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Knee OsteoarthritisNCT07166068

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

A study testing Manual Therapy (Mobilization with Movement) and Exercise in people with Knee Osteoarthritis, run by University of Jazan at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Manual Therapy (Mobilization with Movement) and Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSaudi Arabia
Study dates
1 May 2025to 27 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Jazan University Hospital

    Jizan, Jazan Region, 82722

Other trials in Saudi Arabia

About this study

Official title: The Effect of Mobilization With Movement Versus Sham 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.

Being tested
Manual Therapy (Mobilization with Movement), Exercise, sham mobilization
Keywords
Knee OA, MWM, Manual Therapy, CRP, ESR
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • ExerciseOther

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

  • sham mobilizationOther

    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.

Study groups in NCT07166068
Study groupRoleWhat they receive
Intervention GroupExperimentalThe intervention group will receive mobilization with movement for the affected knee with standard care (exercise program to strengthen the musculature of the knee).
Receives: Other: Manual Therapy (Mobilization with Movement); Other: Exercise
Control GroupPlacebo comparatorThe control group will receive sham mobilization with movement for the affected knee with standard care (exercise program to strengthen the musculature of the knee).
Receives: Other: Exercise; Other: sham mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-Reactive Protein (CRP)

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

    Measured: Baseline and 4 weeks post-intervention.

  2. Erythrocyte Sedimentation Rate (ESR)

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

    Measured: Baseline and 4 weeks post-intervention.

Secondary outcomes (2)

  1. Pain Intensity

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

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

  2. Functional Status

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start1 May 2025
  3. Primary completion27 Nov 2025
  4. Study completion27 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166068
Sponsor's protocol ID
(HAPO-10-Z-001)
Status last verified
Sep 2026
First submitted
28 Nov 2024
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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/healthcare11050728.

    PubMed 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.

    PubMed 34505846

  • Ayoub AH, Muslem MZ, Ahmed MM, Al Aqeel AA, Khired ZA, Alnajai MM, Alshami AM. Effects of Mobilization with Movement Versus Sham Mobilization on Inflammatory Biomarkers and Clinical Outcomes in Patients with Knee Osteoarthritis: A Randomized Double-Blind Clinical Trial. Medicina (Kaunas). 2026 Oct 18;62(10):2016. doi: 10.3390/medicina62102016.

    PubMed 42942546

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy (Mobilization with Movement) and Exercise in people with Knee Osteoarthritis, run by University of Jazan at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-Reactive Protein (CRP) (time frame: Baseline and 4 weeks post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07166068, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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