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

Shandong University

Status: Active, not recruiting

Conditions: Rehabilitation Therapy; Knee Arthroplasty, Total

Treatments: Device: Cyclic Compression Cryotherapy; Behavioral: Conventional rehabilitation treatment.; Behavioral: Phased Rehabilitation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07089212

KYLL-202502-012-1

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

  2. 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).

  3. 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

conventional rehabilitation treatment.

Active Comparator group

Description:

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).

Treatment:

Behavioral: Conventional rehabilitation treatment.

Cyclic cryotherapy combined with staged rehabilitation treatment.

Experimental group

Description:

The experimental group received cyclic compression cryotherapy combined with phased rehabilitation training in addition to the conventional rehabilitation program, with a total intervention duration of 12 weeks.

Treatment:

Behavioral: Phased Rehabilitation Training

Device: Cyclic Compression Cryotherapy