Klinische Studien Radar

Numerical rating scale

The NRS is a commonly used pain assessment tool〔42〕, especially for joint pain, such as knee pain. The scale consists of 11 numbers, ranging from 0 to 10, each representing a different level of pain, and the patient chooses the number that best represents his or her current level of pain according to his or her own pain perception.The NRS score is accurate and concise, and was once regarded as the gold standard for pain assessment by the American Pain Society.

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

WOMAC index

According to the 2020 guidelines for the diagnosis and treatment of osteoarthritis of the knee, four types of indexes are recommended to reflect symptoms and signs, quality of life, structural changes in the joints, and long-term regression. Among them, WOMAC is often chosen as the main outcome index of osteoarthritis index based on the study period, which mainly includes five parts: pain, symptoms, ability to perform activities of daily living, motor function, and quality of life, and the scores can be divided into three grades, and the higher WOMAC index indicates the more serious KOA.

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

40m FPWT

The 40m FPWT for the knee is a test that evaluates knee function, lower extremity muscle strength and walking ability〔44〕. The tester uses a stopwatch or timer to accurately record the total time it takes the subject to complete a 40-meter walk. The shorter the time, the better the subject's knee function, lower limb muscle strength and walking ability.

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

RMDQ

The RMDQ is a questionnaire used to assess functional impairment due to low back pain. The scale consists of 24 items with scores ranging from 0-24, with higher scores indicating more significant functional impairme

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

Depressive condition

Clinically significant depressive symptoms were assessed using the HAMD-17.The HAMD-17 consists of 17 entries, with higher scores indicating more severe depression.

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

Anxious situation

The patients' anxiety symptoms were assessed using the HAMA, which consists of 14 entries, with higher scores indicating more severe anxiety.

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

Insomnia Severity Index

The ISI score was used to assess the sleep quality of the patients.The ISI is an assessment of the status of self-perceived insomnia symptoms in the last two weeks.There are seven items with a total score of 0-28.The higher the score, the more severe the insomnia.

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.

Pain self-efficacy questionnaire

PSEQ assesses the impact of pain on patients' daily life, which consists of 10 items scored from 0-60, with higher scores indicating greater self-efficacy.

For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.