Clinical trial NCT04717167: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: dry needling
central pain processing
pain
EMG measurements
muscle coactivation
gait pattern
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 61
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain sensation
timeFrame: Change from baseline pain sensation at 15minutes postintervention
measure: Pain sensation
timeFrame: Change from baseline pain sensation at 15minutes postintervention
measure: Pain sensation
timeFrame: Change from baseline pain sensation at 3days postintervention
measure: Pain sensation
timeFrame: Change from baseline pain sensation at 3days postintervention
measure: Pain sensation
timeFrame: Change from 15minutes postintervention pain sensation at 3days postintervention
measure: Pain sensation
timeFrame: Change from 15minutes postintervention pain sensation at 3days postintervention
measure: Pain pressure thresholds
timeFrame: Change from baseline central pain processing at 15minutes postintervention
measure: Temporal summation
timeFrame: Change from baseline central pain processing at 15minutes postintervention
measure: Conditioned pain modulation
timeFrame: Change from baseline central pain processing at 15minutes postintervention
Secondary outcomes:
measure: Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Muscle coactivation of musculus Vastus medialis and musculus Biceps femoris
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Muscle coactivation of musculus Vastus lateralis and musculus Biceps femoris
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius lateralis
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Stride time (seconds)
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Stride length (meters)
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Step time (meters/second)
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Stance phase (%)
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Step length (meters)
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
measure: Step width (meters)
timeFrame: Change from baseline muscle coactivation at 15minutes postintervention
Other outcomes:
Locations:
Study officials:
affiliation: Universiteit Antwerpen
name: Sophie Vervullens
role: PRINCIPAL_INVESTIGATOR
References:
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.