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CompletedNCT03639441Updated Aug 20, 2019

Dry Needling Treatment for Knee Osteoarthritis

An interventional study of dry needling and Transcutaneous electrical nerve stimulation in Knee Osteoarthritis, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The population affected by degenerative knee arthritis is very large. The investigator performed dry needle (DN) treatments with acupuncture needles. This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of dry needle therapy on patellar pain in patients with degenerative arthritis.

Read the 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.

The investigator performed dry needle (DN) treatments with acupuncture needles. Stimulating the effected muscle, the investigator move the needle forward and backward several times. Muscle twitch may occur by our procedure. The pain caused by myofascial trigger points can be decreased effective simultaneously. So far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet.

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 dry 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 dry needle therapy on patellar pain in patients with degenerative arthritis. The assessment tools included the VAS, WOMAC , Lequesnes index, Gait speed test and the Muscle Tension Changes in the Lower Extremities.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • dry needling
  • myofascial trigger point
  • muscle tone
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 33 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Dry needling

    In this arm, the subjects will receive the intervention of DN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.

    Procedure: dry needling

  • Active comparator
    Transcutaneous Electric Nerve Stimulation

    In this arm, the subjects will receive the intervention of Transcutaneous Electric Nerve Stimulation on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.

    Procedure: Transcutaneous electrical nerve stimulation

Interventions

  • Proceduredry needling

    Dry needling, also known as myofascial trigger point dry needling, is an well-proved technique in alternative medicine similar to acupuncture. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. Dry needling is sometimes also known as intramuscular stimulation (IMS).

  • ProcedureTranscutaneous electrical nerve stimulation

    Transcutaneous electrical nerve stimulation (TENS or 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 (\<10 Hz) with an intensity that produces motor contraction.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. Gait speed test

    The measurement method is to ask the patient to walk a distance of four meters, and then the time taken by the tester to measure, take two measurements and take the average value. In this experiment, the function of the patient's walking is mainly measured by this evaluation method. Whether it is improved, if the patient's walking time is reduced, it can effectively prove the patient's exercise performance.

    Time frame: 1 day

07

Study locations

1 site
  • China Medical University Hospital
    Taichung, 999079, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03639441
Lead sponsor
China Medical University Hospital
Responsible party
Li-Wei Chou (Minister of Rehabilitation, China Medical University Hospital) — Principal investigator
First posted
Aug 21, 2018
Start date
Oct 2, 2018
Primary completion
May 7, 2019
Completion
May 21, 2019
Last update
Aug 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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