Clinical trial NCT04135339: Efficacy of Exercise on Post Needling Soreness
Official title: Efficacy of Exercise on Post Needling Soreness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Needling Soreness
Myofascial Pain
Myofascial Pain Syndrome
Myofascial Trigger Point Pain
Keywords: pain
trigger points
physical therapy
dry needling
therapeutic exercise
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change of post needling soreness.
timeFrame: 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:
measure: Change of pressure pain threshold after dry needling.
timeFrame: 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:
measure: Pain intensity during dry needling
timeFrame: Before exercise session (i.e. during dry needling).
measure: Pressure pain threshold before dry needling
timeFrame: Before intervention (i.e. dry needling and exercise session).
measure: Demographic data.
timeFrame: First assessment before intervention (i.e. dry needling and exercise session).
measure: Demographic data.
timeFrame: First assessment before intervention (i.e. dry needling and exercise session).
measure: Anthropometric data.
timeFrame: First assessment before intervention (i.e. dry needling and exercise session).
measure: Anthropometric data.
timeFrame: First assessment before intervention (i.e. dry needling and exercise session).
Locations:
city: Madrid
country: Spain
facility: Nicola Sante Diciolla
Study officials:
affiliation: University of Alcalá, Madrid, Spain.
name: María Torres Lacomba, PT, PhD
role: STUDY_DIRECTOR
References: