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

NCT07166068 | Recruiting

• 1 other identifier: (HAPO-10-Z-001)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee OA; MWM; Manual Therapy; CRP; ESR

Outcome Measures

Primary Outcomes (2)

• C-Reactive Protein (CRP)

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

  Baseline and 4 weeks post-intervention.

• Erythrocyte Sedimentation Rate (ESR)

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

  Baseline and 4 weeks post-intervention.

Secondary Outcomes (2)

• Pain Intensity

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

• Functional Status

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Manual Therapy (Mobilization with Movement); Other: Exercise

Control Group

PLACEBO COMPARATOR

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).

Other: Exercise; Other: sham mobilization

Interventions

Exercise OTHER

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

Control Group; Intervention Group

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.

Control Group

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

Jazan University Hospital

Jizan, Jazan Region, 82722, Saudi Arabia

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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)

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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/healthcare11050728.

  PMID: 36900733 BACKGROUND

• 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 BACKGROUND

Related Links

• OARSI is the premier international organization for scientists and healthcare professionals focused on osteoarthritis research, prevention, and treatment.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Musculoskeletal Manipulations; Movement; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity

Central Study Contacts

Abdulraouf Ayoub, PT

CONTACT

+966500057742; aayoub@jazanu.edu.sa

Mohammed Moslem, PT

CONTACT

+966504579544; m.zm2020@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: While participants and outcome assessors are blinded to treatment allocation, therapists delivering the MWM and sham mobilization interventions are aware of the assigned treatment for each participant. However, therapists are blinded to all outcome measures, including pain scores, inflammatory marker results, and functional assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Physical Therapy, Principal Investigator

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: September 10, 2025
• Study Start: September 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: April 20, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

SA (1)