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Completed

NCT Number: NCT04135339

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nicola Sante Diciolla

Madrid, 28003, Spain

About this study

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

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change of post needling soreness.

    Time frame: 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.

    Visual analog scale (VAS) of 100 mm: 0 mm indicates absence of post needling soreness and 100 mm indicates maximum post needling soreness intensity

Secondary outcomes

  1. Change of pressure pain threshold after dry needling.

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

    Analog algometer (kilograms/squared centimeters -kg/cm2-).

Other outcomes

  1. Pain intensity during dry needling

    Time frame: Before exercise session (i.e. during dry needling).

    Visual analog scale (VAS) of 100 mm: 0 mm indicates absence of pain and 100 mm indicates maximum pain intensity.

  2. Pressure pain threshold before dry needling

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

    Analog algometer (kilograms/squared centimeters -kg/cm2-).

  3. Demographic data.

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

    Age (years).

  4. Demographic data.

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

    Gender (male/female).

  5. Anthropometric data.

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

    Height (meters -m-).

  6. Anthropometric data.

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

    Weight (kilograms-kg-).

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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