Soft Tissue Manipulation for Soreness

(OptMeasSkin Trial)

Overseen By Matt Sinclair

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Migraine, Cardiovascular, Pulmonary, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how soft tissue manipulation (a type of gentle massage) affects back soreness. The study involves imaging skin movements while a clinician applies light touch and compression techniques. Participants will be divided into groups based on their level of muscle tightness, such as active, normal, or latent stiffness. This trial suits those experiencing non-vascular headaches with neck muscle issues, like tender spots or stiffness. As an unphased trial, participants contribute to foundational research that may lead to new therapeutic insights.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that soft tissue manipulation is safe?

Research has shown that soft tissue manipulation, like the kind used in this study, is generally safe. This type of physical therapy involves gently stretching and pressing on muscles and tissues to alleviate muscle soreness and tension.

Studies have found that most people tolerate soft tissue manipulation well. It helps relax muscles, improve blood flow, and break down scar tissue. Recipients of this treatment often feel better afterward and experience few, if any, side effects.

Solid evidence of serious negative effects from soft tissue manipulation is lacking. Most reported side effects are mild, such as temporary soreness or slight bruising. Overall, it is considered a low-risk treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about soft tissue manipulation for soreness because it offers a hands-on approach to directly address muscle stiffness, unlike traditional options like pain relievers or physical therapy exercises. What sets this technique apart is its focus on myofascial stiffness levels, specifically targeting active, normal, and latent stiffness through expert palpation. This personalized approach could lead to quicker and more effective relief by directly manipulating the affected tissues. By honing in on the precise areas of stiffness, this method could potentially provide a more immediate and lasting solution than conventional treatments.

What evidence suggests that soft tissue manipulation is effective for soreness?

This trial will evaluate the effects of soft tissue manipulation on various levels of myofascial stiffness. Research has shown that soft tissue massage can relieve muscle soreness and improve flexibility. Studies have found that these techniques can break down scar tissue and ease muscle tension. This treatment also boosts blood flow, aiding faster muscle recovery. People with conditions like myofascial pain have reported significant improvement after similar therapies. Overall, evidence suggests that soft tissue massage is a promising method to reduce soreness and muscle stiffness. ^{1 3 5 6 7}

Who Is on the Research Team?

Gregory Gerling, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This clinical trial is for individuals experiencing nociceptive pain or soreness, particularly in the back area. Participants should be comfortable with having their skin movements imaged and undergoing manual soft tissue manipulation by a clinician.

Inclusion Criteria

I have headaches due to neck muscle issues, but no serious illness.

I am an adult.

Exclusion Criteria

I have a known heart, lung, or metabolic condition.

I have conditions like arthritis or seizures that could cause back or neck pain.

I suffer from migraine headaches.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Assessment and Intervention

Participants undergo a series of assessments including demographic questionnaire, pain level rating, and manual clinical assessments followed by a massage intervention

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects post-intervention

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Soft tissue manipulation

Trial Overview The study is testing how imaging of skin surface movements can help identify differences in myofascial tissue stiffness during manual therapy interventions like stretching and compressing the soft tissues.

How Is the Trial Designed?

Group I: Manual therapy intervention Experimental Treatment 1 Intervention

Those participants with myofascial pain in the cervicothoracic region are assessed by manual palpation by a trained clinician.

Soft tissue manipulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Soft tissue mobilization for:

• Muscle injury
• Muscle spasm
• Contractures
• Carpal Tunnel Syndrome
• Arthritis
• Scar tissue
• Whiplash
• Fibromyalgia
• Sciatica

Approved in European Union as Soft tissue mobilization for:

• Muscle injury
• Muscle spasm
• Contractures
• Carpal Tunnel Syndrome
• Arthritis
• Scar tissue
• Whiplash
• Fibromyalgia
• Sciatica

Approved in Canada as Soft tissue mobilization for:

• Muscle injury
• Muscle spasm
• Contractures
• Carpal Tunnel Syndrome
• Arthritis
• Scar tissue
• Whiplash
• Fibromyalgia
• Sciatica

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

A survey of 853 health care professionals revealed that 83% use Instrument-assisted soft tissue mobilization (IASTM) in their practice, with most having significant experience (average of 15 years) and formal training (86%).

Despite the widespread use of IASTM, many practitioners (71%) reported uncertainty in quantifying the force applied during treatment, highlighting a need for better training and standardization to optimize treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Practice Patterns Among Health Care Professionals for Instrument-Assisted Soft Tissue Mobilization. Cheatham, SW., Baker, RT., Larkins, LW., et al.[2022]

A study involving 80 amateur overhead athletes showed that instrument-assisted soft tissue mobilization (IASTM), tissue flossing, and kinesiology taping all significantly improved shoulder strength and functional performance compared to control shoulders.

IASTM was particularly effective, leading to greater improvements in shoulder internal rotation compared to kinesiology taping immediately after treatment and 45 minutes later, indicating its potential as a preferred intervention for enhancing shoulder function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Instrument-Assisted Soft Tissue Mobilization, Tissue Flossing, and Kinesiology Taping on Shoulder Functional Capacities in Amateur Athletes. Angelopoulos, P., Mylonas, K., Tsepis, E., et al.[2022]

Instrument assisted soft-tissue mobilization (IASTM) is widely used in sports medicine, but there is currently no consensus on clinical standards for its application, including guidelines on indications, precautions, and tool hygiene.

There is a call for the development of best practice standards for IASTM, emphasizing the need for collaboration among sports medicine professionals and researchers to establish these guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INSTRUMENT ASSISTED SOFT-TISSUE MOBILIZATION: A COMMENTARY ON CLINICAL PRACTICE GUIDELINES FOR REHABILITATION PROFESSIONALS. Cheatham, SW., Baker, R., Kreiswirth, E.[2022]

The study involved 49 participants across two phases, where instrument assisted soft tissue techniques (IASTT) were applied to myofascial trigger points (MTrP) in the upper back, but results showed no significant difference in sensitivity improvement between the treatment and control groups.

The findings suggest that the pressure dolorimeter used for measuring MTrP sensitivity may have acted as a treatment itself, indicating that a different assessment method is needed to accurately evaluate the effectiveness of IASTT on MTrPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of instrument assisted soft tissue treatment techniques on myofascial trigger points. Gulick, DT.[2022]

A pilot study involving 10 IASTM-trained clinicians demonstrated that they could consistently apply similar forces during treatment sessions, regardless of their level of clinical experience, indicating reliable force application in IASTM interventions.

The study found that most clinicians maintained a mean force difference of less than 1N (100g) across sessions, with a Coefficient of Variation (CV) between 8 to 20%, suggesting that IASTM can be effectively standardized for therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Force Production Reliability across Different Levels of Clinical Experience during a Simulated One-handed Instrument-Assisted Soft Tissue Mobilization Treatment: A Pilot Study. Syeda, M., Bartholomew, J., Santiago, SV., et al.[2023]

A systematic review of 7 randomized controlled trials found that instrument assisted soft tissue mobilization (IASTM) showed no significant benefits for treating musculoskeletal pathologies compared to control groups, suggesting limited efficacy in this area.

However, IASTM was associated with significant short-term improvements in joint range of motion (ROM) within 24 hours, indicating it may be effective for enhancing flexibility immediately after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of instrument assisted soft tissue mobilization: a systematic review. Cheatham, SW., Lee, M., Cain, M., et al.[2022]

In a study involving 11 trained clinicians, the average peak force applied during Instrument-assisted Soft Tissue Mobilization (IASTM) was found to be 6.7 N, with individual forces ranging from 2.6 to 14.0 N, indicating a wide variability in force application among practitioners.

The forces measured in this study were comparable to previous research on IASTM treatments, suggesting that the force levels used by clinicians are clinically relevant and can inform future studies on the impact of IASTM on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instrument-Assisted Soft Tissue Mobilization Forces Applied by Trained Clinicians During a Simulated Treatment. Martonick, NJP., Reeves, AJ., Whitlock, JA., et al.[2022]

A systematic review of nine trials involving various participants found that instrument-assisted soft tissue mobilization (IASTM) did not show clinically important differences in improving pain, function, or range of motion compared to other treatments or placebo.

In trials comparing IASTM to no treatment, only one trial indicated small improvements in muscle performance, suggesting that IASTM may not be effective for individuals without extremity or spinal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Instrument-Assisted Soft Tissue Mobilization in Athletes, Participants Without Extremity or Spinal Conditions, and Individuals with Upper Extremity, Lower Extremity, and Spinal Conditions: A Systematic Review. Nazari, G., Bobos, P., MacDermid, JC., et al.[2022]

Citations

1. physio-pedia.com physio-pedia.com/Instrument_Assisted_Soft_Tissue_Mobilization

Instrument Assisted Soft Tissue Mobilization IASTM is a skilled myofascial intervention used for soft-tissue treatment. It is based on the principles of James Cyriax cross-friction massage.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5039777/

The efficacy of instrument assisted soft tissue mobilization Five studies measured the effects of IASTM on subjects with musculoskeletal pathology which included: lateral epicondylitis, carpel tunnel syndrome, myofascial ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1360859217303170

Instrument-assisted soft tissue mobilization increases ... A 5-min intervention using three IASTM techniques can effectively increase the PPT of a MTrP in six treatments over a three-week period of time.

4. touroscholar.touro.edu touroscholar.touro.edu/cgi/viewcontent.cgi?article=1052&context=chhs_pubs

An Analysis of Graston Technique® for Soft-Tissue Therapy The results from this meta-analysis suggest that patients show clinically significant improvement when the GT is combined with physical ...

5. barringtonortho.com barringtonortho.com/blog/how-to-use-manual-therapy-techniques-for-pain-relief

How to Use Manual Therapy Techniques for Pain Relief Soft Tissue Mobilization: A technique used to break down scar tissue, release tension, and improve blood circulation in the muscles and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6409241/

Astym® therapy: a systematic review - PMC This therapy was developed to address soft-tissue dysfunctions by stimulating the regeneration of soft tissues and the resorption of inappropriate scar tissue/ ...

7. media.lanecc.edu media.lanecc.edu/users/howardc/PTA101/101Massage/101Massage4.html

Types of Soft Tissue Mobilization/Manipulation Use of a variety of manual techniques to promote relaxation and general wellness, relieves stress; no identifiable health problem.