Efficacy of Exercise on Post Needling Soreness

NCT ID: NCT04135339

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-09-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A. Eccentric exercise.

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

Group Type: EXPERIMENTAL

Eccentric exercise

Intervention Type: 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.

Group B. Concentric exercise.

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

Group Type: EXPERIMENTAL

Concentric exercise.

Intervention Type: 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.

Group C. Isometric exercise.

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

Group Type: EXPERIMENTAL

Isometric exercise.

Intervention Type: 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.

Group D. Control.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Nicola Sante Diciolla

Physiotherapist, Master of Sciences, Associate Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María Torres Lacomba, PT, PhD

Role: STUDY_DIRECTOR

University of Alcalá, Madrid, Spain.

Locations

Nicola Sante Diciolla

Madrid, , Spain

Countries

Spain

Other Identifiers

CEI/HU/2019/27

Identifier Type: -

Identifier Source: org_study_id