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临床试验/NCT06620965
NCT06620965已完成不适用

A Comparison of the Effectiveness of PNF and Mulligan Mobilization Techniques with Classic Physiotherapy Modalities in People with Neck Pain

Kahramanmaras Sutcu Imam University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

The aim of this study is to compare the effectiveness of PNF (Proprioceptive Neuromuscular Facilitation) and Mulligan Mobilization techniques with classical physiotherapy modalities in individuals with neck pain.

详细描述

Forty individuals with neck pain aged between 18-55 years will be randomly divided into two groups, PNF and Mulligan group. Classical physiotherapy modalities will be applied to all individuals 5 days a week. PNF group will receive PNF techniques three days a week and Mulligan group will receive Mulligan mobilization techniques three days a week. Participants will be treated for 4 weeks. The pain level of the patients whose demographic data were recorded; Visual Analog Scale (VAS), pressure pain threshold; algometer, range of motion (ROM); universal goniometer, functionality; Neck Disability Index, kinesiophobia; Tampa Kinesiophobia Scale, quality of life; SF-36 Quality of Life Scale, mood; Beck Depression Inventory, cervical muscle performance level; cervical performance tests will be measured before and after treatment.

Post-treatment pain intensity, kinesiophobia and depression level; the effectiveness of pressure pain threshold, ROM, functionality, quality of life and cervical muscle performance level will be compared within and between groups.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Complaint of neck pain for at least 3 months
  • Volunteer between the ages of 18-55
  • Receiving a diagnosis of chronic neck pain by a physician

排除标准

  • Having undergone a surgical procedure for the spine
  • Exercise therapy and/or physical therapy within the last 1 year
  • History of fracture in the cervical region
  • Radiculopathy, myelopathy (motor and sensory loss), or neurological impairment
  • Presence of Cardiac Pacemaker
  • Positive vertebrobasilar artery test
  • Having a blood clotting disorder
  • Presence of cancer
  • Being diagnosed with rheumatoid arthritis
  • Those with systemic diseases targeting the cervical region
  • Presence of active infection

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: From enrollment to the end of treatment at 4 weeks

The intensity of pain was assessed separately during rest and activity using the Visual Analog Scale (VAS). The patient was informed that on a 10 cm ruler, a score of 0 indicated no pain and a score of 10 represented the most severe pain imaginable, and was asked to mark the point that represented their pain level. The marked point was then measured in centimeters on the ruler and recorded as the pain intensity data.

Pressure pain threshold test

时间窗: From enrollment to the end of treatment at 4 weeks

In the pressure pain threshold assessment, algometer capable of measuring up to 200 Newtons with a precision of 0.1 Newton was used. The pressure application surface of the algometer was blunt and non-sharp, with a diameter of 1 square centimeter. The individual was seated in a relaxed posture, facing away from the physiotherapist during the measurement. Prior to the assessment, the painful tender area was identified through palpation based on the patient's guidance. Before the application, the individual was informed, and the compression pressure was gradually increased perpendicularly to the surface. The patient was asked to indicate the moment when the pressure sensation transitioned to pain. Three measurements were taken at one-minute intervals, and the average of these measurements was recorded as the pressure pain threshold value.

Assessment of Joint Range of Motion (ROM)

时间窗: From enrollment to the end of treatment at 4 weeks

Active cervical range of motion for flexion, extension, right-left rotation, and right-left lateral flexion was assessed by the researcher using a Universal Goniometer. The goniometer was positioned at the pivot point of each movement, and the individual was instructed to move their neck to its full extent. During the assessment, patients were asked to keep their feet on the ground, sit with their hands resting on their thighs, and maintain a neutral pelvis. Movements were performed at a steady pace with shoulders and back stabilized, and a 5-10 second rest in a neutral position was required after each movement. For cervical flexion and extension, the physiotherapist stood beside the individual, aligning the pivot with the acromion and following the ear's midline projection. For lateral flexion, the physiotherapist stood behind the individual, aligning the pivot with the C7 spinous process and following the cervical vertebrae's spinal protrusions.

Assessment of Functional Level

时间窗: From enrollment to the end of treatment at 4 weeks

To assess patients' functional levels, the Turkish version of the Neck Disability Index (NDI) was used. This test evaluates disability in daily life due to neck pain. Each section is scored from 0 to 5, with 5 indicating complete disability and 0 indicating no disability, resulting in a total of 6 possible scores. Scores range from 0 to 50. The 10-section test assesses the impact of pain on pain level, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and recreational activities. Scores are categorized as follows: 0-4 indicates no disability, 5-14 indicates mild disability, 15-24 indicates moderate disability, 25-34 indicates severe disability, and 35 or above indicates complete disability. The test-retest reliability of the Turkish version, as assessed by Telci and colleagues, has an Intraclass Correlation Coefficient (ICC) value of 0.979, indicating excellent reliability.

Assessment of Kinesiophobia

时间窗: From enrollment to the end of treatment at 4 weeks

To measure fear of movement and re-injury in patients, the Tampa Scale for Kinesiophobia, developed by Kori and colleagues, was used. The Turkish version, adapted by Tunca-Yılmaz and their team in 2011, has demonstrated excellent test-retest reliability with an Intraclass Correlation Coefficient (ICC) of 0.806 (95% confidence interval = 0.720-0.867). The test comprises 17 questions, with scores ranging from a minimum of 17 to a maximum of 68. Higher scores indicate a higher level of kinesiophobia in the individual.

Assessment of Quality of Life

时间窗: From enrollment to the end of treatment at 4 weeks

Patients' health-related quality of life was assessed using the Turkish version of the Short Form-36 (SF-36), validated and reliability-tested by Koçyiğit and colleagues. Reliability was evaluated using Cronbach's alpha coefficients, which ranged from 0.7324 to 0.7612, indicating acceptable internal consistency. Item-total score correlations, which measure the relationship between each item and the total score, ranged from 0.4712 to 0.8872. Validity was assessed by examining correlations with other measures, with correlation coefficients ranging from 0.44 to 0.65. The SF-36 consists of 36 items across 8 subscales: physical function, social function, general health, vitality, mental health, pain, and role limitations due to physical and emotional problems. Each subscale is scored from 0 to 100, with higher scores indicating better quality of life.

Emotional State Assessment

时间窗: From enrollment to the end of treatment at 4 weeks

Patients' emotional state was evaluated using the Turkish version of the Beck Depression Inventory. The Turkish validity and reliability study was conducted by Hisli in 1988. Reliability analysis, including item analysis (r: 0.80) and split-half techniques (r: 0.74), showed good correlation coefficients. For validity, the correlation coefficient with the Minnesota Multiphasic Personality Inventory scale was r: 0.50 (moderate). The questionnaire consists of 21 items, each with 4 response options. Patients were asked to select the option that best describes how they felt over the past week. Each item is scored from 0 to 3, with a maximum possible score of 63.

Assessment of Muscular Endurance

时间窗: From enrollment to the end of treatment at 4 weeks

Cervical Flexors: To evaluate cervical flexors, the patient was instructed to lie supine. The physiotherapist placed their hand under the patient's occiput. The patient's head was positioned in flexion, approximately 2.5 cm off the surface, and held straight. The patient was asked to maintain this position as long as possible, and the duration was recorded in seconds. The timing was stopped and recorded when the patient could no longer maintain the position or if the flexion was disrupted. Cervical Extensors: For evaluating cervical extensors, the patient was positioned face down, with their arms at their sides and head hanging off the edge of the bed. The physiotherapist supported and positioned the patient accordingly. Once the patient achieved the correct position, the test and stopwatch were started simultaneously. The test ended and the duration was recorded in seconds when the patient lost the position.

次要结局

未报告次要终点

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faruk Daniisman

Principal Investigator

Kahramanmaras Sutcu Imam University

研究点 (2)

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