The Effect of Dry Needling in Patients With Knee Osteoarthritis

NCT04717167 | Completed

• 1 other identifier: B3000201630444
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Keywords

dry needling; central pain processing; pain; EMG measurements; muscle coactivation; gait pattern

Outcome Measures

Primary Outcomes (9)

• Pain sensation

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

  Change from baseline pain sensation at 15minutes postintervention

• 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.

  Change from baseline pain sensation at 15minutes postintervention

• Pain sensation

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

  Change from baseline pain sensation at 3days postintervention

• 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.

  Change from baseline pain sensation at 3days postintervention

• Pain sensation

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

  Change from 15minutes postintervention pain sensation at 3days postintervention

• 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.

  Change from 15minutes postintervention pain sensation at 3days postintervention

• Pain pressure thresholds

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

  Change from baseline central pain processing at 15minutes postintervention

• Temporal summation

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

  Change from baseline central pain processing at 15minutes postintervention

• Conditioned pain modulation

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

  Change from baseline central pain processing at 15minutes postintervention

Secondary Outcomes (12)

• Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus

  Change from baseline muscle coactivation at 15minutes postintervention

• Muscle coactivation of musculus Vastus medialis and musculus Biceps femoris

  Change from baseline muscle coactivation at 15minutes postintervention

• Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus

  Change from baseline muscle coactivation at 15minutes postintervention

• Muscle coactivation of musculus Vastus lateralis and musculus Biceps femoris

  Change from baseline muscle coactivation at 15minutes postintervention

• Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis

  Change from baseline muscle coactivation at 15minutes postintervention

Study Arms (2)

DN group

EXPERIMENTAL

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.

Other: Dry Needling

Sham needling (SN) group

SHAM COMPARATOR

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.

Other: Sham Needling

Interventions

Dry Needling OTHER

DN group

Sham Needling OTHER

Sham needling (SN) group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Related Publications (1)

• 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.

  PMID: 34821140 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Sophie Vervullens

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: December 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share