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Completed

NCT Number: NCT04717167

The Effect of Dry Needling in Patients With Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Other

Sham Needling

Other

Primary outcomes

  1. Pain sensation

    Time frame: Change from baseline pain sensation at 15minutes postintervention

    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.

  2. Pain sensation

    Time frame: Change from baseline pain sensation at 15minutes postintervention

    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.

  3. Pain sensation

    Time frame: Change from baseline pain sensation at 3days postintervention

    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.

  4. Pain sensation

    Time frame: Change from baseline pain sensation at 3days postintervention

    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.

  5. Pain sensation

    Time frame: Change from 15minutes postintervention pain sensation at 3days postintervention

    Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.

  6. Pain sensation

    Time frame: Change from 15minutes postintervention pain sensation at 3days postintervention

    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.

  7. Pain pressure thresholds

    Time frame: Change from baseline central pain processing at 15minutes postintervention

    Measured with an digital algometer (kilogram force/ square cm)

  8. Temporal summation

    Time frame: Change from baseline central pain processing at 15minutes postintervention

    Measured with an digital algometer (kilogram force/ square cm)

  9. Conditioned pain modulation

    Time frame: Change from baseline central pain processing at 15minutes postintervention

    Measured with an digital algometer (test stimulus) and an inflatable cuff (conditioning stimulus). (kilogram force/ square cm)

Secondary outcomes

  1. Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    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.

  2. Muscle coactivation of musculus Vastus medialis and musculus Biceps femoris

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    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.

  3. Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    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.

  4. Muscle coactivation of musculus Vastus lateralis and musculus Biceps femoris

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    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.

  5. Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    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.

  6. Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius lateralis

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    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.

  7. Stride time (seconds)

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.

  8. Stride length (meters)

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.

  9. Step time (meters/second)

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.

  10. Stance phase (%)

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.

  11. Step length (meters)

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.

  12. Step width (meters)

    Time frame: Change from baseline muscle coactivation at 15minutes postintervention

    measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Official study title

The Effect of One Dry Needling Session on Pain and Central Pain Processing in Patients With Knee Osteoarthritis: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 20, 2021
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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