Physiotherapy in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Comparative Effects of Different Physiotherapy Methods on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05636059
• Other study ID #: LithuanianSportsU-12
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 11, 2023

Study information

• Verified date: April 2023
• Source: Lithuanian Sports University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 11, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Therapeutic exercise
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 + cryotherapy
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 + joint mobilization
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.

Locations

Country	Name	City	State
Lithuania	Lithuanian Sports University	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian Sports University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and after 18 days
Primary	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.	Baseline and after 18 days
Primary	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.	Baseline and after 18 days
Primary	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).	Baseline and after 18 days
Primary	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.	Baseline and after 18 days