ClinicalTrials.gov
ClinicalTrials.gov Menu

Dry Needling Treatment for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03639441
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Li-Wei Chou, China Medical University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: dry needling Procedure: Transcutaneous electrical nerve stimulation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Dry Needling for Knee Osteoarthritis: A Single-Blind and Randomized-Controlled Trial
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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
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).

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

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.





Primary Outcome Measures :
  1. Visual Analog Scales [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Pressure Pain Threshold [ Time Frame: 1 day ]
    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

  2. Muscle tension [ Time Frame: 1 day ]
    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.

  3. Gait speed test [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639441


Contacts
Contact: LI-Wei Chou, PhD +886-4-22052121 ext 2381 chouliwe@mail.cmuh.org.tw
Contact: Ching-Hsuan Huang, MD +886-4-22052121 ext 1205 lauren8.huang@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 999079
Contact: Chou Li-Wei, PhD    +886-4-22052121 ext 2381    chouliwe@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital

Responsible Party: Li-Wei Chou, Minister of Rehabilitation, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03639441     History of Changes
Other Study ID Numbers: CMUH107-REC2-100
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li-Wei Chou, China Medical University Hospital:
dry needling
myofascial trigger point
muscle tone

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases