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Efficacy of Exercise on Post Needling Soreness

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ClinicalTrials.gov Identifier: NCT04135339
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Nicola Sante Diciolla, University of Alcala

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. 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.


Condition or disease Intervention/treatment Phase
Post Needling Soreness Myofascial Pain Myofascial Pain Syndrome Myofascial Trigger Point Pain Other: Eccentric exercise Other: Concentric exercise. Other: Isometric exercise. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Exercise on Post Needling Soreness
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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-).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135339


Contacts
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Contact: Nicola Sante Diciolla, PT, MSc +34695069558 nicola.s.diciolla@gmail.com

Locations
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Spain
Nicola Sante Diciolla Recruiting
Madrid, Spain, 28003
Contact: Nicola Sante Diciolla, PT, MSc    +34695069558    nicola.s.diciolla@gmail.com   
Sponsors and Collaborators
University of Alcala
Investigators
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Study Director: María Torres Lacomba, PT, PhD University of Alcalá, Madrid, Spain.
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Responsible Party: Nicola Sante Diciolla, Physiotherapist, Master of Sciences, Associate Researcher, University of Alcala
ClinicalTrials.gov Identifier: NCT04135339    
Other Study ID Numbers: CEI/HU/2019/27
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 1 year
Access Criteria:
  • Research interest in effects of exercise on post needling soreness.
  • Ethical Committee approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicola Sante Diciolla, University of Alcala:
pain
trigger points
physical therapy
dry needling
therapeutic exercise
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases