Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.

November 12, 2019 updated by: Sammar Abbas, Isra University
Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon. This study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.

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

A total of 39 athletes with knee pain were recruited and randomly divided into two groups. 30 subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.The data was collected through general demographic questionnaire, PRTEE questionnaire to determine the level of pain and functional disability and Hand grip strength chart to measure grip strength while having epicondylitis.

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.
30

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
      • Rawalpindi, Punjab, Pakistan
        • Sammar Abbas

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age group 20-50 years of both gender.
  • Vas < 7
  • Positive mills test and cozens test.
  • Local tenderness on palpation over lateral epicondyle of the humerus.
  • From sub-acute to chronic more than 2 weeks.

Exclusion Criteria:

  • Any previous pathology of bone around elbow.
  • Corticosteroid injection in the preceeding 3 months.
  • Absence of clinical signs of tennis elbow.
  • Any other systemic illness like metabolic, metastatic, infective disorders.
  • Any other neurological abnormalities.
  • Allergies to Mulligan tape.

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: None (Open Label)

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.
Active Comparator: (DTF massage & Mill's manipulation)(Group 1)
For any given subject in group 1, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in 1st group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week.
Other: Cyriax approach i.e. DTF massage and Mill's manipulation
Each patient in group I i.e. Cyriax group was given 20-minute session. Each session started in sitting position and initially deep transverse friction massage was done at lateral compartment of the elbow joint and immediately after that mill's manipulation at elbow joint with flexion at wrist joint in pronated arm position. This session was repeated three times a week for one month (Total 12 sessions/ one month).
Active Comparator: ( Taping & MWM) (Group 2).
For any given subject in group 2, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in second group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week.
Other: Mulligan approach i.e. Taping and MWM
Each patient in group II i.e. Mulligan group was given 30 to 45-minute session. Each session started in sitting position and it included mobilization with movement which was given in such a way that initially lateral glide at elbow joint was performed and after holding it, I asked the patient to make a fist and open the fist. In this way, I repeated this procedure 36 times and after 12 repetitions, a short rest period was given. Taping was applied after mobilization around the elbow joint over extensor carpi radialis muscles. This session was repeated three times a week for one month (Total 12 sessions/ one month).

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
Patient related tennis elbow evaluation pain scale
Time Frame: Upto 4 weeks
Pain associated with daily tasks is measured through Patient related tennis elbow evaluation pain scale with categories as "0" for no pain and "10" for worst imaginable pain.
Upto 4 weeks
Patient related tennis elbow evaluation functional disability scale
Time Frame: Upto 4 weeks
Degree of difficulty in performing daily tasks associated with elbow joint is measured through Patient related tennis elbow evaluation functional disability scale in categories as "0" for no difficulty in task and "10" for unable to do a task.
Upto 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hand grip strength chart index
Time Frame: Upto 4 weeks
It is also measured through hand grip dynamo meter with reference values according to gender description.
Upto 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.
Isra University

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.
March 1, 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.
September 30, 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.
October 15, 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).
January 26, 2019

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.
February 19, 2019

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.
February 20, 2019

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.
November 13, 2019

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.
November 12, 2019

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.
November 1, 2019

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.
  • IIRS-1702-M.Phil OPT-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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