Heel Pain SyndromeNCT04060576
Post-needling Soreness After Internal Gastrocnemius Muscle Treatment
A study testing Dry needling treatment with a thinner needle, Dry needling treatment with a medium-sized needle and Dry needling treatment with a thickest needle in people with Heel Pain Syndrome, run by University of Alcala at 2 sites in Spain.
Trial summary
Mechanical hyperalgesia areas, also known as myofascial trigger points, are treated by manual therapy or invasive technics. Dry needling achieves an improvement of the symptomatology in 70% of the subjects, being the acute patients the most benefited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heel Pain Syndrome
- What is being tested?
- Dry needling treatment with a thinner needle, Dry needling treatment with a medium-sized needle and Dry needling treatment with a thickest needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Sep 2019to 20 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65.
- Plantar Fasciitis diagnosis.
- Presence of hyperalgesic area in the internal gastrocnemius.
Who cannot join
- Belenophobia
- Hypothyroidism Presence of hyperalgesic area in the internal gastrocnemius - Diabetes
- Lymphedema o lymphatic surgery Muscle diseases
- Anticoagulant consumption Knee or ankle surgery
- Analgesic consumption during the study
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Instituto Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28807
Grupo Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28871
About this study
Official title: Post-Needling Soreness Depending On The Needle Diameter On Dry Needling On The Most Hyperalgesic Area Of The Internal Gastrocnemius In Plantar Fasciitis: A Randomised Controlled Trial
Mechanical hyperalgesia areas, also known as myofascial trigger points, are treated by manual therapy or invasive technics. Dry needling achieves an improvement of the symptomatology in 70% of the subjects, being the acute patients the most benefited. However, bruising, bleeding, pain during treatment or post-needling soreness. Plantar fasciitis is the most common cause of interior heel pain, affects approximately 10% of the general population and is one of the most benefited pathologies in the long term by the application of dry needling The gauge of the needle chosen for the treatment can influence post-needling soreness intensity and pressure pain threshold.
Objective To evaluate the relation between post-needling soreness intensity and needle diameter on the treatment of the most hyperalgesic point of the internal gastrocnemius.
Hypothesis Post-needling soreness intensity and pressure pain threshold depend on needle diameter applied in the treatment of the most hyperalgesic point of the internal gastrocnemius.
Read the detailed description
Intervention:
Two zones are established:
- Zone 1: where researcher nº 1 controls the data management and sample randomization.
- Zone 2: where researcher nº 2 locates the most hyperalgesic area and measures pressure point threshold variable and researcher nº 3 performs dry needling puncture.
Researcher nº 1 explains to the subjects how the study works, collects the confidential documents and scores the independent variables (sex, age and BMI). Every subject receives an identification code and is randomly assign to a intervention group (A, B or C) Researcher nº 2 makes delivery of the document where the variables pressure pain threshold and post-needling soreness intensity will be written down. Firstly, the visual analogue scale compliance prior to the intervention is requested. After that, the subject is placed in prone position on the stretcher with a slight knee flexion and the most hyperalgesic area in the internal gastrocnemius of the lower limb with plantar fasciitis is located and marked.
Researcher nº 2 performs the algometry at the most hyperalgesic area (3 measurements with 30 seconds between them), writes down the results of pressure pain threshold variable and leaves the room.
Researcher nº 3 receives a needle from researcher nº 1 ignoring its diameter (colour tab is removed). Firstly, contamination is prevented by disinfection, then, 10 insertions are made at the marked point (the number of local twitch response are counted) and the needle used is thrown in the sanitary waste container. Ischemic compression is performed for 60 seconds followed by an analytical stretch of the internal gastrocnemius for 30 seconds.
Once researcher nº 3 has finished the intervention leaves the room and researcher nº 2 returns to repeat the measurements (post-needling soreness intensity, by filling in VAS, and pressure pain threshold, performing algometry).
Researcher nº 2 reminds the subject to complete VAS at 12, 24, 48 and 72 hours (suggesting setting an alarm) and makes an appointment 48 hours after to perform the third measure of pressure pain threshold variable.
When all the data needed for the study has been collected, researcher nº1 gathers results and exports them for statistical interpretation.
- Conditions
- Heel Pain Syndrome
- Being tested
- Dry needling treatment with a thinner needle, Dry needling treatment with a medium-sized needle, Dry needling treatment with a thickest needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling treatment with a thinner needleProcedure or surgery
We will make an application with the dry needling technique with a fine needle on the myofascial trigger points of the gastrocnemius muscle.
Dry needling treatment with a medium-sized needleProcedure or surgery
We will make an application with the dry needling technique with a medium-sized needle on the myofascial trigger points of the gastrocnemius muscle.
Dry needling treatment with a thickest needleProcedure or surgery
We will make an application with the dry needling technique with the thickest needle on the myofascial trigger points of the gastrocnemius muscle.
| Study group | Role | What they receive |
|---|---|---|
| Group A treated with a 16-gauge needle | Experimental | Group A is intervened on the gastrocnemius muscle with a 16-gauge needle. Receives: Procedure: Dry needling treatment with a thinner needle |
| Group B treated with a 25-gauge needle | Experimental | Group B is intervened on the gastrocnemius muscle with a 25-gauge needle. Receives: Procedure: Dry needling treatment with a medium-sized needle |
| Group C treated with a 32-gauge needle | Experimental | Group C is intervened on the gastrocnemius muscle with a 32-gauge needle. Receives: Procedure: Dry needling treatment with a thickest needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-needling soreness intensity
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Measured: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
Pressure Pain Threshold
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. A lower threshold is a worse result. A higher threshold is a better result.
Measured: Change from Baseline Pressure Pain Threshold at 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start8 Sep 2019
- Primary completion16 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel Pain SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Tomas Gallego-Izquierdo, Dr, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060576
- Sponsor's protocol ID
- CEIM/HU/2019/01
- Status last verified
- Jan 2020
- First submitted
- 14 Aug 2019
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Needling Soreness Depending On The Needle Diameter On Dry Needling On The Most Hyperalgesic Area Of The Internal Gastrocnemius In Plantar Fasciitis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04060576
- Acronym / sponsor ID
- CEIM/HU/2019/01
- Conditions
- Heel Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 19 Aug 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.
Mechanical hyperalgesia areas, also known as myofascial trigger points, are treated by manual therapy or invasive technics. Dry needling achieves an improvement of the symptomatology in 70% of the subjects, being the acute patients the most benefited. However, bruising, bleeding, pain during treatment or post-needling soreness. Plantar fasciitis is the most common cause of interior heel pain, affects approximately 10% of the general population and is one of the most benefited pathologies in the long term by the application of dry needling The gauge of the needle chosen for the treatment can influence post-needling soreness intensity and pressure pain threshold.
Objective To evaluate the relation between post-needling soreness intensity and needle diameter on the treatment of the most hyperalgesic point of the internal gastrocnemius.
Hypothesis Post-needling soreness intensity and pressure pain threshold depend on needle diameter applied in the treatment of the most hyperalgesic point of the internal gastrocnemius.
Detailed description
Intervention:
Two zones are established:
- Zone 1: where researcher nº 1 controls the data management and sample randomization.
- Zone 2: where researcher nº 2 locates the most hyperalgesic area and measures pressure point threshold variable and researcher nº 3 performs dry needling puncture.
Researcher nº 1 explains to the subjects how the study works, collects the confidential documents and scores the independent variables (sex, age and BMI). Every subject receives an identification code and is randomly assign to a intervention group (A, B or C) Researcher nº 2 makes delivery of the document where the variables pressure pain threshold and post-needling soreness intensity will be written down. Firstly, the visual analogue scale compliance prior to the intervention is requested. After that, the subject is placed in prone position on the stretcher with a slight knee flexion and the most hyperalgesic area in the internal gastrocnemius of the lower limb with plantar fasciitis is located and marked.
Researcher nº 2 performs the algometry at the most hyperalgesic area (3 measurements with 30 seconds between them), writes down the results of pressure pain threshold variable and leaves the room.
Researcher nº 3 receives a needle from researcher nº 1 ignoring its diameter (colour tab is removed). Firstly, contamination is prevented by disinfection, then, 10 insertions are made at the marked point (the number of local twitch response are counted) and the needle used is thrown in the sanitary waste container. Ischemic compression is performed for 60 seconds followed by an analytical stretch of the internal gastrocnemius for 30 seconds.
Once researcher nº 3 has finished the intervention leaves the room and researcher nº 2 returns to repeat the measurements (post-needling soreness intensity, by filling in VAS, and pressure pain threshold, performing algometry).
Researcher nº 2 reminds the subject to complete VAS at 12, 24, 48 and 72 hours (suggesting setting an alarm) and makes an appointment 48 hours after to perform the third measure of pressure pain threshold variable.
When all the data needed for the study has been collected, researcher nº1 gathers results and exports them for statistical interpretation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A treated with a 16-gauge needle | Experimental | Procedure: Dry needling treatment with a thinner needleGroup A is intervened on the gastrocnemius muscle with a 16-gauge needle. |
| Group B treated with a 25-gauge needle | Experimental | Procedure: Dry needling treatment with a medium-sized needleGroup B is intervened on the gastrocnemius muscle with a 25-gauge needle. |
| Group C treated with a 32-gauge needle | Experimental | Procedure: Dry needling treatment with a thickest needleGroup C is intervened on the gastrocnemius muscle with a 32-gauge needle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-65.
- Plantar Fasciitis diagnosis.
- Presence of hyperalgesic area in the internal gastrocnemius.
Key exclusion criteria (5 listed)
- Belenophobia
- Hypothyroidism Presence of hyperalgesic area in the internal gastrocnemius - Diabetes
- Lymphedema o lymphatic surgery Muscle diseases
- Anticoagulant consumption Knee or ankle surgery
- Analgesic consumption during the study
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 |
|---|---|---|
| Dry needling treatment with a thinner needleWe will make an application with the dry needling technique with a fine needle on the myofascial trigger points of the gastrocnemius muscle. | Procedure or surgery | Group A treated with a 16-gauge needle |
| Dry needling treatment with a medium-sized needleWe will make an application with the dry needling technique with a medium-sized needle on the myofascial trigger points of the gastrocnemius muscle. | Procedure or surgery | Group B treated with a 25-gauge needle |
| Dry needling treatment with a thickest needleWe will make an application with the dry needling technique with the thickest needle on the myofascial trigger points of the gastrocnemius muscle. | Procedure or surgery | Group C treated with a 32-gauge needle |
Primary outcome
Post-needling soreness intensity
Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Pressure Pain Threshold
Time frame: Change from Baseline Pressure Pain Threshold at 72 hours
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. A lower threshold is a worse result. A higher threshold is a better result.
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 22 Jan 2020.
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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.
Tomas Gallego-Izquierdo, Dr study chair
Alcala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling treatment with a thinner needle, Dry needling treatment with a medium-sized needle and Dry needling treatment with a thickest needle in people with Heel Pain Syndrome, run by University of Alcala at 2 sites 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 3 inclusion and 5 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Post-needling soreness intensity (time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.). 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 22 Jan 2020.