Efficacy of Exercise on Post Needling Soreness

Sponsor

University of Alcala (Other)

Overall Status

Completed

CT.gov ID

NCT04135339

Collaborator

(none)

Enrollment

Location

Arms

14.1

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

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.	N/A

Detailed Description

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.

Outcome measures. Pain intensity, by analog visual scale (VAS). Pressure pain threshold (PPT), by analog algometer. Demographics and anthropometrics.

Study Design

Study Type:

Interventional

Actual Enrollment :

69 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 :

Jul 1, 2019

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change of post needling soreness. [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

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

Other Outcome Measures

Pain intensity during dry needling [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.
Pressure pain threshold before dry needling [Before intervention (i.e. dry needling and exercise session).]
Analog algometer (kilograms/squared centimeters -kg/cm2-).
Demographic data. [First assessment before intervention (i.e. dry needling and exercise session).]
Age (years).
Demographic data. [First assessment before intervention (i.e. dry needling and exercise session).]
Gender (male/female).
Anthropometric data. [First assessment before intervention (i.e. dry needling and exercise session).]
Height (meters -m-).
Anthropometric data. [First assessment before intervention (i.e. dry needling and exercise session).]
Weight (kilograms-kg-).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).