Physiotherapy in Knee Osteoarthritis

NCT05636059 | Completed

• 1 other identifier: LithuanianSportsU-12
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee function; womac; quality of life; joint mobilization; physiotherapy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Exercise

EXPERIMENTAL

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.

Other: Therapeutic exercise

Exercise + cryotherapy

EXPERIMENTAL

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.

Other: Exercise + cryotherapy

Exercise + joint mobilization

EXPERIMENTAL

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.

Other: Exercise + joint mobilization

Interventions

Therapeutic exercise 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

Exercise + cryotherapy 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 + cryotherapy

Exercise + joint mobilization 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.

Exercise + joint mobilization

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• stage II of the knee OA;
• affected knee joint;
• pain of at least 3 points on the VAS.

You may not qualify if:

• Severe cardiovascular disease;
• Oncological Disorders;
• Allergy to cold / cold intolerance;
• Impaired lower limbs blood circulation;
• Fear of confined spaces;
• Pregnancy or lactation.

Sponsors & Collaborators

• Lithuanian Sports University: lead

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

Related Publications (1)

• Dudoniene V, Bitinas D, Zlibinaite L. Comparison of three different therapeutic interventions in the management of knee osteoarthritis: Randomized controlled parallel group pilot trial. Osteoarthr Cartil Open. 2025 Oct 17;7(4):100697. doi: 10.1016/j.ocarto.2025.100697. eCollection 2025 Dec.

  PMID: 41211535 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy; Exercise; Cryotherapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vilma Dudonienė, PhD

  Lithuanian Sports University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: April 11, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

LI (1)