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Recovery MethodNCT06634862

Comparison of the Effects of Intermittent Pneumatic Compression, Graston Technique and Percussive Therapy

A study testing Normatec Air Compression, Soft Tissue Mobilization and Percussive therapy in people with Recovery Method, run by Okan University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to compare the effects of intermittent pneumatic pressure, percussive therapy and graston after a fatigue protocol applied to the leg muscles. Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Recovery Method
What is being tested?
Normatec Air Compression, Soft Tissue Mobilization and Percussive therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Dec 2024to 18 May 2025
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 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • To be between 25-45 years old.
  • Not having any chronic disease.
  • Not doing active sports for at least 6 months.
  • Not having any previously diagnosed lower extremity pathology.
  • Not having a chronic lower extremity problem and not having a major trauma (fracture, anterior cruciate ligament injury, etc.).
  • Not having any cognitive problem that prevents them from following and adapting to a specific exercise programme.
  • No visual, vestibular and neurological disorders.

Who cannot join

  • Having a chronic disease.
  • Any musculoskeletal problem in the lower extremities.
  • Use of sedative medication due to chronic disease (rheumatism, lung and/or heart etc.)
  • Regular use of painkillers, muscle relaxants or anti-inflammatory drugs.
  • Any history of surgery on the lower extremity.
  • Any history of pain in the lower extremity during the fatigue protocol.
  • Pregnancy.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Okan University

    Istanbul, Tuzla, 34959

    Emine Atıcı, +90 532 478 86 48, emine.atici@okan.edu.tr

    Melis Beril Yazıcı

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Intermittent Pneumatic Compression, Graston Technique and Percussive Therapy on Muscle Pain, Muscle Tone and Balance After Quadriceps Fatigue Protocol

The aim of this study was to compare the effects of intermittent pneumatic pressure, percussive therapy and graston after a fatigue protocol applied to the leg muscles.

Read the detailed description

a- Subject and Objective (the importance of the subject, why this subject is the problem and the objectives of the study will be written based on the literature with the narration of the researcher):

Studies on the intermittent pneumatic compression device, graston technique and percussive therapy (massage weapons) have focused on investigating their use in athlete health. During the literature review, it was realised that the use of these and other auxiliary therapies and elements that increase the speed of recovery has not been investigated for sedentary individuals. The necessity and benefits of regular exercise for sedentary individuals as well as athletes in daily life have been proven by many studies. It has become a common belief that exercise should be a part of the life of every adult individual, whether athlete or sedentary, in order to maintain a healthy life. Furthermore, enjoyment of exercise and perceived exercise intensity play an important role in the adherence of sedentary individuals; moderate intensity exercise is more likely to be enjoyable and adaptive for this population. Psychological factors such as mood and self-efficacy also influence exercise behaviours in sedentary individuals, with negative exercise-related cognitions potentially moderating the exercise-effect relationship and affecting feelings of pleasure during and after exercise. However, one of the biggest obstacles for sedentary individuals to form a sports habit is the fatigue and muscle pain they experience after exercise. These effects, which make it difficult to continue daily life the next day, distract the person from the habit of exercising regularly. Furthermore, the psychosocial benefits of incorporating regular exercise into the daily life flow are well documented and emphasise the wider positive impact of exercise beyond physical health.

Intermittent Pneumatic Compression (IPC) is a mechanical method used to apply compression to limbs and has a number of therapeutic uses. The device consists of a pair of inflatable sleeves wrapped around the leg and an electric pneumatic pump that inflates the sleeves with air, compressing deep veins and displacing blood proximally. The working principle of IPC is based on passively increasing blood flow by applying external pressure to the extremity, but the exact physiological mechanisms are only partially understood. However, despite its widely recognised use and positive effects on circulatory conditions, the literature on the use of IPC in musculoskeletal treatment is limited. The available evidence has been investigated in several studies, including the efficacy of IPC, its effect on vasodilatory effects in distal skeletal muscle and its effect on serum indices of muscle function, pain and muscle damage. Studies have also reported improvements in exercise duration as well as fatigue when using pneumatic compression during rest after warm-up exercises. IPC devices are particularly popular among endurance athletes because they have the potential to reduce exercise-induced muscle damage. Research on IPC has shown that the devices increase muscle blood flow during exercise and increase blood flow during post-exercise recovery. More research is needed on the effects of IPC in musculoskeletal treatment, especially on exercise-induced muscle damage and pain. In conclusion, IPC devices have shown promising results in various therapeutic applications, especially in athlete rehabilitation and post-exercise recovery. Furthermore, all of this information demonstrates the great potential of these devices for health and sports applications.

The Graston Technique (GT) is a form of instrument-assisted soft tissue mobilisation that uses stainless steel instruments to perform manual therapy on soft tissues. It is widely used by clinicians to treat various soft tissue disorders. Research has reported that it effectively promotes collagen synthesis and inhibition of adhesion of treated tissues. Furthermore, the graston technique has been used to manage pain and range of motion limitations caused by scar tissue and musculoskeletal injuries. Overall, the graston technique has been studied in a variety of contexts and has demonstrated potential effects on range of motion, pain relief and musculoskeletal conditions. Some studies reported direct effects on specific outcomes, while others emphasised its potential when combined with other therapeutic interventions. These findings contribute to the understanding of the graston technique as a modality for soft tissue mobilisation and musculoskeletal disorders in the field of physiotherapy and rehabilitation, particularly highlighting its potential to manage muscle pain and promote recovery. In conclusion, the graston technique is a widely used form of instrument-assisted soft tissue mobilisation with reported efficacy in the management of various musculoskeletal disorders.

Percussive therapy has gained popularity in recent years as a potential intervention to alleviate post-exercise muscle pain and fatigue. This therapy involves the use of a mechanical system to provide percussive massage and its effectiveness in promoting recovery and reducing muscle soreness has been a topic of interest in the field of sports medicine and rehabilitation. Several studies have investigated the acute effects of percussive therapy on muscle recovery and pain, aiming to understand its potential benefits for athletes and individuals engaged in physical activities. Furthermore, the use of percussive therapy with resistance training has been shown to have acute effects on movement velocity, suggesting the potential to influence exercise performance and recovery. These findings contribute to the understanding of how percussive therapy can influence muscle function and recovery processes. In the context of pain management, exercise therapy has been advocated as an effective treatment for chronic low back pain, suggesting the potential for therapeutic interventions, including percussive therapy, to address musculoskeletal pain and discomfort. Although the acute effects of percussive therapy on muscle recovery have been the focus of research, the underlying mechanisms and long-term effects of this therapy need to be further investigated. Understanding the impact of percussive therapy on muscle regeneration, inflammation and tissue repair processes may provide valuable insights into its potential to enhance recovery and reduce muscle fatigue. In conclusion, research on massage gun or percussive therapy demonstrates its potential as a valuable intervention to address post-exercise muscle pain and fatigue. Further investigation of the underlying mechanisms, long-term effects and comparative effectiveness of percussive therapy may provide valuable insights into its role in promoting muscle recovery and enhancing exercise performance.

Considering all these, it is necessary to compare these modalities among each other and to investigate their contribution to the health of sedentary individuals as well as athletes. Although there are studies in the literature on the comparison of these modalities with classical physiotherapy and rehabilitation modalities, there is no comparative study on their contribution to the recovery process. In addition to its contribution to the literature, this study is thought to be useful for physiotherapists who use these and similar modalities in the clinical environment.

The main aim of this study was to investigate the effects of these therapeutic treatment modalities on post-exercise muscle pain, muscle tone and fatigue. Post-exercise recovery is a very popular topic in recent times, especially for athletes. Many different methods are used for this purpose in the clinical environment. In this study, the effectiveness of these modalities on recovery and their superiority over each other will be investigated.

H0 Hypothesis: Intermittent pneumatic compression, graston technique and percussive therapy have no effect on muscle pain, muscle tone and balance after quadriceps fatigue protocol.

H1 Hypothesis: Intermittent pneumatic compression device application is more effective than graston technique and percussive therapy on muscle pain, muscle tone and balance after quadriceps fatigue protocol.

H2 Hypothesis: Graston technique application is more effective than intermittent pneumatic compression device and percussive therapy on muscle pain, muscle tone and balance after quadriceps fatigue protocol.

H3 Hypothesis: Percussive therapy is more effective than intermittent pneumatic compression device and graston technique on muscle pain, muscle tone and balance after quadriceps fatigue protocol.

Conditions
Recovery Method
Being tested
Normatec Air Compression, Soft Tissue Mobilization, Percussive therapy
Keywords
Recovery, Quadriceps Fatigue Protocol, Intermittent pneumatic pressure, Soft Tissue Mobilization Technique, Percussive therapy, Muscle Fatigue, Muscle Tone

What participants receive

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

  • Normatec Air CompressionOther

    Intermittent pneumatic pressure has been used in other studies, usually for deep vein thrombosis and vascular disorders. In this way, it has not been compared with other recovery interventions for post-exercise recovery applications.

  • Soft Tissue MobilizationOther

    The soft tissue mobilisation technique has been investigated in other studies in terms of its effect on soft tissue and its role recovery. In this way, there is no comparison with other recovery interventions for post-exercise recovery applications.

  • Percussive therapyOther

    Percussive therapy has been investigated in device research and athlete health. In this way, it has not been compared with other recovery interventions for post-exercise recovery applications.

Study groups in NCT06634862
Study groupRoleWhat they receive
intermittent pneumatic pressure groupOtherIntermittent Pneumatic Compression (IPC) is a mechanical method of applying compression to the limbs and has a number of therapeutic uses. The device consists of a pair of inflatable sleeves wrapped around the leg and an electric pneumatic pump that inflates the sleeves with air, compressing the deep veins and displacing blood proximally. The working principle of IPC is based on passively increasing blood flow by applying external pressure to the extremity, but the exact physiological mechanisms are only partially understood. However, despite its widely recognised use and positive effects on circulatory conditions, the literature on the use of IPC in musculoskeletal treatment is limited. The available evidence has been investigated in several studies, including the efficacy of IPC, its effect on vasodilatory effects in distal skeletal muscle and its effect on serum indices of muscle function, pain and muscle damage. Studies have also reported improvements in exercise duration as wel
Receives: Other: Normatec Air Compression
Soft Tissue Mobilization Technique GroupOtherThe Graston Technique (GT) is a form of instrument-assisted soft tissue mobilisation that uses stainless steel instruments to perform manual therapy on soft tissues. It is widely used by clinicians to treat various soft tissue disorders. Research has reported that it effectively promotes the inhibition of adhesion of treated tissues and collagen synthesis. Furthermore, the graston technique has been used to manage pain and range of motion limitations caused by scar tissue and musculoskeletal injuries. Overall, the graston technique has been studied in a variety of contexts and has demonstrated potential effects on range of motion, pain relief and musculoskeletal conditions. Some studies reported direct effects on specific outcomes, while others emphasised its potential when combined with other therapeutic interventions. These findings contribute to the understanding of the graston technique as a modality for soft tissue mobilisation and musculoskeletal disorders in the field of physio
Receives: Other: Soft Tissue Mobilization
Percussive Therapy GroupOtherPercussive therapy has gained popularity in recent years as a potential intervention to alleviate muscle soreness and fatigue after exercise. This therapy involves the use of a mechanical system to provide percussive massage and its effectiveness in promoting recovery and reducing muscle soreness has been a topic of interest in the field of sports medicine and rehabilitation. Several studies have investigated the acute effects of percussive therapy on muscle recovery and pain, aiming to understand its potential benefits for athletes and individuals engaged in physical activities. Furthermore, the use of percussive therapy with resistance training has been shown to have acute effects on movement speed, suggesting the potential to influence exercise performance and recovery. These findings contribute to the understanding of how percussive therapy can influence muscle function and recovery processes. In the context of pain management, exercise therapy is advocated as an effective treatm
Receives: Other: Percussive therapy
control groupNo interventionIn the control group, quadriceps fatigue protocol was applied, measurements were taken on two separate days and no intervention was made.

What is being measured

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

  1. Star Balance Test

    On the floor, 4 strips of adhesive tape, previously cut 2 metres long, will be glued in such a way that they form 45 degree angles between them. The participant will align in the centre of the star and perform the reaching on one leg in anterior, anteromedial, anterolateral, posterior posterolateral, posteromedial, medial and lateral directions. The test will be performed anti-clockwise if the participant's initial leg is right and the participant will reach with the left leg; clockwise if the initial leg is left and the participant will reach with the right leg. During the test, the participant will be asked to keep his/her hands on his/her waist and not to change his/her position throughout the test. Then the participant will be asked to reach to the last point he/she can reach, touch his/her toe to the strip and return to the starting position. Then he/she will be asked to move to the other line in the specified direction and complete a total of 8 lines in this way.

    Measured: The balance test will take 10 minutes in total before and after the intervention.

  2. Muscle pain measurement with algometer

    Pressure-pain threshold (PPT) will be measured with a hand-held pressure algometer. The participant will be comfortably seated in an ordinary chair with an adjustable seat and backrest and arms resting on a soft support placed on either side of the chair. The chair height and arm rests will be adjusted so that the subject's knees and hips are in 90° flexion. Two sites/muscles will be marked for use in PPT determinations to avoid peripheral sensitisation due to frequent, multiple PPT assessments at the same site. In M. quadriceps femoris, a site 2.5 cm proximal and 2.5 cm distal to the midpoint between the apex patella and groin will be marked bilaterally. The researcher will instruct the participants to press the button on their own as soon as the pressure sensation becomes painful. The rate of pressure increase of the device will be kept between approximately 40-60kPa.

    Measured: It will take 30 minutes in total before and after the intervention.

  3. Muscle tone measurement with MyotonPRO

    Measurements of bilateral rectus femoris muscles will be taken twice on the same day and time of the week, one week apart.The first measurement will be made without any intervention and the second measurement will be made after the protocol has been implemented.The test lead of the MyotonPRO will be placed on the skin over the area perpendicular to the surface of the muscle belly and the device will then be placed in the measurement position and held steady while the device automatically performs a series of predefined measurements.The device will be used in multiscan mode, where a measurement consists of the average of 10 mechanical touches one second apart. In the control group and in the first measurement of the experimental groups, the measurement will be performed after the participant has rested for 15 minutes after the fatigue protocol as described above.The second measurement in the experimental groups will be performed as described above without resting after the intervention

    Measured: It will take 30 minutes in total before and 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 posted10 Oct 2024
  2. Study start2 Dec 2024 (estimated)
  3. Primary completion16 Mar 2025 (estimated)
  4. Study completion18 May 2025 (estimated)

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
Model description
Four groups, together with a control group with no intervention. One group will receive pneumatic pressure treatment, one group will receive soft tissue mobilisation (graston) treatment and another group will receive percussive therapy treatment.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06634862
Sponsor's protocol ID
OU-FTR-MBY-01
Status last verified
Oct 2024
First submitted
8 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: When the study is finalised, researchers who want to use my data can send me an e-mail and use my data.

Publications

  • Stedge HL, Armstrong K. The Effects of Intermittent Pneumatic Compression on the Reduction of Exercise-Induced Muscle Damage in Endurance Athletes: A Critically Appraised Topic. J Sport Rehabil. 2021 Jan 8;30(4):668-671. doi: 10.1123/jsr.2020-0364.

    PubMed 33418535
  • Machado AF, Ferreira PH, Micheletti JK, de Almeida AC, Lemes IR, Vanderlei FM, Netto Junior J, Pastre CM. Can Water Temperature and Immersion Time Influence the Effect of Cold Water Immersion on Muscle Soreness? A Systematic Review and Meta-Analysis. Sports Med. 2016 Apr;46(4):503-14. doi: 10.1007/s40279-015-0431-7.

    PubMed 26581833

Questions about this trial

What is this clinical trial studying?

A study testing Normatec Air Compression, Soft Tissue Mobilization and Percussive therapy in people with Recovery Method, run by Okan 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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?

Results are not available in the source record.

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

Contact Melis Beril Yazıcı (+905379778141, fzt.melisbyazici@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Star Balance Test (time frame: The balance test will take 10 minutes in total before and after the intervention.). The study lists 3 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 NCT06634862, 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 15 Oct 2024.

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