Lateral Elbow TendinopathyNCT06369701
Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members
A study testing Compressive tissue floss band in people with Lateral Elbow Tendinopathy, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Elbow Tendinopathy
- What is being tested?
- Compressive tissue floss band
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- United States military service members stationed at JBSA between the ages of 18 to 65
- Report of lateral elbow pain
- Can perform either a modified push-up or push-up for 1 minute.
Who cannot join
- Under 18 years old or over 65 years old
- Recent surgical treatment of the involved upper extremity
- Current fracture of the involved upper extremity
- Open wounds at the treatment area
- History of skin diseases
- Tumors at the treatment area
Show all 19Show fewer
- History of a peripheral vascular condition
- History of chronic inflammatory processes
- Latex allergy
- History of varicose veins
- History of vein inflammation
- History of thrombosis
- Diagnosed with diabetes
- Diagnosed with cardiac insufficiency Stage C or D
- Diagnosed with lymphedema
- Currently taking blood thinners
- Currently receiving high-dose corticosteroids
- Currently receiving other therapy for the elbow pain
- Presently diagnosed with cervical radiculopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: The Effects of a Compressive Tissue Flossing Program on the Symptoms of Lateral Elbow Tendinopathy in United States Service Members
The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements.
Read the detailed description
The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. I hypothesize that tissue flossing with a band for a 2-minute session daily will decrease patient's report of pain on the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements. If this method is shown to acutely decrease the symptoms of LET, it would give occupational therapists a potential home exercise program that is easy to initiate and only takes 2 minutes per day for patients to perform. This could prove to be an effective and low-cost method for service members to treat elbow pain symptoms. This technique could be used in austere environments where traditional musculoskeletal rehabilitation may not be available.
Specific Aim 1: Assess the acute effects of compressive tissue flossing on the symptoms of lateral elbow tendinopathy in United States service members.
I will accomplish this by recording the patient's report of pain on the Defense and Veteran's Pain Rating Scale, their Patient-Rated Tennis Elbow Evaluation outcome measure score, and their maximal grip strength in the affected UE before CTF, immediately after CTF, and at the 1-week follow-up after completing tissue flossing daily for 2 minutes. I will compare the outcomes from each measurement to evaluate the effects of CTF on lateral elbow pain symptoms.
- Conditions
- Lateral Elbow Tendinopathy
- Being tested
- Compressive tissue floss band
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressive tissue floss bandDevice
Compressive tissue flossing (CTF) is a compressive technique that uses a latex elastic band to compress the tissues and restrict the circulation of fluids in the targeted area for a short time. CTF acts on the mechanoreceptors in the underlying fascial layers, causing blood reperfusion of the compressed tissue, and/or causing fascial shearing and the sliding potential of the fascia to be restored (Starrett \& Cordoza, 2015). Proposed benefits from references include improving joint mobility in the joints of the limbs (Starrett \& Cordoza, 2015), improving muscular power, and decreasing pain with motion (Angelopoulos et al., 2021) (Cage et al., 2022) (Jianhong et al., 2021).
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's report of pain on the Defense and Veteran's Pain Rating Scale
This pain scale assesses the participant's perceived pain on a scale from 0-10. ) being no pain and 10 being as bad as the pain could possibly be. A participant rating their pain lower post-intervention would indicate a positive outcome.
Measured: 1 week
Patient-Rated Tennis Elbow Evaluation
Minimum value is 0 and maximum value is 100. 0 indicates that lateral elbow pain has no effect on the participant, whereas an increased score indicates the participant's lateral elbow pain has an increased effect on ability to perform activities and a worse outcome.
Measured: 1 week
Maximal grip strength in the affected upper extremity
Maximal grip strength will be recorded by the participant squeezing a calibrated dynamometer, which is a measurement tool used to calculate grip strength in pounds per square inch. The amount of grip strength generated in pounds per square inch in the affected upper extremity will be compared to maximal grip strength after the intervention is implemented day 1 and after 1 week.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start13 Feb 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Lateral Elbow TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subjects repeated measures design
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, John Edgar Elam, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369701
- Sponsor's protocol ID
- C.2024.019
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angelopoulos P, Mylonas K, Tsepis E, Billis E, Vaitsis N, Fousekis K. The Effects of Instrument-Assisted Soft Tissue Mobilization, Tissue Flossing, and Kinesiology Taping on Shoulder Functional Capacities in Amateur Athletes. J Sport Rehabil. 2021 Apr 9;30(7):1028-1037. doi: 10.1123/jsr.2020-0200.
PubMed 33837162Arce-Esquivel, A., Cage, S., J Warner, B., & Stevenson, P. (2018). Flossing bands to treat Keinböck's disease in a collegiate men's basketball player: A case report. International Physical Medicine & Rehabilitation Journal, 3(2). https://doi.org/10.15406/ipmrj.2018.03.00096
Buckenmaier CC 3rd, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Pain Med. 2013 Jan;14(1):110-23. doi: 10.1111/j.1526-4637.2012.01516.x. Epub 2012 Nov 8.
PubMed 23137169Cage, S. A., Warner, B. J., Gallegos, D. M., Stevenson, P., & Arce-Esquivel, A. A. (2022). Effect of flossing bands on pain and perceived level of function in collegiate baseball pitchers. Journal of Advances in Sports and Physical Education, 5(6), 115-118. https://doi.org/10.36348/jaspe.2022.v05i06.001
Cheatham SW, Baker R. Quantification of the Rockfloss(R) Floss Band Stretch Force at Different Elongation Lengths. J Sport Rehabil. 2020 Mar 1;29(3):377-380. doi: 10.1123/jsr.2019-0034.
PubMed 31094647Escolar-Reina P, Medina-Mirapeix F, Gascon-Canovas JJ, Montilla-Herrador J, Jimeno-Serrano FJ, de Oliveira Sousa SL, del Bano-Aledo ME, Lomas-Vega R. How do care-provider and home exercise program characteristics affect patient adherence in chronic neck and back pain: a qualitative study. BMC Health Serv Res. 2010 Mar 10;10:60. doi: 10.1186/1472-6963-10-60.
PubMed 20219095Fenwick SA, Hazleman BL, Riley GP. The vasculature and its role in the damaged and healing tendon. Arthritis Res. 2002;4(4):252-60. doi: 10.1186/ar416. Epub 2002 Feb 13.
PubMed 12106496Figueiredo, I. M., Sampaio, R. F., Mancini, M. C., Silva, F. C., & Souza, M. A. (2007). Test of grip strength using the Jamar dynamometer. Acta Fisiátrica, 14(2). https://doi.org/10.5935/0104-7795.20070002
Galis J, Cooper DJ. Application of a Floss Band at Differing Pressure Levels: Effects at the Ankle Joint. J Strength Cond Res. 2022 Sep 1;36(9):2454-2460. doi: 10.1519/JSC.0000000000003833. Epub 2020 Oct 8.
PubMed 33038093Jianhong, G., Soon, C. C., Seng, T. J., Zaremohzzabieh, Z., & Samsudin, S. (2021). The effect of tissue flossing technique on sports and injury prevention and rehabilitation: A systematic review of recent research. International Journal of Human Movement and Sports Sciences, 9(6), 1157-1173. https://doi.org/10.13189/saj.2021.090611
Kaneda H, Takahira N, Tsuda K, Tozaki K, Kudo S, Takahashi Y, Sasaki S, Kenmoku T. Effects of Tissue Flossing and Dynamic Stretching on Hamstring Muscles Function. J Sports Sci Med. 2020 Nov 19;19(4):681-689. eCollection 2020 Dec.
PubMed 33239941Kaneda, H., Takahira, N., Tsuda, K., Tozaki, K., Sakai, K.. (2020b) 'The effects of tissue flossing and static stretching on gastrocnemius exertion and flexibility', Isokinetics and Exercise Science, 28(2), pp. 205-213. https://doi.org/10.3233/IES-192235
Kiefer, B. N., Lemarr, K. E., Enriquez, C. C., Tivener, K. A., & Daniel, T. (2017). A pilot study: Perceptual effects of the voodoo floss band on glenohumeral flexibility. International Journal of Athletic Therapy & Training, 22(4), 29-33.
Kelly CF, Oliveri Z, Saladino J, Senatore J, Kamat A, Zarour J, Douris PC. The Acute Effect of Tissue Flossing on Pain, Function, and Perception of Movement: A Pilot Study. Int J Exerc Sci. 2023 Jul 1;16(3):855-865. doi: 10.70252/OKAO5505. eCollection 2023.
PubMed 37637031Konrad A, Mocnik R, Nakamura M. Effects of Tissue Flossing on the Healthy and Impaired Musculoskeletal System: A Scoping Review. Front Physiol. 2021 May 21;12:666129. doi: 10.3389/fphys.2021.666129. eCollection 2021.
PubMed 34093228
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Compressive Tissue Flossing Program on the Symptoms of Lateral Elbow Tendinopathy in United States Service Members
- ClinicalTrials.gov ID
- NCT06369701
- Acronym / sponsor ID
- C.2024.019
- Conditions
- Lateral Elbow Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements.
Detailed description
The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. I hypothesize that tissue flossing with a band for a 2-minute session daily will decrease patient's report of pain on the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements. If this method is shown to acutely decrease the symptoms of LET, it would give occupational therapists a potential home exercise program that is easy to initiate and only takes 2 minutes per day for patients to perform. This could prove to be an effective and low-cost method for service members to treat elbow pain symptoms. This technique could be used in austere environments where traditional musculoskeletal rehabilitation may not be available.
Specific Aim 1: Assess the acute effects of compressive tissue flossing on the symptoms of lateral elbow tendinopathy in United States service members.
I will accomplish this by recording the patient's report of pain on the Defense and Veteran's Pain Rating Scale, their Patient-Rated Tennis Elbow Evaluation outcome measure score, and their maximal grip strength in the affected UE before CTF, immediately after CTF, and at the 1-week follow-up after completing tissue flossing daily for 2 minutes. I will compare the outcomes from each measurement to evaluate the effects of CTF on lateral elbow pain symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Within-subjects repeated measures design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- United States military service members stationed at JBSA between the ages of 18 to 65
- Report of lateral elbow pain
- Can perform either a modified push-up or push-up for 1 minute.
Key exclusion criteria (19 listed)
- Under 18 years old or over 65 years old
- Recent surgical treatment of the involved upper extremity
- Current fracture of the involved upper extremity
- Open wounds at the treatment area
- History of skin diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compressive tissue floss bandCompressive tissue flossing (CTF) is a compressive technique that uses a latex elastic band to compress the tissues and restrict the circulation of fluids in the targeted area for a short time. CTF acts on the mechanoreceptors in the underlying fascial layers, causing blood reperfusion of the compressed tissue, and/or causing fascial shearing and the sliding potential of the fascia to be restored (Starrett \& Cordoza, 2015). Proposed benefits from references include improving joint mobility in the joints of the limbs (Starrett \& Cordoza, 2015), improving muscular power, and decreasing pain with motion (Angelopoulos et al., 2021) (Cage et al., 2022) (Jianhong et al., 2021). | Device | – |
Primary outcome
Patient's report of pain on the Defense and Veteran's Pain Rating Scale
Time frame: 1 week
This pain scale assesses the participant's perceived pain on a scale from 0-10. ) being no pain and 10 being as bad as the pain could possibly be. A participant rating their pain lower post-intervention would indicate a positive outcome.
Patient-Rated Tennis Elbow Evaluation
Time frame: 1 week
Minimum value is 0 and maximum value is 100. 0 indicates that lateral elbow pain has no effect on the participant, whereas an increased score indicates the participant's lateral elbow pain has an increased effect on ability to perform activities and a worse outcome.
Maximal grip strength in the affected upper extremity
Time frame: 1 week
Maximal grip strength will be recorded by the participant squeezing a calibrated dynamometer, which is a measurement tool used to calculate grip strength in pounds per square inch. The amount of grip strength generated in pounds per square inch in the affected upper extremity will be compared to maximal grip strength after the intervention is implemented day 1 and after 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 33837162Angelopoulos P, Mylonas K, Tsepis E, Billis E, Vaitsis N, Fousekis K. The Effects of Instrument-Assisted Soft Tissue Mobilization, Tissue Flossing, and Kinesiology Taping on Shoulder Functional Capacities in Amateur Athletes. J Sport Rehabil. 2021 Apr 9;30(7):1028-1037. doi: 10.1123/jsr.2020-0200.
- BackgroundArce-Esquivel, A., Cage, S., J Warner, B., & Stevenson, P. (2018). Flossing bands to treat Keinböck's disease in a collegiate men's basketball player: A case report. International Physical Medicine & Rehabilitation Journal, 3(2). https://doi.org/10.15406/ipmrj.2018.03.00096
- Background: PubMed 23137169Buckenmaier CC 3rd, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Pain Med. 2013 Jan;14(1):110-23. doi: 10.1111/j.1526-4637.2012.01516.x. Epub 2012 Nov 8.
- BackgroundCage, S. A., Warner, B. J., Gallegos, D. M., Stevenson, P., & Arce-Esquivel, A. A. (2022). Effect of flossing bands on pain and perceived level of function in collegiate baseball pitchers. Journal of Advances in Sports and Physical Education, 5(6), 115-118. https://doi.org/10.36348/jaspe.2022.v05i06.001
- Background: PubMed 31094647Cheatham SW, Baker R. Quantification of the Rockfloss(R) Floss Band Stretch Force at Different Elongation Lengths. J Sport Rehabil. 2020 Mar 1;29(3):377-380. doi: 10.1123/jsr.2019-0034.
- Background: PubMed 20219095Escolar-Reina P, Medina-Mirapeix F, Gascon-Canovas JJ, Montilla-Herrador J, Jimeno-Serrano FJ, de Oliveira Sousa SL, del Bano-Aledo ME, Lomas-Vega R. How do care-provider and home exercise program characteristics affect patient adherence in chronic neck and back pain: a qualitative study. BMC Health Serv Res. 2010 Mar 10;10:60. doi: 10.1186/1472-6963-10-60.
- Background: PubMed 12106496Fenwick SA, Hazleman BL, Riley GP. The vasculature and its role in the damaged and healing tendon. Arthritis Res. 2002;4(4):252-60. doi: 10.1186/ar416. Epub 2002 Feb 13.
- BackgroundFigueiredo, I. M., Sampaio, R. F., Mancini, M. C., Silva, F. C., & Souza, M. A. (2007). Test of grip strength using the Jamar dynamometer. Acta Fisiátrica, 14(2). https://doi.org/10.5935/0104-7795.20070002
- Background: PubMed 33038093Galis J, Cooper DJ. Application of a Floss Band at Differing Pressure Levels: Effects at the Ankle Joint. J Strength Cond Res. 2022 Sep 1;36(9):2454-2460. doi: 10.1519/JSC.0000000000003833. Epub 2020 Oct 8.
- BackgroundJianhong, G., Soon, C. C., Seng, T. J., Zaremohzzabieh, Z., & Samsudin, S. (2021). The effect of tissue flossing technique on sports and injury prevention and rehabilitation: A systematic review of recent research. International Journal of Human Movement and Sports Sciences, 9(6), 1157-1173. https://doi.org/10.13189/saj.2021.090611
- Background: PubMed 33239941Kaneda H, Takahira N, Tsuda K, Tozaki K, Kudo S, Takahashi Y, Sasaki S, Kenmoku T. Effects of Tissue Flossing and Dynamic Stretching on Hamstring Muscles Function. J Sports Sci Med. 2020 Nov 19;19(4):681-689. eCollection 2020 Dec.
- BackgroundKaneda, H., Takahira, N., Tsuda, K., Tozaki, K., Sakai, K.. (2020b) 'The effects of tissue flossing and static stretching on gastrocnemius exertion and flexibility', Isokinetics and Exercise Science, 28(2), pp. 205-213. https://doi.org/10.3233/IES-192235
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compressive tissue floss band in people with Lateral Elbow Tendinopathy, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's report of pain on the Defense and Veteran's Pain Rating Scale (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369701, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.