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临床试验/NCT07306312
NCT07306312Enrolling By Invitation不适用

Psychological Predictors of Pain and Disability in Patients With Chronic Low Back Pain After Manual Therapy

University of Thessaly1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

Low back pain has been reported to cause more disability than any other musculoskeletal health condition worldwide. About eight out of ten people will experience back pain at least once in their lifetime. The parameters that are usually evaluated in a low back pain condition are pain, functional disability and range of motion of the lumbar spine. There are studies that associate psychological conditions (self-efficacy, kinesiophobia, catastrophology, depression, anxiety) with pain and functional disability in patients with low back pain. However, the ability of psychological factors to predict progression after a program of physical therapy or therapeutic methods is not well studied.

The main purpose of this study is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability after a manual therapy physiotherapy program in patients with chronic low back pain. A secondary purpose is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability following a program of Pain Neuroscience Education (PNE) in patients with chronic low back pain. In addition, as a secondary purpose, it will be to investigate the effect of combining manual therapy therapy with PNE compared to manual therapy alone in patients with chronic low back pain.

This study will involve 60 people aged 18-65 with chronic low back pain, who will be randomly divided by lots into 2 groups of 30 people. The 1st group (30 people) will be treated with manual therapy based on Maitland's principles (interview, evaluation, mobilization), without any use of physiotherapy machines, but with the use of personalized exercises. The 2nd group (30 people) will do the same as group 1 and additional volunteers will participate in before, in a training program in Pain Neuroscience Education (PNE). The total number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of the sessions will be 2 times a week and the total duration of the intervention will be 3 weeks. The associations between psychological states and clinical characteristics (pain, disability and range of motion) will be carried out with the Pearson or Spearman correlation coefficient depending on whether the data are parametric or not. Multiple regression models will also be created with predictive factors for psychological states and a predictive variable for each of the clinical parameters. The significance level will be set to p=0.05.

详细描述

Sample A total of 60 people with chronic low back pain will participate in the study and will be divided by lot into two groups of 30 people. The statistical calculation of the sample was made in the following way. We have 5 predictive factors (self-efficacy, depression, kinesiophobia, catastrophism and anxiety) and one predictive factor. According to the regression model we will need 10 people for each variable (i.e. 50 people). However, since we will divide the individuals into 2 groups, in order to have statistical strength in the measurements that will be made, we will take 30 people in each group Participants will be taken through convenience sampling. Participation in the survey will be voluntary and all those who take part will sign a consent form, after detailed information through the information form.

Equipment and Materials The equipment that will be used to conduct the study includes: a) a special electric manual therapy bed, adjustable in height, with recline and hole for the face b) two inclinometers to measure the range of motion of the lumbar spine, c) a mechanical algometer for measuring the pain threshold of the lumbar spine, d) specific questionnaires.

Interventions In both intervention groups, manual therapy based on Maitland's principles (interview, evaluation, mobilization) will be applied without the use of physiotherapy machines, but with the use of therapeutic exercise. The physiotherapist who will apply the techniques is a certified therapist of manual therapy Maitland Concept with 8 years of experience in the application of the method. The number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of sessions will be 2 times a week and the total duration of the intervention will be 3 weeks.

The International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) defines orthopaedic manual physical therapy as: "a specialized area of physiotherapy for the management of neuromusculoskeletal disorders, based on clinical reasoning, using very specific therapeutic approaches, including manual techniques and therapeutic exercises. Orthopedic hand-held physiotherapy also includes, and is guided by, the available scientific and clinical data and the biopsychosocial context of each individual patient".

The effectiveness of manual therapy in the treatment of low back pain (LBP) has been supported by various studies, indicating its potential benefits in reducing pain, improving impotence and trajectory range. Manual therapy includes techniques such as manipulation and mobilization, which have shown positive results in enhancing range of motion and relieving discomfort in patients with low back pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants should be between 18 and 65 years of age,
  • the pain in the lumbar region should last for more than 3 months, with at least one attack per week,
  • they should not have undergone physiotherapy in the last 6 months prior to the intervention
  • have a good knowledge of the Greek language and an adequate level of knowledge, to be informed and sign the consent form and questionnaires

排除标准

  • people with clinical conditions that are contraindicated for physiotherapy,
  • patients who report red flags,
  • people with a history of lumbar surgery,
  • people with diagnosed neuromuscular diseases that significantly impair movement,
  • people with cardiovascular and respiratory diseases that cause severe shortness of breath or angina
  • people with mental disorders, as long as they hinder communication and cooperation with the researcher.

研究组 & 干预措施

Manual therapy

Experimental

Participants with low back pain will be treated with manual therapy based on Maitland's principles

干预措施: Manual therapy (Other)

Manual therapy plus Pain Neuroscience Education

Active Comparator

Participants with low back pain will be treated with manual therapy based on Maitland's principles but before that, volunteers will be participated, in a Pain Neuroscience Education (PNE) program

干预措施: Manual therapy plus Pain Neuroscience Education (Other)

结局指标

主要结局

Pain intensity

时间窗: From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment

The assessment of pain will be recorded with the Numeric Pain Rating Scale - NPRS questionnaire. "Zero is equivalent to no pain and 10 indicates the worst possible pain."

次要结局

  • Disability(From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Konstantinos Prentzas

Principal Investigator, PhD candidate, Physiotherapy Department University of Thessaly

University of Thessaly

研究点 (1)

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