Efficacy of Exercise on Post Needling Soreness

NCT04135339 | Completed

• 1 other identifier: CEI/HU/2019/27
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To analyse the variables that, a priori, can influence the evolution of pain.

Conditions

Post Needling Soreness; Myofascial Pain; Myofascial Pain Syndrome; Myofascial Trigger Point Pain

Keywords

pain; trigger points; physical therapy; dry needling; therapeutic exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of pressure pain threshold after dry needling.

  2 minutes after dry needling, just after exercise session (not for control group), 24 hours after exercise session, 48 hours after exercise session.

Other Outcomes (6)

• Pain intensity during dry needling

  Before exercise session (i.e. during dry needling).

• Pressure pain threshold before dry needling

  Before intervention (i.e. dry needling and exercise session).

• Demographic data.

  First assessment before intervention (i.e. dry needling and exercise session).

Study Arms (4)

Group A. Eccentric exercise.

EXPERIMENTAL

15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.

Other: Eccentric exercise

Group B. Concentric exercise.

EXPERIMENTAL

15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.

Other: Concentric exercise.

Group C. Isometric exercise.

EXPERIMENTAL

15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.

Other: Isometric exercise.

Group D. Control.

NO INTERVENTION

15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.

Interventions

Eccentric exercise OTHER

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.

Group A. Eccentric exercise.

Concentric exercise. OTHER

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.

Group B. Concentric exercise.

Isometric exercise. OTHER

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.

Group C. Isometric exercise.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Nicola Sante Diciolla

Madrid, 28003, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• María Torres Lacomba, PT, PhD

  University of Alcalá, Madrid, Spain.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Master of Sciences, Associate Researcher

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: October 22, 2019
• Study Start: July 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: September 1, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year
• Access Criteria: * Research interest in effects of exercise on post needling soreness. * Ethical Committee approval.

Locations

ES (1)