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

University of Jazan

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Other: Manual Therapy (Mobilization with Movement); Other: sham mobilization; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07166068

(HAPO-10-Z-001)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

The intervention group will receive mobilization with movement for the affected knee with standard care (exercise program to strengthen the musculature of the knee).

Treatment:

Other: Exercise

Other: Manual Therapy (Mobilization with Movement)

Control Group

Placebo Comparator group

Description:

The control group will receive sham mobilization with movement for the affected knee with standard care (exercise program to strengthen the musculature of the knee).

Treatment:

Other: Exercise

Other: sham mobilization