Pain management · 2026
Amplifying the effects of comprehensive exercise through pre-exercise expectation framing in patients with knee osteoarthritis: study protocol for an assessor-blinded randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Mahmoudi Maryam Bagheri, Letafatkar Amir, Hadadnezhad Malihe, Shojaedin Seyed Sadredin, Rossettini Giacomo
Аннотация
INTRODUCTION: Knee osteoarthritis (KOA) is a major cause of pain and disability worldwide. Although exercise therapy is recommended as first-line treatment, outcomes vary considerably. Treatment expectations may influence rehabilitation response. This randomized controlled trial (RCT) protocol investigates whether brief pre-exercise expectation framing affects pain and functional outcomes in individuals with KOA undergoing structured rehabilitation.
METHODS: This assessor-blinded, three-arm superiority RCT will recruit 90 participants with symptomatic, radiographically confirmed KOA from the outpatient physiotherapy department of Kharazmi University, Tehran, Iran. Participants will be randomized (1:1:1) to receive comprehensive knee exercises combined with positive, negative, or neutral expectation framing. All groups will complete an 18-session supervised exercise program over six weeks. Expectation framing will be delivered once before the first session. Primary outcomes are pain intensity and disability. Secondary outcomes include knee kinematics, muscle activity, pain catastrophizing, self-efficacy, kinesiophobia, and treatment expectations. Assessments will be conducted at baseline, post-intervention, and three-month follow-up; expectation ratings will also be collected immediately after framing to verify the manipulation.
DISCUSSION: This trial will evaluate whether pre-exercise expectation framing influences rehabilitation outcomes in KOA and clarify the role of treatment expectations in clinical practice.
CLINICAL TRIAL REGISTRATION: The http://www.irct.ir identifier is IRCT20250811066819N1.
METHODS: This assessor-blinded, three-arm superiority RCT will recruit 90 participants with symptomatic, radiographically confirmed KOA from the outpatient physiotherapy department of Kharazmi University, Tehran, Iran. Participants will be randomized (1:1:1) to receive comprehensive knee exercises combined with positive, negative, or neutral expectation framing. All groups will complete an 18-session supervised exercise program over six weeks. Expectation framing will be delivered once before the first session. Primary outcomes are pain intensity and disability. Secondary outcomes include knee kinematics, muscle activity, pain catastrophizing, self-efficacy, kinesiophobia, and treatment expectations. Assessments will be conducted at baseline, post-intervention, and three-month follow-up; expectation ratings will also be collected immediately after framing to verify the manipulation.
DISCUSSION: This trial will evaluate whether pre-exercise expectation framing influences rehabilitation outcomes in KOA and clarify the role of treatment expectations in clinical practice.
CLINICAL TRIAL REGISTRATION: The http://www.irct.ir identifier is IRCT20250811066819N1.