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Combined Cyclic Compression Cryotherapy and Phased Rehabilitation Training for Recovery After Knee Replacement

The Efficacy of Cyclic Compression Cryotherapy Combined With Phased Rehabilitation Training on Lower Limb Functional Recovery in Patients After Total Knee Arthroplasty

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07089212
Enrollment
100
Registered
2025-07-28
Start date
2025-04-23
Completion date
2025-09-01
Last updated
2025-07-28

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

Conditions

Knee Arthroplasty, Total, Rehabilitation Therapy

Brief summary

Total knee arthroplasty (TKA) is an effective treatment for severe knee joint diseases; however, postoperative complications such as pain, swelling, and delayed functional recovery remain common challenges. Cyclic compression cryotherapy, which applies alternating cold and pressure to the knee joint, can effectively reduce swelling and alleviate pain. Meanwhile, phased rehabilitation training, tailored to the specific recovery stages post-surgery, facilitates targeted exercise interventions to promote functional restoration of the knee joint.

Interventions

BEHAVIORALPhased Rehabilitation Training

Rehabilitation is divided into three postoperative phases: Early Phase (Weeks 1-2): Focus on edema control, quadriceps activation, and passive/active-assisted range of motion (ROM) exercises. Intermediate Phase (Weeks 3-6): Progress to strength training, endurance exercises, and early proprioception drills. Late Phase (Weeks 7-12): Advance to functional training , dynamic proprioception, and full ROM restoration.

DEVICECyclic Compression Cryotherapy

Initiation: Begin within 24 hours postoperatively. Each session lasts 20-30 minutes, administered 2-3 times daily. Procedure: Apply a cryotherapy wrap circumferentially around the knee using a pneumatic compression device, with precise control of pressure and temperature. Pressure Settings: Start at Level I-II (low-to-moderate) and adjust incrementally based on patient tolerance. Temperature Control: Maintain at 10-12°C.

BEHAVIORALConventional rehabilitation treatment.

The control group underwent a 12-week conventional rehabilitation program, which primarily included muscle strength training, endurance training, proprioception training, and joint range of motion (ROM) exercises. Assessments were conducted at baseline (before treatment), as well as at 2 weeks, 6 weeks, and 12 weeks post-treatment. The evaluated outcomes included knee joint ROM, muscle strength, knee function, pain levels, and activities of daily living (ADL).

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosed with knee osteoarthritis (KOA) and within 12 weeks after total knee arthroplasty (TKA). 2. Aged 18-70 years. 3. First-time unilateral TKA (non-revision surgery). 4. Physically and cognitively capable of completing required assessments. 5. Able to fully adhere to the study protocol. 6. Willing to participate in and complete the entire rehabilitation program. 7. No contraindications for surgery or postoperative rehabilitation. 8. Intact cognitive function (able to provide informed consent and follow instructions). 9. Available for all follow-up evaluations.

Exclusion criteria

* 1\. Severe cardiovascular or cerebrovascular diseases. 2. Neuromuscular impairments affecting the lower limbs. 3. Concurrent hip or ankle joint disorders. 4. Intolerance to pain (unable to tolerate rehabilitation protocols). 5. Primary or metastatic bone tumors. 6. Rheumatoid arthritis (RA) or other systemic inflammatory arthropathies. 7. Severe obesity (BMI ≥35) or malnutrition (clinically diagnosed). 8. Inability to comply with study assessments (e.g., due to cognitive or physical limitations). 9\. Visual dysfunction impairing task performance. 10. Functional impairment of the non-operated limb hindering testing/training. 11. Ankylosing spondylitis (AS). 12. History of allergic hypersensitivity to interventions used in the study. 13. Hemorrhagic predisposition (e.g., coagulation disorders, anticoagulant use). 14\. Active tuberculosis or chronic myelitis. 15. History of substance dependence (e.g., opioids, alcohol). 16. Psychiatric disorders (e.g., schizophrenia, major depression). 17. Severe dysfunction of major organs (e.g., hepatic, renal, pulmonary).

Design outcomes

Primary

MeasureTime frame
Knee Function ScoresAt 6 weeks after completion of treatment.

Secondary

MeasureTime frame
Range of Motion (ROM)At 6 weeks after completion of treatment.
Muscle StrengthAt 6 weeks after completion of treatment.
Activities of Daily Living (ADLs)At 6 weeks after completion of treatment.
Visual Analog Scale (VAS)At 6 weeks after completion of treatment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026