The Effect of Dry Needling in Patients With Knee Osteoarthritis

NCT ID: NCT04717167

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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).

Study Groups

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DN group

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.

Group Type EXPERIMENTAL

Dry Needling

Intervention Type OTHER

Sham needling (SN) group

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.

Group Type SHAM_COMPARATOR

Sham Needling

Intervention Type OTHER

Interventions

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Dry Needling

Intervention Type OTHER

Sham Needling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Sophie Vervullens

Doctoral Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sophie Vervullens

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

References

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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.

Reference Type DERIVED
PMID: 34821140 (View on PubMed)

Other Identifiers

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B3000201630444

Identifier Type: -

Identifier Source: org_study_id

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