Clinical trial NCT05033717: Effects of Tissue Flossing Technique for Bicipital Tendinitis
Official title: Effects of Tissue Flossing Technique Versus Static Stretching Exercises of Bicep Muscle on Pain, Range of Motion and Function in Athletes With Bicipital Tendinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bicipital Tendinitis
Keywords: Flossing
Flexibility
ROM
Prevention
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will be a Randomized control trial conducted to check the effects of tissue flossing technique versus static stretching exercises of bicep muscle on pain, range of motion and function in patients with bicipital tendinitis, so that we can have best treatment option for them. Duration will be of 6 months. Purposive sampling will be done. Subjects fulfilling eligibility criteria from Allied hospital Faisalabad, will be randomly allocated in two groups via lottery method. Baseline assessment will be done. Group A participants will be given baseline treatment along with tissue flossing. Group B participants will be given stretching exercises along with baseline treatment for two weeks, 3 sessions per week. Post intervention assessment will be done via, Numeric pain rating scale(NPRS),Shoulder Pain And Disability Index (SPADI) and goniometric measurements of shoulder ranges. Data will be analyzed by using SPSS version 20.

Detailed description: Inflammation of the bicep tendon is also known as "Bicipital Tendinitis" occurs most commonly in overhead athletes like racquet players, swimmers, gymnasts, tennis players, baseball pitchers, and rowing athletes. Tissue Flossing is a relatively novel practice that initially got recognition in weightlifting athletes. This technique has Japanese origin also known as the "Katsu Technique" or "Blood Flow Restriction technique" BFR. It works on the principle of optimizing the blood circulation to the muscles for fitness, early rehabilitation, and recovery within safe ranges.

The purpose of the current study is to determine the effects of the tissue flossing technique on the physical rehabilitation of bicipital tendinitis. It is a randomized controlled trial with the subjects having a history of bicipital tendinitis, shoulder pain, and recreational athletes with difficulty in overhead activities. Subjects with a history of neurological and psychological disorders, hypertension or heart diseases and with chronic arthritis will be excluded.

Participants will be randomly placed into experimental and control groups. The experimental group will receive bicep-strengthening exercises after flossing. The Control group will receive bicep-strengthening exercises after bicep-stretching exercises. The total duration of this study will be six months with an assessment performed at baseline, before and after the treatment sessions. Numeric Pain rating scale, Goniometer, and Shoulder Pain and Disability Index will be used to measure the outcomes. Data will be analyzed statistically by using parametric or non-parametric tests after the completion of this study.

Eligibility criteria: Inclusion Criteria:

* Bicep tendinitis with age 18 to 45 years
* Subjects with a history of repetitive overhead activities and pain in bicipital groove.
* Recent history of adhesive capsulitis.
* Chronic bicep weakness with history of recreational activities.
* Recreational athletes with history of pain and difficulty in overhead movements

Exclusion Criteria:

* Tumors of joint or bone.
* latex allergy
* Hypertension (i.e., resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg)
* Venous thrombotic disease
* Heart disease
* Respiratory disease;
* Dermatitis
* Psychiatric condition e.g depression,
* Recent history of shoulder fracture or humerus fracture.
* Rheumatoid arthritis.
* Osteoarthritis.
* Hyper-laxity of shoulder joint.
* Instability of shoulder
* Neuromuscular disorder
* Inflammatory disorder

Primary outcomes:
measure: Numeric pain rating scale
timeFrame: 2nd Week
measure: Shoulder pain and disability index
timeFrame: 2nd Week
measure: Goniometer
timeFrame: 2nd Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Allied hospital Faisalabad, Pakistan
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil Ur Rehman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Care IP, Renee Yacoub C. REHABILITATION FOLLOWING BICEPS BRACHII AND SUPRASPINATUS TENDINOPATHIES IN A 5-YEAR-OLD HAVANESE. 2019.
citation: Driller MW, Overmayer RG. The effects of tissue flossing on ankle range of motion and jump performance. Phys Ther Sport. 2017 May;25:20-24. doi: 10.1016/j.ptsp.2016.12.004. Epub 2016 Dec 12.
citation: 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.
citation: 6. Kiefer BN, Lemarr KE, Enriquez CC, Tivener KA, Daniel T. A pilot study: perceptual effects of the voodoo floss band on glenohumeral flexibility. International Journal of Athletic Therapy and Training. 2017;22(4):29-33.
citation: Borda J, Selhorst M. The use of compression tack and flossing along with lacrosse ball massage to treat chronic Achilles tendinopathy in an adolescent athlete: a case report. J Man Manip Ther. 2017 Feb;25(1):57-61. doi: 10.1080/10669817.2016.1159403. Epub 2016 May 30.
citation: Ekeberg OM, Bautz-Holter E, Keller A, Tveita EK, Juel NG, Brox JI. A questionnaire found disease-specific WORC index is not more responsive than SPADI and OSS in rotator cuff disease. J Clin Epidemiol. 2010 May;63(5):575-84. doi: 10.1016/j.jclinepi.2009.07.012.
citation: Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.
citation: 5. Parish E. Joint and Muscle Flossing.