Condition category
Musculoskeletal Diseases
Date applied
20/06/2018
Date assigned
24/07/2018
Last edited
22/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Trigger points are muscular "knots" which can often be felt as tightness or aches in muscles. They are commonly found in both sportspeople and the general population alike. One common treatment technique which has recently gained popularity is that of dry needling. Dry needling uses acupuncture type needles to directly stimulate the trigger point and in doing so, release the tightness (contraction) and pain associated with the trigger point. There are two categories of trigger points: active (trigger points which generate pain spontaneously) and latent (trigger points which only generate pain if stimulated). Because dry needling relaxes the trigger point within muscles, some temporary weaknesses have been reported previously. If these weaknesses were to occur in a muscle which is crucial in stability, athletes may be at an increased risk of injury. The gluteus medius is one such muscle which plays a pivotal role in maintaining hip stability during movements and single leg tasks. It is located on the outermost part of the pelvis and controls the side to side movement of the leg (frontal plane), providing what is known as lumbo-pelvic-hip stability. Decreases in either hip strength or hip stability have been linked to a host of lower limb injuries to the foot, ankle, knee, thigh, hip and even lower back. Trigger points are commonplace in the gluteus medius of multi-directional athletes because of the demands placed on maintaining hip stability during sprinting, cutting, jumping and landing. As such, dry needling is a technique frequently performed on the gluteus medius yet it is still unclear as to the appropriate time before performance which dry needling should be performed, or more importantly, avoided due to possible temporary decreases in hip strength and stability. The aim of this study is to measure hip strength and single leg stability before and after dry needling.

Who can participate?
Male, third level student of the Institute of Technology Carlow, aged 18 to 45, participating in a multi-directional jump-sport (e.g. gaelic football, hurling, soccer, volleyball, basketball, handball) more than 3 times per week, with 2 to 5 latent myofascial trigger points present in their self-reported preferred jumping leg

What does the study involve?
Participants are randomly allocated to be treated with dry needling or dummy dry-needling (placebo) where the needle does not break the skin. Participants only receive the treatment once and it is performed on between 2 and 5 trigger points. There is a quick informal conversation about how the participant feels about the treatment received, their soreness and their confidence to perform in their given sport. Hip strength and single leg stability are measured before, immediately after and 3, 7, 10 and 14 days after the treatment.

What are the possible benefits and risks of participating?
Participants should they volunteer, may benefit from dry needling as it may reduce tension in their gluteus medius and allow their muscle to perform better in the long term. Some soreness is expected both during the dry needling treatment and in the 24 hours afterwards with slight weaknesses possibly being felt by participants. The participants may also have a slight bruise as a result of the needle piercing the skin.

Where is the study run from?
Institute of Technology Carlow (Ireland)

When is the study starting and how long is it expected to run for?
September 2017 to August 2019

Who is funding the study?
Institute of Technology Carlow (Ireland)

Who is the main contact?
Mr Aaron Byrne
Aaron.Byrne@itcarlow.ie

Trial website

Contact information

Type

Scientific

Primary contact

Mr Aaron Byrne

ORCID ID

Contact details

K221 Dargan Centre
Institute of Technology Carlow
Kilkenny Road
Carlow
0000
Ireland
+353 (0)862331849
aaron.byrne@itcarlow.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

182

Study information

Scientific title

The longitudinal effects of dry needling of latent myofascial trigger points in gluteus medius on hip strength and single-leg time to stabilisation in multi directional and jump-sport athletes

Acronym

Study hypothesis

1. Dry needling will cause a short term decrease in hip strength
2. Dry needling will cause a short term increase in time to stabilisation

Ethics approval

Ethics in Research Committee in the Departments of Science and Health of the Institute of Technology Carlow, Ireland, 26/10/2017, ref: 182

Study design

Randomised placebo-controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Latent myofascial trigger points in gluteus medius

Intervention

All participants will be randomly assigned one of the treatments and will not know which treatment they are receiving (single-blinded):
1. Dry needling (intra-muscular stimulation)
2. Placebo dry needling (blunted needle, zero skin penetration)

Participants will only receive the single treatment once and it will be performed on between 2 and 5 trigger points. There will also be a quick informal conversation about how the participant feels about the treatment received, their soreness and their confidence to perform in their given sport.

Hip strength and single leg stability are measured before, immediately after and 3, 7, 10 and 14 days after the treatment. Hip strength will be measured using a portable strain gauge (hand-held dynamometer) which will be fitted to the end of a stabilisation device. Single leg stability will be recorded on a force plate in the form of “time to stabilisation” which records the amount of time needed to stabilise the body to within a certain threshold of bodyweight (5%), a lower time to stabilisation corresponds to better stability as they are able to stabilise faster.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured before, immediately after and 3, 7, 10 and 14 days after the treatment:
1. Hip abduction strength (maximal voluntary isometric contraction), measured using a portable strain gauge (hand-held dynamometer)
2. Hip internal rotation strength (maximal voluntary isometric contraction), measured using a portable strain gauge (hand-held dynamometer)
3. Hip external rotation strength (maximal voluntary isometric contraction), measured using a portable strain gauge (hand-held dynamometer)
4. Single-leg time to stabilisation, recorded on a force plate

Secondary outcome measures

The secondary outcome measures will be qualitative by nature and obtained through semi-structured interviews upon the completion of each of the follow-up measurements of stability (immediately post treatment, 3, 7, 10 and 14 days post treatment). All interviews will be conducted in private by a single interviewer and will be audio recorded for thematic analysis at a later date in order to give greater depth as to the effects dry needling may have on sporting performance.
1. Perceived stability
2. Perceived ability to perform in their given sport
3. Confidence in ability to perform
4. Local soreness (VAS)

Overall trial start date

01/09/2017

Overall trial end date

01/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Participants meet inclusion criteria if they:
1. Are a male, third level student of the Institute of Technology Carlow
2. Are aged between 18 and 45 years
3. At the time of testing, are participating in a multi-directional jump-sport including but not limited to; gaelic football, hurling, soccer, volleyball, basketball, handball more than 3 times per week
3. Have, as identified in a formal screening session; between 2 and 5 latent myofascial trigger points present in their self-reported preferred jumping leg

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

n=50 participants divided evenly between both intervention (dry needling) and placebo (zero skin penetration) groups

Participant exclusion criteria

Participants will be excluded if they:
1. Have, at the time of testing, any injury to the lower limb or low back. Injury is defined as "any injury that prevents a player from taking a full part in all training and match play activities” (Brooks et al. 2005)
2. Present with signs of or report during screening process, any neurological or bleeding disorders
3. Have a needle phobia or aicmophobia

Recruitment start date

01/09/2018

Recruitment end date

22/12/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

Institute of Technology Carlow
Kilkenny Road
Carlow
0000
Ireland

Sponsor information

Organisation

Institute of Technology Carlow

Sponsor details

Kilkenny Road
Carlow
0000
Ireland

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Institute of Technology Carlow

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study is being conducted as completion of a Research MSc in Rehabilitative Sciences, as such, the total study, protocols used, data analysis undertaken will all be represented in the submission. It is planned to publish in a high impact factor journal approximately one year from the completion and submission of the dissertation and the completion of the trial.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Aaron Byrne (aaron.byrne@itcarlow.ie). Upon the completion of the trial, all anonymised raw datasets will be made available upon request and will also be present in appendices of the final dissertation submission.

Intention to publish date

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes