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Clinical Trials/NCT05137834
NCT05137834
Completed
N/A

The Effect of Postoperative Rehabilitation With a "Peanut Ball" After Total Knee Replacement. A Randomized Study Evaluating Postoperative Pain and Knee Function.

Region Skane1 site in 1 country300 target enrollmentJanuary 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Region Skane
Enrollment
300
Locations
1
Primary Endpoint
Visual analogue scale (VAS) (0-100)
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

The purpose of this randomized controlled study is to evaluate the effect of postoperative exercise with a "peanut ball" after total knee replacement, on pain, intake of pain killers, knee function, and health-related quality of life.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be included in the study. At baseline, before surgery, all patients will meet a nurse, a physical therapist, and an orthopedic doctor and answer questions about their health condition and do functional tests. Each week is randomized to be either "peanut ball" or standard exercise week, with all patients during that week receiving the same treatment. Thus, depending on what week the patients are operated they will be mobilized with postoperative exercise with a "peanut ball" or to a standard exercise program (no peanut ball) 3-5 times/day for 6 weeks. All patients randomized to exercise with a "peanut ball" will receive a ball for free to bring home. At the ward, the nurses will ask about the patient's pain level two times a day and register all medicines. The physical therapist will introduce the exercise and inform the patients to do the exercise 3-5 times/day a´ 15 minutes and fill in all exercises in an exercise diary. 2 weeks after surgery all patients have a standard visit to a nurse and a physical therapist at the orthopedic department. At this visit, the nurse will register the pain level and all intake of medicine and the physical therapist will measure the range of movement and the sit to stand test. 3 months after surgery all patients have a standard visit to a physical therapist at the orthopedic department. At this visit, all outcomes will be filled in or measured.

Registry
clinicaltrials.gov
Start Date
January 10, 2021
End Date
December 30, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.

Exclusion Criteria

  • Patients who do not understand and talk the Swedish language
  • Patients with dementia
  • Revision surgery of the knee
  • Unicompartmentmental knee replacement

Outcomes

Primary Outcomes

Visual analogue scale (VAS) (0-100)

Time Frame: Change from baseline (before surgery) to 3 months after surgery

The scale is from 0-100 and a higher value is associated with more pain. 0:no pain and 100: most possible pain.

Secondary Outcomes

  • Forgotten Joint Score (FJS)(Change from baseline (before surgery) to 3 months after surgery.)
  • Range of movement(Change from baseline (before surgery) to 3 months after surgery)
  • Knee injury and Osteoarthritis Outcome Score (KOOS-12)(Change from baseline (before surgery) to 3 months after surgery.)
  • Euro Qol-five dimensions, Visual analogue scale (EQ-5D VAS)(Change from baseline (before surgery) to 3 months after surgery.)
  • 30 second sit to stand test(Change from baseline (before surgery) to 3 months after surgery.)

Study Sites (1)

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