The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia

NCT05781230 | Completed

• 1 other identifier: 126
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Pain, Acute

Keywords

Total Knee Arthroplasty; Exercises intensity; pressure pain threshold; exercise-induced hypoalgesia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

HIE program

EXPERIMENTAL

HIE program ; High Intensity Exercises Program. 3 sets of 15 repetition

Behavioral: High Intensity Exercises Program; Behavioral: Low Intensity Exercises Program

LIE Program

EXPERIMENTAL

Low Intensity Exercises program 2 sets of 8 repetition

Behavioral: High Intensity Exercises Program; Behavioral: Low Intensity Exercises Program

Interventions

High Intensity Exercises Program BEHAVIORAL

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.

HIE program; LIE Program

Low Intensity Exercises Program BEHAVIORAL

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

HIE program; LIE Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients had undergone primary unilateral total knee replacement surgery
• Patients hospitalized for at least seven days were enrolled in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Merve Karapinar

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Acute Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MERVE KARAPINAR, PT

  RESEARCH ASSİSSTANT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were block-randomized based on intensity of exercises. The randomization sequence was produced by an external investigator using a computer-generated randomization sequence (Microsoft Excel, Microsoft, Redmond, WA, USA) to generate either a 0 or 1, corresponding with high intensity exercises or low intensity exercises, respectively
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 23, 2023
• Study Start: January 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 1, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

TU (1)