Physical Therapy Techniques for Pain

Overseen By Sherry Alexander

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida Gulf Coast University

Disqualifiers: Concussion, Traumatic brain injury, Stroke, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different physical therapy methods affect brainwave patterns. Participants will undergo either joint manipulation (involving spinal or joint adjustments), exercise routines like yoga and aerobics, or soft tissue massage. The goal is to determine how these treatments might alter brain activity and potentially ease pain. Suitable candidates for the manipulation group have not experienced thoracic spine pain or injuries in the past six months. For the exercise group, participants should be new to regular workouts and comfortable with moderate exercise sessions. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could lead to new pain management techniques.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking medications that affect bone health, you may not be eligible for the manipulation group.

What prior data suggests that these physical therapy techniques are safe for pain management?

Research shows that joint manipulation is generally safe, though some soreness may occur afterward. Serious problems are rare. Exercise is also safe for most people and may cause mild soreness, which typically resolves quickly. Exercise can help manage pain and is usually well-tolerated. Soft tissue massage is another safe option, relieving pain and discomfort without causing serious issues. Overall, these treatments are well-tolerated and carry a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these physical therapy techniques for pain because they explore different ways of addressing pain management beyond traditional medications like NSAIDs or opioids. Joint manipulation offers a unique approach by using Grade V-Thrust techniques, which may provide immediate relief through physical adjustment of specific joints. Exercise therapy, incorporating aerobic, anaerobic, and yoga exercises, focuses on strengthening and flexibility, potentially reducing pain through improved physical function. Soft tissue massage, particularly instrument-assisted techniques, aims to alleviate pain by enhancing blood flow and reducing muscle tension. These methods are noteworthy for their potential to manage pain without pharmaceuticals, offering alternative and holistic options for patients.

What evidence suggests that this trial's physical therapy techniques could be effective for pain?

Research has shown that joint manipulation, a treatment under study in this trial, can be as effective as other recommended treatments for spine pain. It often matches or surpasses other methods in reducing pain. Exercise, another treatment arm in this trial, has also proven effective in lowering pain levels. Many studies emphasize that an exercise routine can significantly reduce pain. Soft tissue massage, the third treatment option in this trial, particularly with special tools, has been reported to decrease pain and improve movement. Overall, these treatments hold promise for pain relief. ^{1 6 7 8 9}

Who Is on the Research Team?

Rob Sillevis

Principal Investigator

FGCU

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with no thoracic spine pain or injuries in the past 6 months. Participants should either be novice exercisers able to do a moderate workout for 15 minutes, or have healthy bones without conditions like osteoporosis. Those with a history of brain injury or central nervous system disorders cannot join.

Inclusion Criteria

I haven't had any upper back pain or injuries in the last 6 months.

You are new to exercising and don't exercise regularly. You can handle doing 15 minutes of moderate intensity exercises without any problems.

Exclusion Criteria

I do not have weak bones or any condition that affects my skeleton.

I have a history of brain injury or disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Resting Brainwave Activity Measurement

Identify typical resting brain wave activity in asymptomatic subjects using EEG

1 week

1 visit (in-person)

Physical Therapy Interventions

Subjects undergo physical therapy interventions including joint manipulation, exercise, and soft tissue massage, with brain wave response measured

2 weeks

3 visits (in-person)

Intervention in Symptomatic Subjects

Repeat measures and interventions in subjects experiencing pain, including FGCU college athletes with recent ankle sprains

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Joint Manipulation
• Soft tissue massage

Trial Overview

The study aims to observe changes in brainwave activity during physical therapy interventions such as joint manipulation, exercise, and soft tissue massage to identify any predictable patterns.

How Is the Trial Designed?

Group I: Soft tissue massage Experimental Treatment 3 Interventions

Instrument assisted soft tissue massage

Group II: Joint manipulation Experimental Treatment 3 Interventions

Grade V-Thrust manipulation with audible sound and without audible sounds of C1-C2, T7, MTP 2 and MCP2 joints.

Group III: Exercise Experimental Treatment 3 Interventions

Aerobic, anaerobic, and yoga exercises

Who Is Running the Clinical Trial?

Florida Gulf Coast University

Lead Sponsor

Trials

14

Recruited

690+

Published Research Related to This Trial

A scoping review of 98 studies revealed a lack of a common definition or classification system for adverse events following spinal and peripheral joint manipulation, which complicates patient safety efforts.

The review identified various descriptors for adverse events, such as causality and symptom severity, highlighting the need for a standardized approach to improve clarity and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. Funabashi, M., Gorrell, LM., Pohlman, KA., et al.[2022]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

A survey of 575 Italian physiotherapists revealed that most consider high-velocity low-amplitude spinal manipulation (SM) safe and effective for the thoracic (74.1%) and lumbar (72.2%) spines, but only 56.8% felt the same about the upper cervical spine.

Physiotherapists with knowledge of clinical prediction rules were more likely to feel comfortable performing SM and to view it as safe, while those without musculoskeletal specialization tended to be more cautious, especially regarding upper cervical SM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, beliefs, and attitudes of spinal manipulation: a cross-sectional survey of Italian physiotherapists. Mourad, F., Yousif, MS., Maselli, F., et al.[2022]

Cervical high-velocity low-amplitude (HVLA) manipulation significantly increases cervical range of motion and mouth opening, with a large effect size (d > 0.80), indicating its efficacy in improving mobility.

In patients with lateral epicondylalgia, cervical HVLA manipulation not only enhances pain-free handgrip strength but also appears to lower blood pressure in individuals with hypertension, suggesting potential cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cervical High-Velocity Low-Amplitude Techniques on Range of Motion, Strength Performance, and Cardiovascular Outcomes: A Review. Galindez-Ibarbengoetxea, X., Setuain, I., Andersen, LL., et al.[2017]

Moderate quality evidence from 19 trials indicates that a combination of mobilisation, manipulation, and soft tissue techniques significantly reduces pain and improves patient satisfaction for acute neck pain compared to short wave diathermy.

Low quality evidence suggests that mobilisation and manipulation can provide clinically important pain relief and improved function for chronic cervicogenic headaches, although no significant differences were found when combined with other physical medicine modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy with or without physical medicine modalities for neck pain: a systematic review. D'Sylva, J., Miller, J., Gross, A., et al.[2018]

A systematic review of 7 studies found no significant differences in pain improvement between spinal manipulation or mobilization and physical therapy or exercise for patients with neck pain.

The review indicated minimal differences in long-term outcomes such as disability and functional improvement, suggesting that both treatment approaches may be similarly effective for managing neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcomes of manipulation or mobilization therapy compared with physical therapy or exercise for neck pain: a systematic review. Schroeder, J., Kaplan, L., Fischer, DJ., et al.[2021]

Innovative physiotherapeutic methods, including joint mobilization and manipulation, are developed based on the latest research in tissue physiology and anatomy, enhancing manual therapy techniques.

Specialized methods for soft tissue treatment, such as muscle energy techniques and trigger point therapies, require tailored approaches that consider each patient's functional state for effective rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Special methods and techniques applied in orthopedic rehabilitation]. Retmański, A.[2022]

The field of animal rehabilitation is increasingly adopting manual therapy techniques that have been effective in human physical therapy, including range-of-motion exercises, soft tissue mobilization, and neuromuscular facilitation.

These manual therapy approaches are now commonly used in veterinary practice, with documented goals and effects, indicating a growing recognition of their benefits for animal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy in veterinary rehabilitation. Hesbach, AL.[2016]

High velocity low amplitude (HVLA) cervical manipulation techniques are effective in managing various musculoskeletal disorders, such as cervicalgia and shoulder pain, by influencing pain modulation, mobility, and strength in both the treated area and surrounding regions.

While HVLA techniques show promise, especially for those with musculoskeletal issues, their impact on strength in healthy individuals remains unclear, and there are potential risks associated with their use, although complications are rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of High Velocity Low Amplitude Cervical Manipulations on the Musculoskeletal System: Literature Review. Giacalone, A., Febbi, M., Magnifica, F., et al.[2020]

Cervical manipulation and mobilization techniques for neck pain are generally effective but can be associated with rare serious adverse events, as highlighted by a review of studies from 1998 to 2009.

The review found that while 17 out of 76 studies reported no major adverse events, minor adverse events like transient neurological symptoms and increased neck pain were noted, indicating a need for better reporting of adverse events in manual therapy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Carlesso, LC., Gross, AR., Santaguida, PL., et al.[2022]

The study aimed to test a combined therapeutic approach for neck pain, involving spinal manipulation techniques, and involved 6 patients over 6 weeks, with 5 out of 6 showing improvement on the Neck Disability Index.

The trial highlighted the importance of thorough planning and training for conducting a randomized clinical trial, as well as the need for patient comfort, with 2 out of 5 patients reporting discomfort from the treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study assessing manual therapies to different regions of the spine for patients with subacute or chronic neck pain. Strunk, RG., Hondras, MA.[2023]

High-velocity low-amplitude thrust (HVLAT) manipulation and mobilization may have distinct neurophysiologic effects that are not solely dependent on the mechanical effects of joint cavitation, suggesting they should be evaluated as separate treatments.

The review discusses various hypotheses for how HVLAT manipulation works, including the release of synovial folds and the relaxation of hypertonic muscles, indicating that the mechanisms behind its efficacy are complex and multifaceted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms and effects of spinal high-velocity, low-amplitude thrust manipulation: previous theories. Evans, DW.[2022]

Manual therapy techniques, which involve skilled hand movements, can effectively improve tissue flexibility, increase range of motion, and reduce pain and inflammation in dogs, similar to their use in humans.

The article focuses on specific manual therapy techniques for various joints and areas in dogs, particularly highlighting the methods developed by Australian physical therapist G.D. Maitland, which have been clinically applied since the 1960s.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Joint mobilization. Saunders, DG., Walker, JR., Levine, D.[2005]

Preliminary evidence suggests that manual therapies, exercise, and acupuncture may be effective in managing certain types of musculoskeletal pain, although the quality of evidence from randomized clinical trials is limited.

Basic science research indicates that various physical therapy modalities could have therapeutic effects, but more high-quality clinical trials are needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological treatments for musculoskeletal pain. Wright, A., Sluka, KA.[2019]

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