KT Tape for Collarbone Fractures

Overseen By Alice Pennington, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Neuromuscular disorder, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling. There have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment KT Tape for Collarbone Fractures?

Research on Kinesio Taping (KT) shows it is used in physical therapy to help with pain and swelling in conditions like shoulder pain and after knee surgery, but there is no strong evidence proving its benefits. This suggests it might help with collarbone fractures, but more specific research is needed. ^{1 2 3 4 5}

Is KT Tape safe for use in humans?

KT Tape is generally considered safe for use in humans as it is a drug-free, elastic, adhesive tape made from cotton and is latex-free. It has been used in various studies for conditions like rotator cuff disease, ACL reconstruction, and rib fractures without reports of significant safety concerns. ^{1 3 5 6 7}

How does KT Tape treatment differ from other treatments for collarbone fractures?

KT Tape is unique because it is a drug-free, elastic, adhesive tape made from cotton that is used to support and stabilize injuries without restricting movement. Unlike other treatments that may involve medication or immobilization, KT Tape aims to reduce pain and improve circulation through its application. ^{3 5 6 7 8}

Research Team

Shawn R Gilbert, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for children with recent clavicle fractures (within a week of injury). They must be able to report their pain levels throughout the healing process. Children with conditions like osteogenesis imperfecta or those who can't communicate their pain are not eligible.

Inclusion Criteria

I have a broken collarbone.

My injury happened less than a week ago.

Exclusion Criteria

I cannot or will not report my pain levels until I am healed.

You have a pre-existing condition affecting your muscles or nerves, such as osteogenesis imperfecta.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either KT Tape or an arm sling for clavicle fracture management

3 weeks

Daily monitoring for pain and analgesic use

Follow-up

Participants are monitored for pain, analgesic use, and disability 6 weeks after the initial injury

1 week

1 visit (in-person)

Treatment Details

Interventions

• Arm Sling
• KT Tape

Trial Overview The study is testing if KT Tape, an elastic tape used for muscle support, can help reduce pain and disability better than the traditional arm sling in kids with broken collarbones.

Participant Groups

Group I: KT Tape Group Experimental Treatment 2 Interventions

Group II: Arm Sling Group Active Control 1 Intervention

KT Tape is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as KT Tape for:

• Muscle support
• Joint stability
• Pain relief

Approved in European Union as Kinesio Tape for:

• Muscle support
• Joint stability
• Pain relief

Approved in Canada as RockTape for:

• Muscle support
• Joint stability
• Pain relief

Approved in Japan as KT Tape for:

• Muscle support
• Joint stability
• Pain relief

Approved in China as Kinesio Tape for:

• Muscle support
• Joint stability
• Pain relief

Approved in Switzerland as KT Tape for:

• Muscle support
• Joint stability
• Pain relief

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

In a study of 52 male patients aged 18 to 45 who underwent ACL reconstruction, Kinesio Taping (KT) combined with standard rehabilitation significantly reduced pain and edema during the early recovery phase compared to standard rehabilitation alone.

While KT showed benefits in pain and edema reduction at the second week and continued to show significant edema reduction at four weeks, other recovery measures did not differ significantly between the groups, suggesting further research is needed to explore KT's effects on muscle activation and strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of Kinesio Taping in improving pain and edema during early rehabilitation after Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized, Control Study. Labianca, L., Andreozzi, V., Princi, G., et al.[2023]

Kinesiology taping (KT) combined with conservative treatments significantly improves disability and range of motion in individuals with shoulder pain, with large effect sizes of -1.35 for disability and 0.96 for range of motion based on a systematic review of 10 studies.

Despite the positive outcomes, only two of the studies demonstrated good treatment fidelity, indicating that the consistency of KT application may affect the reliability of the results and should be considered when interpreting the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Treatment Fidelity of Kinesiology Taping in Conjunction With Conservative Treatment Interventions Among Individuals With Shoulder Pain: A Systematic Review with Meta-Analysis. Salamh, PA., Hanney, WJ., Cory, CS., et al.[2023]

In a study involving 45 patients with neck pain, Kinesio taping (KT) did not provide additional benefits over conventional rehabilitation methods, as all groups showed similar improvements in pain and neck mobility.

While all treatment groups, including KT, placebo, and conventional rehabilitation, experienced significant increases in neck flexion, there were no significant differences between the groups, indicating that KT may not be necessary for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of kinesio taping in addition to conventional rehabilitation treatment on pain, cervical range of motion and quality of life in patients with neck pain: A randomized controlled trial. Puerma-Castillo, MC., García-Ríos, MC., Pérez-Gómez, ME., et al.[2018]

Kinesio taping (KT) significantly reduced edema and increased pain threshold in patients after anterior cruciate ligament (ACL) reconstruction, with notable improvements observed on the 7th and 14th postoperative days compared to a control group.

The intervention group showed edema levels returning to preoperative measurements by the 14th day, while the control group did not experience similar benefits, highlighting KT's potential effectiveness in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of kinesio-taping on the acute phase of the post-operative reconstruction of the anterior cruciate ligament: A randomized controlled trial. Valladares, JR., Carvalho, LC., Yanagihara, GR., et al.[2023]

Kinesio Taping (KT) shows uncertain effects on pain, function, and range of motion in adults with rotator cuff disease, based on a systematic review of 23 trials involving 1054 participants, indicating little to no benefit compared to sham taping or conservative treatments.

However, there is low-certainty evidence suggesting that KT may improve quality of life compared to conservative treatments, with a notable improvement in quality of life scores observed in one study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinesio taping for rotator cuff disease. Gianola, S., Iannicelli, V., Fascio, E., et al.[2023]

In a study involving 30 patients with isolated rib fractures, kinesiotaping combined with NSAID therapy (flurbiprofen) significantly reduced pain more effectively than NSAID therapy alone after 4 days.

Both treatment groups showed a reduction in pain intensity, but kinesiotaping demonstrated superior efficacy, suggesting it is a safe and effective adjunct treatment for rib fractures in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinesiotaping for isolated rib fractures in emergency department. Akça, AH., Şaşmaz, Mİ., Kaplan, Ş.[2023]

In a study of 60 patients who underwent ACL reconstruction, Kinesio-Taping (K-Tape) did not significantly reduce early postoperative pain compared to a control group, with pain levels being similar in both groups.

The study found no significant differences in other postoperative discomfort measures or patient satisfaction, indicating that K-Tape may not be an effective intervention for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inefficacy of Kinesio-Taping(®) on early postoperative pain after ACL reconstruction: Prospective comparative study. Laborie, M., Klouche, S., Herman, S., et al.[2018]

Kinesio taping (KT) showed significant short-term improvements in pain and range of motion for patients with acute whiplash-associated disorders, but long-term outcomes were similar to those without KT.

Overall, the systematic review found insufficient evidence to support the effectiveness of KT for most musculoskeletal injuries, highlighting a need for more high-quality studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Mostafavifar, M., Wertz, J., Borchers, J.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The effectiveness of Kinesio Taping in improving pain and edema during early rehabilitation after Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized, Control Study. [2023]

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

The Efficacy and Treatment Fidelity of Kinesiology Taping in Conjunction With Conservative Treatment Interventions Among Individuals With Shoulder Pain: A Systematic Review with Meta-Analysis. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of kinesio taping in addition to conventional rehabilitation treatment on pain, cervical range of motion and quality of life in patients with neck pain: A randomized controlled trial. [2018]

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

Effect of kinesio-taping on the acute phase of the post-operative reconstruction of the anterior cruciate ligament: A randomized controlled trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Kinesio taping for rotator cuff disease. [2023]

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

Kinesiotaping for isolated rib fractures in emergency department. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Inefficacy of Kinesio-Taping(®) on early postoperative pain after ACL reconstruction: Prospective comparative study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. [2022]