Effects of Tissue Flossing Technique for Bicipital Tendinitis

January 3, 2022 updated by: Riphah International University

Effects of Tissue Flossing Technique Versus Static Stretching Exercises of Bicep Muscle on Pain, Range of Motion and Function in Athletes With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan
        • Allied hospital Faisalabad, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Tissue Flossing Technique
Other: Tissue Flossing Technique

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.
Active Comparator: Group B
Static Stretching exercises
Other: Static Stretching Technique

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2nd Week
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.
2nd Week
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
2nd Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC//0413 Aroofa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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