NCT06369701

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 13, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

February 13, 2024

Last Update Submit

August 6, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1 week

Interventions

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).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (28)

  • 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.

    PMID: 33837162BACKGROUND
  • Arce-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
  • 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.

    PMID: 23137169BACKGROUND
  • Cage, 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
  • 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.

    PMID: 31094647BACKGROUND
  • Escolar-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.

    PMID: 20219095BACKGROUND
  • Fenwick 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.

    PMID: 12106496BACKGROUND
  • Figueiredo, 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
  • 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.

    PMID: 33038093BACKGROUND
  • Jianhong, 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
  • 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.

    PMID: 33239941BACKGROUND
  • Kaneda, 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 37637031BACKGROUND
  • Konrad 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.

    PMID: 34093228BACKGROUND
  • Lai WC, Erickson BJ, Mlynarek RA, Wang D. Chronic lateral epicondylitis: challenges and solutions. Open Access J Sports Med. 2018 Oct 30;9:243-251. doi: 10.2147/OAJSM.S160974. eCollection 2018.

    PMID: 30464656BACKGROUND
  • Nirschl RP, Pettrone FA. Tennis elbow. The surgical treatment of lateral epicondylitis. J Bone Joint Surg Am. 1979 Sep;61(6A):832-9.

    PMID: 479229BACKGROUND
  • Poltawski, L., & Watson, T. (2011). Measuring clinically important change with the patient-rated tennis elbow evaluation. Hand Therapy, 16(3), 52-57. https://doi.org/10.1258/ht.2011.011013

    BACKGROUND
  • Ross, S., & Kandassamy, G. (2017). The effects of tack and floss active joint mobilization on ankle dorsiflexion range of motion using voodoo floss bands. Journal of Physical Therapy. https://research.edgehill.ac.uk/en/publications/the-effects-of-tack-and-floss-active-joint-mobilisation-on-ankle--2

    BACKGROUND
  • Sanders TL, Maradit Kremers H, Bryan AJ, Ransom JE, Morrey BF. Health Care Utilization and Direct Medical Costs of Tennis Elbow: A Population-Based Study. Sports Health. 2016 Jul;8(4):355-8. doi: 10.1177/1941738116650389. Epub 2016 May 23.

    PMID: 27215568BACKGROUND
  • Shafiee E, MacDermid JC, Walton D, Vincent JI, Grewal R. Psychometric properties and cross-cultural adaptation of the Patient-Rated Tennis Elbow Evaluation (PRTEE); a systematic review and meta-analysis. Disabil Rehabil. 2022 Sep;44(19):5402-5417. doi: 10.1080/09638288.2021.1938248. Epub 2021 Jul 1.

    PMID: 34196231BACKGROUND
  • Smith-Forbes EV, Howell DM, Willoughby J, Armstrong H, Pitts DG, Uhl TL. Adherence of Individuals in Upper Extremity Rehabilitation: A Qualitative Study. Arch Phys Med Rehabil. 2016 Aug;97(8):1262-1268.e1. doi: 10.1016/j.apmr.2015.11.008. Epub 2015 Dec 15.

    PMID: 26702766BACKGROUND
  • Starrett, K., & Cordoza, G. (2015). Becoming a supple leopard: The ultimate guide to resolving pain, preventing injury, and optimizing athletic performance (2nd ed.). Las Vegas, Victory Belt Publishing Inc.

    BACKGROUND
  • Urits I, Markel M, Choi P, Vij N, Tran A, An D, Berger AA, Cornett E, Kaye AD, Viswanath O. Minimally invasive treatment of lateral epicondylitis. Best Pract Res Clin Anaesthesiol. 2020 Sep;34(3):583-602. doi: 10.1016/j.bpa.2020.08.004. Epub 2020 Aug 8.

    PMID: 33004169BACKGROUND
  • Vogrin M, Novak F, Licen T, Greiner N, Mikl S, Kalc M. Acute Effects of Tissue Flossing on Ankle Range of Motion and Tensiomyography Parameters. J Sport Rehabil. 2020 Apr 22;30(1):129-135. doi: 10.1123/jsr.2019-0160.

    PMID: 32320948BACKGROUND
  • Vrabie, D., Abalasei, B., & Iacob, G. (2021). Comparative study regarding the benefits of using medical flossing in lateral epicondylitis. Sport & Society. https://doi.org/10.36836/2021/2/41

    BACKGROUND
  • Wolf JM, Mountcastle S, Burks R, Sturdivant RX, Owens BD. Epidemiology of lateral and medial epicondylitis in a military population. Mil Med. 2010 May;175(5):336-9. doi: 10.7205/milmed-d-09-00086.

    PMID: 20486505BACKGROUND
  • Wu SY, Tsai YH, Wang YT, Chang WD, Lee CL, Kuo CA, Chang NJ. Acute Effects of Tissue Flossing Coupled with Functional Movements on Knee Range of Motion, Static Balance, in Single-Leg Hop Distance, and Landing Stabilization Performance in Female College Students. Int J Environ Res Public Health. 2022 Jan 27;19(3):1427. doi: 10.3390/ijerph19031427.

    PMID: 35162447BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within-subjects repeated measures design
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Army-Baylor Doctor of Science in Occupational Therapy Fellow

Study Record Dates

First Submitted

February 13, 2024

First Posted

April 17, 2024

Study Start

February 13, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations