- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07695402
Combined Therapy and Jones Technique for Upper Trapezius Myofascial Trigger Points
Clinical Effects of Combined Therapy, Jones Technique, and Their Combination in Women With Upper Trapezius Myofascial Trigger Points: A Four-Arm Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Descrição detalhada
Myofascial trigger points (MTrPs) in the upper trapezius muscle are frequently associated with neck pain, reduced pressure pain threshold, and impaired upper limb function. Several conservative interventions have been proposed for the treatment of MTrPs; however, evidence comparing manual therapy and combined electrotherapy remains limited.
This single-center, randomized, sham-controlled, parallel-group clinical trial evaluated the effects of the Jones Technique and combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]) in women aged 18 to 40 years presenting with active myofascial trigger points in the upper trapezius muscle.
Participants were randomly allocated (1:1:1:1) into four groups: (1) Jones Technique; (2) combined therapy; (3) combined therapy plus Jones Technique; and (4) sham control. Randomization was performed using block randomization stratified by age. Participants underwent a single treatment session.
Baseline assessments included demographic data, pain intensity measured using the Visual Analog Scale (VAS), pressure pain threshold measured with a pressure algometer, upper limb disability (DASH), sleep quality (Pittsburgh Sleep Quality Index), quality of life (SF-36), and physical activity level (IPAQ). Immediately after the intervention, pain intensity, pressure pain threshold, and participant satisfaction were reassessed.
The primary outcome was pressure pain threshold. Secondary outcomes included pain intensity, upper limb disability, sleep quality, quality of life, physical activity level, and participant satisfaction.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Rio Grande do Sul
-
São Leopoldo, Rio Grande do Sul, Brasil
- Physical Therapy Teaching Clinic, Universidade do Vale do Rio dos Sinos (UNISINOS)
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Female participants aged 18 to 40 years.
- Presence of active myofascial trigger points in the upper trapezius muscle for no longer than 12 weeks.
- Neck pain lasting less than 3 months.
- Pain intensity of at least 3 cm on the 10-cm Visual Analog Scale (VAS).
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Presence of a cardiac pacemaker or other contraindications to electrotherapy.
- Pregnancy.
- Uncontrolled cardiovascular disease.
- Psychiatric disorders that could interfere with study participation.
- Thrombosis or coagulation disorders.
- History of tumors or neoplasms.
- Physical therapy or myofascial treatment within the previous 3 weeks.
- Treatment for myofascial trigger points within the previous 3 months.
- Current use of analgesic medications.
- Cervical musculoskeletal disorders (e.g., cervical osteoarthritis or other cervical lesions).
- History of cervical trauma or surgery.
- Cervical spondylosis or spondylolisthesis with radiculopathy.
- Fibromyalgia or other systemic rheumatic diseases.
- Other musculoskeletal disorders that could interfere with the study outcomes.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Jones Technique
Participants received a single session of the Jones Technique for the treatment of active myofascial trigger points in the upper trapezius muscle.
|
Manual therapy technique applied to active myofascial trigger points of the upper trapezius muscle.
Participants were positioned in prone lying, and sustained pressure with positional release was applied to each trigger point for 90 seconds.
Five trigger points were treated during a single treatment session.
|
|
Experimental: Combined Therapy
Participants received a single session of combined therapy consisting of therapeutic ultrasound combined with transcutaneous electrical nerve stimulation (TENS) applied to active myofascial trigger points in the upper trapezius muscle.
|
Combined therapy consisting of pulsed therapeutic ultrasound (1 MHz, 20% duty cycle, 1.0 W/cm²) delivered simultaneously with transcutaneous electrical nerve stimulation (TENS; biphasic asymmetric waveform, 200 μs pulse duration, 100 Hz).
Treatment was applied to five active upper trapezius myofascial trigger points during a single 10-minute session.
|
|
Experimental: Combined Therapy + Jones Technique
Participants received the Jones Technique followed immediately by combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]) during a single treatment session.
|
Participants received the Jones Technique followed immediately by combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]) during a single treatment session.
|
|
Comparador Falso: Sham Control
Participants underwent all study assessments and received sham treatment consisting of inactive combined therapy (device turned off) and a simulated Jones Technique without therapeutic pressure.
|
Participants underwent sham treatment consisting of inactive combined therapy with the device turned off and a simulated Jones Technique performed without therapeutic pressure.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pressure Pain Threshold (PPT)
Prazo: Baseline and immediately after the intervention (single treatment session)
|
Pressure pain threshold assessed using a pressure algometer at five active myofascial trigger points in the upper trapezius muscle.
The pressure pain threshold is recorded in kg/cm².
Higher values indicate greater pressure tolerance and therefore a better outcome.
|
Baseline and immediately after the intervention (single treatment session)
|
|
Pain Intensity
Prazo: Baseline and immediately after the intervention
|
Pain intensity assessed using the Visual Analog Scale for Pain (VAS).
Scores range from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate worse pain.
|
Baseline and immediately after the intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Upper Limb Disability
Prazo: Baseline
|
Upper limb disability assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.
Higher scores indicate worse upper limb function.
|
Baseline
|
|
Sleep Quality
Prazo: Baseline
|
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
Total scores range from 0 to 21, where higher scores indicate poorer sleep quality.
|
Baseline
|
|
Quality of life
Prazo: Baseline
|
Quality of life assessed using the 36-Item Short Form Health Survey (SF-36).
Scores for each domain range from 0 to 100, where higher scores indicate better health-related quality of life.
|
Baseline
|
|
Physical Activity Level
Prazo: Baseline
|
Physical activity level assessed using the International Physical Activity Questionnaire (IPAQ).
Participants are classified into low, moderate, or high physical activity levels based on the questionnaire scoring protocol.
Higher physical activity classification indicates a better outcome.
|
Baseline
|
|
Participant Satisfaction
Prazo: Immediately after the intervention
|
Participant satisfaction assessed immediately after treatment using a 7-point Likert scale.
Scores range from 1 (strongly disagree/very dissatisfied) to 7 (strongly agree/very satisfied).
Higher scores indicate greater participant satisfaction.
|
Immediately after the intervention
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 7.119.287
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .