Efficacy of Exercise on Post Needling Soreness
Primary Purpose
Post Needling Soreness, Myofascial Pain, Myofascial Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Eccentric exercise
Concentric exercise.
Isometric exercise.
Sponsored by
About this trial
This is an interventional treatment trial for Post Needling Soreness focused on measuring pain, trigger points, physical therapy, dry needling, therapeutic exercise
Eligibility 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).
Sites / Locations
- Nicola Sante Diciolla
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Group A. Eccentric exercise.
Group B. Concentric exercise.
Group C. Isometric exercise.
Group D. Control.
Arm Description
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change of pressure pain threshold after dry needling.
Analog algometer (kilograms/squared centimeters -kg/cm2-).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04135339
Brief Title
Efficacy of Exercise on Post Needling Soreness
Official Title
Efficacy of Exercise on Post Needling Soreness
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Needling Soreness, Myofascial Pain, Myofascial Pain Syndrome, Myofascial Trigger Point Pain
Keywords
pain, trigger points, physical therapy, dry needling, therapeutic exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A. Eccentric exercise.
Arm Type
Experimental
Arm Description
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
Arm Title
Group B. Concentric exercise.
Arm Type
Experimental
Arm Description
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
Arm Title
Group C. Isometric exercise.
Arm Type
Experimental
Arm Description
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
Arm Title
Group D. Control.
Arm Type
No Intervention
Arm Description
15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle.
Intervention Type
Other
Intervention Name(s)
Eccentric exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Concentric exercise.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Isometric exercise.
Intervention Description
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 Outcome Measure Information:
Title
Change of post needling soreness.
Description
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 Outcome Measure Information:
Title
Change of pressure pain threshold after dry needling.
Description
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 Pre-specified Outcome Measures:
Title
Pain intensity during dry needling
Description
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).
Title
Pressure pain threshold before dry needling
Description
Analog algometer (kilograms/squared centimeters -kg/cm2-).
Time Frame
Before intervention (i.e. dry needling and exercise session).
Title
Demographic data.
Description
Age (years).
Time Frame
First assessment before intervention (i.e. dry needling and exercise session).
Title
Demographic data.
Description
Gender (male/female).
Time Frame
First assessment before intervention (i.e. dry needling and exercise session).
Title
Anthropometric data.
Description
Height (meters -m-).
Time Frame
First assessment before intervention (i.e. dry needling and exercise session).
Title
Anthropometric data.
Description
Weight (kilograms-kg-).
Time Frame
First assessment before intervention (i.e. dry needling and exercise session).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Torres Lacomba, PT, PhD
Organizational Affiliation
University of Alcalá, Madrid, Spain.
Official's Role
Study Director
Facility Information:
Facility Name
Nicola Sante Diciolla
City
Madrid
ZIP/Postal Code
28003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
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Efficacy of Exercise on Post Needling Soreness
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