Physiotherapy in Knee Osteoarthritis

NCT ID: NCT05636059

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-04-11

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic exercise

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Exercise + cryotherapy

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Exercise + joint mobilization

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian Sports University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vilma Dudonienė, PhD

Role: STUDY_DIRECTOR

Lithuanian Sports University

Locations

Lithuanian Sports University

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

LithuanianSportsU-12

Identifier Type: -

Identifier Source: org_study_id