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临床试验/NCT07830836
NCT07830836Enrolling By Invitation不适用

Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints

Poznan University of Physical Education1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
300
试验地点
1
主要终点
Assessment of muscle tone using Myoton PRO of selected muscles, in standing position.

研究概览

简要总结

Study Summary: Effectiveness of Physiotherapy and Osteopathy in Treating Spinal and Temporomandibular Joint Pain About the Study and Its Objective This study is conducted by Artur Hołodniuk, MSc, a physiotherapist and academic lecturer. The primary goal of the project is to evaluate the effectiveness of various manual and physical techniques in treating pain in the spine (cervical and lumbar regions) and the temporomandibular joints (TMJ). The therapy aims to reduce muscle tension, improve mobility, and alleviate symptoms associated with conditions such as discopathy or degenerative changes.

Who Can Benefit from Participation?

The project is addressed to individuals struggling with:

pain and stiffness in the neck and lower back, pain in the masseter and temporal muscles, limited jaw mobility, as well as headaches and gluteal pain, tension resulting from a sedentary lifestyle or physical strain. Phase One: Comprehensive Diagnostics

Before therapy begins, each participant undergoes a series of modern and safe measurements for a multi-dimensional health analysis:

Myotomy: An objective assessment of selected muscle tension. Stabilometric Platform: Analysis of body posture and balance control. Jaw Grip Strength: Checking the functional performance of the stomatognathic system.

Diaphragm Research Belt: Evaluating respiratory and stabilizing functions of the diaphragm.

Fukuda Test: Assessing vestibular function and spatial orientation. Questionnaires: Standardized tools to determine pain intensity, sleep quality, and the impact of symptoms on daily life.

Phase Two: Applied Treatment Methods

The study utilizes six main forms of support, tailored individually to the patient's needs:

General Osteopathic Treatment (GOT): A holistic manual approach involving gentle joint mobilizations and soft tissue work to restore the body's functional balance and range of motion.

Visceral Therapy: Precise, gentle manual work with the internal organs of the chest and abdomen to improve their mobility and reduce tensions transmitted to the spine.

Pulsed Magnetic Field: 30-minute treatments using low-frequency fields to achieve analgesic, anti-inflammatory, and edema-reducing effects.

Positional Placement: Adopting specifically selected body positions using bolsters or pillows to offload painful structures and promote relaxation.

External Stabilization: The use of a cervical collar or lumbar corset for temporary stabilization and offloading of the spine, protecting tissues while preventing secondary muscle weakness.

Safety and Contraindications

All applied techniques are non-invasive. Before starting, the therapist conducts a detailed interview to exclude contraindications, such as:

acute inflammation, infections with fever, fresh injuries, or fractures, active cancer or advanced osteoporosis, electronic implants like pacemakers (specifically for magnetic field therapy), high-risk pregnancy. Possible Reactions: Following therapy, temporary reactions may occur, such as fatigue, tissue tenderness, sleepiness, or a short-term increase in pain, which typically subside quickly.

Important Information for Participants Voluntary Participation: Participation is entirely voluntary. You may withdraw at any stage without providing a reason.

Insurance: Participants are covered by appropriate civil liability insurance for the duration of the study.

Privacy: Personal data (name, age, weight) is protected and used solely for identification purposes within the research project.

Contact Information

Individuals interested in participating or seeking further clarification may contact the lead researcher directly:

Phone: 796 947 765 E-mail: arturholodniuk@o2.pl

详细描述

Physiotherapeutic and Osteopathic Management in Pain Complaints of the Cervical and Lumbar Spine and in the Temporomandibular Joints

Detailed project description

Study assumptions Pain of the spine, both in the cervical and lumbar regions, as well as in the temporomandibular joints, is one of the most common reasons why patients report to primary care physicians, physiotherapists, and osteopaths. It is estimated that as many as 70-80% of the population experience at least one episode of spinal pain during their lifetime, and many of these cases concern acute pain, appearing suddenly and significantly limiting functioning. In contrast, symptoms of temporomandibular joint disorders, including pain, affect about 5-12% of people worldwide [1-3].

Acute spinal pain, although often transient, may lead to chronicity of symptoms, absence from work, decreased quality of life, and significant social and economic costs. Particularly important are the actions taken in the first phase of symptoms, which influence the pace of recovery and the risk of recurrence. In clinical practice, various methods of treatment of acute painful dysfunctions are used, including: manual therapy (including structural and visceral osteopathy), physical therapy modalities (e.g., magnetic field therapy), and conservative methods (semi-rigid orthopedic collar Ortel C2 Plus Thuasne, lumbosacral orthosis LB3000 Orliman) [4-6].

There are many studies devoted to chronic spinal pain and temporomandibular joint pain, whereas the acute phase is analyzed much less frequently, even though it is often crucial for the further course of treatment. It is also worth noting that many current therapeutic methods are based mainly on the experience and intuition of specialists, rather than on unequivocal scientific evidence [7-9].

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-40 years - adults who are professionally or socially active.
  • An acute pain episode of the cervical or lumbar spine - symptom duration not exceeding 6 weeks, with no previous chronic or recurrent episodes of pain in this area.
  • Ability to move independently and communicate - without cognitive or motor impairments that could prevent test performance or therapeutic cooperation.
  • Consent to participate in the study - informed consent signed after receiving full information about the aim, course, and methods of the study.
  • Ability to participate in the entire therapeutic and measurement cycle - no time-related or health-related obstacles preventing completion of the study.
  • Pain in the temporomandibular joint area, intensified during jaw movements or chewing.
  • Presence of clicking, popping, or grinding in the temporomandibular joint during jaw movement.
  • Pain in the temporomandibular joint area, intensified during jaw movements or chewing

排除标准

  • Chronic pain - pain complaints lasting longer than 6 weeks or occurring cyclically during the last year (more than 3 episodes).
  • Advanced degenerative, neurological, or post-traumatic changes. Radicular symptoms - sensory disturbances and reduced muscle strength in the upper and lower limbs.
  • Neoplasms, rheumatic, infectious, or metabolic diseases of the spine.
  • Postoperative status within a period shorter than 6 months - insufficient tissue healing and risk of secondary damage.
  • Mental or neurological disorders that hinder cooperation or the reliable completion of questionnaires (e.g. severe depression, dementia, cognitive disorders).
  • Current pharmacological treatment affecting the neuromuscular system - e.g. antiepileptic drugs, opioids, high doses of corticosteroids.
  • Participation in other clinical studies or use of other therapy (physiotherapy, osteopathy, physical medicine) within the last 4 weeks.
  • Women during menstruation.
  • The study participant may discontinue participation in the study at any stage due to: withdrawal from the study, failure to comply with the protocol recommendations, or consultation with another specialist due to worsening of the condition.
  • Pregnancy.

研究组 & 干预措施

Magnetic field therapy

Experimental

In the treatment of acute cervical and lumbar spine pain, low-frequency pulsed magnetic field therapy is applied as an analgesic, anti-inflammatory, and anti-edematous modality. The procedure lasts 30 minutes and is performed using the same parameters for both regions: magnetic field intensity 4 mT, pulse frequency 15 Hz, and pulsatile mode. In cervical pain syndromes, this therapy helps reduce pain, muscle tension, and tissue swelling, while improving local microcirculation. In lumbar pain complaints, it contributes to pain relief, reduction of paraspinal muscle tension, improved blood supply, and stimulation of metabolic activity in tissues. Its anti-inflammatory effect may also support faster restoration of spinal mobility and improve the patient's overall functional comfort.

干预措施: Magnetic field therapy (Other)

Use of a ceriaical collar

Experimental

Before the procedure, the physiotherapist selects an orthopedic collar appropriate to the patient's neck height and circumference, explains the purpose of its use, and positions the patient sitting or supine with the head in a neutral position. The collar is applied by gently lifting the chin, supporting the mandible with the contoured front part, and placing the lower edge evenly on the sternum and clavicles. The posterior part is then positioned behind the neck and secured with Velcro straps, ensuring proper stabilization without excessive pressure, breathing difficulty, discomfort, or impaired swallowing. After fitting, the patient is instructed to wear the collar for 3 hours, avoid sudden head movements, and monitor for adverse symptoms such as pressure pain, dizziness, or dyspnea. Light daily activities are allowed if recommended. After 3 hours, the patient removes the collar carefully while maintaining the head in a neutral position and reports any concerning symptoms.

干预措施: Use of a ceriaical collar (Other)

Use of a stabilizing brace for the lumbar spina

Experimental

The physiotherapist selects a lumbar brace appropriate to the patient's body shape and trunk circumference, explains its purpose, and positions the patient standing or sitting with the trunk upright and the spine in a neutral position. The brace is applied over the lower back so that it covers the lumbar region and fits closely to the body. The lateral parts are brought forward and fastened over the abdomen with even tension; additional elastic straps may be tightened to improve stabilization without restricting breathing or causing discomfort. The therapist then checks the brace position, symmetry, and patient comfort. The brace is worn for 3 hours during daily activities performed according to therapeutic recommendations. The patient is advised to avoid heavy loads, sudden twisting movements, and lifting. They should monitor for pressure, abdominal pain, dyspnea, or skin irritation. After 3 hours, the patient removes the brace independently, checks the skin, and stores the brace.

干预措施: Use of a stabilizing brace for the lumbar spina (Other)

Positioning postures

Experimental

Positioning postures are used in acute pain management to find a body position in which symptoms are clearly reduced or completely relieved. The selected posture should be comfortable, natural, and free from forced tension. The therapist identifies the most relieving position and maintains it for 30 minutes, making small corrections if pain or discomfort reappears. In cervical spine pain, the patient lies supine with the head supported on a pillow or in the therapist's hands. Gentle movements such as slight flexion, extension, rotation, or lateral flexion are introduced until the most comfortable setting is found, often slight flexion combined with rotation away from the painful side. In lumbar spine pain, the patient also lies supine, while the therapist tests hip and knee flexion, support under the legs, or slight pelvic rotation. The chair position is most often the most relieving. The aim is to reduce pain, relax muscles, and unload spinal structures.

干预措施: Positioning postures (Other)

Visceral therapy

Experimental

Visceral therapy begins with 3-5 minutes of patient preparation in the supine position with slightly flexed knees to relax the abdominal wall. After a brief interview and palpatory assessment of the abdomen, thorax, and pelvis, the therapist identifies areas of increased tension and dysfunction. The first 10-minute phase focuses on structures functionally related to the cervical spine, including gentle mobilization of the upper thoracic outlet, cervicothoracic junction, clavicular region, esophagus, stomach, and cervical fascial structures, in order to reduce tension and improve drainage. The next 15-minute phase addresses the lumbar region through mobilization of the respiratory diaphragm, liver, gallbladder, intestinal flexures, urinary bladder, and associated pelvic fascial structures. Additional work on the parietal and visceral peritoneum aims to improve organ mobility and reduce fascial restrictions. The final 5 minutes include global balancing techniques, followed by postural

干预措施: Visceral Therapy (Other)

General Osteopathic Treatment

Experimental

General Osteopathic Treatment (GOT) begins with the patient in a relaxed supine position. After brief palpation of the neck, shoulder girdle, and pelvis, the therapist starts rhythmic mobilization of the upper limbs and shoulder girdle, using smooth, moderate movements to induce relaxation and reduce tension in the cervical region and indirectly in the temporomandibular area. The next stage involves gentle mobilization of the cervical spine with subtle flexion, extension, rotation, lateral flexion, and light traction synchronized with exhalation, aiming to decrease muscle tension, unload intervertebral joints, and improve circulation. The therapist then mobilizes the hips, lower limbs, and pelvis with light traction, oscillation, and rotational movements to restore lumbar balance and reduce low back pain. The final phase includes global, gait-like alternating limb movements coordinated with breathing, promoting overall relaxation, fascial balance, and integration of body tensions.

干预措施: General Osteopathic Treatment (Other)

结局指标

主要结局

Assessment of muscle tone using Myoton PRO of selected muscles, in standing position.

时间窗: 2 months

Muscle tone assessment is performed using the Myoton PRO device in a standardized standing position. Before measurement, the patient is instructed to stand upright in a relaxed posture, with the feet placed comfortably apart and the upper limbs resting freely alongside the body. The examiner identifies and marks the selected measurement points bilaterally, then applies the probe perpendicularly to the skin surface over each muscle. The device delivers a brief mechanical impulse and records objective biomechanical parameters of muscle tone and stiffness. The examination includes the following muscles: masseter, temporalis, lateral and medial pterygoids, digastric, suboccipital, sternocleidomastoid, descending part of trapezius, suprahyoid, infrahyoid, erector spinae in the cervical and lumbar regions, splenius capitis, splenius cervicis, latissimus dorsi, rectus abdominis, external oblique, gluteus maximus, and gluteus medius. Measurements are performed under the same conditions before

Assessment of jaw-maxilla clenching force

时间窗: 2 months

The level of tension between the maxilla and mandible bones corresponds to the anatomical position of the tentorium cerebelli and the tongue. The authors designed a dedicated measuring device used to assess the clenching force between the maxilla and mandible bones. The construction consists of two parallel beams, between which strain gauges were placed, recording their deformation under the influence of pressure force. The signal from the strain gauges was then transmitted to a force meter, which displayed the result in units of mass (kilograms). The obtained result was entered into an Excel sheet. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position. The therapist held the measuring device during the examination.

Assessment of diaphragm muscle tension force-pushing force

时间窗: 2 months

Measurement of diaphragm muscle tension is intended to correspond to pushing force. Due to the lack of possibility of checking the pushing force for the entire abdominal press, it was assumed that only the tension of the diaphragm muscle would be measured. To verify the measurement, a device consisting of a belt to which a force gauge was attached was used. The belt was fastened to the participant at the level of the lower ribs, corresponding to the diaphragm level. The force gauge registered the force value, presenting the result in units of mass (kilograms). The read results were then entered into an Excel sheet for further analysis. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position.

Assessment of ground reaction forces

时间窗: 2 months

To assess ground reaction forces (feet), the Computerised Stability Platform CQStab2P-vUSB-1506 was used. For statistical analysis, anterior-posterior and medial-lateral sway were taken into account. The obtained results were entered into an Excel file. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position.

次要结局

未报告次要终点

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (1)

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