✯✯✯ Idiopathic Frozen Shoulder Case Study
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Osteopathy Master Class by Simeon Ashes: Treating the frozen shoulder- a trigger point perspective
Original data may include carefully filling out the adverse event report form, recording the start time, the severity, the final outcome, the relationship with acupuncture treatment, the details of the treatment, and should immediately consult the relevant departments to take the necessary treatment. The trial of a SAE patient will be discontinued and become a withdraw subject, while all costs for handling adverse events will be covered by this study.
The project will evaluate the safety of vital signs and the incidence of adverse acupuncture reactions. Incidence of adverse events: Adverse events will be referred as any unintended symptoms, signs, or health conditions that occurred after the start of the study. However, adverse events will not have a relationship with the treatment of this study. Adverse events include dizziness, hematoma, bleeding, infection, and abnormal pain at the treatment site. The number of adverse reactions will be counted at the end of the study, divided by the total number of each group, and the analysis will be carried out for the adverse events.
All statistical analysis will be carried out by the professionals using SPSS v The participants in the statistical analysis will be unaware as well for the specific grouping content of the trial. Patients who participate in randomization and receive at least one treatment will be included in the analysis. Frequencies and percentages will be used to count the data. For the balance of basic values, analysis of variance or chi-square test or rank sum test will be used.
For the primary and secondary outcome, the analysis of variance will be used. If confounding factors have an impact on the results, then the co-variance analysis will be used. For the safety analysis, the incidence of three groups of adverse events will be compared using a chi-square test, and the adverse events that will occur in this trial will be listed.
At the same time, the paired t test will be used to compare the differences between the groups before and after treatment. The comparison among the three groups before and after treatment will be analyzed by variance. The rate changes before and after treatment in the three groups will be measured by chi-square test or non-parametric test. This study will use a randomized control design, and the randomization protocol will be held by the management team of the study team who do not participate in the project to ensure random allocation and control biases. This study is limited to the inclusion criteria and will establish a clear inclusion and exclusion criteria to control biases.
This study will use blind method evaluation and will evaluate the efficacy and safety by evaluators who do not know the grouping situation to ensure the reliability of the research results. During the study, the pain tester, muscle strength, and joint mobility test will be carried out according to various standard operating procedures to control biases. The quality control inspection of this study will be conducted by the researcher to designate at least one non-quality implementer to conduct a quality check on the research of each center of the subject to control the bias. Initial meeting of the project will be held to conduct unified training. Key training will be carried out on the project implementation plan and SOP, so that each participant will master the research process and specific implementation rules to ensure the reliability of the conclusion.
During the study, each center will be supervised regularly to control biases. Paper CRFs will be used to record all the information required from the protocol which will be collected from the hospital. There will be an instructions page at the start of each postal questionnaire and for the more complex hospital CRFs. Each trial participant will have a unique identification number that will be pre-recorded on all CRFs. Initially, the data will be listed on the CRF form, and after interviewing 20 participants, the data of clinical research will be input in a group of 20 cases.
Besides, the input approach will be double-input, which will be input by two data input personnel without contact. Meanwhile, the data manager will compare the differences with the initial data and fill in the reasons for it. During the trial, a monthly data inspection will be needed, and the content involves data assembled by every center abnormal data, and delayed data in progress tracking. The data input in the paper type of CRF form will be received from the primary data. Furthermore, the researcher will preserve the copies of the test-related data, the data of the subject, and all other initial data until the announcement from the team leader to discard them. Moreover, researchers at the center should obey the rule of confidentiality of the trial.
After the primary data which will be held for 3 years, non-research team members cannot browse and borrow it. As this test is a multi-center study, therefore, before the start of each research center, the team leader from every unit will monitor the research center. They will check whether the research-related facilities and equipment are complete and well prepared, and whether or not the researchers are proficient in the test operation process and equipment use.
The chief investigator of the team leader unit will inform each clinical center investigator of their responsibilities, and how to correctly and completely fill in the relevant documents for the trial. Through the investigator training session, the investigator and his team will understand the trial plan, completing the CRF form, use of the evaluation tools, as well as the test procedures.
Then the chief investigator of the team leader unit will visit the start-up status of each center. During the test, the third-party data management staff will regularly and strictly monitor the filling of the CRF form. The third-party data management staff will mainly monitor whether the researcher screens the subjects in accordance with the admission criteria. During the inspection, the CRF form will be checked if it is accurate, directly with reference to the original data. Explain the entire contents of the informed consent form to the subject in a simple and understandable language. The subject will voluntarily participate in the clinical trial and has the right to withdraw at any stage of the trial without discrimination and retaliation.
The personal data and information of the participants participating in the trial will be kept confidential, and subjects may be assigned to different trial groups to take different treatments. Informed consent should be signed by the subject or other legal representative. Investigators will have the authority to terminate patient participation at any time if the investigator deems it is in the best interests of the patient. Termination criteria are as follows: 1 Patients with serious adverse reactions or combined with other critical illnesses in the study. If the protocol changes during the implementation of the study, researchers will communicate the important protocol modifications e.
Patients may receive acupuncture treatments such as trigger points during the study. Moreover, patients will receive free color Doppler ultrasound, muscle strength measurement, pain threshold measurement, infrared thermography, and various evaluation tests. Some patients may experience fainting, pain, bleeding, hematoma, or infection during acupuncture treatment. When such circumstance will arise, the patient will be handled properly and recorded in a timely manner. Idiopathic frozen shoulder is a common and painful disease with a long course. Although the disease has a certain tendency of self-healing, it lasts for prolonged time. It is difficult for the affected side of shoulder joint to fully return in normal function.
If it does not function properly, it may lead to functional disability and directly affects the day-today life of the patient. Worldwide, chronic shoulder pain is considered as one of the indications as most amenable to treat with acupuncture [ 26 , 27 ]. According to the results of previous systematic reviews and clinical studies [ 28 , 29 ], acupuncture as a main treatment for frozen shoulders has a good therapeutic effect, and the key factors affecting the effect of acupuncture are acupuncture techniques and acupuncture sites. The acupuncture method used in this study is stuck-moving needle acupuncture therapy.
The acupuncture sites are selected from the local MTrp of the shoulder joint. At present, there is no significant clinical research which can prove whether the combination of the stuck-moving needle and MTrp is better than the combination of ordinary acupuncture and the acupuncture point. Our pilot study showed that stuck-moving needle used for acupuncture MTrp was effective in improving the pain and movement limitation of the patients with idiopathic frozen shoulder. However, this study was a single case observation in a single center, without a control group. Therefore, in our study, we designed a multi-center, large-sample, randomized controlled clinical trial to evaluate the efficacy and safety of stuck-moving needle acupuncture the MTrp in improving pain and range of motion in patients with idiopathic frozen shoulder.
The ultimate aim of the study was to select an effective acupuncture therapy for patients with idiopathic frozen shoulder. Stuck-moving needle therapy is derived from traditional acupuncture therapy, clinical practices, learning from needles e. In addition, it has multi-angle and multi-directional treatment effects, especially for stiffness, swelling, adhesion contracture, and nodular tissue decompression and reduction.
It is considered to be the perfect combination of traditional acupuncture theory and modern medical theory, as well as minimally invasive technology. Most important point which distinguishes stuck-moving needle therapy from other therapies and generating unique curative effects is its dynamic nature. Then, the operator is assisted by auxiliary movements. During the process of acupuncture in the right hand, the left hand moderately lifts the operation site. The third one is the cooperative movement of the patient [ 20 ]. In the process of applying the needle, the doctor may guide the patient to perform appropriate activities. In recent years, stuck-moving needle therapy is widely used in clinical practices and exhibited promising effects in treating patients with joint and muscle pain [ 30 , 31 , 32 , 33 ].
The needle application site is a key factor that affects the effect of acupuncture. In this study, the operation site of the stuck-moving needle is the localized MTrp of the shoulder joint. Studies in recent years have found that the occurrence of frozen shoulders is often related to the muscles around the shoulder joint related to the pain points [ 34 , 35 ]. These muscles include deltoid muscle, biceps, pectoralis major, pectoralis minor, and coracobrachialis muscle. These points of muscle are common, and it can cause pain and impair shoulder movement. If it can be accurately positioned in clinical treatment for effective treatment, the effect will be greatly improved.
Based on the characteristics of MTrp with tenderness and referred pain [ 36 ], we used a pain meter to determine the location of the local pain points in the shoulder joint and then performed a stuck-moving needle operation with a marker to ensure the accuracy of the operation. The stuck-moving needle acupuncture method can increase the stimulation intensity, breadth, and depth of acupuncture. It is applied to the Trp for the localized activation of the shoulder joint, making the local capillaries of the Trp quickly contract and relax, improve the state of local tissue microcirculation, and accelerate the local metabolism.
At the same time, by increasing the intensity of acupuncture, it can increase the rapid release of certain analgesics in the pain point. This relieves pain symptoms. The setting of control group also plays an important role in the efficacy evaluation. It is the basis of accurate evaluation of curative effect. According to the WHO published guidelines for clinical research in acupuncture and moxibustion requirements for the establishment of control groups in clinical studies of acupuncture and moxibustion, we set up two control groups.
Exercise programs are the basic treatment and also a control group. The common acupuncture group is a positive control group, and the stuck-moving needle was used to acupuncture MTrp as the treatment group, to verify the effectiveness of treatment group. The selection of appropriate outcome is crucial when designing clinical trials. The measurement time was from baseline through the week follow-up period. However, this study also has its limitation. First, the implementation of the blind method is difficult due to the nature of acupuncture, and the masking of acupuncturists is quite difficult to achieve.
However, the statistician will be masked. Follow-up was performed at week 4 and week Frozen shoulder is a chronic degenerative osteoarthropathy with a long course and the high possibility of recurrence. Therefore, for the future trial design, the follow-up time should be appropriately extended and comprehensive evaluation should be carried out with the long-term treatment effect for frozen shoulder by the stagnant acupuncture method. Nonetheless, the trials carried out in this study and subsequent results will provide more reliable evidence for clinical treatment of FS. Protocol version V1. The first participant was enrolled on 02 Jan. Recruitment will be complete on 30 Jan. Risk factors in idiopathic adhesive capsulitis: a case control study.
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Bone Joint J. Codman EA. The shoulder: rupture of the supraspinatus tendon and other lesions in or about the subacromial bursa. Boston: privately printed; Google Scholar. Research progress in the study of periarthritis of shoulder. Foreign Med Bone Sci. Relationships between capsular stiffness and clinical features in adhesive capsulitis of the shoulder. Definition, diagnosis, treatment, and prognosis of frozen shoulder: a consensus survey of shoulder specialists. Clin Orthop Surg. Treatment strategy for frozen shoulder. Research progress on the treatment of frozen shoulder. China Mod Doct. Reeves B. The natural history of the frozen shoulder syndrome.
Scand J Rheumatol. Shane PB. Idiopathic frozen shoulder. R Aust Coll Gen Pract. Evidence-based clinical guidelines for the diagnosis, assessment and physiotherapy management of contracted frozen shoulder: a quick reference summary. Investigation of the effectiveness of acupuncture in the treatment of frozen shoulder. Mater Sociomed. Font Size Small Normal Large.
Frozen shoulder adhesive capsulitis. Formulary drug information for this topic. No drug references linked in this topic. Formulary Print Share. In a questionnaire study of randomly selected adults, frozen shoulder was found to affect 8. The condition is most common in the fifth and sixth decades of life, with the peak age in the mids.
Onset before the age of 40 is rare. Women are more often affected than men. The non-dominant shoulder is involved slightly more often. In 6 to 17 percent of patients, the other shoulder becomes affected within five years [ 5 ]. Patients with diabetes mellitus are at greater risk of developing frozen shoulder, with a prevalence of 10 to 20 percent [ 1,3, ]. However, a subsequent cross-sectional study showed that the point prevalence of frozen shoulder in patients with long-lasting type 1 diabetes was as high as 59 percent and the lifetime prevalence 76 percent [ 13 ].
To continue reading this article, you must log in with your personal, hospital, or group practice subscription. Subscribe Log In. Literature review current through: Sep This topic last updated: Oct 20, The content on the UpToDate website is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your own physician or other qualified health care professional regarding any medical questions or conditions. All rights reserved. The clinical picture of the painful diabetic shoulder--natural history, social consequences and analysis of concomitant hand syndrome. Acta Med Scand ; Reeves B.
The natural history of the frozen shoulder syndrome. Scand J Rheumatol ; Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence. Muscles Ligaments Tendons J ; Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum ; Frozen shoulder. Semin Arthritis Rheum ; Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am ; Natural history of frozen shoulder: fact or fiction? A systematic review. Physiotherapy ; Shoulder pain with particular reference to the frozen shoulder. Frozen shoulder: a long-term prospective study. Ann Rheum Dis ; Hazleman BL. The painful stiff shoulder. Rheumatol Phys Med ; Long-term outcome of frozen shoulder.
J Shoulder Elbow Surg ; A long-term follow-up. Arch Phys Med Rehabil ; Whelton C, Peach CA. Review of diabetic frozen shoulder. Eur J Orthop Surg Traumatol ; We are pleased to report that after 8 treatments over a course of 3 months Mrs B has made a very good recovery. She is now completely pain free and has almost a full range of motion in his shoulder. Anatomy of a Frozen Shoulder.
Adhesive capsulitis presentation is generally broken into three distinct stages. As a general rule patients should have participated in some form of therapy for at least 2 months, and shown no progress. Once a frozen shoulder is suspected, osteopathic treatment should be started as soon as possible, if the recovery time is to be shortened as much as possible. Medical opinion is that frozen shoulders typically take 18 — 24 months to recover if untreated.Download references. A Idiopathic Frozen Shoulder Case Study comparative study of short term response Pamela Cummins Research Paper blind injection versus sonographic-guided injection of local corticosteroids in patients Idiopathic Frozen Shoulder Case Study painful shoulder. Frozen Idiopathic Frozen Shoulder Case Study a long-term prospective study. CML: Contributed to the design of Idiopathic Frozen Shoulder Case Study review and its processes, and contributed to Icfe And Ecf Case Study Essay writing up, revising and editing Idiopathic Frozen Shoulder Case Study this manuscript. A randomized Idiopathic Frozen Shoulder Case Study trial of arthroscopic capsular release versus hydrodilatation in the treatment Idiopathic Frozen Shoulder Case Study primary Idiopathic Frozen Shoulder Case Study shoulder.