Fu's Subcutaneous Needling Treatment for Knee Osteoarthritis

NCT04356651 | Completed

• 1 other identifier: CMUH107-REC3-027
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Fu's subcutaneous needling; myofascial trigger point; muscle tone

Outcome Measures

Primary Outcomes (6)

• Visual Analog Scales

  The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end The right shift indicates more and more pain. Take a pen and let the patient draw a short line vertically on the line, representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases, it can represent the treatment is helpful for the improvement of the patient's pain.

  1 day

• Pressure Pain Threshold

  Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom

  1 day

• Muscle tension

  Muscle tension is the muscle's resistance to passive stretch during resting state. The measuring tool called Myotone will calculate three parameters such as tone, elasticity and stiffness automatically and get a value to represent the muscle tension. If the value decrease, it can represent the treatment is helpful for the subjective muscle relax.

  1 day

• GyKo

  GyKo is an inertial measurement tool for the analysis of the movement of any body segment

  1 day

• WOMAC

  The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).

  1 day

• Lequesne'Index

  A pain scale measures a patient's pain intensity or other features.

  1 day

Study Arms (2)

Fu's subcutaneous needling(FSN)

EXPERIMENTAL

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.

Procedure: Fu's subcutaneous needling(FSN)

Transcutaneous Electric Nerve Stimulation

ACTIVE COMPARATOR

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.

Procedure: Transcutaneous Electric Nerve Stimulation

Interventions

Fu's subcutaneous needling(FSN) 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.

Fu's subcutaneous needling(FSN)

Transcutaneous Electric Nerve Stimulation 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.

Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
• There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 999079, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 36498758 DERIVED

• 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.

  PMID: 34675644 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Li-Wei Chou,, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Minister of Rehabilitation

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: July 7, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 10, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

TW (1)