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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if KT Tape can reduce pain and disability in children with collarbone fractures more effectively than a traditional arm sling. The focus is on whether this elastic tape, known for muscle support, can stabilize fractures better than a sling. Children who sustained a collarbone fracture within the last week may qualify for this trial. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for improved recovery.

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 prior data suggests that KT Tape is safe for treating clavicle fractures in children?

Research shows that kinesiology tape, such as KT Tape, is generally safe to use. Past studies found no side effects like skin irritation or redness. This tape primarily aids muscle problems rather than directly addressing broken bones, but it effectively reduces pain and improves comfort for various injuries.

KT Tape is drug-free, introducing no chemicals into the body, which makes it a low-risk choice for many. Studies have shown that it can help manage pain and speed up recovery in different situations.

Overall, KT Tape appears well-tolerated with few side effects, making it a promising option for managing pain and discomfort from collarbone fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

KT Tape is unique because it offers a non-invasive, flexible alternative to the traditional arm sling for collarbone fractures. Unlike slings, which immobilize the arm, KT Tape provides support while allowing for some movement, potentially aiding in more comfortable healing and maintaining muscle strength. Researchers are excited about KT Tape because it might improve patient comfort and mobility during recovery, which is a significant benefit over the standard immobilization approach.

What evidence suggests that KT Tape is effective for clavicle fractures?

Research has shown that kinesiology tape (KT tape) can help manage pain and speed recovery for people with broken collarbones. In this trial, participants will join either the KT Tape Group or the Arm Sling Group. KT tape often leads to better healing and helps individuals return to their usual activities more quickly. Studies have found that KT tape improves bone healing. Additionally, KT tape is more comfortable and causes less skin irritation than other methods, making it a promising option for reducing pain and disability in children with collarbone fractures. ^{1 6 7 8 9}

Who Is on the Research Team?

Shawn R Gilbert, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12333271/

Beyond the splint: efficacy and safety of kinesio taping for ... KT emerged as the most effective modality, offering enhanced patient comfort, superior pain management, and accelerated functional recovery in ...

2. actaorthopaedica.be actaorthopaedica.be/assets/3219/18-Dedeoglu_Bukars.pdf

Kinesiotaping therapy for midshaft clavicular fractures Compared with an arm sling only, an arm sling with kinesiotaping can yield better clinical functional results, higher union rates, and a shorter the time to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35512165/

Kinesiotaping therapy for midshaft clavicular fractures An arm sling with kinesiotaping can yield better clinical functional results, higher union rates, and a shorter the time to return to work due to the early ...

4. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/trial/47952

Conservative treatment of clavicular fractures with kinesio ... The aim of our study is to investigate the effectiveness of kinesio tape in patients with clavicle fractures in comparison to the standard ...

5. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/22136-kinesiology-tape-a-descriptive-survey-of-healthcare-professionals-in-the-united-states

Kinesiology Tape: A Descriptive Survey of Healthcare ... The purpose of this study was to survey and document the beliefs and clinical application methods of KT among healthcare professionals in the United States.

6. youtube.com youtube.com/watch?v=S3Re_dty3Ko

RockTape - Kinesiology Tape Instruction - Collar Bone Here we'll detail the steps on applying Rock tape kinesiology tape to the collar bone. This application is simple and effective for reducing pain.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8169012/

Kinesiology Tape: A Descriptive Survey of Healthcare ... The purpose of this study was to survey and document the beliefs and clinical application methods of KT among healthcare professionals in the United States.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04622137

Kinesiotaping Therapy for Clavicular Fractures ... The investigators aimed to evaluate the effectiveness of the kinesiotaping technique for the conservative treatment of clavicle midshaft fractures. The ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675719307910

Kinesiotaping for isolated rib fractures in emergency ... Kinesiotape (KT) is a drug-free elastic therapeutic tape used for treating various musculoskeletal problems such as injury, dysfunction and pain. We aimed to ...