Physical Therapy ModalitiesNCT05193695
How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
A study testing Treadmill exercise in people with Physical Therapy Modalities and Pain Measurement, run by Becerra, Pablo at 1 site in Chile.
Trial summary
Ankle fractures are one of the main causes of hospitalization due to injuries in Chile, which also have a discharge and partial load time of approximately 12 weeks in the recovery process. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Therapy Modalities, Pain Measurement, Trigger Point Pain, Myofascial
- What is being tested?
- Treadmill exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 9 Aug 2018to 30 Apr 2019
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 18 and 60 years of age.
- Man or woman.
- At least one trigger point, active or latent, in the triceps sural muscle of the fractured ankle.
- Perform full load without using technical aids.
Who cannot join
- Use of analgesics.
- Insurmountable fear of needles.
- Immune disease.
- Clotting disorders.
- Sensory disorders.
- Psychiatric / psychological illness.
- Cancer.
- Rheumatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heat or Excesice in Treadmill as Techique to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
Ankle fractures are one of the main causes of hospitalization due to injuries in Chile, which also have a discharge and partial load time of approximately 12 weeks in the recovery process. This generates disuse and atrophy of the posterior musculature of the leg called the triceps sural, which makes it difficult to restart and perform the gait. We conducted this research because practically all patients with this type of diagnosis have trigger points in these muscles, and dry needling technique is one of the best for its treatment, but has the disadvantage that it produces post dry needling pain of 48 hours and there is not enough information, or consensus on which method is better to reduce post dry needling pain. This study aims to prove wich technique is most useful in reducing pain post dry needling for the treatment of trigger points in the triceps sural muscle in ankle post fracture patients.
- Conditions
- Physical Therapy Modalities, Pain Measurement, Trigger Point Pain, Myofascial, Ankle Fractures, Rehabilitation, Needles
- Being tested
- Treadmill exercise
- Keywords
- Humans, Excercise therapy, Hot temperature, Post dry needling, Range of motion, articular, Muscle Strength
- Medical subject headings
- Myofascial Pain Syndromes, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill exerciseOther
Also called Treadmill after dry needling
the patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients remained in the supine position for 20 minutes lying on a stretcher after dry needling. |
| Treadmill | Experimental | The patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002). Receives: Other: Treadmill exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain intensity
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
Measured: Change from baseline (baseline and immediately after treatment)
Ankle Range of Motion (ROM)
It is the degree of angular movement allowed by the ankle joint measured by kinovea.
Measured: Change from baseline (baseline and immediately after treatment)
Secondary outcomes (1)
Muscular strength of triceps sural
By means of the heel rise test, the patient must perform a bipodal plantiflexion measured in the maximum number of repetitions in 30 seconds.
Measured: Change from baseline (baseline and immediately after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start9 Aug 2018
- Primary completion4 Apr 2019
- Study completion30 Apr 2019
Why it stopped: full sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Therapy ModalitiesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becerra, Pablo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Yañez Becerra, Becerra, Pablo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193695
- Sponsor's protocol ID
- Becerra
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat or Excesice in Treadmill as Techique to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
- ClinicalTrials.gov ID
- NCT05193695
- Acronym / sponsor ID
- Becerra
- Conditions
- Physical Therapy Modalities, Pain Measurement, Trigger Point Pain, Myofascial, Ankle Fractures, Rehabilitation, Needles
- Keywords
- Humans, Excercise therapy, Hot temperature, Post dry needling, Range of motion, articular, Muscle Strength
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: full sample size
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Becerra, PabloUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 18 Jan 2022 (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.
Ankle fractures are one of the main causes of hospitalization due to injuries in Chile, which also have a discharge and partial load time of approximately 12 weeks in the recovery process. This generates disuse and atrophy of the posterior musculature of the leg called the triceps sural, which makes it difficult to restart and perform the gait. We conducted this research because practically all patients with this type of diagnosis have trigger points in these muscles, and dry needling technique is one of the best for its treatment, but has the disadvantage that it produces post dry needling pain of 48 hours and there is not enough information, or consensus on which method is better to reduce post dry needling pain. This study aims to prove wich technique is most useful in reducing pain post dry needling for the treatment of trigger points in the triceps sural muscle in ankle post fracture patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients remained in the supine position for 20 minutes lying on a stretcher after dry needling. |
| Treadmill | Experimental | Other: Treadmill exerciseThe patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages between 18 and 60 years of age.
- Man or woman.
- At least one trigger point, active or latent, in the triceps sural muscle of the fractured ankle.
- Perform full load without using technical aids.
Key exclusion criteria (8 listed)
- Use of analgesics.
- Insurmountable fear of needles.
- Immune disease.
- Clotting disorders.
- Sensory disorders.
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 |
|---|---|---|
| Treadmill exerciseAlso: Treadmill after dry needlingthe patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002) | Other | Treadmill |
Primary outcome
Perceived pain intensity
Time frame: Change from baseline (baseline and immediately after treatment)
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
Ankle Range of Motion (ROM)
Time frame: Change from baseline (baseline and immediately after treatment)
It is the degree of angular movement allowed by the ankle joint measured by kinovea.
1 secondary outcome
Muscular strength of triceps sural
Time frame: Change from baseline (baseline and immediately after treatment)
Results and safety
The study was stopped early (reason given: full sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill exercise in people with Physical Therapy Modalities and Pain Measurement, run by Becerra, Pablo at 1 site in Chile.
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 4 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: stopped early, as of the sponsor's last update on 31 Jan 2022. 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 Chile. 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 was stopped early (reason given: full sample size). Results are not available in the source record.
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?
Perceived pain intensity (time frame: Change from baseline (baseline and immediately after treatment)). The study lists 2 primary outcomes in all. 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 31 Jan 2022.