Effect of Central Nervous System Focused Therapy in Frozen Shoulder Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- The Pain Catastrophizing Scale
研究概览
简要总结
Frozen shoulder has been considered a self-limiting and benign disease with complete resolution of pain and ROM, but this can sometimes last for years. This prolonged pain and disability deprives patients of their routine life, occupational and recreational activities. Although appropriate treatment is needed so that they can quickly return to their lives, definitive treatment strategies have not been established and many different management strategies are used. The aim of this study is to investigate whether pain education and sensory education applied together with conventional physiotherapy are more effective than conventional physiotherapy alone.In this study, 21 people diagnosed with frozen shoulder who were referred by the doctor of Esenler Medipol Hospital, Department of Physical Therapy and Rehabilitation will be included in the study.
Outcome measures: Pain Beliefs Scale, Pain Catastrophizing Scale, PainDetect Questionnaire, Tampa Kinesiophobia Scale, Shoulder Pain and Disability Index, Visual Analog Scale, Electrogoniometer, Two-point discrimination test, Numeric Rating Sleep Scale and Right/ Left Judgement Task.
This study was designed as a prospective randomized controlled trial. 21 people were included in the study. Participants were randomly divided into two groups: Conventional physiotherapy group (CP group) (n=11), Conventional physiotherapy plus central nervous system focused treatment group (CP+CNS group) (n=10). Conventional physiotherapy was applied to both groups for 45-60 minutes, 5 days a week for 4 weeks.
The CP group treatment session will take place as follows: Scapular mobilization, passive stretches, stick exercises, pendulum exercises and shoulder flexion, extension, internal rotation, external rotation, horizontal abduction/ adduction strengthening exercises.
The CP+CNS group received central nervous system focused therapy that included chronic pain education, localization training, graphesthesia, graded motor imagery and mirror therapy in addition to conventional physiotherapy.
The IG group protocol includes:
- week: Initial Evaluation, Conventional physiotherapy (CP), Chronic Pain Education, Localization Training Level 1, Right / Left Discrimination Training
- week: CP, Motor Imagery, Localization Training Level 2
- week: CP, Grafestesis Training, Isometric Exercise
- week: CP, Mirror Therapy, Functional Exercises, Final Evaluation
详细描述
First week:
- Initial Evaluation
- Conventional physiotherapy (CP) (5 days)
- Chronic Pain Education (5 days):Chronic pain education is a therapeutic treatment strategy that explains the patient's past experiences of pain in terms of neurobiological and neurophysiological rather than anatomical or biomechanical models. Detailed chronic pain education is needed to redefine the concept of pain and to convince the patient that the cause of their symptoms is hypersensitivity of the central nervous system rather than local tissue damage. For this reason, chronic pain education modules were created by the researcher to be presented to the participants in order to change their pain beliefs through the reconceptualization of pain. Nociceptive mechanisms in acute pain and chronic pain were explained comparatively at the beginning. A presentation supported by visuals and examples was prepared to guide during the chronic pain education, but a flexible schedule of 15-20 minutes was created by increasing the number of examples and in more detail according to the education level of the patient, preventing the patient from being bored during the session.
- Localization Therapy Level 1 (5 days): This level only the localization of the stimulus was trained. A grid-like sticky paper with 9 holes punched was placed over the affected shoulders of the participants and the training began by showing a standard photograph of the shoulder on which the 9-hole grid was marked. The spacing of the grids was determined on the basis of available data based on two-point separation of the shoulder joint.This data range was 43.18 mm ± 10.37 mm. The standard limits for placement of the 9-hole grid on the shoulder are as follows: 1 cm proximal to the acromioclavicular joint and the lower border of the insertion of the deltoid muscle. The thick end of the probe and the 9-hole grill and their placement on the shoulder are introduced. After the familiarization period, the patient continues training with the thick end of the probe (2 seconds) using a random number sequence. In the first week, stimulus was applied by asking random numbers 4 days a week, 3 sets every day and 20 numbers in each set.
- Right / Left Discrimination Training (5 days): In the first week, an online computer program, Recognise Shoulder (Recognise Online, NOI Group, Adelaide, SA, Australia) was used to present participants with randomly selected photographs of their right or left shoulder. Shoulder photos presented in various directions. Participants were asked to press one of the buttons on the left and right of the screen to indicate whether the photograph was of the right or left shoulder. An important point here was to give the response corresponding to the body part as quickly as possible, and for this purpose, the participants were asked to respond within 5 seconds during the application. The training was carried out in three sets, each set consisting of 30 photographs.
Second week:
- Conventional physiotherapy (CP)
- Motor Imagery (5 days): In our study, participants were asked to imagine they were moving their painful shoulders with motor imagery training. Participants were asked to sit in a comfortable position, close their eyes, and imagine being in an environment where they felt comfortable. Photographs containing 8 shoulder postures were used in the training. 8 photos were applied in two sets and 20 repetitions. Each photograph was shown live to the participants by the physiotherapist and the participant was asked to imagine the motion shown as painless, smooth and full range of motion. Participants were asked not to imagine watching themselves while imagining shoulder movements, but to perform the movements in the first person.
- Localization Training level 2 (5 days): They were asked to distinguish both the localization of the stimulus and the size of the probe used. The working pattern is the same as for localization level 1, but two types of probes are used, pointed (pencil tip) and coarse tip (mushroom). Three randomly applied sets of both position and probe sizes and a random array of 20 numbers in each set were used.
Third week:
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
- None
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
- 否
入选标准
- •Being diagnosed with frozen shoulder with chronic pain lasting more than 3 months
- •Being between the ages of 18-65
- •Absence of fracture, dislocation or arthritis in the shoulder area evaluated by routine x-ray examination
- •Patients who were not prescribed any medical treatment other than analgesics in the last 3 months were included.
排除标准
- •Wide scar around the shoulder
- •History of bilateral concurrent frozen shoulder
- •If there has been surgical intervention on the affected shoulder
- •Rotator cuff calcification
- •Cervical radiculopathy
- •History of physical therapy program for the same shoulder in the last 6 months
结局指标
主要结局
The Pain Catastrophizing Scale
时间窗: Change from The Pain Catastrophizing Scale at 4 weeks
The PCS is used to evaluate the patient's feelings, thoughts, and emotions related to pain and catastrophizing. it is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points
Two Point Discrimination Test
时间窗: Change from two point discrimination test at 4 weeks
The two-point discrimination test is the evaluation of the ability to perceive stimuli applied from two different points at the same time. A commercially available mechanical caliper will be used to measure two-point separation on the non-dominant and dominant shoulders. These areas within the shoulder will correspond to the C5, C6 and C7 dermatomes. Participants will be instructed to report to the tester if they repeatedly feel two points or if the pressure is greater than a light touch.Care should be taken that the warning given while performing the test does not cause pain. Evaluation will be made with the aid of an esthesiometer. The esthesiometer is used to measure the person's 2-point sensory threshold on the skin. The ruler opens until you feel the 2 points and the value is recorded.
Visual Analog Scale (VAS)
时间窗: Change from Visual Analog Scale (VAS) at 4 weeks
It is used to assess pain. Although pain has been defined in many different ways, the most widely accepted is the International Association for the Study of Pain (IASP); It is a definition of "sensory, emotional, unpleasant feeling related to the past experiences of the person, whether due to an organic cause originating from any part of the body or not" (20). Visual Analogue Scale (VAS) is a reliable and valid pain measurement method in the evaluation of the severity of chronic pain (21). There is a numeric horizontal line between zero and ten. Zero means "no pain" and ten means "unbearable pain". Below the horizontal scale are facial expressions.
Pain Beliefs Scale
时间窗: Change from pain beliefs scale at 4 weeks
It was developed by Edwards et al. in 1992. They mention that the most important purpose of developing the scale is to understand the psychological and organic attributions of chronic pain patients to the origin of pain, which have not been investigated until that time. In the original form of this scale, there are a total of 20 items covering beliefs about the sources of pain and the treatment method. Two subtests were created: Organic Beliefs subtest consisting of 8 items and Psychological Beliefs subtest consisting of 4 items. Scores range from 1 to 6 for each item. The total score for each subtest is calculated by adding the scores obtained from the items in that subtest and dividing by the number of items belonging to that subtest.
Right/left Judgement Task
时间窗: Change from right/left judgement task at 4 weeks
For laterality assessment, SSDG was assessed with the Neuro Orthopedic Institute (NOI) Recognise Shoulder™ online program using an iPad. In order to gain familiarity, individuals were asked to mark whether 15 photos from the rapid test category belonged to the right or left shoulder. In the actual assessment, they were asked to answer 30 shoulder photos from the rapid test category as right and left as soon as possible. Mean response times (RT) in milliseconds (ms) and percentage of correct responses were reported separately for both the affected and unaffected shoulder region as the two main outcome measures. Responses below 500 ms and above 15000 ms were considered invalid.
Electrogoniometer
时间窗: Change from electrogoniometer at 4 weeks
Normal joint movements measurement is evaluated with active or passive movements. The most used instrument for the objective evaluation of these movements is the electrogoniometer. All joints are placed according to the anatomical position before measurement and this position is considered as the zero initial position. The electrogoniometer should not touch the body during measurement and should be placed lateral to the joint. In this study, shoulder joint electrogoniometer measurements will be made. Shoulder flexion, abduction, internal rotation, external rotation will be measured at the beginning and at the end of the 4th week, with an electrogoniometer, normal range of motion will be measured.
次要结局
- Tampa Kinesiophobia Scale (TKS)(Change from tampa kinesiophobia scale (TKS) at 4 weeks)
- Shoulder Pain and Disability Index (SPADI)(Change from shoulder pain and disability index (SPADI) at 4 weeks)
- Pain Detect (PD-Q)(Change from shoulder pain detect (PD-Q)at 4 weeks)
- Sleep Scale(Change from sleep scale at 4 weeks)
- Graded Chronic Pain Scale-Revised(Change from graded chronic pain scale-revised at 4 weeks)
研究者
AYŞE GÜRLÜK
Physiotherapist
Medipol University