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

NCT ID: NCT07166068

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2026-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Manual Therapy (Mobilization with Movement)

Intervention Type 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

Intervention Type OTHER

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

Control Group

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).

Group Type PLACEBO_COMPARATOR

Exercise

Intervention Type OTHER

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

sham mobilization

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Exercise

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jazan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Abdulraouf Hamad Ayoub

Lecturer, Department of Physical Therapy, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jazan University Hospital

Jizan, Jazan Region, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Abdulraouf Ayoub, PT

Role: CONTACT

+966500057742

Mohammed Moslem, PT

Role: CONTACT

+966504579544

Facility Contacts

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Abdulraouf Ayoub, PT

Role: primary

+966500057742

Mohammed Ahmed, PhD

Role: backup

+966562819650

References

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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.

Reference Type BACKGROUND
PMID: 35127909 (View on PubMed)

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)

Reference Type 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.

Reference Type BACKGROUND
PMID: 26384360 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 36900733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34505846 (View on PubMed)

Related Links

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https://oarsi.org/

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

Other Identifiers

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(HAPO-10-Z-001)

Identifier Type: -

Identifier Source: org_study_id

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