Efficacy of Exercise on Post Needling Soreness

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain; Myofascial Pain Syndrome; Post Needling Soreness; Myofascial Trigger Point Pain
• Intervention / Treatment: Other: Eccentric exercise; Other: Concentric exercise.; Other: Isometric exercise.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28003
    • Nicola Sante Diciolla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of at least one latent myofascial trigger point (MTrP) in the medial gastrocnemius muscle.

Exclusion Criteria:

• Other lower limb pathologies which no permit the application of the interventions (e.g. lower limb fractures; sprain in acute phase; etc).
• Active MTrPs in the medial gastrocnemius muscle (related to tendinopathies, plantar fascitis).
• Fibromyalgia.
• Osteosynthesis materials.
• Pregnancy.
• Fear of needles.
• Previous application of dry needling (in gastrocnemius muscles).
• Other treatments of MTrPs during the three months previous to the study (in gastrocnemius muscles).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A. Eccentric exercise.; 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.	Other: Eccentric exercise; The exercise session will consist of 3 sets of 15 reps, 3´´ per rep, with 30'' rest between sets, of the previous treated gastrocnemius muscle (by DN). Each rep will be a pure eccentric contraction.
Experimental: Group B. Concentric exercise.; 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.	Other: Concentric exercise.; The exercise session will consist of 3 sets of 15 reps, 3´´ per rep, with 30'' rest between sets, of the previous treated gastrocnemius muscle (by DN). Each rep will be a pure concentric contraction.
Experimental: Group C. Isometric exercise.; 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.	Other: Isometric exercise.; The exercise session will consist of 3 sets of 15 reps, 3´´ per rep, with 30'' rest between sets, of the previous treated gastrocnemius muscle (by DN). Each rep will be a pure isometric contraction.
No Intervention: Group D. Control.; 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of post needling soreness.	Visual analog scale (VAS) of 100 mm: 0 mm indicates absence of post needling soreness and 100 mm indicates maximum post needling soreness intensity	2 minutes after dry needling, just after exercise session (not for control group), 6 hours after exercise session, 12 hours after exercise session, 24 hours after dry exercise session, 48 hours after exercise session, 72 hours after exercise session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of pressure pain threshold after dry needling.	Analog algometer (kilograms/squared centimeters -kg/cm2-).	2 minutes after dry needling, just after exercise session (not for control group), 24 hours after exercise session, 48 hours after exercise session.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity during dry needling	Visual analog scale (VAS) of 100 mm: 0 mm indicates absence of pain and 100 mm indicates maximum pain intensity.	Before exercise session (i.e. during dry needling).
Pressure pain threshold before dry needling	Analog algometer (kilograms/squared centimeters -kg/cm2-).	Before intervention (i.e. dry needling and exercise session).
Demographic data.	Age (years).	First assessment before intervention (i.e. dry needling and exercise session).
Demographic data.	Gender (male/female).	First assessment before intervention (i.e. dry needling and exercise session).
Anthropometric data.	Height (meters -m-).	First assessment before intervention (i.e. dry needling and exercise session).
Anthropometric data.	Weight (kilograms-kg-).	First assessment before intervention (i.e. dry needling and exercise session).

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Study Director: María Torres Lacomba, PT, PhD, University of Alcalá, Madrid, Spain.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pain; physical therapy; trigger points; dry needling; therapeutic exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CEI/HU/2019/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data (IPD) will be available to those researchers who are interested in researching about the exercise effects on post needling soreness mailing with one of the members of the research group.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Research interest in effects of exercise on post needling soreness.; Ethical Committee approval.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No