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Completed

NCT Number: NCT07166068

The Effect of Mobilization on Inflammatory Biomarkers in Patients With Knee Osteoarthritis.

This study is designed to investigate whether a hands-on therapy called Mobilization with Movement (MWM) can reduce pain and inflammation in individuals with knee osteoarthritis (OA). The investigators will compare MWM to a sham treatment that resembles mobilization but does not involve the specific therapeutic movements. Both groups will also receive standard care, including exercise and education about managing knee OA.

A total of 40 adults (aged 18 years and older) with moderate to severe knee OA will be enrolled. Participants will be randomly assigned to either the MWM group or the sham group. Each intervention will be delivered twice per week over a four-week period.

Outcomes will include measures of inflammation obtained from blood samples, self-reported pain levels, and assessments of knee function before and after the intervention period. It is hypothesized that individuals allocated to the MWM group will demonstrate reduced inflammation and pain compared with those in the sham group. The findings of this study may help clarify the potential role of MWM as a treatment option for knee OA.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jazan University Hospital

Jizan, Jazan Region, 82722, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of unilateral or bilateral knee osteoarthritis (OA) according to the criteria of the American College of Rheumatology
  • Age ≥ 18 years
  • Kellgren-Lawrence grade 2 or 3 knee OA
  • Pain intensity > 3 on a visual analogue scale (VAS)
  • Body mass index (BMI) between 18.5 and 30 kg/m²

Exclusion criteria

  • Knee or lower limb surgery within the last six months.
  • Significant joint disorders (e.g., rheumatoid arthritis, gout, or other inflammatory arthritis).
  • Recent significant acute infections.
  • Contraindications to mobilization with movement.
  • Current or recent use systemic glucocorticoids, intra-articular glucocorticoid injections or intra-articular hyaluronic acid injections.

Treatment and study plan

Manual Therapy (Mobilization with Movement)

Other

A continuous glide to the tibia will be a combined simultaneously by whether medial, lateral, anterior, posterior, or rotational-during active knee flexion and extension repeated movement as applied by Mulligan.

Exercise

Other

standard care (exercise program to strengthen the musculature of the knee)

sham mobilization

Other

The therapist will simulate MWM by performing slight external rotation of the skin only. This mimics the tactile sensation of true MWM without affecting the underlying joint mechanics.

Primary outcomes

  1. C-Reactive Protein (CRP)

    Time frame: Baseline and 4 weeks post-intervention.

    CRP levels will be measured in unit of measure (mg/L) using a high-sensitivity assay.

  2. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline and 4 weeks post-intervention.

    ESR will be measured in mm/hr using the Westergren method.

Secondary outcomes

  1. Pain Intensity

    Time frame: The outcome measure will be assessed at the baseline and 4 weeks post-intervention.

    The pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. Functional Status

    Time frame: The outcome measure will be assessed at the baseline and 4 weeks post-intervention.

    Functional status will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale.

Sponsors and collaborators

Lead sponsor

University of Jazan

Other Gov

Registry information

Official study title

The Effect of Mobilization With Movement Versus Sham Mobilization on Inflammatory Biomarkers in Patients With Knee Osteoarthritis.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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