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Completed

NCT Number: NCT05636059

Physiotherapy in Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian Sports University

Kaunas, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 + 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 + 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.

Primary outcomes

  1. Change from baseline Pain at 18 days

    Time frame: Baseline and after 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.

  2. Change from baseline Quality of Life at 18 days

    Time frame: Baseline and after 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.

  3. Change from baseline Knee Ranges of Motions at 18 days

    Time frame: Baseline and after 18 days

    Using goniometer the range of knee motions were evaluated: flexion, extension. Each motion was measured three times and averaged value was used.

  4. Change from baseline Knee Muscle Strength at 18 days

    Time frame: Baseline and after 18 days

    The muscle strength of knee flexion and extension was evaluated using manual muscle testing technique (Oxford 5 point scale).

  5. Change from baseline Knee Health Status at 18 days

    Time frame: Baseline and after 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.

Sponsors and collaborators

Lead sponsor

Lithuanian Sports University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Dec 5, 2022
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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