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A randomized controlled trial of sleep management combined with traditional Chinese medicine rehabilitation in the treatment of chronic knee pain after total knee arthroplasty

A Randomized Controlled Trial of Sleep Management Combined with Traditional Chinese Medicine Rehabilitation for Chronic Knee Pain after Total Knee Arthroplasty

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001184
Enrollment
Unknown
Registered
2025-06-16
Start date
2024-01-20
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain

Interventions

Control Group:standard pharmacologic pain management
Intervention Group:Sleep management combined with chinese rehabilitation exercise

Sponsors

The Second Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Eligible participants must meet the following criteria: aged between 40 and 75 years having undergone unilateral or bilateral total knee arthroplasty (TKA) at least three months prior to enrollment and currently experiencing persistent chronic knee pain with a Visual Analog Scale (VAS) score of =3. The pain must be associated with impaired daily functioning or reduced sleep quality. Participants must have adequate cognitive capacity to understand the study procedures and independently complete all assessments. Written informed consent is required from all individuals prior to enrollment.

Exclusion criteria

Exclusion criteria: The following individuals will be excluded from the study: patients with serious postoperative complications such as infections prosthesis loosening or major bone fractures; those with a history of major neurological conditions (e.g. Parkinsons disease stroke) or psychiatric disorders (e.g. major depressive disorder schizophrenia); current use of opioids or sedative medications that could affect pain perception; a documented history of primary insomnia or other severe sleep disorders; receipt of structured psychological therapy or comprehensive rehabilitation within the past three months; and individuals with severe cardiovascular disease malignancies endocrine disorders or other chronic illnesses that may compromise adherence to the study protocol or pose safety concerns.

Design outcomes

Primary

MeasureTime frame
Hospital for Special Surgery Knee Score;Visual Analogue Scale;knee swelling;Range of Motion;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;

Countries

China

Contacts

Public ContactLi Fei

Anhui University of Chinese Medicine

leagcen@163.com19933738961

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026