The research question is: is the use of corticosteroid injections for osteoarthritis of the first metatarsophalangeal joint in adults a safe and effective method of reducing pain and improving joint function?
In order to ensure a systematic review, minimise the risk of bias and provide transparency for replication of the process, a pre-determined research methodology protocol was used, based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist [17]. This was registered with PROSPERO. (Trial registration number: CRD42019135950. Available from: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42019135950).
Selection criteria
Inclusion
Pre-determined inclusion and exclusion criteria were used. Only systematic reviews, randomised controlled trials (RCTs), quasi randomised trials and controlled clinical trials were considered for inclusion as they form the hierarchy of evidence and are most likely to provide a robust evidence base suitable for informing clinical practice [18]. Those papers found were then screened for the following criteria:
- Trials in which an IA CSI into the 1st MPJ used for the treatment of OA in adults,
- Diagnosis and grading of OA in participants could be achieved via clinical examination and/ or via radiological means [19],
- Any gender or ethnicity was considered.
In order to be able to determine the efficacy of treatment, trials were required to have provided quantitative or qualitative measures both pre- and post-intervention in order to be able to ascertain the mean differences relating to pain and/or joint function outcomes.
Exclusion
Trials in which intradermal, subcutaneous, intramuscular or extracapsular corticosteroid injections were performed were excluded, as were not trials that tested the efficacy of IA CSIs for conditions other than for OA, or tested CSIs at joints other than the 1st MPJ. Due to the high risk of bias, cohort and case studies, articles based on expert opinion, retrospective studies and narrative-based literature reviews were excluded [18].
Search strategy and data sources
To answer the research question a keyword search of six electronic databases (AMED, CINAHL, EMBASE, MEDLINE, PUBMED, and COCHRANE) up to February 2020 was undertaken by graduate research podiatrist (GB) to identify clinical trials that had tested the efficacy of IA CSI for the treatment of 1st MPJ OA.
AMED (1985 to 05.02.2020)
CINAHL (1982 to 05.02.2020)
EMBASE (1974 to 05.02.2020)
MEDLINE (1950 to 05.02.2020)
PUBMED (1966 to 05.02.2020)
COCHRANE (1966 to 05.02.2020)
No date or language restrictions were applied. Reference lists were reviewed, and key author searches were made to reduce the risk of any pertinent literature being missed. A list of keywords and results yielded are provided in table 1.
Table 1: Search terminology and results yielded by database
#
|
Database
|
Search term
|
Results
|
1
|
AMED
|
(osteoarthritis).ti,ab
|
2945
|
2
|
AMED
|
(hallux).ti,ab
|
1252
|
3
|
AMED
|
(metatarsophalangeal).ti,ab
|
771
|
4
|
AMED
|
(injection).ti,ab
|
2035
|
5
|
AMED
|
(steroid).ti,ab
|
454
|
6
|
AMED
|
(hallux limitus).ti,ab
|
62
|
7
|
AMED
|
(hallux rigidus).ti,ab
|
178
|
8
|
AMED
|
(1 AND 2)
|
35
|
9
|
AMED
|
(1 AND 3)
|
37
|
10
|
AMED
|
(6 OR 7 OR 8 OR 9)
|
272
|
11
|
AMED
|
(4 AND 10)
|
5
|
23
|
CINAHL
|
(osteoarthritis).ti,ab
|
21838
|
24
|
CINAHL
|
(hallux).ti,ab
|
2033
|
25
|
CINAHL
|
(metatarsophalangeal).ti,ab
|
1197
|
26
|
CINAHL
|
(injection).ti,ab
|
43132
|
27
|
CINAHL
|
(steroid).ti,ab
|
15241
|
28
|
CINAHL
|
(hallux limitus).ti,ab
|
100
|
29
|
CINAHL
|
(hallux rigidus).ti,ab
|
319
|
30
|
CINAHL
|
(23 AND 24)
|
63
|
31
|
CINAHL
|
(23 AND 25)
|
82
|
32
|
CINAHL
|
(28 OR 29 OR 30 OR 31)
|
472
|
33
|
CINAHL
|
(26 AND 32)
|
13
|
34
|
EMBASE
|
(osteoarthritis).ti,ab
|
79498
|
35
|
EMBASE
|
(hallux).ti,ab
|
5812
|
36
|
EMBASE
|
(metatarsophalangeal).ti,ab
|
3924
|
37
|
EMBASE
|
(injection).ti,ab
|
581417
|
38
|
EMBASE
|
(steroid).ti,ab
|
163137
|
39
|
EMBASE
|
(hallux limitus).ti,ab
|
153
|
40
|
EMBASE
|
(hallux rigidus).ti,ab
|
664
|
41
|
EMBASE
|
(34 AND 35)
|
183
|
42
|
EMBASE
|
(34 AND 36)
|
258
|
43
|
EMBASE
|
(39 OR 40 OR 41 OR 42)
|
1068
|
44
|
EMBASE
|
(37 AND 43)
|
21
|
45
|
EMBASE
|
(38 AND 43)
|
12
|
46
|
CINAHL
|
(27 AND 32)
|
5
|
48
|
AMED
|
(5 AND 10)
|
4
|
49
|
Medline
|
(osteoarthritis).ti,ab
|
54837
|
50
|
Medline
|
(hallux).ti,ab
|
4904
|
51
|
Medline
|
(metatarsophalangeal).ti,ab
|
3209
|
52
|
Medline
|
(injection).ti,ab
|
449653
|
53
|
Medline
|
(steroid).ti,ab
|
125109
|
54
|
Medline
|
(hallux limitus).ti,ab
|
139
|
55
|
Medline
|
(hallux rigidus).ti,ab
|
586
|
56
|
Medline
|
(49 AND 50)
|
137
|
57
|
Medline
|
(49 AND 51)
|
189
|
58
|
Medline
|
(54 OR 55 OR 56 OR 57)
|
858
|
59
|
Medline
|
(52 AND 58)
|
13
|
60
|
Medline
|
(53 AND 58)
|
5
|
61
|
PubMed
|
(osteoarthritis).ti,ab
|
80277
|
62
|
PubMed
|
(hallux).ti,ab
|
6554
|
63
|
PubMed
|
(metatarsophalangeal).ti,ab
|
4096
|
64
|
PubMed
|
(injection).ti,ab
|
708493
|
65
|
PubMed
|
(steroid).ti,ab
|
936715
|
66
|
PubMed
|
(hallux limitus).ti,ab
|
167
|
67
|
PubMed
|
(hallux rigidus).ti,ab
|
656
|
68
|
PubMed
|
(61 AND 62)
|
251
|
69
|
PubMed
|
(61 AND 63)
|
298
|
70
|
PubMed
|
(66 OR 67 OR 68 OR 69)
|
1054
|
71
|
PubMed
|
(64 AND 70)
|
26
|
72
|
PubMed
|
(65 AND 70)
|
10
|
Risk of bias
In order to assess their validity, RCTs were reviewed using the Critical Appraisal Skills Programme (CASP) checklist [20], which uses six quality assessments of studies and considers the risk of (selection, performance, detection, attrition and reporting) bias. Systematic reviews were appraised using a Centre for Evidence-Based Medicine (CEBM) appraisal tool for systematic reviews [21] which uses six quality assessments to determine validity of reviews based on methodological design. Each quality assessment for data was awarded a ‘low’, ‘high’ or ‘unclear’ risk of bias. Two reviewers independently (GB, GF) appraised the studies and results were collated. If there was disparity between results, a discussion was to be raised. If consensus could not be achieved the senior author (INR - a consultant podiatric surgeon with a special interest in injection therapy) was appointed to make the final decision. Evidence from the identified literature was considered and an appropriate weighting awarded based on the quality of evidence they provided.
Initial inter-rater results following an appraisal of studies was 84% consistent between two reviewers. Following a discussion regarding the variation in quality assessment, 100% consensus between reviewers was achieved. Evidence from the identified literature was considered and an appropriate weighting awarded based on the quality of evidence they provided. Themes regarding joint pain, function and the safety of CSIs are discussed. Due to only one RCT being identified for inclusion, no meta-analysis was possible.
Data extraction
Data was extracted from research that fulfilled the inclusion criteria by using a pre-determined list of parameters to determine the efficacy of the intervention and validity of methods used for testing. These parameters considered: the design of study, sample size, demographics, diagnostic criteria used, disease severity, intervention tested (type, dosage, method of administration), outcomes, follow up and results. Reported adverse effects (type, duration and severity) were recorded to determine the safety of the intervention. Data from these themes was entered into a spreadsheet to be used for discussion.