PARTNERS HUMAN RESEARCH COMMITTEE PROTOCOL SUMMARY

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1 PARTNERS HUMAN RESEARCH COMMITTEE PROTOCOL SUMMARY Answer all questions accurately and completely in order to provide the PHRC with the relevant information to assess the risk-benefit ratio for the study. Do not leave sections blank. PRINCIPAL/OVERALL INVESTIGATOR David Ring, MD PROTOCOL TITLE Prospective Randomized Comparison: Neoprene Vs. Thermoplast Short Opponens Splinting. FUNDING Department Fund VERSION DATE April 16, 2010 SPECIFIC AIMS Concisely state the objectives of the study and the hypothesis being tested. The purpose of our study is to compare two available types of short opponens splints for trapeziometacarpal arthritis: Neoprene (Pre-fabricated) Vs. Custom Thermoplastic. Our comparison will be prospective and randomized, using as a primary outcome the DASH score[1] after 5 to 15 weeks of treatment with either one of the splints. Primary null hypothesis: There is no statistical difference in arm-specific disability (as measured with the DASH [1]) 5 to 15 weeks after prescription of a pre-fabricated neoprene hand-based thumb spica splint with the MP included and the IP joint free or a similar custom-made thumb spica splint from thermoplast. Secondary Hypotheses: DASH [1] scores at presentation and five to fifteen weeks after initiation of splint treatment correlate with scores on measure of psychological dysfunction including the Pain Anxiety Symptoms Scale[4], the Pain Catastrophizing Scale[5] and the Center for the Epidemiological Study of Depression Scale (CES-D)[7], and these correlations will be independent of the splint type. There are no statistical differences in the change in DASH score between the initial visit and 5 to 15 weeks after initiation of splinting. There are no statistically or clinically significant differences in patient satisfaction when wearing either splint for daily activities. There are no statistical differences in amount of splint usage. Version Date: June 1,

2 There is not a statistical or clinical difference regarding ability to perform daily functional activities while wearing either splint. BACKGROUND AND SIGNIFICANCE Provide a brief paragraph summarizing prior experience important for understanding the proposed study and procedures. Osteoarthritis of the thumb carpometacarpal joint is a common condition that affects approximately 16% to 25% of postmenopausal woman and causes pain, swelling, instability, deformity and loss of motion. This condition has been staged in 4 periods according to the degree of severity. Mild stages or stages 1 and 2 are usually treated conservatively by stabilization of the joint, which can be aggressively achieved by surgical ligament reconstruction or conservatively with thumb splints. Splinting is a typical treatment for osteoarthritis of the thumb with the goals of managing pain, stabilizing the CMC joint, and improving overall thumb function [11-15]. There are limited studies showing the effectiveness of splinting for this condition indicating they are successful in decreasing pain [11,12,13, 15] and improving function in activities of daily living [11, 15] as well as radiographically improving joint stability [11,15]. What is less clear is, once patients leave the clinic setting, how compliant they are with their splinting regimen. Patients with chronic illnesses tend to have compliance issues when it comes to their care [14]. Also, there are limited studies comparing different modalities of splinting. A recent study compared custom-made short opponens thermoplastic splint with the metacarpo-phalangeal (MP) joint free to a pre-fabricated short neoprene splint. They found that patients preferred the neoprene splint but both splints provided some degree of pain relief, reduction of subluxation of the MP joint and improvement in function [11]. Our purpose is to objectively quantify the various benefits of splinting for patients with thumb arthritis using the DASH score and assess if there is a difference between the pre-fabricated neoprene splint and the custommade short opponens thermoplastic splint with the MP included. RESEARCH DESIGN AND METHODS Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled by researchers study-wide and by Partners researchers. Provide a brief summary of the eligibility criteria (for example, age range, gender, medical condition). Include any local site restrictions, for example, Enrollment at Partners will be limited to adults although the sponsor s protocol is open to both children and adults. We estimate the need to evaluate 60 subjects in total to detect a difference of 10% between the two prospective cohorts in terms of DASH scoring (primary outcome) at a power level of 90% and a two-tailed t-test with p < Version Date: June 1,

3 0.05. Accounting for patients that may not complete the protocol, we plan to enroll 60 subjects per group for a total of 120 patients. Patients will be enrolled in the outpatient clinic at the Hand Surgery Service at Massachusetts General Hospital. Inclusion criteria: Patients aged 18 or older. Males and females diagnosed using clinical criteria as having CMC Thumb Arthritis. Radiological diagnosis is not necessary Exclusion criteria: Patients with previous history of CMC Thumb Arthritis treated surgically. Briefly describe study procedures. Include any local site restrictions, for example, Subjects enrolled at Partners will not participate in the pharmacokinetic portion of the study. Describe study endpoints. Patients cared for the attending surgeons on the MGH Orthopaedic Hand and Upper Extremity Service that satisfy the inclusion and inclusion criteria will be invited to participate. After informed consent, the subject will complete a data sheet with demographic information with the help of a research assistant. After completing this form the patient will be randomly assigned to one of the prospective cohorts: Group A Neoprene or Group B Thermoplast Short Opponens Splint. The patient will then complete several questionnaires including: the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire; the Pain Anxiety Symptoms Scale; the Pain Catastrophizing Scale; and the Center for Epidemiological Study of Depression Scale (CES-D). Pinch and grip strength will be recorded. An Occupational Therapist will explain the protocol of splinting to the patient and will provide the Neoprene or the Thermoplast short Opponens splint according to the result of the randomization. The patient will use the splint and its protocol for 5 to 15 weeks. Then he/she will come back and repeat the protocol of evaluation that they did at the beginning of the study. Standard treatment includes a 5 to 15 week visit to check on splint fit, efficacy, and satisfaction, and to review treatment options. Participation in this study does not increase the costs to be billed to the patient insurance for study related procedures. If for some reason the patient is not able to make it for a follow-up appointment or if they miss their appointment, we will conduct the two questionnaires over the phone. Version Date: June 1,

4 For studies involving treatment or diagnosis, provide information about standard of care at Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care. Provide information on available alternative treatments, procedures, or methods of diagnosis. The current standard nonoperative treatment for patients diagnosed with CMC Thumb arthritis consists of education, pain medication, and short opponens splinting. Alternative treatments including steroid injection and surgery are also offered to patients. Patients will have the opportunity to choose and injection or surgery rather than participating in this study. Describe how risks to subjects are minimized, for example, by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk or by using procedures already being performed on the subject for diagnostic or treatment purposes. There are no risks associated with splint use. Describe explicitly the methods for ensuring the safety of subjects. Provide objective criteria for removing a subject from the study, for example, objective criteria for worsening disease/lack of improvement and/or unacceptable adverse events. The inclusion of objective drop criteria is especially important in studies designed with placebo control groups. Any problems will be immediately addressed. Intolerance of the splint will not result in being dropped from the study as splint use is one of the things we are interested in tracking. Subjects can withdraw themselves from the trial at any time. FORESEEABLE RISKS AND DISCOMFORTS Provide a brief description of any foreseeable risks and discomforts to subjects. Include those related to drugs/devices/procedures being studied and/or administered/performed solely for research purposes. In addition, include psychosocial risks, and risks related to privacy and confidentiality. When applicable, describe risks to a developing fetus or nursing infant. The subject will be inconvenienced by having to complete study related questionnaires (about 30 minutes). EXPECTED BENEFITS Describe both the expected benefits to individual subjects participating in the research and the importance of the knowledge that may reasonably be expected to result from the study. Provide a brief, realistic summary of potential benefits to subjects, for example, It is hoped that the treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects. Indicate how the results of the study will benefit future patients with the disease/condition being studied and/or society, e.g., through increased knowledge of human physiology or behavior, improved safety, or technological advances. Version Date: June 1,

5 The benefits will be mainly to society since with this study we will test and evaluate the utility of splinting for CMC Thumb Arthritis and determine if there is a difference between splinting methods (Neoprene Vs. Thermoplast Short Opponens Splint). We expect patients with both types of splints to find their splint useful for pain relief. EQUITABLE SELECTION OF SUBJECTS The risks and benefits of the research must be fairly distributed among the populations that stand to benefit from it. No group of persons, for example, men, women, pregnant women, children, and minorities, should be categorically excluded from the research without a good scientific or ethical reason to do so. Please provide the basis for concluding that the study population is representative of the population that stands to potentially benefit from this research. All adult subjects who satisfy the inclusion/exclusion criteria are eligible for enrollment in this study regardless of sex, race or ethnicity. Vulnerable populations will not be recruited. When people who do not speak English are excluded from participation in the research, provide the scientific rationale for doing so. Individuals who do not speak English should not be denied participation in research simply because it is inconvenient to translate the consent form in different languages and to have an interpreter present. We will not enroll patients not able to speak in English since the instruments we are using as outcome measures have only been validated in English. For guidance, refer to the following Partners policy: Obtaining and Documenting Informed Consent of Subjects who do not Speak English RECRUITMENT PROCEDURES Explain in detail the specific methodology that will be used to recruit subjects. Specifically address how, when, where and by whom subjects will be identified and approached about participation. Include any specific recruitment methods used to enhance recruitment of women and minorities. Subjects will be invited to participate in the study during their routine office visit for the initial care of CMC Thumb Arthritis. Provide details of remuneration, when applicable. Even when subjects may derive medical benefit from participation, it is often the case that extra hospital visits, meals at the hospital, parking fees or other inconveniences will result in additional out-of-pocket expenses related to Version Date: June 1,

6 study participation. Investigators may wish to consider providing reimbursement for such expenses when funding is available We will help with any billing disputes and are prepared to cover any costs derived from splinting for which the disputes cannot be resolved. For guidance, refer to the following Partners policies: Recruitment of Research Subjects Guidelines for Advertisements for Recruiting Subjects Remuneration for Research Subjects CONSENT PROCEDURES Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent (i.e., how long subjects will be given to consider participation). For most studies involving more than minimal risk and all studies involving investigational drugs/devices, a licensed physician investigator must obtain informed consent. When subjects are to be enrolled from among the investigators own patients, describe how the potential for coercion will be avoided. Subjects will be invited to enroll during visit to the orthopaedic hand clinic. The study protocol will be explained in detail and informed consent obtained prior to the initiation of any treatment. Subjects will be given a copy of the informed consent form, and be informed that their participation is voluntary and that they can withdraw at any time during the study. Subjects make take as long as they like to consider participation, provided they still meet all enrollment criteria. NOTE: When subjects are unable to give consent due to age (minors) or impaired decisionmaking capacity, complete the forms for Research Involving Children as Subjects of Research and/or Research Involving Individuals with Impaired Decision-making Capacity, available on the New Submissions page on the PHRC website: For guidance, refer to the following Partners policy: Informed Consent of Research Subjects Version Date: June 1,

7 DATA AND SAFETY MONITORING Describe the plan for monitoring the data to ensure the safety of subjects. The plan should include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the planned frequency of review; and (3) who will be responsible for this review and for determining whether the research should be altered or stopped. Include a brief description of any stopping rules for the study, when appropriate. Depending upon the risk, size and complexity of the study, the investigator, an expert group, an independent Data and Safety Monitoring Board (DSMB) or others might be assigned primary responsibility for this monitoring activity. NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects under his/her care. All data from subjects will be filed in locked cabinets in the research office in individualized research folders, independent of clinical charts or any other medical record in electronic format. Any magnetic or electronic information will be saved in password-protected computers to which only research coordinator and persons involved with the research project will have access. Describe the plan to be followed by the Principal Investigator/study staff for review of adverse events experienced by subjects under his/her care, and when applicable, for review of sponsor safety reports and DSMB reports. Describe the plan for reporting adverse events to the sponsor and the Partners IRB and, when applicable, for submitting sponsor safety reports and DSMB reports to the Partners IRBs. When the investigator is also the sponsor of the IND/IDE, include the plan for reporting of adverse events to the FDA and, when applicable, to investigators at other sites. NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal investigator must follow the Partners Human Research Committee guidelines for Adverse Event Reporting A fulltime research fellow will be responsible for monitoring outcomes. No independent monitoring will occur. All investigators and study staff will be responsible for reporting adverse effects to the research fellow. The research fellow coordinating the study will report adverse events to the IRB in accordance with the IRB adverse event reporting procedures. MONITORING AND QUALITY ASSURANCE Describe the plan to be followed by the principal investigator/study staff to monitor and assure the validity and integrity of the data and adherence to the IRB-approved protocol. Specify who will be responsible for monitoring, and the planned frequency of monitoring. For example, specify who will review the accuracy and completeness of case report form entries, source documents, and informed consent. Version Date: June 1,

8 NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is ultimately responsible for ensuring that the study is conducted at his/her investigative site in accordance with the IRB-approved protocol, and applicable regulations and requirements of the IRB. There will be a full-time research coordinator responsible for adherence to all IRB rules and guidelines and for the accuracy and completeness of all forms, entries, and informed consent. For guidance, refer to the following Partners policies: Data and Safety Monitoring Plans and Quality Assurance Adverse Event Reporting Guidelines PRIVACY AND CONFIDENTIALITY Describe methods used to protect the privacy of subjects and maintain confidentiality of data collected. This typically includes such practices as substituting codes for names and/or medical record numbers; removing face sheets or other identifiers from completed surveys/questionnaires; proper disposal of printed computer data; limited access to study data; use of password-protected computer databases; training for research staff on the importance of confidentiality of data, and storing research records in a secure location. NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be considered and are strongly encouraged when the research involves the collection of sensitive data, such as sexual, criminal or illegal behaviors. All participants are given a participation number/code at the time of enrollment. This code is kept on all data sheets instead of the patient name. Subject information is only accessible by Partners authorized investigators and will not be shared with outside entities. The final results after statistical analysis will not be will be shared with the any institution. SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE PARTNERS Specimens or data collected by Partners investigators will be sent to research collaborators outside Partners, indicate to whom specimens/data will be sent, what information will be sent, and whether the specimens/data will contain identifiers that could be used by the outside collaborators to link the specimens/data to individual subjects. Version Date: June 1,

9 Not applicable. Specifically address whether specimens/data will be stored at collaborating sites outside Partners for future use not described in the protocol. Include whether subjects can withdraw their specimens/data, and how they would do so. When appropriate, submit documentation of IRB approval from the recipient institution. Not applicable. RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE PARTNERS When specimens or data collected by research collaborators outside Partners will be sent to Partners investigators, indicate from where the specimens/data will be obtained and whether the specimens/data will contain identifiers that could be used by Partners investigators to link the specimens/data to individual subjects. When appropriate, submit documentation of IRB approval and a copy of the IRB-approved consent form from the institution where the specimens/data were collected. Not applicable. REFERENCES: 1. Hudak, P.L., P.C. Amadio, and C. Bombardier, Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med, (6): p Aitkin, R., Measurement of feelings using visual analogue scales. Proceedings of Royal Society of Medicine,, : p Scott, J.H., Graphic representation of pain. Pain, : p McCracken, L.M., C. Zayfert, and R.T. Gross, The Pain Anxiety Symptoms Scale: development and validation of a scale to measure fear of pain. Pain, (1): p Osman, A., et al., The Pain Catastrophizing Scale: further psychometric evaluation with adult samples. J Behav Med, (4): p Whaler, H., Wahler physical symptoms inventory manual. 1983, Los Angeles: Wester Psychological Services. 7. Ensel, W.M., Measuring Depression: The CES-D Scale, in Social Support, life events and depression, N.D. Lin, A; Ensel, W, Editor. 1986, Academic Press: New York. 8. Hartigan, B.J., P.J. Stern, and T.R. Kiefhaber, Thumb carpometacarpal osteoarthritis: arthrodesis compared with ligament reconstruction and tendon interposition. J Bone Joint Surg Am, A(10): p Armstrong, A.L., J.B. Hunter, and T.R. Davis, The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg [Br], (3): p Aune, S., Osteo-arthritis in the first carpo-metacarpal joint; an investigation of 22 cases. Acta Chir Scand, (6): p Weiss, S., LaStayo, P., Mills, A., Bramlet, D. Splinting the Degenerative Basal Joint: Custom-made or Prefabricated Neoprene?. Journal of Hand Ther. 2004; 17: Swigart CR, Eaton, RG, Glickel SZ, Johnson C. Splinting in the Treatment of Arthritis of the First Carpometacarpal Joint. J Hand Surg (Am). 1999; 24A:1: Coditz, JC. The Biomechanics of a Thumb Carpometacarpal Immobilization Splint: Design and Fitting. J Hand Ther; Feinberg, J Effect of the Arthritis Health Professional on Compliance with Use of Resting Hand Splints by Patients with Rheumatoid Arthritis. Arthritis Care and Research. 1992; 5:1: Version Date: June 1,

10 15. Weiss, S., LaStayo, P., Mills, A., Bramlet, D. Prospective Analysis of Splinting the First Carpometacarpal Joint: An Objective, Subjective, and Radiographic Assessment. Journal of Hand Ther, 2000; 13: Version Date: June 1,