- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07672093
Effects of Dry Needling on Latent Myofascial Trigger Points of the Extensor Digitorum Communis (DRYNEED)
Effects of Dry Needling and Electrical Dry Needling on Latent Myofascial Trigger Points of the Extensor Digitorum Communis: A Randomized Clinical Trial
This randomized single-blind clinical trial aims to compare the effects of different dry needling and electrical dry needling techniques applied to latent myofascial trigger points in the extensor digitorum muscle of the dominant forearm in healthy adults.
Participants will be randomly allocated to one of five groups: a control group, a Hong fast-in and fast-out dry needling group, a rotational dry needling group, a bipolar electrical dry needling group, or a monopolar electrical dry needling group. The main outcomes will be post-needling soreness intensity and duration. Secondary outcomes will include pain during the needling procedure, pressure pain threshold assessed by algometry, handgrip strength, range of motion of finger flexion and wrist palmar flexion, perceived comfort during the intervention, and perceived interference of post-needling soreness with daily activities.
Assessments will be performed at baseline, 5 minutes after the intervention, and at 24, 48, and 72 hours after the intervention.
연구 개요
상태
정황
상세 설명
Myofascial trigger points are hyperirritable spots located within a taut band of skeletal muscle. Latent myofascial trigger points do not cause spontaneous pain but may contribute to motor dysfunction, increased fatigability, reduced range of motion, and altered muscle performance. Dry needling is a commonly used physiotherapy technique for the treatment of myofascial trigger points. However, post-needling soreness is one of the most frequent adverse effects associated with this intervention and may influence patient comfort, adherence, and functional performance in the hours following treatment.
Electrical dry needling, also known as intramuscular electrical stimulation, combines dry needling with transcutaneous electrical nerve stimulation applied through the inserted needle. Different modalities of electrical dry needling are used in clinical practice, including bipolar and monopolar applications. Nevertheless, limited evidence is available regarding the effect of these techniques on post-needling soreness, particularly when short-duration monopolar stimulation is applied using a pointer-type device.
The aim of this randomized single-blind clinical trial is to compare the effects of different dry needling and electrical dry needling techniques applied to latent myofascial trigger points in the extensor digitorum muscle of the dominant forearm in healthy adults. The primary objective is to compare the effect of electrical dry needling versus Hong fast-in and fast-out dry needling on the intensity and duration of post-needling soreness. Secondary objectives include comparing post-needling soreness among the different dry needling techniques, analyzing immediate changes in handgrip strength, assessing changes in finger flexion and wrist palmar flexion range of motion, evaluating pain during the needling procedure, assessing pressure pain threshold by algometry, and analyzing perceived comfort and interference of post-needling soreness with daily activities.
Healthy adults with a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm will be recruited. Participants will be randomly assigned to one of five groups: control group, Hong fast-in and fast-out dry needling group, rotational dry needling group, bipolar electrical dry needling group, or monopolar electrical dry needling group. Participants in the control group will not receive any dry needling intervention but will undergo the same assessment schedule as the intervention groups.
In the Hong fast-in and fast-out dry needling group, a sterile needle will be inserted into the latent myofascial trigger point and repeated fast-in and fast-out movements will be performed. In the rotational dry needling group, a sterile needle will be inserted into the latent myofascial trigger point and a rotational dry needling technique will be applied according to the study protocol. In the bipolar electrical dry needling group, a sterile needle will be inserted into the latent myofascial trigger point, an adhesive electrode will be placed near the needle, and a TENS current will be applied for 15 minutes. In the monopolar electrical dry needling group, a sterile needle will be inserted into the latent myofascial trigger point and stimulation will be applied using a Pointer Plus Excel-II device for 3 minutes.
Outcome assessments will be performed at baseline and 5 minutes after the intervention. Post-needling soreness intensity and duration will also be recorded at 24, 48, and 72 hours after the intervention. The study will use separated roles for recruitment, assessment, intervention delivery, and data analysis in order to reduce bias. Outcome assessors and the researcher responsible for data analysis will be blinded to group allocation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tania López Hernández, Phd
- 전화번호: 34+620438175
- 이메일: tania.lopez@urv.cat
연구 장소
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Tarragona
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Reus, Tarragona, 스페인, 43203
- 모병
- Facultat de Medicina i Ciències de la Salut
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연락하다:
- Tania López Hernández, Phd
- 전화번호: 34+620438175
- 이메일: tania.lopez@urv.cat
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 to 40 years.
- Healthy participants with a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
- No pathology affecting the upper limb where the intervention will be applied.
- No episode of pain in the upper limb during at least the previous two months.
- No contraindications to dry needling or electrical dry needling techniques.
- Voluntary signature of the informed consent form.
- Willingness to follow the protocol proposed by the research team.
Exclusion Criteria:
- Needle phobia.
- Coagulation disorders.
- Pregnancy.
- Thyroid disorders.
- Altered skin integrity in the treatment area.
- Epilepsy.
- Local or systemic infection.
- Diagnosed neurological disorders affecting pain perception or neuromuscular function in the region of interest, such as multiple sclerosis or peripheral neuropathies.
- Generalized chronic pain conditions, such as fibromyalgia.
- Weekly use of analgesic medication, including anti-inflammatory drugs, opioids, or other pain-relieving medication.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: No Intervention: Control Group
Participants allocated to the control group will not receive any dry needling or electrical dry needling intervention.
Outcome variables will be recorded following the same assessment schedule as in the intervention groups.
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실험적: Experimental: Hong Fast-In and Fast-Out Dry Needling Group
Participants allocated to this group will receive dry needling using the fast-in and fast-out technique described by Hong, applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
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The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once the needle has reached the trigger point, 10 fast-in and fast-out movements will be performed.
The number of local twitch responses will be recorded.
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실험적: Experimental: Rotational Dry Needling Group
Participants allocated to this group will receive dry needling using a rotational technique applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
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The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once the needle has reached the trigger point, the rotational dry needling technique will be applied according to the predefined study protocol.
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실험적: Experimental: Bipolar Electrical Dry Needling Group
Participants allocated to this group will receive bipolar electrical dry needling applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
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The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once a local twitch response has been obtained, the needle will remain inserted and will act as the negative pole.
An adhesive electrode connected to the positive pole will be placed approximately one centimeter from the needle.
A TENS current will be applied for 15 minutes at a frequency of 2 Hz and a pulse width of 120 milliseconds.
The intensity will be increased until visible, non-painful contractions of the extensor digitorum muscle are achieved.
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실험적: Experimental: Monopolar Electrical Dry Needling Group
Participants allocated to this group will receive monopolar electrical dry needling using a Pointer device, applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
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The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once a local twitch response has been obtained, the needle will remain inserted in the trigger point.
The metallic tip of the Pointer Plus Excel-II device will be placed in contact with the needle, and a TENS current will be applied for 3 minutes at a frequency of 2 Hz and a pulse width of 220 milliseconds.
The intensity will be increased until visible, non-painful contractions of the extensor digitorum muscle are achieved.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Post-needling soreness intensity
기간: 1 week
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Post-needling soreness intensity will be assessed using a numerical pain rating scale.
Participants will rate the intensity of local soreness perceived in the needling area, clearly differentiated from any other type of pain.
Higher scores indicate greater pain intensity.
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1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of post-needling soreness
기간: 1 week
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The duration of post-needling soreness will be recorded in hours, from the moment of onset until complete disappearance, based on participant self-report during the 24-, 48-, and 72-hour follow-up assessments.
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1 week
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Pressure pain threshold
기간: 1 week
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Pressure pain threshold will be assessed using pressure algometry over the treated region.
The value will be recorded as the minimum pressure that induces the first sensation of pain.
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1 week
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Range of motion of finger flexion and wrist palmar flexion
기간: 1 week
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Range of motion of finger flexion and wrist palmar flexion will be assessed using a two-arm goniometer and recorded in degrees.
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1 week
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Pain during needling
기간: Immediately after the intervention
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Pain perceived during the application of the dry needling or electrical dry needling technique will be assessed using a numerical pain rating scale.
Participants will be asked to report the intensity of pain experienced during the procedure.
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Immediately after the intervention
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Handgrip strength
기간: 1 week
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Handgrip strength will be assessed using a hand dynamometer and recorded in kilograms.
Measurements will be performed at baseline, 5 minutes after the intervention, and 1 week after the intervention.
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1 week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tania López Hernández, Unviersitat Rovira i Virgili
간행물 및 유용한 링크
일반 간행물
- Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
- Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.
- Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
- Leon-Hernandez JV, Martin-Pintado-Zugasti A, Frutos LG, Alguacil-Diego IM, de la Llave-Rincon AI, Fernandez-Carnero J. Immediate and short-term effects of the combination of dry needling and percutaneous TENS on post-needling soreness in patients with chronic myofascial neck pain. Braz J Phys Ther. 2016 Jul 11;20(5):422-431. doi: 10.1590/bjpt-rbf.2014.0176.
- Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
- Perreault T, Ball A, Dommerholt J, Theiss R, Fernandez-de-Las-Penas C, Butts R. Intramuscular Electrical Stimulation to Trigger Points: Insights into Mechanisms and Clinical Applications-A Scoping Review. J Clin Med. 2022 Oct 13;11(20):6039. doi: 10.3390/jcm11206039.
- Martin-Pintado-Zugasti A, Mayoral Del Moral O, Gerwin RD, Fernandez-Carnero J. Post-needling soreness after myofascial trigger point dry needling: Current status and future research. J Bodyw Mov Ther. 2018 Oct;22(4):941-946. doi: 10.1016/j.jbmt.2018.01.003. Epub 2018 Jan 17.
- Brady S, McEvoy J, Dommerholt J, Doody C. Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. J Man Manip Ther. 2014 Aug;22(3):134-40. doi: 10.1179/2042618613Y.0000000044.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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키워드
기타 연구 ID 번호
- 06/2026
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