Comparative Effects of Hold Relax Technique and Mulligan Mobilization in Post Operative Knee Joint

April 26, 2022 updated by: Riphah International University

Comparative Effects of Hold Relax Technique and Mulligan Mobilization on Pain, ROM and Function in Post Operative Knee Joint: A Randomised Controlled Trail

The aim of this study is to investigate the comparative effects of hold relax technique and mulligan mobilization on pain, ROM and function in post operative knee joint.

Study Overview

Status

Status

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

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

Stiffness or restricted ROM of the knee joint is a term used commonly to describe any traumatic condition occurring within or around the knee joint. It can result from direct and indirect below and is experienced as pain with activity, local tenderness to palpation, and decreased ability to tolerate tension, which results in decreased movement and functional strength. Post-traumatic knee stiffness and loss of range of motion is a common complication of injuries to the knee area. Immobilization of human knees for several weeks or more can result in stiffness and loss of range of motion in the joints. After knee arthroplasties, cruciate ligament repairs and trauma may lead to contracture of muscles and knee instability. Limitations of joint movements both flexion and extension suggests intraarticular pathology.

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 (Anticipated)

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.
34

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
      • Jhang, Punjab, Pakistan, 38000
        • Recruiting
        • Govt. Hospital DHQ
        • Principal Investigator:
          • Imbesat Fatima, MS-OMPT

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both male and female of age 20 to 40 years

    • Knee pain 3 or more on VAS
    • Patients with grade 3 or more than 3 power of knee muscle
    • Subjects with post traumatic stiffness of knee joint having a minimum of 70 degree of knee flexion

Exclusion Criteria:

  • Hypermobile and unstable joint

    • Soft tissue injuries
    • Joint infection and loosening
    • Other complication of post fracture/ TK

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: Mulligan Mobilization with movement
Mulligan Mobilization with movement + Baseline treatment (Moist Heat Pack) Group will receive mulligan mobilization with movement with the frequency of 3 sets and 10 repetitions 3 times a week for 6 weeks.
Other: Mulligan Mobilization
Medial glide MWM for knee flexion (supine) Lateral glide MWM for knee flexion (supine) Medial glide MWM for knee flexion.( prone ) Lateral glide MWM for knee flexion (prone)
Experimental: Hold relax technique
Hold relax technique + Baseline treatment (Moist Heat Pack) Group will receive Hold Relax Technique of PNF included, 5 repetitions will be given 3 times/week for 6 weeks.
Other: Hold Relax
Hold-relax technique of PNF included, the affected knee will be flexed passively to the end of range with the therapist's hand on the patient's lower leg. Patients then performed 5 s of quadriceps contraction against the resistance of the therapist. Patients will be asked not to let move. At the end of 5 s, the patients will be asked to totally relax for 10 s and the therapist pushed the knee into more flexion and hold at that newly acquired range

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: 3 months
The most common validated tool for assessment of pain in clinical tests is the numeric pain rating score (NPRS), a 10-point scale where 0 indicates no pain and 10 indicates severe pain
3 months
Goniometer for Range of motion
Time Frame: 3 months
It is a technique in which instrument named as goniometer purports to measure accurately the movements present in a simple or composite joint. Actually a goniometer is not used so much to measure the exact number of degrees of the movement in the joint as to find out whether there is increase or decrease of such movements. In order to do this, it is desirable that a goniometer should provide an easy method of reference to the joint or joint being examined and also provide a fixed base line point from which to measure any increase or decrease of movement
3 months
Time up and go test for functional ability
Time Frame: 3 months
The test consists of measuring the time it takes for an individual to get up from the chair and walk as fast as possible to a 3-meter walk, turn around, come back and sit down. Time taken to complete the test were measured on stopwatch to the nearest 1/100 of the second
3 months

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.
April 15, 2022

Primary Completion (Anticipated)

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.
August 15, 2022

Study Completion (Anticipated)

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.
September 15, 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).
April 26, 2022

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.
April 26, 2022

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.
May 2, 2022

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.
May 2, 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.
April 26, 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.
April 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/Lhr/22/0110 Imbesat

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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