Effect of Different Mobilization Techniques With Common Use of Interferential Therapy in Patients With Knee OA

September 6, 2023 updated by: AMIR IQBAL, King Saud University

Effectiveness of Maitland Mobilization Versus Mulligan Mobilization Techniques With Common Use of Interferential Therapy in Patients With Knee Joint Osteoarthritis

This study aimed to determine the effects of different manual mobilization techniques on pain, muscle strength, and functional limitations in individuals with knee osteoarthritis (Knee OA). A double-blinded pretest-posttest experimental study. This research employed a two-arm parallel group randomized comparative design. A total of thirty participants diagnosed with knee osteoarthritis were randomly assigned and equally divided into groups 1 and 2, each containing 15 participants. Both Group 1 and Group 2 underwent Maitland and Mulligan mobilization techniques, alongside a common Interferential therapy (IFT) regimen, over the course of three sessions per week for a duration of four weeks. The assessment of pain and functional disability outcomes was conducted through the application of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the baseline and four weeks following the intervention. To determine the effects of the intervention within and between the groups, the outcome scores were subjected to analysis using both dependent and independent t-tests.

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

Knee osteoarthritis (OA) is a prevalent disorder with significant global health implications, its prevalence varying across populations due to intricate factors. Recent investigations highlight an age-related increase in knee OA prevalence, particularly impacting those aged 60 and above, with projections indicating heightened impact due to aging demographics. Recent pathogenesis studies illuminate the intricate molecular and cellular processes underlying knee osteoarthritis (OA), encompassing cartilage degradation, subchondral bone changes, and inflammation.Recent advancements have expanded knee osteoarthritis (OA) management, including medical, surgical, and physiotherapy interventions. Pharmacological treatments such as analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and disease-modifying osteoarthritis drugs (DMOADs) remain fundamental for pain alleviation and inflammation reduction. Intra-articular therapies like corticosteroid injections and hyaluronic acid supplements offer localized relief and potential disease-modifying effects.Surgical interventions like total knee arthroplasty (TKA) provide pain relief and improved function for end-stage OA. Minimally invasive techniques like partial knee replacements and patient-specific implants aim to preserve joint function and enhance outcomes. Physiotherapy and rehabilitation are crucial, in improving stability, muscle strength, and mobility. Studies highlight tailored exercises, neuromuscular training, and proprioceptive exercises in managing OA symptoms. The integration of these approaches underscores comprehensive knee OA management, addressing pain, function, and quality of life. The outcomes of this study could offer evidence-based recommendations for clinicians, aiding them in selecting the most appropriate manual therapy approach to alleviate pain, enhance joint mobility, and improve functional capacity in knee OA patients. Ultimately, this research seeks to contribute to the optimization of knee OA management strategies, improving the well-being of those affected.

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

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11433
        • Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Sub-acute or chronic osteoarthritis of knee.
  • Age between 45-65 years.
  • Gender Male and female.
  • Subjects willing to participate in the study

Exclusion Criteria:

  • Presence of R.A, polyarthritis or systemic inflammatory arthropathies.
  • History of total knee arthroplasty or major knee trauma injury.
  • Fracture of lower limb within the past 6 months.
  • Hip or ankle instability, excessive weakness, surgery or major trauma injury.
  • Intra-articular steroid injection in knee joint within 3 months.
  • Cognitive problems.
  • Patient with severe cardiac or pulmonary disorders.
  • Peripheral vascular disease.
  • Tumour/malignancies/infections.
  • Metallic implants in the lower limbs.
  • Any severe deformity around the knee joint.
  • Kellgren and Lawrence (KL) system47: up to grade 0-III.
  • History of neurological and psychological disorders.
  • High risk health status- e.g.- uncontrolled hypertension, diabetes, heart disease, angina type pain, nocturnal dyspnoea, shortness of breathing, tachycardia etc.
  • Contraindications of IFT and mobilization.

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: Maitland Group
Maitland Group received Maitland's mobilization techninque in addition to an intereferential therapy.
Other: Maitland's mobilization technique
Maitland's mobilization technique was performed on the patients with its all components, such as 1. Distraction 2. Anteroposterior glides 3. Posteroanterior glides 4. Medial glides and 5. Lateral glides.
Other: Interferential Therapy (IFT)
Interferential Therapy was performed on the patients with the following parameters: career frequency 4000Hz; waveform: rectangular; sweep time: 1 second rise and fall and 5 second stay; Treatment duration: 10 minutes; sweep frequency: 10 to 130 Hz. The current intensity was adjusted until the subject reported feeling a strong tingling sensation without causing muscle contraction. A aquatic gel was applied before straping the electopads over treatment area for smooth electrical conduction.
Active Comparator: Mulligan Group
Mulligan Group received Mulligan's mobilization techninque in addition to an intereferential therapy.
Other: Interferential Therapy (IFT)
Interferential Therapy was performed on the patients with the following parameters: career frequency 4000Hz; waveform: rectangular; sweep time: 1 second rise and fall and 5 second stay; Treatment duration: 10 minutes; sweep frequency: 10 to 130 Hz. The current intensity was adjusted until the subject reported feeling a strong tingling sensation without causing muscle contraction. A aquatic gel was applied before straping the electopads over treatment area for smooth electrical conduction.
Other: Mulligan's mobilization techniques
Mulligan's mobilization technique was performed on the patients with its all components using a therapeutic belt, such as 1. Medial mobilization with movement (MWM) for Knee flexion 2. Medial mobilization with movement (MWM) for Knee extension 3. Lateral mobilization with movement (MWM) for Knee flexion 4. Lateral mobilization with movement (MWM) for Knee extension.

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
Functional limitations
Time Frame: 4 weeks
Functional limitations was assessed using the Western Ontario and McMaster Universities (WOMAC) index. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living. 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 0-20 for Pain, 0-8 for Stiffness, and 0-68 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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Burdwan Institute of Medical and Life Sciences (BIMLS)

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.
  • Study Chair: AMIR IQBAL, MPT, King Saud 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 10, 2017

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 14, 2017

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 30, 2017

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 29, 2023

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 29, 2023

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 6, 2023

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.
September 8, 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.
September 6, 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.
September 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.
  • BIMLS/67/2017

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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