Physiotherapy in Knee Osteoarthritis

Sponsor
Lithuanian Sports University (Other)
Overall Status
Completed
CT.gov ID
NCT05636059
Collaborator
(none)
30
1
3
10
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic exercise
  • Other: Exercise + cryotherapy
  • Other: Exercise + joint mobilization
N/A

Detailed Description

Study included 30 participants with knee osteoarthritis. All subjects were randomly divided into one of 3 groups: exercise group, exercise + cryotherapy group, or exercise + joint mobilization group. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparative Effects of Different Physiotherapy Methods on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Sep 1, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Experimental: 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.

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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline Pain at 18 days [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lithuanian Sports University Kaunas Lithuania

Sponsors and Collaborators

  • Lithuanian Sports University

Investigators

  • Study Director: Vilma DudonienÄ—, PhD, Lithuanian Sports University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lithuanian Sports University
ClinicalTrials.gov Identifier:
NCT05636059
Other Study ID Numbers:
  • LithuanianSportsU-12
First Posted:
Dec 5, 2022
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lithuanian Sports University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2023