- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07621016
Effects of Dry Needling in Athletes With Subacromial Pain Syndrome
Effects of Dry Needling on Proprioception, Dynamic Stability, Strength, Pain Perception, and Disability in Athletes With Subacromial Pain Syndrome
The goal of this clinical trial is to evaluate whether dry needling combined with therapeutic exercise improves shoulder proprioception in amateur athletes with subacromial pain syndrome. The study will also assess its effects on dynamic stability, strength, pain, and functional disability.
The main questions this study aims to answer are:
Does dry needling improve shoulder proprioception compared with therapeutic exercise alone? Does dry needling improve dynamic shoulder stability and muscle strength? Does dry needling reduce pain and upper limb disability?
Researchers will compare a group receiving dry needling plus therapeutic exercise with a group performing therapeutic exercise alone to determine whether the combined intervention produces better outcomes.
Participants will:
Be randomly assigned to one of the two treatment groups. Perform a home-based therapeutic exercise program for 3 weeks. Complete assessments of proprioception, dynamic stability, strength, pain, and functional disability before and after the intervention.
연구 개요
상세 설명
Subacromial pain syndrome (SAPS) is one of the most common causes of shoulder pain and dysfunction in both the general population and athletes involved in repetitive upper-limb activities. In sports requiring overhead movements, throwing actions, or repetitive shoulder loading, the increased mechanical demand placed on the glenohumeral joint may contribute to functional impairments, persistent pain, and reduced athletic performance.
Several studies have reported proprioceptive deficits and sensorimotor control alterations in individuals with SAPS. These impairments may affect joint position sense, muscular coordination, and dynamic shoulder stability, potentially contributing to symptom persistence and increasing the risk of recurrent injury. Previous research has also associated proprioceptive deficits with higher pain intensity, functional disability, and reduced neuromuscular control.
Proprioception plays a fundamental role in sensory integration and in the regulation of precise and coordinated shoulder movements. Altered afferent input from muscular and articular structures may impair dynamic stabilization mechanisms and compromise upper-limb function during sports activities.
Dry needling is a minimally invasive physiotherapy technique widely used for the treatment of myofascial trigger points. Previous studies have demonstrated positive effects of dry needling on pain and functional disability in individuals with subacromial pain syndrome. In addition, research conducted in other joints has suggested that dry needling may influence motor control, postural stability, and proprioceptive mechanisms.
Despite the growing clinical interest in this intervention, there is currently limited evidence regarding the effects of dry needling on shoulder proprioception and sensorimotor variables in individuals with SAPS, particularly in athletic populations. Therefore, further investigation is needed to determine whether adding dry needling to a therapeutic exercise program may provide additional benefits for neuromuscular control and shoulder function.
The primary aim of this clinical trial is to evaluate the effectiveness of dry needling combined with therapeutic exercise on shoulder proprioception in amateur athletes with subacromial pain syndrome. Additionally, the study will assess the potential effects of the intervention on dynamic stability, shoulder isometric strength, pain perception, and upper-limb functional disability.
A randomized controlled trial with two parallel groups will be conducted. Participants will be randomly assigned in a 1:1 ratio to:
an experimental group receiving dry needling combined with therapeutic exercise, or a control group receiving therapeutic exercise alone.
The intervention period will last 3 weeks. Participants in the experimental group will receive two dry needling sessions separated by a 10-day interval. The technique will be administered by an experienced physiotherapist with specialized training in dry needling, following a predefined protocol based on the available scientific literature.
The intervention will target myofascial trigger points located in scapulohumeral muscles commonly associated with shoulder pain and subacromial pain syndrome. Trigger points will be identified through standardized clinical examination procedures.
Both groups will perform a structured home-based therapeutic exercise program focused on muscular strengthening, neuromuscular control, and shoulder function. Participants will receive individualized instructions, and adherence to the exercise program will be monitored using follow-up records.
Outcome assessments will be performed by an evaluator blinded to group allocation in order to minimize measurement bias. Measurements will be collected at three time points: baseline, 10 days after the first intervention session, and 10 days after the second intervention session, to evaluate changes in proprioception, dynamic stability, muscular strength, pain, and functional disability.
This study aims to provide clinical evidence regarding the potential role of dry needling as an adjunct to therapeutic exercise in the management of sensorimotor and functional impairments associated with subacromial pain syndrome in athletic populations. The findings may contribute to the development of more effective therapeutic strategies aimed at improving shoulder function and optimizing functional recovery in athletes with this condition.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Pablo Taberner Mortes, PT, MSc
- 전화번호: +34 680869335
- 이메일: pablo.taberner@universidadeuropea.es
연구 연락처 백업
- 이름: Alejandro Sendín Magdalena, PT, MSc, PhD
- 전화번호: +34 652 53 43 10
- 이메일: alejandro.sendin@universidadeuropea.es
연구 장소
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Valencia
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Valencia, Valencia, 스페인, 46006
- Clínica Dr Villarón
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연락하다:
- Pablo Taberner Mortes, PT, MSc
- 전화번호: +34 680869335
- 이메일: pablo.taberner@universidadeuropea.es
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수석 연구원:
- Carlos A Villarón Casales, PT, MSc, PhD
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부수사관:
- Pablo Taberner Mortes, PT, MSc
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부수사관:
- Alejandro Sendín Magdalena, PT, MSc, PhD
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부수사관:
- Mathilde Conde Aparicio, PT, MSc
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부수사관:
- Lucia Ortega Pérez de Villar, PT, MSc, PhD
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부수사관:
- Javier Fenollar Cortes, PT, MSc, PhD
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연락하다:
- Carlos A Villarón Casales, Clin. Dir.
- 전화번호: + 34 611 68 62 26
- 이메일: cvillaron@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Men and women aged between 18 and 40 years.
- Clinical diagnosis of subacromial pain syndrome (SAPS) according to the Dutch Orthopaedic Association criteria: presence of a painful arc and at least two positive tests among the following: Hawkins-Kennedy test, Neer sign, Jobe test, Drop Arm test, or Gerber test.
- Participation in sports involving predominant upper-limb activity between 2 and 4 hours per week.
Exclusion Criteria:
- Previous surgery involving the upper extremities.
- Diagnosis of specific shoulder pathologies other than SAPS at the time of the study.
- Receipt of medical or physiotherapy treatment within the month prior to the intervention.
- Needle phobia or refusal to receive dry needling treatment.
- Presence of vestibular disorders, balance impairments, or vascular alterations that could interfere with study measurements.
- Confirmed or suspected pregnancy.
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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실험적: Dry needling + therapeutic exercise
Participants assigned to the experimental group will receive a combined intervention consisting of dry needling and a structured home-based therapeutic exercise program over a 3-week period.
Dry needling will be applied to active myofascial trigger points in scapulohumeral muscles commonly associated with subacromial pain syndrome, including the supraspinatus, infraspinatus, subscapularis, teres minor, teres major, and anterior and middle deltoid muscles.
Trigger points will be identified through standardized clinical examination based on the presence of a palpable taut band, a hypersensitive spot, reproduction of recognizable pain, and local twitch response.
The intervention will be performed by a physiotherapist with more than 10 years of experience and certified training in dry needling, using a fast in-fast out technique with sterile disposable needles after skin disinfection with chlorhexidine.
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Dry needling will be applied to active myofascial trigger points identified in scapulohumeral muscles commonly associated with subacromial pain syndrome, including supraspinatus, infraspinatus, subscapularis, teres minor, teres major, and anterior and middle deltoid muscles.
Trigger points will be identified through standardized clinical examination.
The intervention will be performed by an experienced physiotherapist using sterile disposable needles and a standardized fast in-fast out technique.
Participants will receive two dry needling sessions separated by a 10-day interval.
Participants will perform a structured home-based therapeutic exercise program focused on shoulder strengthening, neuromuscular control, and sensorimotor function using elastic resistance bands.
The exercise program will be performed three times per week for 3 weeks following a standardized protocol.
Participants will receive individualized instruction, exercise materials, and adherence monitoring throughout the intervention period.
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활성 비교기: Therapeutic exercise
Participants assigned to the control group will receive a structured home-based therapeutic exercise program over a 3-week period without dry needling intervention.
The exercise program will focus on shoulder strengthening, neuromuscular control, and sensorimotor function using elastic resistance bands.
Participants will perform the exercises three times per week for 3 weeks following a standardized protocol.
All participants will receive individualized in-person instruction from a physiotherapist to ensure correct exercise execution.
Participants will also receive the necessary exercise materials and an adherence diary to record compliance throughout the intervention period.
The therapeutic exercise program will be identical to the experimental group in terms of exercise type, frequency, duration, supervision, and home-based format.
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Participants will perform a structured home-based therapeutic exercise program focused on shoulder strengthening, neuromuscular control, and sensorimotor function using elastic resistance bands.
The exercise program will be performed three times per week for 3 weeks following a standardized protocol.
Participants will receive individualized instruction, exercise materials, and adherence monitoring throughout the intervention period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Shoulder Proprioception Assessed With the Joint Position Sense Test
기간: Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Shoulder proprioception will be evaluated using the Joint Position Sense (JPS) test.
Participants will actively reproduce a predefined shoulder position (abduction at 60°), and the absolute angular repositioning error in degrees will be recorded using an inclinometer.
Scores range from 0 degrees (perfect repositioning) to no defined upper limit, with lower values indicating better proprioceptive accuracy.
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Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity Assessed With the Numeric Rating Scale
기간: Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Lower scores indicate lower pain intensity.
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Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Dynamic Shoulder Stability Assessed With the Upper Quarter Y Balance Test
기간: Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Dynamic shoulder stability will be assessed using the Upper Quarter Y Balance Test (YBT-UQ).
Reach distances in the medial, inferolateral, and superolateral directions will be recorded in centimeters, with a minimum score of 0 cm and no predefined upper limit.
Greater reach distance indicates better dynamic stability and sensorimotor performance.
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Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Isometric Shoulder Strength Assessed With Handheld Dynamometry
기간: Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Isometric strength of the shoulder abductors and rotator muscles will be measured using a handheld dynamometer during maximal voluntary isometric contractions.
Force values are recorded in Newtons, with a minimum of 0 N and no predefined upper limit.
Higher force values indicate greater muscle strength.
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Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Upper Limb Disability Assessed With the Disabilities of the Arm, Shoulder and Hand Questionnaire
기간: Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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Functional disability of the upper limb will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, scored from 0 to 100, where 0 indicates no disability and 100 indicates maximum disability.
Higher scores indicate greater disability and functional impairment.
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Baseline, 10 days after the first intervention session, and 10 days after the second intervention session
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공동 작업자 및 조사자
수사관
- 수석 연구원: Carlos A Villaron Casales, PT, MSc, PhD, Universidad Europea de Valencia
간행물 및 유용한 링크
일반 간행물
- Arias-Buria JL, Fernandez-de-Las-Penas C, Palacios-Cena M, Koppenhaver SL, Salom-Moreno J. Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel-Group Trial. J Pain. 2017 Jan;18(1):11-18. doi: 10.1016/j.jpain.2016.08.013. Epub 2016 Oct 5.
- Salom-Moreno J, Ayuso-Casado B, Tamaral-Costa B, Sanchez-Mila Z, Fernandez-de-Las-Penas C, Alburquerque-Sendin F. Trigger Point Dry Needling and Proprioceptive Exercises for the Management of Chronic Ankle Instability: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:790209. doi: 10.1155/2015/790209. Epub 2015 Apr 30.
- Chys M, De Meulemeester K, De Greef I, Murillo C, Kindt W, Kouzouz Y, Lescroart B, Cagnie B. Clinical Effectiveness of Dry Needling in Patients with Musculoskeletal Pain-An Umbrella Review. J Clin Med. 2023 Feb 2;12(3):1205. doi: 10.3390/jcm12031205.
- Ager AL, Borms D, Deschepper L, Dhooghe R, Dijkhuis J, Roy JS, Cools A. Proprioception: How is it affected by shoulder pain? A systematic review. J Hand Ther. 2020 Oct-Dec;33(4):507-516. doi: 10.1016/j.jht.2019.06.002. Epub 2019 Aug 31.
- Gliga AC, Neagu NE, Voidazan S, Popoviciu HV, Bataga T. Effects of a Novel Proprioceptive Rehabilitation Device on Shoulder Joint Position Sense, Pain and Function. Medicina (Kaunas). 2022 Sep 9;58(9):1248. doi: 10.3390/medicina58091248.
- Alfaya FF, Reddy RS, Alkhamis BA, Kandakurti PK, Mukherjee D. Shoulder Proprioception and Its Correlation with Pain Intensity and Functional Disability in Individuals with Subacromial Impingement Syndrome-A Cross-Sectional Study. Diagnostics (Basel). 2023 Jun 17;13(12):2099. doi: 10.3390/diagnostics13122099.
- Blanco-Diaz M, Ruiz-Redondo R, Escobio-Prieto I, De la Fuente-Costa M, Albornoz-Cabello M, Casana J. A Systematic Review of the Effectiveness of Dry Needling in Subacromial Syndrome. Biology (Basel). 2022 Feb 4;11(2):243. doi: 10.3390/biology11020243.
- Para-Garcia G, Garcia-Munoz AM, Lopez-Gil JF, Ruiz-Cardenas JD, Garcia-Guillen AI, Lopez-Roman FJ, Perez-Pinero S, Abellan-Ruiz MS, Canovas F, Victoria-Montesinos D. Dry Needling Alone or in Combination with Exercise Therapy versus Other Interventions for Reducing Pain and Disability in Subacromial Pain Syndrome: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 2;19(17):10961. doi: 10.3390/ijerph191710961.
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SDSA-PS-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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