NCT07618403

Brief Summary

To our knowledge, no studies have been conducted in the literature investigating the relationship between the success of physical therapy programs applied in knee osteoarthritis and patients' pre-treatment expectations. The rationale for this study is to demonstrate the possible relationship between treatment expectations and the benefits seen from conventional physical therapy programs in patients with knee osteoarthritis, and to provide clinicians with a different perspective in knee osteoarthritis treatment planning.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Sep 2027

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

May 24, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

treatment expectationsgonarthrosisphysical treatment

Outcome Measures

Primary Outcomes (1)

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score

    WOMAC score evaluation following the last treatment session. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, validated questionnaire designed to assess pain, stiffness, and physical function in patients with knee and hip osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Patients rate their symptoms on a Likert scale, with higher scores indicating worse pain, stiffness, or functional limitations. The WOMAC is commonly used in clinical research to evaluate the efficacy of various treatments for osteoarthritis.

    From enrollment day to the end of the rehabilitation program at 4 weeks

Secondary Outcomes (3)

  • Pain level; VAS score

    From enrollment day to the end of the rehabilitation program at 4 weeks

  • Timed Up and Go Test (TUG)

    From enrollment day to the end of the rehabilitation program at 4 weeks

  • Stair Climbing Test (SCT)

    From enrollment day to the end of the rehabilitation program at 4 weeks

Study Arms (2)

Those with Low Treatment Expectations

Using the Turkish version of the Treatment Expectation Questionnaire (TEX-Q)(English version is provided in the documents section), patients will be divided into two groups: those with low expectations and those with high expectations.

Other: Physical Therapy

Those with High Treatment Expectations

Using the Turkish version of the Treatment Expectation Questionnaire (TEX-Q)(English version is provided in the documents section), patients will be divided into two groups: those with low expectations and those with high expectations.

Other: Physical Therapy

Interventions

Patients in both groups will receive 15 sessions of a conventional physical therapy program.

Those with High Treatment ExpectationsThose with Low Treatment Expectations

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 50 years and older who present with knee pain and are found to have grade 2 or higher gonarthrosis according to the Kellgren-Lawrence classification on X-ray imaging.

You may qualify if:

  • Agreeing to participate in the study
  • Being over 50 years of age
  • Having a clinically and radiographically confirmed diagnosis of knee osteoarthritis
  • Having grade 2-3-4 knee osteoarthritis according to the Kellgren-Lawrence grading system
  • Being literate

You may not qualify if:

  • Previous knee surgery
  • Conditions that prevent exercise (such as incurable malignancy, active systemic infection, non-union fracture)
  • Presence of accompanying neurological disease affecting the lower extremity
  • Severe cognitive impairment (neuropsychiatric disease or condition that will impede cooperation, such as psychosis, dementia)
  • History of having received injections or other procedures to the knee joint or physical therapy within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.

    PMID: 26405113BACKGROUND
  • Mondloch MV, Cole DC, Frank JW. Does how you do depend on how you think you'll do? A systematic review of the evidence for a relation between patients' recovery expectations and health outcomes. CMAJ. 2001 Jul 24;165(2):174-9.

    PMID: 11501456BACKGROUND
  • Levenig CG, Hasenbring MI, Gunnewig L, Titze C, Elsenbruch S, Schulte TL. Treatment Expectations-You Get What You Expect-and Depression Plays a Role. J Pain. 2024 Sep;25(9):104582. doi: 10.1016/j.jpain.2024.104582. Epub 2024 May 29.

    PMID: 38821312BACKGROUND
  • Myers SS, Phillips RS, Davis RB, Cherkin DC, Legedza A, Kaptchuk TJ, Hrbek A, Buring JE, Post D, Connelly MT, Eisenberg DM. Patient expectations as predictors of outcome in patients with acute low back pain. J Gen Intern Med. 2008 Feb;23(2):148-53. doi: 10.1007/s11606-007-0460-5. Epub 2007 Dec 8.

    PMID: 18066631BACKGROUND
  • Robinson ME, Brown JL, George SZ, Edwards PS, Atchison JW, Hirsh AT, Waxenberg LB, Wittmer V, Fillingim RB. Multidimensional success criteria and expectations for treatment of chronic pain: the patient perspective. Pain Med. 2005 Sep-Oct;6(5):336-45. doi: 10.1111/j.1526-4637.2005.00059.x.

    PMID: 16266354BACKGROUND
  • Abdel-Aziz MA, Ahmed HMS, El-Nekeety AA, Abdel-Wahhab MA. Osteoarthritis complications and the recent therapeutic approaches. Inflammopharmacology. 2021 Dec;29(6):1653-1667. doi: 10.1007/s10787-021-00888-7. Epub 2021 Nov 9.

    PMID: 34755232BACKGROUND
  • Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.

    PMID: 29035179BACKGROUND
  • Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.

    PMID: 33807695BACKGROUND
  • Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/

    PMID: 29939661BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Levent Karatas

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Levent Karatas

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations