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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05659849
Other study ID # UT-217-68-2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 16, 2022
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source University of Tabuk
Contact DR SHAHUL HAMEED PAKKIR MOHAMED, PHD
Phone +966502958236
Email s-mohamed@ut.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the short-term effectiveness of manual therapy with neuromuscular training and conventional physical therapy with neuromuscular training in patients with knee osteoarthritis.


Description:

Knee osteoarthritis (OA) is a major public health problem, characterized by progressive degeneration and loss of articular cartilage, resulting in pain, limitation of movement, imbalance, functional disability, and diminished patient quality of life. Regular participation in physical activity has been recognized for several years as being beneficial in the management of knee OA. The role and effectiveness of manual therapy techniques and conventional physical therapy are evident from the existing literature, but no comparison was found for the combination of neuromuscular training (NMT) in patients with knee OA. Thus, the aim of this study is to compare the short-term effectiveness of manual therapy (MT) versus conventional physical therapy (CPT) with NMT in the management of knee OA after six weeks of treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Complaining of knee pain that has lasted longer than 3 months. - Pain level that is medium (pain score greater than or equal to 4). - No knee injuries. - Treatment not received in another physical therapy clinic in the past three months. - Painful range of motion in the knee. Exclusion Criteria: - History of knee surgery - A systemic arthritic condition - Any other muscular, joint, or neurological condition affecting lower limb function. - Received physical therapy or an intra-articular injection in the knee within the past 3 months.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Manual therapy techniques
Passive joint mobilization techniques are applied to the affected knee joint. For the first week (three sessions), the joint mobilization exercises included grade I or II rhythmic oscillations. During the following weeks, grade III or IV oscillation techniques were applied, depending on the level of tolerance and pain of each patient. In knee distraction, the patients are in a prone position with 50° knee flexion, and the physical therapist applies the techniques. The dorsal and ventral glides was performed with the patient in a supine position.
Device:
Transcutaneous Electrical Nerve Stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS) therapy treats pain using low-voltage electric currents. A small device administers the electrical current to or near nerves. TENS treatment inhibits or changes pain perception.

Locations

Country Name City State
Saudi Arabia University of Tabuk Tabuk North West

Sponsors (1)

Lead Sponsor Collaborator
University of Tabuk

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale The average pain intensity over the last week at the time of testing was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible. 6 weeks
Primary Goniometric measurement for ROM To check the range of motion (ROM) of the knee joint, the joint will be extended as far as it can go while the person is lying on their back three times. The angle at the maximum flexion position was measured with a goniometer, and the average angle was recorded. 6 weeks
Primary Western Ontario and Mc Master Osteoarthritis Index (WOMAC) It is a questionnaire for the evaluation of treatment results in patients with lower extremity osteoarthritis, and it divides difficulties in daily living into scales. WOMAC scores are recorded on a five-point Likert scale of 0-4, where 0 = no pain or limitation, 1 = mild pain or limitation, 2 = moderate pain or limitation, 3 = severe pain or limitation, and 4 = extreme pain or limitation. Maximum scores for pain, stiffness and physical functions were 20, 8, and 68, respectively, with total scores of 96 indicating greater disease severities. 6 weeks
Primary Short-Form Health Survey (SF-36) This instrument consists of 36 items, grouped into eight domains: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, and mental health. A measurement scale with values ranging from 0 (the worst health status) to 100 (the best health status) was used to give each subject and each of the eight dimensions a score. 6 weeks
Primary Single-leg stance time test This test has been used to assess static standing balance in individuals with knee OA. The single-leg stance test was measured by recording the time in seconds (30s maximum) while participants are asked to balance on one leg while keeping their hands on their hips. The test starts when the free foot lifts off the ground and is stopped if: (1) the swing limb touches the ground; (2) the stance foot moves on the floor; (3) the swing foot touches the tested limb; or (4) the hands move away from the hips. 6 weeks
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