AzTrials
AzTrials

Recovery MethodD-NICENCT06739564

Dry Needling and Ice Packing in Recovery.

A study testing ICE PACKING and DRY NEEDLING in people with Recovery Method and Fatigue Intensity, run by University of Bologna at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Recovery is a crucial aspect of soccer training. It has been investigated scientifically, but some unclear aspects remain regarding the optimal strategy. Recovery from maximal effort involves both physical and psychological/perceptual aspects (pain, sleep quality), and the definition of recovery is often misleading… Read more about this study

Who is it for?
Ages 19 to 22 yearsHealthy volunteers can take part
Conditions the study is for
Recovery Method, Fatigue Intensity
What is being tested?
ICE PACKING and DRY NEEDLING
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
1 Mar 2024to 3 Nov 2024
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 19 to 22 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • not having ongoing or past muscular illness in the last three months and regularly take part in training at least 5 times per week.

Who cannot join

  • Exclusion criteria were had an injury in the lower limbs in the last three month and taking any anti-inflammatory or pain killer drugs.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shanghai Tongji University

    Shanghai, China, 200092

Other trials in China

About this study

Official title: Dry Needling Vs Ice Packing in Acute Recovery After a Strenuous Effort in Semi-pro Football Players.

Recovery is a crucial aspect of soccer training. It has been investigated scientifically, but some unclear aspects remain regarding the optimal strategy. Recovery from maximal effort involves both physical and psychological/perceptual aspects (pain, sleep quality), and the definition of recovery is often misleading due to the subjective and objective factors involved. This is a randomized control trial comparing dry needling (DN) to ice packing (ICE) in the acute recovery after an exhaustion running trial in thirty-nine semi-professional soccer players compared to controls. The subjects were assessed before and after the exhaustion tests for sleep, pain perception (Pressure Pain Threshold, PPT), Counter Movement Jump (CMJ), and Surface Muscle Temperature (SMT). We tested 39 semi pro soccer players (males and females).

Read the detailed description

This is a randomized controlled trial involving thirty-nine subjects: 15 in the control group (CG, 6 females, 9 males), 12 in the ice packing group (ICE, 6 males and 6 females), and 12 in the dry needling group (DN, 6 males and 6 females). Semi-professional players from clubs in Shanghai city participated in the study. Inclusion criteria were not having ongoing or past muscular illness in the last three months and regularly take part in training at least 5 times per week. Exclusion criteria were having an injury in the lower limbs in the last three month and taking any anti-inflammatory or pain killer drugs. The participants gave their informed written consent to participate. The subjects visited the laboratory twice on different days.

After 10 minutes of running at a chosen speed, the subject was tested for VO2max (Cosmed K5, Rome, Italy) on a motorized treadmill (Rodby RL2000, Sweden), starting at a comfortable speed and rising one step of 2 km/h every minute until exhaustion. Once VO2max was assessed, the anaerobic threshold (AT) was determined by the Cosmed software using the V-slope method and was later checked and adjusted by two expert observers . Two days after the VO2max test, the subjects visited the laboratory and performed a trial at AT on the treadmill until exhaustion. The trial was stopped by the subject's signalling exhaustion by raising an arm. Blood lactate was measured twice, after the VO2max test and after 3 minutes from the termination of the exhaustion trial using a lactacidometer (Lactate Pro, Germany) to assess the consistency of effort. Body weight and body fat percentage were measured with a Tanita scale-impedenziometer and body height with a Tanita anthropometer. The groups matched for body height, weight, and body fat percentage.

SMT was measured after the exhaustion trial, and after the recovery procedures. After the exhaustion trial, DN and ICE were performed. Ice packs were applied to the quadriceps, hamstrings, and soleus/gastrocnemius muscles for 20 minutes, and DN was performed by inserting the needles at relevant trigger points of the lower limb. PPT was measured before and after the recovery procedures with an FPX50 pressure gauge (Wagner, USA) on the left and right quadriceps, gastrocnemius medialis, and lateralis. The sequence of the measurements after the exhaustion trial followed the same pre-treatment order. A maximal Counter Movement Jump (CMJ) test (best of 3 trials) was recorded with a video analysis app (My Jump Lab, v.4.2.6).

The choice of latent MTrPs (trigger points) was made according to the following criteria [38]: 1) palpable taut band; 2) hypersensitive spot on the taut band; and 3) palpation with the reproduction of the patient's symptoms that include different sensory sensations, including pain spreading to a distant area, deep pain, dull ache, tingling, or burning pain. If the above three points are satisfied, it is an active trigger point, and if both 1 and 2 were met, but not 3, then it was considered a latent trigger point. The quadriceps (rectus femoris, vastus medialis, and vastus lateralis), tensor fasciae latae, hip adductors (adductor longus, adductor brevis), hip abductors (gluteus medius, gluteus maximus), and gastrocnemius were examined in each subject following a protocol regarding patient and limb positions reproduced from previous studies . Diagnostic criteria were applied by physical therapists with five years of experience with myofascial pain.

After the skin was locally sterilized, the MTrPs were transcutaneously punctured with a 0.30 mm × 40 mm or 0.30 mm × 75 mm sterilized disposable stainless-steel acupuncture needle. During dry needling, the left thumb or two fingers pressed or held the taut band. The right hand was used to quickly insert the needle into the latent MTrPs, then punctured back and forth into the taut band in different directions until a local twitch response was elicited. Once the first local twitch response was obtained, the needle was moved up and down at approximately 1 Hz until no more local twitch responses were elicited. After pulling out the needle, ischemic compression with a finger was applied for 10-30 seconds. The DN insertion was made by a certified Chinese medicine clinician.

To measure SMT, a Manual Infrared Camera (BX20, HK micro, Hangzhou, China) with a sensor resolution of 1024 × 768 pixels was employed, with a measurement range from 0 °C to 250 °C, a display of 230 × 240 pixels, a thermal sensitivity of 80 mK, and an 8-mm lens. The infrared thermography imaging acquisition was performed with the participant standing up in a relaxed position 1 m from the camera. It was measured in a region of interest (ROI) through five infrared thermography images of different muscle sectors for each muscle on the quadriceps and calf muscles on both legs. We considered the max and min temperature and the central value in the ROI (region of interest). After removing the highest and lowest values, the mean of the three measurements was used for data analysis. The SMT can be affected by environment temperature and humidity due to sweating, evaporation and vasoconstriction/vasodilation response. To maintain consistency, we controlled the air temperature and humidity in the lab. Specifically, the room temperature and humidity were kept at 20.0-23.0 °C and 60-75%, respectively . Sleep (light, deep, REM, and total sleep time, in hours) was measured with a sleep monitor (Huawei Band 8) the night before the exhaustion test and after the recovery procedures . RPE (Scale 20 items) and Lactate (Lactate Pro, Germany) were measured two times, after the VO2max and after the exhaustion test at 3 and 5 minutes, and the highest value was retained. RPE and Lactate were used to assess the consistency of the exhaustion trial. The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of Tongji University (approval code: tjdxsr029).

Being tested
ICE PACKING, DRY NEEDLING
Keywords
fatigue, recovery, soccer, pain threshold
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICE PACKINGProcedure or surgery

    ICE PACKING ON LOWER LIMB AFTER AN EXHAUSTION EFFORT.

  • DRY NEEDLINGProcedure or surgery

    DRY NEEDLING ON LOWER LIMB AFTER AN EXHAUSTION TRIAL

Study groups in NCT06739564
Study groupRoleWhat they receive
Dry needlingExperimentalDry needling on lower limbs
Receives: Procedure: DRY NEEDLING
Ice packingExperimentalice packing on lower limbs
Receives: Procedure: ICE PACKING
controlsNo interventioncontrol group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surface muscle temperature in degrees Centigrades.

    SMT was measured after the exhaustion trial, and after the recovery procedures. After the exhaustion trial, DN and ICE were performed. Ice packs were applied to the quadriceps, hamstrings, and soleus/gastrocnemius muscles for 20 minutes, and DN was performed by inserting the needles at relevant trigger points of the lower limb. PPT was measured before and after the recovery procedures with an FPX50 pressure gauge (Wagner, USA) on the left and right quadriceps, gastrocnemius medialis, and lateralis. SMT was measured immediately after ICE and DN in a time frame of 20 minutes from the beginning on test to the end. Final data will be reported in 3 months.

    Measured: acute, after a few minutes (20) the data are available. It will be reported in 3 months from the measurement ending.

  2. Pressure pain threshold in algometer units scale.

    PPT was measured before and after the recovery procedures with an FPX50 pressure gauge (Wagner, USA) on the left and right quadriceps, gastrocnemius medialis, and lateralis. Time frame: this outcome is evaluated after 20 minutes. Final data will be reported in 3 months. Final data will be reported in 3 months.

    Measured: acute, after a few minutes (20) the data are available. It will be reported in 3 months from the measurement ending.

  3. Squat Jump in cm

    A maximal Counter Movement Jump (CMJ) test (best of 3 trials) was recorded with a video analysis app (My Jump Lab, v.4.2.6). Time frame: this outcome is evaluated after 30 min from the termination of the test and before the fatigue test. Final data will be reported in 3 months.

    Measured: acute, after a few minutes (20) the data are available. It will be reported in 3 months from the measurement ending.

  4. Perceived effort in RPE scores

    Borg Rate Perceived Excerption (Scale 20 level: higher the level higher the perceived effort) was measured two times, after the VO2max and after the exhaustion test at 3 and 5 minutes, and the highest value was retained. Evaluated after 1 minutes from the termination of fatigue test. Final data will be reported in 3 months.

    Measured: acute, after a few minutes (20) the data are available. It will be reported in 3 months from the measurement ending.

  5. Lactate in mm/L (millimoles x liter)

    Lactate (Lactate Pro, Germany) was measured two times, after the VO2max and after the exhaustion test at 3 and 5 minutes, and the highest value was retained. Lactate was used to assess the consistency of the exhaustion trial. Lactate was evaluated at 3 and 5 minutes after the ending of the exhaustion test. Final data will be reported in 3 months.

    Measured: acute, after a few minutes (20) the data are available. It will be reported in 3 months from the measurement ending.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start1 Mar 2024
  3. Primary completion31 Aug 2024
  4. Study completion3 Nov 2024

Resources

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
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06739564
Sponsor's protocol ID
tjdxsr029
Acronym
D-NICE
Status last verified
Dec 2024
First submitted
3 Dec 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: PRIVACY

Publications

  • You S, Shen Y, Liu Q, Cicchella A. Patellofemoral Pain, Q-Angle, and Performance in Female Chinese Collegiate Soccer Players. Medicina (Kaunas). 2023 Mar 16;59(3):589. doi: 10.3390/medicina59030589.

    PubMed 36984590

Questions about this trial

What is this clinical trial studying?

A study testing ICE PACKING and DRY NEEDLING in people with Recovery Method and Fatigue Intensity, run by University of Bologna at 1 site in China.

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 1 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 18 Dec 2024. 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 China. 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?

Surface muscle temperature in degrees Centigrades. (time frame: acute, after a few minutes (20) the data are available. It will be reported in 3 months from the measurement ending.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06739564, which also lists 1 linked publication.

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 18 Dec 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in