The influence of the dry needling method on the improvement of muscle function

ISRCTN	ISRCTN10378682
DOI	https://doi.org/10.1186/ISRCTN10378682
Secondary identifying numbers	26/2022

Submission date: 16/05/2023
Registration date: 24/05/2023
Last edited: 17/12/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The aim of this study is to assess the effect of dry needling on muscle parameters and the resulting regenerative effects on muscles.

Who can participate?
Mixed martial arts (MMA) fighters aged 18-40 years

What does the study involve?
Participants are randomly allocated to one of two groups. One group undergoes dry needling, which involves inserting an acupuncture needle into the pain point of the calf muscle in order to loosen it and have an analgesic effect. In the control group, it will be a quasi-needle that pricks the skin but does not actually pierce it.

What are the possible benefits and risks of participating?
The researchers want to prove that dry needling is effective not only in the treatment of muscle pain but also helps to relax muscles and can be used as a method of regeneration between exercises. There is a stereotype among MMA fighters and trainers that dry needling cannot be used between efforts because it worsens sports performance. In players undergoing dry needling, a clinically insignificant hematoma (bad bruise) may appear in the case of a puncture in a small blood vessel, and sometimes there may be an unpleasant sensation when local myofibril (muscle fibre) contraction is caused.

Where is the study run from?
Provita Medical Center (Poland)

When is the study starting and how long is it expected to run for?
December 2022 to July 2023

Who is funding the study?
Provita Medical Center (Poland)

Who is the main contact?
Dr Robert Trybulski, rtrybulski@o2.pl

Contact information

Dr Robert Trybulski
Scientific

al.Zjednoczonej Europy 37
Żory
44240
Poland

ORCID ID	0000-0002-4276-4813
Phone	+48 (0)502591428
Email	provitazory@gmail.com

Study information

Study design	Randomized crossover trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Efficacy
Participant information sheet	Not available in web format, please use the contact details to request a consent form
Scientific title	Immediate effect of dry needling therapy on the biomechanical properties and perfusion of the gastrocnemius muscle in mixed martial arts athletes
Study objectives	Current study hypothesis as of 04/07/2023: This study aimed to evaluate the immediate effect of dry needling (DN) on selected muscle biomechanical properties and perfusion of the gastrocnemius and forearm muscles and muscles of the shoulder girdle (deltoid, trapezius, levator scapulae, and rhomboideus) in athletes. The immediate impact of DN in the period between efforts still raises some concerns among trainers, as it is suggested that it may increase muscle pain and worsen athletic performance. The assessment of the microcirculation reaction after the use of DN is little recognized, and the correlation of changes in capillary blood supply and muscle stiffness and tone is innovative. The results obtained as part of these studies should contribute to a better understanding of the links between disturbed muscle tone and local ischemia in latent trigger points (TrP). Previous study hypothesis: The aim of this study was to evaluate the immediate effect of dry needling (DN) on selected muscle biomechanical properties and gastrocnemius muscle perfusion in mixed martial arts (MMA) fighters. Assessing the immediate impact of DN in the period between efforts still raises some concerns among trainers, as it is suggested that it may increase muscle pain and worsen athletic performance. The assessment of the microcirculation reaction after the use of DN is little recognized, and the correlation of changes in capillary blood supply and muscle stiffness and tone is innovative. The results obtained as part of these studies should contribute to a better understanding of the links between disturbed muscle tone and local ischemia in latent trigger points (TrP).
Ethics approval(s)	Approved 12/01/2023, National Council of Physiotherapists (Al. Jerozolimskie 93, Warsaw, 02-001, Poland; +48 (0)22 230 23 80; komjaetykibadan@kif.info.pl), ref: 26/2022
Health condition(s) or problem(s) studied	Improvement of muscle regeneration function in athletes
Intervention	Current interventions as of 04/07/2023: The experiment was conducted according to a randomized crossover design in which each subject participated in a DN familiarization intervention 14 days prior to the study. The DN procedure was carried out in accordance with the safety rules, previously disinfecting the puncture site. TrP was defined by signs of palpable tenderness and a taut band approximately four fingers below the popliteal fossa in the medial head of the gastrocnemius muscle of both legs. DN was performed in a standardized prone position with feet hanging freely off the table. (Fernández-de-las-Peñas & Dommerholt, 2018). A simple method of drawing was used consisting of flipping a coin, where drawing the obverse side meant assigning subsequent participants to group A and the reverse to group B. Participants (n = 60) were randomly divided into two groups: the eDN group (experimental dry needing, n = 30) and the qDN group (quasi dry needing, n = 30). In the eDN group, sterile soma needles 0.30 x 50 mm were used. Each puncture was made with one needle for one TrP looking for a tremor response local twitch response (LTR). An experienced clinician (25 years of professional experience as a physiotherapist and 15 years of DN therapy experience, DN therapy instructor in Poland [exam in Simons Academy]) performed an average of three to five punctures, without leaving the skin border per one TrP. When LTR was not obtained after five punctures, the operator changed the puncture site by stepping out of the skin and changing the needle. The procedure was repeated a second time, near the puncture site, the same for both gastrocnemius muscles (Albin et al., 2020; Fernández-de-las-Peñas & Dommerholt, 2018). If there was no response, further insertions were not continued. The entire procedure lasted from 15 to 30 seconds for one TrP, with secondary ischemic compression for 5 seconds to reduce unpleasant sensations after a possible LTR. In the event of a burning sensation or other adverse reactions, the procedure was stopped, and the puncture site was changed. This situation occurred only in one case. The same procedure was used for subjects in the qDN group. Using a quasi-needle that did not pierce the skin. The quasi needle was manipulated to simulate DN therapy, and the same technique was performed (piston work movements). This mechanism produces a similar feeling to dry needling (Braithwaite et al., 2019). In addition, the participants did not see the techniques performed due to the position. Previous interventions: The experiment was conducted according to a randomized crossover design in which each subject participated in a DN familiarization intervention 14 days prior to the study. The DN procedure was carried out in accordance with the safety rules, previously disinfecting the puncture site. TrP was defined by signs of palpable tenderness and a taut band approximately four fingers below the popliteal fossa in the medial head of the gastrocnemius muscle of both legs. DN was performed in a standardized prone position with feet hanging freely off the table. (Fernández-de-las-Peñas & Dommerholt, 2018). A simple method of drawing was used consisting of flipping a coin, where drawing the obverse side meant assigning subsequent participants to group A and the reverse to group B. Participants (n = 20) were randomly divided into two groups: the eDN group (experimental dry needing, n = 10) and the qDN group (quasi dry needing, n = 10). In the eDN group (n = 10, experimental), sterile soma needles 0.30 x 50 mm were used. Each puncture was made with one needle for one TrP looking for a tremor response local twitch response (LTR). An experienced clinician (25 years of professional experience as a physiotherapist and 15 years of DN therapy experience, DN therapy instructor in Poland [exam in Simons Academy]) performed an average of three to five punctures, without leaving the skin border per one TrP. When LTR was not obtained after five punctures, the operator changed the puncture site by stepping out of the skin and changing the needle. The procedure was repeated a second time, near the puncture site, the same for both gastrocnemius muscles (Albin et al., 2020; Fernández-de-las-Peñas & Dommerholt, 2018). If there was no response, further insertions were not continued. The entire procedure lasted from 15 to 30 seconds for one TrP, with secondary ischemic compression for 5 seconds to reduce unpleasant sensations after a possible LTR. In the event of a burning sensation or other adverse reactions, the procedure was stopped, and the puncture site was changed. This situation occurred only in one case. The same procedure was used for subjects in the qDN group (quasi, n = 10). Using a quasi-needle that did not pierce the skin. The quasi needle was manipulated to simulate DN therapy, and the same technique was performed (piston work movements). This mechanism produces a similar feeling to dry needling (Braithwaite et al., 2019). In addition, the participants did not see the techniques performed due to the position.
Intervention type	Other
Primary outcome measure	Current primary outcome measures as of 04/07/2023: 1. Muscle tone (T = Hz), stiffness (S = N/m), and elasticity (E= NaN ), measured with a myotonometer (MyotonPRO AS, Myoton Ltd, Estonia 2021) at rest, 5 minutes, 24 hours after DN therapy 2. Muscle pain threshold (P PT= kG or N) measured with the FDIX algesimeter (Wagner Instruments, Greenwich, CT, USA 2013) at rest, 5 minutes, 24 hours after DN therapy 3. Perfusion unit (PU) index measured using laser Doppler flowmetry (LDF) (Perimed, Sweden 2004) at rest, 5 minutes and 24 hours after DN therapy 4. Muscle power (relative strength index [RSI]) measured using ForceDecks measuring platform (Vald Performance Australia 2012) at rest, 5 minutes and 24 hours after DN therapy 5. Maximum isometric force measured by electronic dynamometer 106 China 2022 at rest, 5 minutes and 24 hours after DN therapy All measurements measured between 10-12 AM Previous primary outcome measures: 1. Muscle tone (T = Hz), stiffness (S = N/m), and elasticity (E= NaN ), measured with a myotonometer (MyotonPRO AS, Myoton Ltd, Estonia 2021) at rest, 5 minutes, 24 hours after DN therapy 2. Muscle pain threshold (P PT= kG or N) measured with the FDIX algesimeter (Wagner Instruments, Greenwich, CT, USA 2013) at rest, 5 minutes, 24 hours after DN therapy 3. Perfusion unit (PU) index measured using laser Doppler flowmetry (LDF) (Perimed, Sweden 2004) at rest, 5 minutes and 24 hours after DN therapy 4. Muscle power (relative strength index [RSI]) measured using ForceDecks measuring platform (Vald Performance Australia 2012) at rest, 5 minutes and 24 hours after DN therapy All measurements measured between 10-12 AM
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	06/12/2022
Completion date	15/07/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Male
Target number of participants	60
Total final enrolment	20
Key inclusion criteria	1. Aged 18-40 years 2. Minimum of 3 years of training experience 3. Documented record (data of professional fights on tapology.com, amateur fights on mmapolska.org) of amateur or professional fights, at least three 4. Training at least four times a week 5. Participants in the study had to be abstinent from training for 48 hours and abstain from training for 24 hours during the study 6. Due to PU measurements, they were asked to refrain from consuming ergogenic drinks for 4 hours before the test
Key exclusion criteria	1. Elevated blood pressure before the test (blood pressure >140/90 mmHg) 2. People with musculoskeletal system injuries, damage or unspecified skin and myofascial lesions 3. Participants were also not allowed to have a tattoo at the measurement site because it interfered with tissue perfusion measurements 4. Needle phobia 5. Extreme fatigue 6. Fever 7. Infection 8. Allergy to nickel 9. Exclusion could occur at any time during the study at the participant's request
Date of first enrolment	15/03/2023
Date of final enrolment	15/07/2023

Locations

Countries of recruitment

Poland

Study participating centre

Provita Medical Center

al.Zjednoczonej Europy 37
Żory
44240
Poland

Sponsor information

Provita Medical Center
Hospital/treatment centre

al.Zjednoczonej Europy 37
Żory
44240
Poland

Phone	+48 (0)502591428
Email	provitazory@gmail.com
Website	https://www.rehabilitacja-provita.pl

Funders

Funder type

Hospital/treatment centre

Provita Medical Center

No information available

Results and Publications

Intention to publish date	30/08/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in an impact factor journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Robert Trybulski (rtrybulski@o2.pl). Type of data that will be shared: a personal survey containing personal data. Data will be made available on request by email.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Acute Effects of the Dry Needling Session on Gastrocnemius Muscle Biomechanical Properties, and Perfusion with Latent Trigger Points - A Single-Blind Randomized Controlled Trial in Mixed Martial Arts Athletes	01/02/2024	14/02/2024	Yes	No
Results article	effects of compression contrast therapy (CT) and dry needling therapy	01/03/2024	07/08/2024	Yes	No
Results article	Adverse Reactions to Dry Needling Therapy: Insights from Polish Physiotherapy Practice	21/11/2024	17/12/2024	Yes	No
Results article	Biomechanical Profile after Dry Needling in Mixed Martial Arts	19/07/2024	17/12/2024	Yes	No

Editorial Notes

17/12/2024: Publication references added.
07/08/2024: Publication reference added.
14/02/2024: Publication reference and total final enrolment added.
17/07/2023: Internal review.
04/07/2023: The following changes were made:
1. The study hypothesis was changed.
2. The overall study end date was changed from 15/06/2023 to 15/07/2023 and the plain English summary was updated to reflect the change.
3. The interventions were changed.
4. The primary outcome measures were changed.
5. The recruitment end date was changed from 15/05/2023 to 15/07/2023.
6. The target number of participants was changed from 20 to 60.
23/05/2023: Study's existence confirmed by the National Council of Physiotherapists.