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

5 Participants Needed

Trial Summary

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 data supports the idea that Soft Tissue Manipulation for Soreness is an effective treatment?

The available research shows that Instrument-Assisted Soft Tissue Mobilization (IASTM), a form of Soft Tissue Manipulation, is used by healthcare professionals to treat muscle and joint issues. A systematic review found that IASTM can be effective for people with various conditions, including those affecting the arms, legs, and spine. However, the evidence is limited, and more research is needed to compare its effectiveness to other treatments like tissue flossing and kinesiology taping, which are also popular among athletes. ^{1 2 3 4 5}

What safety data exists for soft tissue manipulation treatments?

The provided research does not directly address safety data for soft tissue manipulation treatments. The studies focus on the reliability of force application, clinical practice patterns, and efficacy of instrument-assisted soft tissue mobilization (IASTM), but do not specifically evaluate safety outcomes or adverse effects. ^{1 2 5 6 7}

Is soft tissue manipulation a promising treatment for soreness?

Soft tissue manipulation, including techniques like IASTM and Graston Technique, is a popular treatment used by healthcare professionals to help with muscle pain and stiffness. It involves using tools to massage and loosen tight areas, which can improve movement and reduce discomfort. While it's widely used and has potential benefits, more research is needed to fully understand its effectiveness. ^{1 2 5 6 8}

What is the purpose of this trial?

This study involves imaging the skin movements of surface tissue on the back. A clinician will perform assessment and intervention procedures manually, using manual and light movements of stretch and compression.

Research Team

Gregory Gerling, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Normal myofascial stiffness Experimental Treatment 1 Intervention

Those participants with normal myofascial stiffness as assessed by palpation by a trained clinician.

Group II: Latent myofascial stiffness Experimental Treatment 1 Intervention

Those participants with latent myofascial stiffness as assessed by palpation by a trained clinician.

Group III: Active myofascial stiffness Experimental Treatment 1 Intervention

Those participants with active myofascial stiffness as assessed by 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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Instrument-Assisted Soft Tissue Mobilization Forces Applied by Trained Clinicians During a Simulated Treatment. [2022]

3. United States 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. [2022]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Practice Patterns Among Health Care Professionals for Instrument-Assisted Soft Tissue Mobilization. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

The efficacy of instrument assisted soft tissue mobilization: a systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

INSTRUMENT ASSISTED SOFT-TISSUE MOBILIZATION: A COMMENTARY ON CLINICAL PRACTICE GUIDELINES FOR REHABILITATION PROFESSIONALS. [2022]