervention, 1 day after the intervention

  2. Change in Femoral internal rotation angle evaluation

    Femoral internal rotation angle measurement

    Measured: Pre evaluation before the intervention, 1 day after the intervention

  3. Change in frontal plan projection angle evaluation

    Frontal plan projection angle measurement in single leg squat test

    Measured: Pre evaluation before the intervention, 1 day after the intervention

Timeline

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

  1. First posted9 Dec 2020
  2. Study start1 Jun 2019
  3. Primary completion30 Nov 2020
  4. Study completion30 Dec 2020

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled study
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660604
Sponsor's protocol ID
IASTM-24.11.20
Status last verified
Jan 2021
First submitted
24 Nov 2020
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Pisirici P, Ufuk Sakul B. Investigation of the functional and biomechanical effect of instrument-assisted soft tissue mobilization technique in individuals with asymptomatic dynamic knee valgus - Randomized controlled trial. J Bodyw Mov Ther. 2024 Jul;39:263-269. doi: 10.1016/j.jbmt.2024.02.040. Epub 2024 Mar 6.

    PubMed 38876637

Questions about this trial

What is this clinical trial studying?

A study testing Graston Technique® in people with Dynamic Knee Valgus and Force Production, run by Bahçeşehir 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 4 inclusion and 9 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 26 Jan 2021. 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?

Change in isokinetic strength measurement (time frame: Pre evaluation before the intervention, 1 day after the intervention). 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 NCT04660604, which also lists 1 linked publication.

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 26 Jan 2021.

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