NCT03639441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 16, 2018

Last Update Submit

August 19, 2019

Conditions

Keywords

dry needlingmyofascial trigger pointmuscle tone

Outcome Measures

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.

    1 day

Secondary Outcomes (3)

  • Pressure Pain Threshold

    1 day

  • Muscle tension

    1 day

  • Gait speed test

    1 day

Study Arms (2)

Dry needling

EXPERIMENTAL

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

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 total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.

Procedure: Transcutaneous electrical nerve stimulation

Interventions

dry needlingPROCEDURE

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).

Dry needling

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.

Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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.
  • People with central or peripheral nerve disease.
  • Cognitive impairment, unable to cooperate with the experimenter.
  • Patients currently receiving other treatments for knee osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 999079, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Dry NeedlingTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesElectric Stimulation TherapyRehabilitationAnalgesiaAnesthesia and Analgesia

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

August 16, 2018

First Posted

August 21, 2018

Study Start

October 2, 2018

Primary Completion

May 7, 2019

Study Completion

May 21, 2019

Last Updated

August 20, 2019

Record last verified: 2018-08

Locations