Ergon Technique Versus PNF Stretching on Hamstring Flexibility in Knee Osteoarthritis

March 15, 2023 updated by: Riphah International University

Comparison of Ergon Technique Versus Proprioceptive Neuromuscular Facilitation Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis

The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A&B) of 30 participants in each group by sealed envelope method. Hot pack will be applied to both groups for 15 minutes at the start of intervention. ERGON Technique(IASTM) will be applied to group A along with strengthening exercise. Proprioceptive Neuromuscular Facilitation (PNF) stretching will be given to group B along with strengthening exercise. A 35 minute session will be given to the patients and 3 sessions will be given once a week. Intervention will be given for 6 weeks. The outcome measure will be Visual analog Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Active Knee Extension Test (AKE) will be measured at baseline and at the end of 6th week. Data will be analyzed by SPSS 22.

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

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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.
57

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
      • Islamabad, Pakistan, 44000
        • RHS Rehabilitation Centre

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

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral/bilateral osteoarthritis
  • Participants with unilateral/bilateral hamstring tightness
  • 200 from Active Knee Extension test
  • Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis

Exclusion Criteria:

  • Participant failing to fall in the category below will be excluded from the study:
  • Any lower extremity injury in past 3 months
  • Any fracture or surgery done for pelvis, hip or knee.
  • Any neurological symptoms.
  • Any recent knee reconstructive surgery
  • Burns of lower extremities
  • Other musculoskeletal disorders associated with knee joint, Iliotibial band, adductor muscle and Sartorius muscle tightness

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.
Experimental: ERGON Technique Group
Patients in this group will receive ERGON Technique along with conventional therapy
Other: ERGON Technique
  • Hot pack for 15 minutes.
  • Patient position: Prone with knee flexion approximately 45◦.
  • Position of therapist: Standing at the affected side of patient.
  • Technique:Massage cream will be applied on the hamstring and overactive or short muscle fibres that are restricted.The instrument will be applied parallel to the muscle fibers, both in a distal to proximal and them proximal to distal direction as needed.Then gentle massage stroking from the origin to the insertion will be performed using the instrument. Instrument Assisted Soft Tissue Mobilization(IASTM) will be applied for 5 minutes.
  • Strengthening exercises for quadriceps and hamstring will then be performed.
  • Isometrics exercises of Quadriceps: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets.
  • Isometrics exercises Hamstrings: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets.
  • Wall sits: For 10 seconds, 5 sets.
Experimental: Proprioceptive Neuromuscular Facilitation(PNF) stretching Group
Patients in this group will receive Proprioceptive Neuromuscular Facilitation (PNF) stretching along with conventional therapy
Other: Proprioceptive Neuromuscular Facilitation (PNF) stretching
  • The patient will be laid down prone and moist heat will be given for 15 minutes prior to stretching the hamstrings.
  • Then patient will be lying supine with hip in 90⁰ of flexion. Patient's knee will be extended until a very mild stretching sensation is felt in hamstring muscles.
  • Then patient will be asked to flex the knee against the resistance applied by hand of therapist.
  • The patient will be asked to use a force of around 50% of maximal strength and an isometric form of contraction will be gained in the hamstring muscles. The patient will hold the contraction for 8 seconds and then the therapist command to relax the hamstring muscle.
  • Immediately after the muscle relaxation the therapist further stretches the hamstring muscles up to a point where the subject reported a mild to moderate stretching sensation without any pain and will be held for 30 seconds.
  • The procedure will be repeated 3 times in every session.

Strengthening Exercises:

  • Same as ERGON Group

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
Visual Analog Scale (VAS)
Time Frame: 6 Weeks
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. It is used to find out the intensity of pain.
6 Weeks
Western Ontario and McMaster Universities Arthritis Index(WOMAC)
Time Frame: 6 Weeks
The Western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.
6 Weeks
Active Knee Extension Test
Time Frame: 6 Weeks
The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.
6 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.
Riphah International 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.
January 10, 2022

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.
May 30, 2022

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.
June 25, 2022

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 26, 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.
October 26, 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.
November 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.
March 17, 2023

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.
March 15, 2023

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.
March 1, 2023

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.
  • Narmeen Anjum

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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