Clinical trial NCT04356651: Fu's Subcutaneous Needling Treatment for Knee Osteoarthritis
Official title: Efficacy of Fu's Subcutaneous Needling for Knee Osteoarthritis: a Single-blind and Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Fu's subcutaneous needling
myofascial trigger point
muscle tone
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The population affected by degenerative knee arthritis is very large. The investigator performed Fu's subcutaneous needling (FSN). This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling (FSN) therapy on patellar pain in patients with degenerative arthritis.

Detailed description: The population affected by degenerative knee arthritis is very large. According to a survey conducted by the Ministry of Health and Welfare, the prevalence of osteoarthritis of the knee in Taiwan is about 3.5 million people, accounting for about 15% of the total population. Its effects are a heavy burden on socio-economic costs, and in addition to being included in medical expenses, serious cases can lead to incapacity to work; therefore, the disease is an important factor in causing disability and disability First, it is worth our attention.

Floating needle is a kind of dry needle therapy, which has been used in the treatment of degenerative arthritis for more than 20 years. It has been clearly annotated in the treatment strategy that it uses disposable floating needle needles at the superficial subcutaneous fascia, Parallel to the muscle to sweep away, and with reperfusion activities, muscle pain caused by muscle fascia and soft tissue pain with immediate and good pain relief effect, but still lack of treatment and rigorous evaluation of the establishment.

For the reasons of the degenerative arthritis pain, the clinical observation is not entirely due to the cause of joint deformity or cartilage damage, soft tissue lesions around the knee is also a common source of pain, the use of floating needle for the diagnosis of soft tissue injury , And observed its efficacy, which is also the core of this study.

This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of floating needle therapy on patellar pain in patients with degenerative arthritis. The assessment tools included the VAS, WOMAC , Lesquesne index, the Muscle Tension Changes in the Lower Extremities, and Gyko .

Eligibility criteria: Inclusion Criteria:

- 1.Volunteers who are older than 50 years old and can cooperate with the experiment.

2.Established diagnosis of unilateral or bilateral degenerative knee arthritis. 3.There is a local trigger point around the unilateral or bilateral knee joint which on the muscle of Vastus lateralis, Vastus medialis, Gastrocnemius, or Tibialis anterior.

Exclusion Criteria:

* 1.There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.

  2.There has been a history of drug abuse (including excess alcohol) that affects pain assessors.

  3.Have received knee surgery. 4.People with central or peripheral nerve disease. 5.Cognitive impairment, unable to cooperate with the experimenter. 6.Patients currently receiving other treatments for knee osteoarthritis

Primary outcomes:
measure: Visual Analog Scales
timeFrame: 1 day
measure: Pressure Pain Threshold
timeFrame: 1 day
measure: Muscle tension
timeFrame: 1 day
measure: GyKo
timeFrame: 1 day
measure: WOMAC
timeFrame: 1 day
measure: Lequesne'Index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Li-Wei Chou,, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiu PE, Fu Z, Jian GW, Huang CH, Li TM, Chou LW. Evaluating Effectiveness of Fu's Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial. J Pain Res. 2021 Oct 9;14:3163-3172. doi: 10.2147/JPR.S333299. eCollection 2021.