Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis

October 18, 2020 updated by: AMIR IQBAL, King Saud University

Efficacy of Taping Technique in Addition to the Supervised Exercises Protocol on Pain and Functional Status in Individuals With Patello-femoral Arthritis

Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the large weight-bearing joints of the lower extremity such as the knee and hip joints. The study was aimed to find out the efficacy of the tapping technique in addition to the supervised exercise protocol on pain intensity and functional status of an individual with patella-femoral arthritis.

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

The study was based on a controlled pretest-posttest experimental group design. After initial screening, forty individuals (mean age 55years, ranged 40-60years) with patello-femoral arthritis randomly (n=20each) assigned into two group A and B. Group A received taping technique in addition to the supervised exercises protocol while group B received supervised exercises protocol only. Both the groups received their specified treatment 5 consecutive days in a week for 4weeks. Data collected for the variables (VAS and WOMAC) at day1 pre-intervention (baseline) and at day 28th post-intervention. The t-test used for within and between group analysis with keeping the p<0.05.

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.
40

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

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11433
        • Rehabilitation Research Chair

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The individuals with unilateral patella-femoral osteoarthritis
  • Aged between 40-60years;
  • Pain more than 3cm on VAS;
  • Crepitus on movement,
  • Showing osteophytes on standing skyline view of radiograph (Kallgren/Lawrence grade ≥2),
  • found positive for the special tests (coordination test for the muscle vastus medialis, apprehension test for patellar, Clarke's test, and Waldron's test with phase I and II)

Exclusion Criteria:

  • The individuals with involvement of tibio-femoral joint;
  • Presence of patella alta/baja;
  • History of rheumatoid arthritis/traumatic knee, knee surgeries within six months
  • On steroid injection, neurological deficit, fragile skin around the knee, allergic to tape;
  • Poor cooperation

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: Double

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
Group A received a taping technique in addition to the supervised exercises protocol
Other: Taping technique
Fixmull stretch and Leukotape (rigid tape) were used in taping to guide the patellar trajectory orientation while performing the movement. Individuals were asked to lay down in supine position with knee in a slightly bent position. Fixomull stretch was used as an adhesive pre-wrap to protect the skin and provide some of the checking force. The main check strap was provided by stripes of rigid tape (Leukotape). The knee cap was taped, started on the outer aspect of the knee cap and pulled inwards. Finished at the back of the inside of the knee. Two further pieces of tape (Fixomull Stretch and Leukotape) applied distal to the patella unloaded the infrapatellar fat pad.
Other: A supervised exercise protocol
Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;
Active Comparator: Group B
Group B received supervised exercises protocol only
Other: A supervised exercise protocol
Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;

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
Pain Intensity
Time Frame: 4-weeks
Knee pain assessed by Visual Analog Scale (VAS). It is a 10-cm horizontal line marked with 0 (no pain) and 10 (worst pain) on its either end.
4-weeks
Functional status
Time Frame: 4-weeks
Functional status of knee assessed by functional subscale of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It has eight test-questions. The test questions are scored on a scale of 0 - 4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-32 for Physical Function.
4-weeks

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.
King Saud University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: AMIR IQBAL, MPT-Ortho, Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia

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.
June 5, 2019

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.
October 13, 2019

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 19, 2019

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).
October 11, 2020

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.
October 11, 2020

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.
October 19, 2020

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.
October 20, 2020

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.
October 18, 2020

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.
October 1, 2020

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.
  • RRC-2019-16

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

product manufactured in and exported from the U.S.

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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