Back to resultsPhysiotherapy in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Therapeutic exercise
Exercise + cryotherapy
Exercise + joint mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee function, womac, quality of life, joint mobilization, physiotherapy
Eligibility Criteria
Inclusion Criteria: stage II of the knee OA; affected knee joint; pain of at least 3 points on the VAS. Exclusion Criteria: Severe cardiovascular disease; Oncological Disorders; Allergy to cold / cold intolerance; Impaired lower limbs blood circulation; Fear of confined spaces; Pregnancy or lactation.
Sites / Locations
- Lithuanian Sports University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Exercise
Exercise + cryotherapy
Exercise + joint mobilization
Arm Description
32 sessions in total, 2 times a day, 30 min. one session. Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Exercise program - 16 sessions in total, once a day, 30 min. one session. Cryotherapy - 8 sessions in total, two-three times a week, one session - 2 min. duration, temperature -60 to -140 C degrees. Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Exercise program - 16 sessions in total, once a day, 30 min. one session, two-three times a week. Joint mobilization - 8 sessions in total, anterior - posterior tibia femoral glide, patella motion, lateral and medial movement. Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Outcomes
Primary Outcome Measures
Change from baseline Pain at 18 days
Pain was assessed using a visual analogue scale (VAS) that used a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the VAS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.
Change from baseline Quality of Life at 18 days
The SF-36 quality of life questionnaire is used to assess health-related quality of life. The questionnaire consists of 36 questions and reflects 8 areas of life: physical activity, activity limitation due to physical ailments and/or emotional disorders, social relationships, emotional state, energy and vitality, pain, general health assessment. The questionnaire can be completed by the subject or by a specialist conducting the study. Answers are scored. Numerical value of each area from 0 to 100 points. The more points collected, the better the quality of life. Test reliability is 0.791.
Change from baseline Knee Ranges of Motions at 18 days
Using goniometer the range of knee motions were evaluated: flexion, extension. Each motion was measured three times and averaged value was used.
Change from baseline Knee Muscle Strength at 18 days
The muscle strength of knee flexion and extension was evaluated using manual muscle testing technique (Oxford 5 point scale).
Change from baseline Knee Health Status at 18 days
Self-administered Western Ontario and McMaster Universities (WOMAC) index was used to to quantify the health status of patients with knee osteoarthritis. It is the most common used clinical tools for evaluating patients with knee OA. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living.
Secondary Outcome Measures
Full Information
NCT ID
NCT05636059
First Posted
November 23, 2022
Last Updated
April 19, 2023
Sponsor
Lithuanian Sports University
1. Study Identification
Unique Protocol Identification Number
NCT05636059
Brief Title
Physiotherapy in Knee Osteoarthritis
Official Title
Comparative Effects of Different Physiotherapy Methods on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
April 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Osteoarthritis symptoms can be managed with non-drug treatments such as patient education, exercise or weight loss interventions. Cryotherapy is one of the effective method to reduce joint inflammation, pain and improve function. Another method is joint mobilization, which can also reduce pain and improve function. Based on this theory, it was hypothesized that cryotherapy will have better effect on pain and the quality of life, whereas joint mobilization will be more effective on knee function. The aim of the study was to compare the effects of different physiotherapy methods on pain, knee joint function and quality of life in individuals with osteoarthritis.
Detailed Description
Study included 63 participants with knee osteoarthritis. All subjects were randomly assigned to one of 3 groups: exercise group (n=21), exercise + cryotherapy group (n=21), or exercise + joint mobilization group (n=21). VAS scale was used to assess the pain, quality of life was evaluated with Short Form 36 Health Survey Questionnaire (SF-36) questionnaire, knee ranges of motion were measured using a goniometer, strength of the muscles was assessed on the Oxford 5 point scale, The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to evaluate knee osteoarthritis. All the participants received 30 intervention sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee function, womac, quality of life, joint mobilization, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
32 sessions in total, 2 times a day, 30 min. one session. Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Arm Title
Exercise + cryotherapy
Arm Type
Experimental
Arm Description
Exercise program - 16 sessions in total, once a day, 30 min. one session. Cryotherapy - 8 sessions in total, two-three times a week, one session - 2 min. duration, temperature -60 to -140 C degrees.
Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Arm Title
Exercise + joint mobilization
Arm Type
Experimental
Arm Description
Exercise program - 16 sessions in total, once a day, 30 min. one session, two-three times a week.
Joint mobilization - 8 sessions in total, anterior - posterior tibia femoral glide, patella motion, lateral and medial movement.
Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
32 sessions in total, 2 times a day, 30 min. one session. Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Intervention Type
Other
Intervention Name(s)
Exercise + cryotherapy
Intervention Description
Exercise program - 16 sessions in total, once a day, 30 min. one session. Cryotherapy - 8 sessions in total, two-three times a week, one session - 2 min. duration, temperature -60 to -140 C degrees.
Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Intervention Type
Other
Intervention Name(s)
Exercise + joint mobilization
Intervention Description
Exercise program - 16 sessions in total, once a day, 30 min. one session, two-three times a week.
Joint mobilization - 8 sessions in total, anterior - posterior tibia femoral glide, patella motion, lateral and medial movement.
Exercise program consisted of: cycling stationary bike, isometric and isotonic exercise for knee flexion / extension, hip flexion / extension / abduction / adduction, exercise with resistance bands, weights, and gymnastic ball.
Primary Outcome Measure Information:
Title
Change from baseline Pain at 18 days
Description
Pain was assessed using a visual analogue scale (VAS) that used a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the VAS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.
Time Frame
Baseline and after 18 days
Title
Change from baseline Quality of Life at 18 days
Description
The SF-36 quality of life questionnaire is used to assess health-related quality of life. The questionnaire consists of 36 questions and reflects 8 areas of life: physical activity, activity limitation due to physical ailments and/or emotional disorders, social relationships, emotional state, energy and vitality, pain, general health assessment. The questionnaire can be completed by the subject or by a specialist conducting the study. Answers are scored. Numerical value of each area from 0 to 100 points. The more points collected, the better the quality of life. Test reliability is 0.791.
Time Frame
Baseline and after 18 days
Title
Change from baseline Knee Ranges of Motions at 18 days
Description
Using goniometer the range of knee motions were evaluated: flexion, extension. Each motion was measured three times and averaged value was used.
Time Frame
Baseline and after 18 days
Title
Change from baseline Knee Muscle Strength at 18 days
Description
The muscle strength of knee flexion and extension was evaluated using manual muscle testing technique (Oxford 5 point scale).
Time Frame
Baseline and after 18 days
Title
Change from baseline Knee Health Status at 18 days
Description
Self-administered Western Ontario and McMaster Universities (WOMAC) index was used to to quantify the health status of patients with knee osteoarthritis. It is the most common used clinical tools for evaluating patients with knee OA. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living.
Time Frame
Baseline and after 18 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stage II of the knee OA;
affected knee joint;
pain of at least 3 points on the VAS.
Exclusion Criteria:
Severe cardiovascular disease;
Oncological Disorders;
Allergy to cold / cold intolerance;
Impaired lower limbs blood circulation;
Fear of confined spaces;
Pregnancy or lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Dudonienė, PhD
Organizational Affiliation
Lithuanian Sports University
Official's Role
Study Director
Facility Information:
Facility Name
Lithuanian Sports University
City
Kaunas
Country
Lithuania
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy in Knee Osteoarthritis
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