NCT04135339

Efficacy of Exercise on Post Needling Soreness

Completed NA Last updated 12 May 2021

What this trial tests

NA trial testing Eccentric exercise in Post Needling Soreness in 69 participants. Completed in 1 September 2020.

Timeline

1 July 2019

Primary endpoint
31 October 2019

1 September 2020

Quick facts

Lead sponsor	University of Alcala
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	69
Start date	1 July 2019
Primary completion	31 October 2019
Estimated completion	1 September 2020
Sites	1 location across Spain

Drugs / interventions tested

• Eccentric exercise
• Concentric exercise.
• Isometric exercise.

Conditions studied

• Post Needling Soreness — all drugs for Post Needling Soreness →
• Myofascial Pain — all drugs for Myofascial Pain →
• Myofascial Pain Syndrome — all drugs for Myofascial Pain Syndrome →
• Myofascial Trigger Point Pain — all drugs for Myofascial Trigger Point Pain →

Sponsor

University of Alcala

Who can join

18 and older, any sex, with Post Needling Soreness or Myofascial Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction. The myofascial trigger point (MTrP) is a clinical entity related to different clinical pictures of pain. Dry needling (DN) would be the most appropriate therapeutic option for its treatment, although it has mild-moderate adverse effects, such as post-needling soreness (PNS). The exercise could be a strategy for its management, but no recommendations on the most effective mode have been found.

Objectives

1. To determine the effectiveness of the exercise, differentiated according to the dominant mode (concentric, eccentric, isometric), in order to reduce the PNS of latent MTrPs.
2. To analyse the variables that, a priori, can influence the evolution of pain.

Methods. Study design .A randomized clinical trial. Scenario Private or home-based consultation in Global Physiotherapy, Madrid, Spain.

Participants. Voluntaries, with no symptoms in the triceps surae muscle,\>18 years old, who present at least one latent MTrP in medial gastrocnemius. Subjects with: other pathologies of lower limbs, active MTrP in the medial gastrocnemius muscle, contraindications to DN, prior application of DN and/or other therapies in MTrPs during the three months previous to the study (in gastrocnemius muscles) will be excluded.

Intervention After DN of the medial gastrocnemius muscle, participants will be randomly allocated to four groups (three experimental groups and one control). In the experimental groups, subjects will be instructed to perform exercise protocols, differentiated according to the dominant contraction (concentric, eccentric, isometric) in muscle the gastrocnemius previously treated.

Outcome measures. Pain intensity, by analog visual scale (VAS). Pressure pain threshold (PPT), by analog algometer. Demographics and anthropometrics.

Protocol. Before and immediately after DN, the PPT will be evaluated in the latent MTrP. Pain intensity will also be assessed using VAS at two times: the first referred to pain during DN and the other referred to PNS two minutes after DN. The subjects will then be randomly divided into: a control group without any intervention after DN, and three experimental groups with different exercise protocols (differentiated by the dominant contraction: 3 sets x 15 reps, 3s each contraction, 30s of rest between sets) . The pain intensity will be recorded again by VAS, after the exercise session and at 6h, 12h, 24h, 48h, 72h after DN. PPT will also be assessed 2min after DN, after the exercise session and at 24h, and 48h after DN.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of Exercise on Postneedling Soreness: A Randomized Controlled Trial.
   Diciolla NS, Pérez-Clemente C, Cámara-Caballero M, Matienzo-Barreto A, et al · · 2021 · cited 4× · PMID 34884230 · DOI 10.3390/jcm10235527