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).
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
- Conditions the study is for
- Dynamic Knee Valgus, Force Production, Frontal Plan Projection Angle
- 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
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.
- Conditions
- Dynamic Knee Valgus, Force Production, Frontal Plan Projection Angle, Instrument-assisted Soft Tissue Mobilization, Postural Stability
- 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 group | Role | What they receive |
|---|---|---|
| Graston Technique® Group | Experimental | Participants 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 Group | No intervention | Control 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.
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)
Change in postural stability evaluation
static and dynamic single leg postural stability
Measured: Pre evaluation before the intervention, 1 day after the intervention
Change in Femoral internal rotation angle evaluation
Femoral internal rotation angle measurement
Measured: Pre evaluation before the intervention, 1 day after the intervention
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.
- First posted9 Dec 2020
- Study start1 Jun 2019
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dynamic Knee ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Pelin Pişirici, Bahçeşehir University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04660604
- Acronym / sponsor ID
- IASTM-24.11.20
- Conditions
- Dynamic Knee Valgus, Force Production, Frontal Plan Projection Angle, Instrument-assisted Soft Tissue Mobilization, Postural Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Graston Technique® Group | Experimental | Device: Graston Technique®Participants 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 |
| Control Group | No intervention | –Control group is followed up for 6 weeks without intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graston Technique®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. | Device | Graston Technique® Group |
Primary outcome
Change in isokinetic strength measurement
Time frame: Pre evaluation before the intervention, 1 day after the intervention
gluteus medius eccentric strength evaluated with Cybex® Norm isokinetic dynamometer
3 secondary outcomes
Change in postural stability evaluation
Time frame: Pre evaluation before the intervention, 1 day after the intervention
Change in Femoral internal rotation angle evaluation
Time frame: Pre evaluation before the intervention, 1 day after the intervention
Change in frontal plan projection angle evaluation
Time frame: Pre evaluation before the intervention, 1 day after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 38876637Pisirici 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.