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Dry Needling Treatment for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
dry needling
Transcutaneous electrical nerve stimulation
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring dry needling, myofascial trigger point, muscle tone

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling

Transcutaneous Electric Nerve Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
August 16, 2018
Last Updated
August 19, 2019
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03639441
Brief Title
Dry Needling Treatment for Knee Osteoarthritis
Official Title
Efficacy of Dry Needling for Knee Osteoarthritis: A Single-Blind and Randomized-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
dry needling, myofascial trigger point, muscle tone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcutaneous Electric Nerve Stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
dry needling
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
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 Measure Information:
Title
Visual Analog Scales
Description
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 Outcome Measure Information:
Title
Pressure Pain Threshold
Description
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
Title
Muscle tension
Description
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
Title
Gait speed test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteers who are older than 50 years old and can cooperate with the experiment Established diagnosis of unilateral or bilateral degenerative knee arthritis. 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: 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. People with central or peripheral nerve disease. Cognitive impairment, unable to cooperate with the experimenter. Patients currently receiving other treatments for knee osteoarthritis
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
999079
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dry Needling Treatment for Knee Osteoarthritis

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