Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Osteoarthritis:

July 14, 2026 updated by: Dr Noreen Sher Muhammad, University of Faisalabad

Comparative Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Managing Knee Osteoarthritis: A Randomized Clinical Trial

Knee osteoarthritis was a common degenerative joint condition that caused pain, stiffness, reduced range of motion, and functional limitations. This study compared two manual therapy techniques: Joint Distraction and Passive Joint End-Range Overpressure. The goal was to determine which technique was more effective at reducing pain, improving knee range of motion, enhancing function, and improving quality of life in patients with knee osteoarthritis. Participants were randomly assigned to receive either Joint Distraction or Passive Joint End-Range Overpressure for 4 weeks.

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

This study was a randomized clinical trial. A sample of 26 participants aged 40-60 with Grade 2 or Grade 3 Knee Osteoarthritis was recruited from DHQ Hospital and Madinah Teaching Hospital Faisalabad. Participants were randomly assigned to two groups (n=13 each). Group A received the Joint Distraction Technique involving sustained traction of the knee joint for 20 minutes at the patient's perceived threshold. Group B received Passive Joint End-Range Overpressure involving Maitland Grade IV mobilization for 3 minutes, twice, with a 30-second rest interval. Both groups received a 10-minute hot pack before their respective techniques. Interventions occurred 3 times per week for 4 weeks (12 sessions total). Outcome measures included the Visual Analogue Scale (VAS), Goniometer, Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), and Knee Injury and Osteoarthritis Outcome Scale (KOOS), measured at baseline and after 4 weeks.

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.
26

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 Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • The University of Faisalabad

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Patients diagnosed with Grade 2 or Grade 3 Knee Osteoarthritis.
  • A Kellgren-Lawrence Grade (KLG) of at least 2.
  • Age between 40-60 years.
  • Knee pain for at least 6 months.
  • A minimum pain score of 3 on the Visual Analogue Scale (VAS).

Exclusion Criteria

  • Acute inflammation.
  • Total Knee Replacement (TKR) surgery.
  • Any lumbar spine disease (disc herniation or lumbar stenosis).
  • Intra-articular injection.
  • Recent tibia or femur fracture.
  • Any systemic inflammatory arthritic condition or neurological condition (e.g., rheumatoid arthritis or stroke).

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: Single

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
The joint distraction is the manual approach in knee osteoarthritis. This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis.
Other: Joint distraction GROUP A

The joint distraction is the manual approach in knee osteoarthritis. This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis. A specialized greave would be created to distract the knee joint.

Using a platform beneath the lower leg to create counterpressure, the knee would be put in flexion while sustained traction will be performed for 20 minutes while the patient would be in a supine posture. In each session, the traction would be adjusted to the patients' perceived threshold. The least amount of work that caused patients to get distracted would be employed as a diversion
Experimental: GROUP B
The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively. End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint.
Other: Passive Joint End-Range Overpressure TO GROUP B
The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively. End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint. Depending on the patient's level of pain and tolerance, an oscillatory accessory approach using Grade III or IV was carried out. Patients positioned their knees in their true end range while lying supine on the plinth. The most limited or reproducible knee pain was caused by the accessory approach that was employed. By moving the therapist's body without making any additional movements, the physical contact accurately replicated the hand position of the mobilization. For three minutes, Maitland mobilization was carried out twice at a rate of one oscillation every one or two seconds, with a 30-second break in between

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 months

Primary Outcome Measure Pain Tool Used: Visual Analogue Scale (VAS)

The Visual Analogue Scale (VAS) was used to assess the patient's pain level. Participants were asked to rate their pain on a scale from 0 to 10.

0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-10 = Severe pain This scale was used to categorize the intensity of pain experienced by patients with knee osteoarthritis.
4 months

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
Quality of Life / Broader Function
Time Frame: 4 months

Quality of Life / Broader Function Tool Used: KOOS Questionnaire (Knee Injury and Osteoarthritis Outcome Scale.

The KOOS questionnaire was used to assess:

Pain Symptoms Activities of Daily Living (ADLs) Sport and Recreation Function Knee-related Quality of Life

It contains 42 items divided into five sections:

Pain = 9 items Symptoms = 7 items Activities of Daily Living = 17 items Sport and Recreation Function = 5 items Quality of Life = 4 items

Each item is scored from 0 to 4.

Maximum score:

42 items × 4 = 168

Interpretation (Percentage Based):

< 40% = Extreme disability 40-59% = Severe problems 60-79% = Moderate problems 80-99% = Mild disability This questionnaire evaluates the overall impact of knee osteoarthritis on function and quality of life.4 months
4 months
Disability
Time Frame: 4 months

Secondary Outcome Measures

1) Osteoarthritis Symptoms and Functions Tool Used: WOMAC Questionnaire (Western Ontario McMaster Universities Osteoarthritis Index)

The WOMAC questionnaire was used to assess:

Pain Stiffness Physical function

It contains 24 items divided into three sections:

Pain = 5 items Stiffness = 2 items Physical Function = 17 items Each question has 5 response options ranging from None to Extreme.

Scoring:

Each item = 0-4 points Pain section total = 20 Stiffness section total = 8 Physical function section total = 68 Total WOMAC score = 96

Interpretation:

0-30 = Mild 31-60 = Moderate 61-96 = Severe The higher the score, the greater the symptoms and functional limitations.
4 months
Passive Range of Motion
Time Frame: 4 months

Passive Range of Motion Tool Used: Goniometer

A goniometer was used to assess joint range of motion.

The instrument consists of three parts:

Moving Arm - aligned with the body segment that moves. Stationary Arm - aligned with the body segment that remains stationary. Fulcrum - positioned over the joint being assessed.

The goniometer was used to measure the knee joint's range of motion before and after treatment.
4 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.
University of Faisalabad

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.
December 25, 2025

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 12, 2026

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.
May 25, 2026

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).
June 23, 2026

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.
July 14, 2026

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.
July 17, 2026

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.
July 17, 2026

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.
July 14, 2026

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.
July 1, 2026

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.
  • TUF/EIRB/143/2025

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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