Fu's Subcutaneous Needling Treatment for Knee Osteoarthritis

NCT ID: NCT04356651

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2021-01-10

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 .

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fu's subcutaneous needling(FSN)

In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately.

Group Type: EXPERIMENTAL

Fu's subcutaneous needling(FSN)

Intervention Type: PROCEDURE

In this study, physician will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin from anterior superior iliac spine(ASIS) to 1/3 superior border of patella. Then the physician will push forward the needle parallel to the skin surface. The physician will sway the needle 45 times in 30 seconds. After swaying the needle, the physician will instruct the subject to do sole dorsiflexion for 10 seconds resisting the physician's opposite force, then the subject take a rest for 10 seconds. The above actions are 3 repetitions. Then the subject do knee flexion and extension for 10 seconds, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the physician will take out the needle to finish the treatment.

Transcutaneous Electric Nerve Stimulation

In this arm, the subjects will receive the intervention of Transcutaneous Electric Nerve Stimulation on Day1, Day2 and Day4, in the total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finished, the subjects will receive assessments on Day8 and Day15, separately.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electric Nerve Stimulation

Intervention Type: PROCEDURE

Transcutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied at high frequency (\>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (\<10Hz) with an intensity that produces motor contraction.

Interventions

Fu's subcutaneous needling(FSN)

In this study, physician will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin from anterior superior iliac spine(ASIS) to 1/3 superior border of patella. Then the physician will push forward the needle parallel to the skin surface. The physician will sway the needle 45 times in 30 seconds. After swaying the needle, the physician will instruct the subject to do sole dorsiflexion for 10 seconds resisting the physician's opposite force, then the subject take a rest for 10 seconds. The above actions are 3 repetitions. Then the subject do knee flexion and extension for 10 seconds, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the physician will take out the needle to finish the treatment.

Intervention Type: PROCEDURE

Transcutaneous Electric Nerve Stimulation

Transcutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied at high frequency (\>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (\<10Hz) with an intensity that produces motor contraction.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li-Wei Chou

Minister of Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Wei Chou,, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

References

Chiu PE, Fu Z, Sun J, Jian GW, Li TM, Chou LW. Efficacy of Fu's Subcutaneous Needling in Treating Soft Tissue Pain of Knee Osteoarthritis: A Randomized Clinical Trial. J Clin Med. 2022 Dec 2;11(23):7184. doi: 10.3390/jcm11237184.

Reference Type: DERIVED

PMID: 36498758 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34675644 (View on PubMed)

Other Identifiers

CMUH107-REC3-027

Identifier Type: -

Identifier Source: org_study_id