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The Effect of Dry Needling in Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry Needling
Sham Needling
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring dry needling, central pain processing, pain, EMG measurements, muscle coactivation, gait pattern

Eligibility Criteria

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

Inclusion Criteria:

  • A minimum age of fifty years old;
  • Diagnosed with KOA based on the American College of Rheumatology (ACR) clinical classification criteria(48), including:

    • A Kellgren-Lawrence grade of minimum two on radiography;
    • At least three months of chronical knee pain.

Exclusion Criteria:

  • Patients suffering from autoimmune and/or neurological disorders
  • Patients who had a major trauma/fracture of the lower limb in the past six months -
  • Patients who experienced other musculoskeletal problems than OA

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    DN group

    Sham needling (SN) group

    Arm Description

    All identified MTrPs were inserted with a sterile filiform needle (0,30mm x 40mm or 0,30mm x 75mm, depending on the muscle) that moved up- and downwards until a local twitch response was elicited. When the repeated local twitch response fade away or the subject reported too much pain, the needle was removed. After the treatment, a 15 minutes break(51) was set up and the subjects were not permitted to use a hot pack or to stretch the muscle.

    The SN technique was similar to DN, except for penetrating the muscle. In this technique, the needle only penetrated the skin and was therefore impossible to provoke a local twitch response.

    Outcomes

    Primary Outcome Measures

    Pain sensation
    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
    Pain sensation
    Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
    Pain sensation
    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
    Pain sensation
    Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
    Pain sensation
    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
    Pain sensation
    Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
    Pain pressure thresholds
    Measured with an digital algometer (kilogram force/ square cm)
    Temporal summation
    Measured with an digital algometer (kilogram force/ square cm)
    Conditioned pain modulation
    Measured with an digital algometer (test stimulus) and an inflatable cuff (conditioning stimulus). (kilogram force/ square cm)

    Secondary Outcome Measures

    Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Muscle coactivation of musculus Vastus medialis and musculus Biceps femoris
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Muscle coactivation of musculus Vastus lateralis and musculus Biceps femoris
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius lateralis
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Stride time (seconds)
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Stride length (meters)
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Step time (meters/second)
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Stance phase (%)
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Step length (meters)
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Step width (meters)
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.

    Full Information

    First Posted
    January 13, 2021
    Last Updated
    January 18, 2021
    Sponsor
    Universiteit Antwerpen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04717167
    Brief Title
    The Effect of Dry Needling in Patients With Knee Osteoarthritis
    Official Title
    The Effect of One Dry Needling Session on Pain and Central Pain Processing in Patients With Knee Osteoarthritis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    April 1, 2019 (Actual)
    Study Completion Date
    April 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universiteit Antwerpen

    4. Oversight

    5. Study Description

    Brief Summary
    Research suggests that myofascial trigger points (MTrP) play an important role in explaining pain in patients with musculoskeletal knee disorders. Trigger points are usually defined as hypersensitive tender spots within taut bands of skeletal muscles that are painful on muscle stimulation and that usually elicit referred pain. Treatment of these trigger points could possibly alleviate symptoms in patients with knee pain. However, literature on the effect of trigger point therapy, dry needling in particular, in patients with musculoskeletal knee disorders is scarce. The purpose of this study is to examine the effect of trigger point therapy (dry needling (DN)) on pain, presence of altered central pain processing, muscle features and gait pattern in patients with knee osteoarthritis (KOA). 60 patients with symptomatic KOA will participate in this study. They will randomly be allocated in either an experimental group (EG) (dry needling technique) or a placebo group (PG) (sham needling technique). Pain (Visual analogue scale (VAS) & KOA outcome score (KOOS), muscle features during gait and gait pattern (3D gait analysis and surface electroMyoGraphy (EMG)) and presence of altered central pain processing (Central Sensitization Inventory (CSI), Quantitative Sensory testing (QST)) will be measured at baseline and 15 minutes after the intervention. Additionally, pain will be measured 3 days after the intervention. The investigators hypothesize that the effect on the outcome measures will be significantly larger in the EG compared to the PG.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    dry needling, central pain processing, pain, EMG measurements, muscle coactivation, gait pattern

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    One group will receive dry needling session and one group will receive placebo treatment. A simple randomization on a website (www.randomizer.org) performed by a researcher (IB), independent from the executive researchers.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    A double-blinded study was achieved by giving no information about the assigned intervention to the executive researchers; and only the same general explanation about the intervention type to the subjects (Appendix A). Moreover, subjects were prohibited to see the needling-intervention. The group allocation was solely known by the treating therapists and the independent researcher (IB).
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DN group
    Arm Type
    Experimental
    Arm Description
    All identified MTrPs were inserted with a sterile filiform needle (0,30mm x 40mm or 0,30mm x 75mm, depending on the muscle) that moved up- and downwards until a local twitch response was elicited. When the repeated local twitch response fade away or the subject reported too much pain, the needle was removed. After the treatment, a 15 minutes break(51) was set up and the subjects were not permitted to use a hot pack or to stretch the muscle.
    Arm Title
    Sham needling (SN) group
    Arm Type
    Sham Comparator
    Arm Description
    The SN technique was similar to DN, except for penetrating the muscle. In this technique, the needle only penetrated the skin and was therefore impossible to provoke a local twitch response.
    Intervention Type
    Other
    Intervention Name(s)
    Dry Needling
    Intervention Type
    Other
    Intervention Name(s)
    Sham Needling
    Primary Outcome Measure Information:
    Title
    Pain sensation
    Description
    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
    Time Frame
    Change from baseline pain sensation at 15minutes postintervention
    Title
    Pain sensation
    Description
    Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
    Time Frame
    Change from baseline pain sensation at 15minutes postintervention
    Title
    Pain sensation
    Description
    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
    Time Frame
    Change from baseline pain sensation at 3days postintervention
    Title
    Pain sensation
    Description
    Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
    Time Frame
    Change from baseline pain sensation at 3days postintervention
    Title
    Pain sensation
    Description
    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
    Time Frame
    Change from 15minutes postintervention pain sensation at 3days postintervention
    Title
    Pain sensation
    Description
    Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
    Time Frame
    Change from 15minutes postintervention pain sensation at 3days postintervention
    Title
    Pain pressure thresholds
    Description
    Measured with an digital algometer (kilogram force/ square cm)
    Time Frame
    Change from baseline central pain processing at 15minutes postintervention
    Title
    Temporal summation
    Description
    Measured with an digital algometer (kilogram force/ square cm)
    Time Frame
    Change from baseline central pain processing at 15minutes postintervention
    Title
    Conditioned pain modulation
    Description
    Measured with an digital algometer (test stimulus) and an inflatable cuff (conditioning stimulus). (kilogram force/ square cm)
    Time Frame
    Change from baseline central pain processing at 15minutes postintervention
    Secondary Outcome Measure Information:
    Title
    Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus
    Description
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Muscle coactivation of musculus Vastus medialis and musculus Biceps femoris
    Description
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus
    Description
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Muscle coactivation of musculus Vastus lateralis and musculus Biceps femoris
    Description
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis
    Description
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius lateralis
    Description
    Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Stride time (seconds)
    Description
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Stride length (meters)
    Description
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Step time (meters/second)
    Description
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Stance phase (%)
    Description
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Step length (meters)
    Description
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention
    Title
    Step width (meters)
    Description
    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
    Time Frame
    Change from baseline muscle coactivation at 15minutes postintervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A minimum age of fifty years old; Diagnosed with KOA based on the American College of Rheumatology (ACR) clinical classification criteria(48), including: A Kellgren-Lawrence grade of minimum two on radiography; At least three months of chronical knee pain. Exclusion Criteria: Patients suffering from autoimmune and/or neurological disorders Patients who had a major trauma/fracture of the lower limb in the past six months - Patients who experienced other musculoskeletal problems than OA
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sophie Vervullens
    Organizational Affiliation
    Universiteit Antwerpen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34821140
    Citation
    Vervullens S, Meert L, Baert I, Delrue N, Heusdens CHW, Hallemans A, Van Criekinge T, Smeets RJEM, De Meulemeester K. The effect of one dry needling session on pain, central pain processing, muscle co-contraction and gait characteristics in patients with knee osteoarthritis: a randomized controlled trial. Scand J Pain. 2021 Sep 30;22(2):396-409. doi: 10.1515/sjpain-2021-0091. Print 2022 Apr 26.
    Results Reference
    derived

    Learn more about this trial

    The Effect of Dry Needling in Patients With Knee Osteoarthritis

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