| Course | HCR 557 Clinical Research Design and Methods |
|---|---|
| Module | Module 2 |
| Paper type | Study design analysis paper |
| Length | About 695 words, 5 pages |
| Format | APA 7 student paper |
| School | Arizona State University |
| Program | MS in Clinical Research Management |
| Updated | October 2026 |
Free sample paper for HCR 557 Module 2
Injection, Exercise or Both: A Design and Endpoint Analysis of a Factorial Trial in Lateral Epicondylalgia
Student Name
MS in Clinical Research Management, Arizona State University
HCR 557: Clinical Research Design and Methods
Instructor Name
Month Day, Year
Injection, Exercise or Both: A Design and Endpoint Analysis of a Factorial Trial in Lateral Epicondylalgia
Introduction
Lateral epicondylalgia, or tennis elbow, is a common painful condition of the forearm tendons. Clinicians often combine a corticosteroid injection, which relieves pain quickly, with physiotherapy, which aims at longer-term recovery, yet the combination had not been tested. Coombes et al. (2013) designed a trial to answer that question. This paper analyzes the trial's design, research question, endpoints and measurement tools, using the framework in Browner et al. (2023).
Study Design
The trial was a 2 x 2 factorial randomized controlled trial. Each of 165 adults with unilateral lateral epicondylalgia lasting more than six weeks was assigned to one of four groups: corticosteroid injection, placebo injection, corticosteroid injection plus physiotherapy or placebo injection plus physiotherapy. Recruitment ran from 2008 to 2010 at a university research center and 16 primary care practices in Brisbane, Australia, with one year of follow-up. The injection was blinded, since patients and assessors did not know whether it contained corticosteroid, but physiotherapy could not be blinded.
A factorial design suits this question because it tests two interventions, and their combination, in one trial. Each patient contributes to two comparisons, injection against placebo and physiotherapy against none, so the trial answers two questions with roughly the sample one question would need, provided the treatments do not interact strongly. It can also detect an interaction, which matters here because clinicians assumed the treatments worked together, and reporting guidance asks trials to describe such designs and their analysis fully so readers can judge them (Schulz et al., 2010).
Does the Research Question Meet the Criteria?
Browner et al. (2023) describe a good research question as feasible, interesting, novel, ethical and relevant, the FINER criteria.
The question as stated in the objective, to investigate the effectiveness of corticosteroid injection, multimodal physiotherapy or both, is broad, but the primary outcomes make it specific by naming what effectiveness means and when it is measured.
| Criterion | Assessment |
|---|---|
| Feasible | Yes: a common condition, recruitment from primary care and inexpensive treatments made 165 participants achievable in two years |
| Interesting | Yes: clinicians and patients wanted to know whether the common combination worked |
| Novel | Yes: earlier trials had tested each treatment alone, not together |
| Ethical | Yes: both treatments were in routine use, and a placebo injection carries little risk when the condition usually improves on its own |
| Relevant | Yes: results would directly change primary care practice |
Endpoints and Measurement Tools
| Endpoint | Type | Measurement tool | Time |
|---|---|---|---|
| Complete recovery or much improvement | Primary | Six-point global rating of change scale, dichotomized | 1 year |
| Recurrence | Primary | Recovery or much improvement at 4 or 8 weeks but not later | 1 year |
| Complete recovery or much improvement | Secondary | Global rating of change | 4 and 26 weeks |
| Pain and function | Secondary | Pain scales and disability questionnaire | Several time points |
| Pain-free grip strength | Secondary | Dynamometer | Several time points |
Are the Endpoints Aligned With the Objectives?
The objective was to judge effectiveness, which for a condition that often lasts many months means lasting recovery, not just short-term relief. The one-year global rating of change and the recurrence endpoint capture exactly that. Recurrence was a particularly well-chosen endpoint, because the clinical concern about corticosteroids was that early relief might be followed by relapse. The results confirmed that concern: one-year recovery was lower after corticosteroid than placebo injection, 83% against 96%, and recurrence was far higher, 54% against 12% (Coombes et al., 2013).
There are two limits to the alignment. First, a global rating of change is subjective; because the injection was blinded the comparison of injections is protected, but physiotherapy patients knew their treatment, so the physiotherapy comparison is more open to bias. Second, a patient-rated global change does not show which aspect of the condition improved, which is why the secondary measures of pain, function and grip strength matter.
Conclusion
The trial used a design well matched to its question, tested a question that meets every FINER criterion and chose primary endpoints that measured what patients and clinicians most needed to know: whether recovery lasted. Its main weakness, the unblinded physiotherapy comparison, follows from the nature of the treatment rather than a design error.
References
Browner, W. S., Newman, T. B., Cummings, S. R., Grady, D. G., Huang, A. J., Kanaya, A. M., & Pletcher, M. J. (2023). Designing clinical research (5th ed.). Wolters Kluwer.
Coombes, B. K., Bisset, L., Brooks, P., Khan, A., & Vicenzino, B. (2013). Effect of corticosteroid injection, physiotherapy, or both on clinical outcomes in patients with unilateral lateral epicondylalgia: A randomized controlled trial. JAMA, 309(5), 461-469. https://doi.org/10.1001/jama.2013.129
Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMJ, 340, c332. https://doi.org/10.1136/bmj.c332
Reading the HCR 557 Module 2 assignment instructions
Paper 1 is due in Module 2 of HCR 557, the module on the research question and measurement, and it is the first of three 100-point papers. The syllabus lists four tasks for one clinical study: explain the study design, explain whether the research question meets the criteria, list the endpoints and measurement tools and explain whether the endpoints are aligned with the study objectives. The criteria are the ones taught in Browner's Designing Clinical Research, the course text, usually remembered as FINER: feasible, interesting, novel, ethical and relevant. Choose a published trial with a full methods section, since you need its design, outcomes and measurement tools in detail, and a trial whose design is interesting enough to explain, such as a factorial, crossover or cluster design, gives you more to say than a simple two-arm study.
How the HCR 557 Module 2 example is put together
The sample opens with the clinical problem and the gap the trial set out to fill. The design section describes randomization, groups, setting and blinding, then explains why a factorial design suits two treatments that are often combined. The research question is tested against each FINER criterion in a table with a one-line judgment. Endpoints appear in a second table with type, measurement tool and timing. The alignment section argues that one-year recovery and recurrence fit the objective, supports the argument with the trial's own results and names two limits, subjectivity and the unblinded physiotherapy arm. The conclusion gives an overall verdict on design, question and endpoints.
Reading the HCR 557 Module 2 grading rubric
Canvas scores Paper 1 out of 100 points. A strong paper names the design precisely and explains why it suits the question, applies each FINER criterion to the study with reasons rather than yes or no, lists every primary and important secondary endpoint with its measurement tool and timing and judges alignment between endpoints and objectives with specific reasoning, including limits. It loses points when the design is mislabeled, when the research question is restated instead of evaluated, when endpoints are listed without tools or times and when alignment is asserted without explanation. Readers also look for awareness of bias, since whether an endpoint is objective or patient-reported, and whether it is blinded, affects how much a reader can trust it.
HCR 557 Module 2 help from the desk
Read the trial's methods section twice and note the design, groups, blinding, setting and follow-up before writing. Use the course text's FINER criteria and apply each to your study. Build an endpoint table with type, tool and timing. For alignment, ask what the objective really wants to know and whether the primary endpoint measures it. Mention one limitation, such as a subjective or unblinded outcome. Avoid choosing a study whose design you cannot explain. Not sure your trial reports enough of its methods? Send the citation to the desk before you start writing. Finally, keep the paper on one trial; comparing two studies dilutes the analysis the rubric rewards.
Write yours, or have the desk draft it
This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.
More HCR 557 and MS in Clinical Research Management sample papers
- HCR 557 Module 4: Paper 2: Sample Size Calculations
- HCR 557 Module 6: Paper 3: Local and International Studies
- HCR 558 Module 4: FDA Warning Letter: Response
- HCR 575 Module 7: Assignment 5: Negotiating the Sponsor's Budget
- HCR 574 Module 1: Paper 1: Common Rule Changes and an IRB's Procedures
- HCR 593 Module 3: Annotated Bibliography for the Applied Project
HCR 557 Module 2 questions, answered
Where can I find a free HCR 557 Module 2 sample paper?
This page has a full HCR 557 Paper 1 sample analyzing the design and endpoints of a factorial trial in lateral epicondylalgia.
What are the FINER criteria for a research question?
Feasible, interesting, novel, ethical and relevant, from Designing Clinical Research.
What is a 2 x 2 factorial trial?
A trial that tests two interventions at once by assigning participants to each combination, so each patient informs two comparisons.
What does it mean for endpoints to align with objectives?
The primary endpoint measures what the objective actually wants to know, at a time point that fits the condition.
Which textbooks does HCR 557 use?
Browner's Designing Clinical Research, fifth edition, and Shah and Pfeiffer's Clinical Research Management.