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Completed

NCT Number: NCT05033717

Effects of Tissue Flossing Technique for Bicipital Tendinitis

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allied hospital Faisalabad, Pakistan

Faisalābad, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tissue Flossing Technique

Other

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.

Static Stretching Technique

Other

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 outcomes

  1. Numeric pain rating scale

    Time frame: 2nd Week

    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.

  2. Shoulder pain and disability index

    Time frame: 2nd Week

    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.

  3. Goniometer

    Time frame: 2nd Week

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2021
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.