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Effect of Mechanical Traction in Patients With Chronic Neck Pain

17 de junho de 2026 atualizado por: Amira saad mohamed

Effect of Mechanical Traction on Functional Outcome and Sleep Quality in Patients With Chronic Neck Pain

This study will be conducted to investigate the effect of mechanical traction on pain, disability, cervical range of motion, sleep quality and insomnia in patients with chronic neck pain. Forty four female patients with chronic neck pain will participate in this study. The patients will be diagnosed as having chronic neck pain based on careful clinical examination by neurologist. Patients in this study will be randomly divided into two equal groups:

Group (A): Patients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy.

Group (B): Patients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week.

Visão geral do estudo

Status

Ativo, não recrutando

Tipo de estudo

Intervencional

Inscrição (Real)

44

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Giza, Egito
        • Cairo University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Female Patients with chronic neck pain.
  • The age of patients will be ranged from 30-45 years old.
  • Duration of pain will be more than six months.

Exclusion Criteria:

  • Other neurological disorders causing sleep disorders as stroke and multiple sclerosis.
  • Pregnancy.
  • History of cervical spine surgery.
  • Psychological disorders such as severe depression or anxiety.
  • Active infection or malignancy in the cervical spine.
  • Body mass index more than 30kg/m2.
  • Diabetic or peripheral neuropathy.
  • Severe myelopathy

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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: Group A (exprimental)
Patients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy. The treatment will be conducted over six weeks, three days per week.

Participants will be positioned in supine on a flat bed. A manual traction test will be performed to ensure that traction did not provoke any pain or unwanted sensations.The mechanical traction will be applied at 45° from the horizontal plane formed by the bed

Mechanical traction was set to 5% of the participant's body weight on day 1 (unless not tolerated) and increased to reach 10% on the 5th day, as pain allowed, and without exceeding 12kg. Within a session, the load will applied progressively over 5 minutes and pain will be monitored using a VAS. The target weight will be then maintained for 20 minutes and then reduced gradually over the last 5 minutes. The patient then will lie still for 10 minutes before getting up

Patients recieved conventional physical therapy treatment in addition to mechanical traction conducted over six weeks, three days per week.

Patients recieved conventional physical therapy which will include:

1-10 minute hot packs on the cervical and upper back. 2- Ultrasound: It will be applied to paraspinal muscles with a frequency of 1 MHz with a continuous mode and 0.5 W/Cm2 for 5 minutes using moving sound head technique.

3- Transcutaneous electrical nerve stimulation: The electrodes will be placed at the level of cervical paraspinal muscles and at the course of affected nerve. The impulse duration will be adjusted to 1ms with an interval of 5 ms. and frequency of 166 Hz for 20 minutes The treatment will be conducted over six weeks, three days per week.

Comparador Ativo: Group B(control)
Patients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week.

Patients recieved conventional physical therapy which will include:

1-10 minute hot packs on the cervical and upper back. 2- Ultrasound: It will be applied to paraspinal muscles with a frequency of 1 MHz with a continuous mode and 0.5 W/Cm2 for 5 minutes using moving sound head technique.

3- Transcutaneous electrical nerve stimulation: The electrodes will be placed at the level of cervical paraspinal muscles and at the course of affected nerve. The impulse duration will be adjusted to 1ms with an interval of 5 ms. and frequency of 166 Hz for 20 minutes The treatment will be conducted over six weeks, three days per week.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
pain intensity
Prazo: pre intervention and re assessed after 6 weeks of treatment
The visual analog scale (VAS) is frequently used to measure pain intensity in patients with cervical spine disorders. The minimum clinically important difference (MCID) is the smallest change in a score that has clinical importance to the patient. Although it has been established for other medical fields, knowledge of the VAS MCID for the cervical spine is sparse, and it has rarely been considered in relation to measurement noise. the score represented in numbers from 0 to 10.
pre intervention and re assessed after 6 weeks of treatment
neck disability
Prazo: pre intervention and re assessed after 6 weeks of treatment
neck disability index questionnaire was used to assess the disability caused by neck pain. The Neck disability index is a commonly used method to determine functional disability level of subjects with neck pain. it is a 10-item questionnaire used to measure self-reported disability related to neck pain, with higher scores indicating greater functional limitation, Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total raw score ranges from 0 to 50, which can be converted to a percentage by doubling the score, giving a range from 0% (no disability) to 100% (complete disability),
pre intervention and re assessed after 6 weeks of treatment
Cervical Range of Motion (CROM)
Prazo: pre intervention and re assessed after 6 weeks of treatment
Cervical Range of Motion (CROM) device. The CROM device is a type of goniometer designed specifically for the cervical spine and was used to measure cervical ROM. It consists of a plastic frame that is mounted over the subject's nose bridge and ears and secured to the head by a felcro strap. Three independent inclinometers attached to the frame and arranged orthogonally to one another indicate the subject's cervical ROM. Cervical Range of Motion (CROM) is measured in angles
pre intervention and re assessed after 6 weeks of treatment
sleep quality
Prazo: pre intervention and re assessed after 6 weeks of treatment
Pittsburg Sleep Quality Index (PSQI) is used to assess sleep quality. The Pittsburg sleep quality index is a self administered questionnaire used to assess sleep quality. It is considered the gold standard for evaluating sleep quality over a period of 1 month. It consists of 19 items and were calculated as the following 7 components: sleep latency, sleep duration, sleep quality, sleep disturbances, sleep efficiency, sleep medication, and daytime dysfunction. Each component of them was weighted equally and scored on a scale from 0-3 for a total score from 0-21. Its validity is confirmed by various studies in different populations of patients
pre intervention and re assessed after 6 weeks of treatment
Insomnia Severity
Prazo: pre intervention and re assessed after 6 weeks of treatment
The Insomnia Severity Index (ISI) is used to assess insomnia. Itis a seven-question questionnaire that is given to the respondent to assess recent problems with falling asleep, maintaining sleep, early awakening and the consequences of insomnia, using five-level points (from 0-none to 4-very, a lot). The ISI score is obtained by summing the points for each item, and it ranges from 0 to 28. Higher scores correspond to insomnia of greater intensity, and can be classified into four categories: no insomnia (0-7), borderline insomnia (8-14), clinically clear insomnia-moderately severe (15-21) and clinically clear insomnia-severe (22-28)
pre intervention and re assessed after 6 weeks of treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de abril de 2026

Conclusão Primária (Estimado)

25 de junho de 2026

Conclusão do estudo (Estimado)

1 de julho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

17 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2026

Primeira postagem (Real)

23 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 012/006273

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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