Effects of Tissue Flossing Technique for Bicipital Tendinitis
Primary Purpose
Bicipital Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Tissue Flossing Technique
Static Stretching Technique
Sponsored by
About this trial
This is an interventional treatment trial for Bicipital Tendinitis focused on measuring Flossing, Flexibility, ROM, Prevention
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
Sites / Locations
- Allied hospital Faisalabad, Pakistan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Tissue Flossing Technique
Static Stretching exercises
Outcomes
Primary Outcome Measures
Numeric pain rating scale
The 11-point numerical pain rating scale (NPRS) is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain), and it has been shown to have concurrent and predictive validity as a measure of pain intensity.
Shoulder pain and disability index
A shoulder pain and disability index (SPADI) is used to measure the pain and disability associated with shoulder pathology. The SPADI is a self-administered index consisting of 13 items divided into two subscales: pain and disability. The SPADI is responsive to change and accurately discriminates among patients who are improved or worsened.
Goniometer
A goniometer is an instrument that measures the available range of motion at a joint. The term Goniometry is derived from two Greek words, gonia, meaning "angle" and metron, meaning "measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT05033717
First Posted
August 27, 2021
Last Updated
January 3, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05033717
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bicipital Tendinitis
Keywords
Flossing, Flexibility, ROM, Prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Tissue Flossing Technique
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Static Stretching exercises
Intervention Type
Other
Intervention Name(s)
Tissue Flossing Technique
Intervention Description
Subjects will receive tissue-flossing intervention on bicep muscle for 30 sec to 2 min with an occlusion pressure of 100 mmHg.
After removal of flossing, participants will perform bicep strengthening exercises at an intensity of 30% of 1 RM with 6-8 rep, 4 sets for a single day and 3 days per week for 2 weeks in total.
Intervention Type
Other
Intervention Name(s)
Static Stretching Technique
Intervention Description
Subjects will perform passive static stretching exercises of bicep muscle. Each stretch will last for 30 sec at 100% of stretch intensity with 4 reps for each, 1 set per day and 3 days per week for total duration of two weeks.
After the application of static stretch, participants will perform bicep strengthening exercises at an intensity of 30% of 1 RM with 6-8 reps, 4 sets for a single day and 3 days per week for 2 weeks in total.
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
The 11-point numerical pain rating scale (NPRS) is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain), and it has been shown to have concurrent and predictive validity as a measure of pain intensity.
Time Frame
2nd Week
Title
Shoulder pain and disability index
Description
A shoulder pain and disability index (SPADI) is used to measure the pain and disability associated with shoulder pathology. The SPADI is a self-administered index consisting of 13 items divided into two subscales: pain and disability. The SPADI is responsive to change and accurately discriminates among patients who are improved or worsened.
Time Frame
2nd Week
Title
Goniometer
Description
A goniometer is an instrument that measures the available range of motion at a joint. The term Goniometry is derived from two Greek words, gonia, meaning "angle" and metron, meaning "measurement
Time Frame
2nd Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allied hospital Faisalabad, Pakistan
City
Faisalābad
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
1. Care IP, Renee Yacoub C. REHABILITATION FOLLOWING BICEPS BRACHII AND SUPRASPINATUS TENDINOPATHIES IN A 5-YEAR-OLD HAVANESE. 2019.
Results Reference
background
PubMed Identifier
28254581
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.
Results Reference
background
PubMed Identifier
31094647
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
28855793
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.
Results Reference
background
PubMed Identifier
19836206
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.
Results Reference
background
PubMed Identifier
24828475
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.
Results Reference
background
Citation
5. Parish E. Joint and Muscle Flossing.
Results Reference
background
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Effects of Tissue Flossing Technique for Bicipital Tendinitis
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