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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05781230
Other study ID # 126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date May 1, 2022

Study information

Verified date March 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity. A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.


Description:

Background: The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity. Methods : A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date May 1, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients had undergone primary unilateral total knee replacement surgery - Patients hospitalized for at least seven days were enrolled in this study. Exclusion Criteria: - Medically stable patients who used glucocorticoids or strong analgesic drugs - Patients had post-traumatic OA, rheumatoid arthritis (RA), psoriatic arthritis, cognitive, hearing and visual problems Patients were diagnosed chronic pain condition were excluded from the study.

Study Design


Intervention

Behavioral:
High Intensity Exercises Program
HIE program consisted of ankle pump exercise, Quadriceps isometric exercise, Terminal extension exercise, Passive-active assistive-active range of motion exercise, Heel sliding exercise, Straight leg raise exercise. All exercises were performed for 3 sets of 15 repetitions.
Low Intensity Exercises Program
LIE program: LIE program was similar to the HIE program. Main differences from the HIE program was repetitions of exercises. All exercises were performed by the patients for 2 sets of 8 repetitions and CPM sessions lasted each exercises session. LIE program took thirty minutes while HIE program lasted sixty minutes. Exercise intensity was monitored using the rating of perceived exertion (RPE) scale, maintaining a range between 6 and 20 RPE (16). PRE< 8 indicates low intensity, PRE>14 indicates high intensity

Locations

Country Name City State
Turkey Merve Karapinar Isparta

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of pain severity . The pain severity evaluated using a visual analogue scale (VAS; scored from 0, no pain, to 100, the worst pain ever). admission to hospital service to discharge from hospital service, an average 5 days
Primary Change of Pressure pain theshold Pressure pain threshold (PPTs) were assessed using a handheld pressure algo-meter admission to hospital service to discharge from hospital service, an average 5 days
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