Post Needling SorenessNCT04135339
Efficacy of Exercise on Post Needling Soreness
A study testing Eccentric exercise, Concentric exercise. and Isometric exercise. in people with Post Needling Soreness and Myofascial Pain, run by University of Alcala at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Needling Soreness, Myofascial Pain, Myofascial Pain Syndrome
- What is being tested?
- Eccentric exercise, Concentric exercise. and Isometric exercise.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of at least one latent myofascial trigger point (MTrP) in the medial gastrocnemius muscle.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
- 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.
Read the 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.
- Conditions
- Post Needling Soreness, Myofascial Pain, Myofascial Pain Syndrome, Myofascial Trigger Point Pain
- Being tested
- Eccentric exercise, Concentric exercise., Isometric exercise.
- Keywords
- pain, trigger points, physical therapy, dry needling, therapeutic exercise
- Medical subject headings
- Myofascial Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseOther
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.
Concentric exercise.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.
Isometric exercise.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.
| Study group | Role | What they receive |
|---|---|---|
| Group A. Eccentric exercise. | Experimental | 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. Receives: Other: Eccentric exercise |
| Group B. Concentric exercise. | Experimental | 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. Receives: Other: Concentric exercise. |
| Group C. Isometric exercise. | Experimental | 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. Receives: Other: Isometric exercise. |
| Group D. Control. | No intervention | 15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (1)
Change of pressure pain threshold after dry needling.
Analog algometer (kilograms/squared centimeters -kg/cm2-).
Measured: 2 minutes after dry needling, just after exercise session (not for control group), 24 hours after exercise session, 48 hours after exercise session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jul 2019
- Primary completion31 Oct 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Needling SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Sante Diciolla, University of Alcala
- Investigators
- María Torres Lacomba, PT, PhD, Study director, University of Alcalá, Madrid, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135339
- Sponsor's protocol ID
- CEI/HU/2019/27
- Status last verified
- May 2021
- First submitted
- 22 Sep 2019
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exercise on Post Needling Soreness
- ClinicalTrials.gov ID
- NCT04135339
- Acronym / sponsor ID
- CEI/HU/2019/27
- Conditions
- Post Needling Soreness, Myofascial Pain, Myofascial Pain Syndrome, Myofascial Trigger Point Pain
- Keywords
- pain, trigger points, physical therapy, dry needling, therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A. Eccentric exercise. | Experimental | Other: Eccentric exercise15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. |
| Group B. Concentric exercise. | Experimental | Other: Concentric exercise.15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. |
| Group C. Isometric exercise. | Experimental | Other: Isometric exercise.15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. |
| Group D. Control. | No intervention | –15 subjects with a latent myofascial trigger point in the medial gastrocnemius muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of at least one latent myofascial trigger point (MTrP) in the medial gastrocnemius muscle.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric exerciseThe 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. | Other | Group A. Eccentric exercise. |
| 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. | Other | Group B. Concentric exercise. |
| 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. | Other | Group C. Isometric exercise. |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Torres Lacomba, PT, PhD study director
University of Alcalá, Madrid, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise, Concentric exercise. and Isometric exercise. in people with Post Needling Soreness and Myofascial Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.