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

Official title

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

Overview

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.

Interventions

• Other Manual Therapy (Mobilization with Movement)
  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.
• Other Exercise
  standard care (exercise program to strengthen the musculature of the knee)
• Other sham mobilization
  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 outcome measures

• C-Reactive Protein (CRP) [Time frame: Baseline and 4 weeks post-intervention.]
• Erythrocyte Sedimentation Rate (ESR) [Time frame: Baseline and 4 weeks post-intervention.]

Secondary outcome measures (2)

• Pain Intensity [Time frame: The outcome measure will be assessed at the baseline and 4 weeks post-intervention.]
• Functional Status [Time frame: The outcome measure will be assessed at the baseline and 4 weeks post-intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Saudi Arabia · 1 center

• Jazan University Hospital — Jizan

Publications

• Li LL, Hu XJ, Di YH, Jiao W. Effectiveness of Maitland and Mulligan mobilization methods for adults with knee osteoarthritis: A systematic review and meta-analysis. World J Clin Cases. 2022 Jan 21;10(3):954-965. doi: 10.12998/wjcc.v10.i3.954. PMID 35127909
• Shabbir M, Gul I, Asghar E, Muhammad N, Mehjabeen H, Rafiq I, Arshad N. Effectiveness Of Maitland's Mobilization And Conventional Physical Therapy On Synovial Biomarkers In Patients With Knee Osteoarthritis; A Randomized Control Trial. Webology. 2022 Apr 1;19(2)
• Hanada M, Takahashi M, Furuhashi H, Koyama H, Matsuyama Y. Elevated erythrocyte sedimentation rate and high-sensitivity C-reactive protein in osteoarthritis of the knee: relationship with clinical findings and radiographic severity. Ann Clin Biochem. 2016 Sep;53(Pt 5):548-53. doi: 10.1177/0004563215610142. Epub 2015 Sep 17. PMID 26384360
• Zaki NA, Saleem TH, Said E, Hassan MH. Evidence of contributory role of inflammation in patients with knee osteoarthritis. SVU-International Journal of Medical Sciences. 2020 Jan 1;3(1):1-6.
• Althomali OW, Amin J, Acar T, Shahanawaz S, Talal Abdulrahman A, Alnagar DK, Almeshari M, Alzamil Y, Althomali K, Alshoweir N, Althomali O, Aldhahi MI, Bin Sheeha BH. Prevalence of Symptomatic Knee Osteoarthritis in Saudi Arabia and Associated Modifiable and Non-Modifiable Risk Factors: A Population-Based Cross-Sectional Study. Healthcare (Basel). 2023 Mar 2;11(5):728. doi: 10.3390/healthcare11050 PMID 36900733
• Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec. PMID 34505846

Identifiers

NCT: NCT07166068 · (HAPO-10-Z-001)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗