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CompletedNCT04135339Updated May 12, 2021

Efficacy of Exercise on Post Needling Soreness

An interventional study of Eccentric exercise and Concentric exercise. in Post Needling Soreness, Myofascial Pain and Myofascial Pain Syndrome, sponsored by University of Alcala. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by University of Alcala · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

Read the 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.

02

Conditions studied

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

Keywords

  • pain
  • trigger points
  • physical therapy
  • dry needling
  • therapeutic exercise
03

In context

Myofascial Pain Syndromes

1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's enrollment of 69 is above the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

University of Alcala is the lead sponsor of 123 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Group A. Eccentric exercise.

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

    Other: Eccentric exercise

  • Experimental
    Group B. Concentric exercise.

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

    Other: Concentric exercise.

  • Experimental
    Group C. Isometric exercise.

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

    Other: Isometric exercise.

  • No intervention
    Group D. Control.

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

Interventions

  • OtherEccentric 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.

  • OtherConcentric 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.

  • OtherIsometric 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.

06

What researchers measure

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

    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.

Secondary outcomes

  1. Change of pressure pain threshold after dry needling.

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

    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.

Other outcomes

  1. 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.

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

  2. Pressure pain threshold before dry needling

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

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

  3. Demographic data.

    Age (years).

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

  4. Demographic data.

    Gender (male/female).

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

  5. Anthropometric data.

    Height (meters -m-).

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

  6. Anthropometric data.

    Weight (kilograms-kg-).

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

07

Study locations

1 site
  • Nicola Sante Diciolla
    Madrid, 28003, Spain
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04135339
Lead sponsor
University of Alcala
Responsible party
Nicola Sante Diciolla (Physiotherapist, Master of Sciences, Associate Researcher, University of Alcala) — Principal investigator
First posted
Oct 22, 2019
Start date
Jul 1, 2019
Primary completion
Oct 31, 2019
Completion
Sep 1, 2020
Last update
May 12, 2021

Study contacts

María Torres Lacomba, PT, PhD
study director · University of Alcalá, Madrid, Spain.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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