Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201902720180705 Date of Approval: 19/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of buffered dextrose on pain occurring during local steroid injection for plantar fasciitis
Official scientific title The effect of addition of buffered dextrose 5% solution on pain occurring during local steroid injection for treatment of plantar fasciitis: a randomized controlled trial
Brief summary describing the background and objectives of the trial Background: 5%dextrose water (D5W) has been previously reported to decrease painful infusions when co-administered with chemotherapeutics and microbiospheres (1, 2).It also has been recently reported to have an immediate analgesic/anesthetic effect on low back pain and radiculopathy when injected epidurally (3). Moreover, D5W has been recently used as a primary hydrodissection injectate for many nerve entrapments in the upper body and torso with proven efficacy and cumulative pain reduction comparable to deep nerve block and with more safety profile than local anesthetic (4). Objective: to examine the potential immediate analgesic effect of D5W when added to the injectate during local steroid injection for treatment of plantar fasciitis. References: 1- Nakashima T., Ogawa Y., Kimura A. et al., “Coadministration of 5% glucose solution has a decrease in bendamustine-related vascular pain grade,” Journal of Oncology Pharmacy Practice 2012; 18 (4): 445–447. 2- Paprottka K. J., Lehner S., Fendler W. P. et al., “Reduced periprocedural analgesia after replacement of water for injection with glucose 5% solution as the infusion medium for 90Y-Resin microspheres,” Journal of Nuclear Medicine 2016; 57 (11): 1679–1684. 3- Maniquis-Smigel L., Reeves K. D., Rosen H. J. et al., “Short term analgesic effects of 5% dextrose epidural injections for chronic low back pain: a randomized controlled trial,” Anesthesiology and Pain Medicine 2017: 7(1), Article ID e42550. 4- Lam SKH, Reeves KD, Cheng AL. Transition from deep regional blocks toward deep nerve hydrodissection in the upper body and torso: method description and results from a retrospective chart review of the analgesic effect of 5% dextrose water as the primary hydrodissection injectate to enhance safety. Biomed Res Int 2017;2017:7920438.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Local injection to decrese painful itervention
Anticipated trial start date 01/10/2018
Actual trial start date 01/10/2018
Anticipated date of last follow up 01/02/2019
Actual Last follow-up date 28/02/2019
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 122
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Local injection One single local injection After strilization and using the medial approach, local injection of triaminiolone acetonide 40mg + 2% lidocaine 0.5 ml. was performed using a 23 gouge needle 1.4 inches. 61 Active-Treatment of Control Group
Experimental Group Local injection Once After strilization and using the medial approach, local injection of triaminiolone acetonide 40mg + 2% lidocaine 0.5 ml. + 0.5 ml. Buffered dextrose 5% solution (D5W) was performed using a 23 gouge needle 1.4 inches. 61
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients ≥18 years Diagnosed as having plantar fasciitis Patients with previous local lnjection treatment during the last three months Patients with previous surgical intervention to the affected heel Pregnant females Patients with rheumatic connective tissue diseases Patients with history of hypersensitivity for the injectate Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/09/2018 Al azhar university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
1 Al azhar university square Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The intensity of pain on visual analogue scal (VAS) from 0 - 10 where 0 points to the lowest degree of pain and 10 points to the maximal intensity during the injection. During the intervention
Secondary Outcome Observation of the injection related side effects and complications During the injection, immediately post injectin, 2 weeks post injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar University hospital in Asiut 1 Al azhar university square, King Faisal Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelhafeez Moshrif El Aref st. Tahta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abdelhafeez Moshrif Al Aref st. Tahta Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohamed Elwan The new st. Mallawy Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelhafeez Moshrif Dr.moshrif@azhar.edu.eg +201062930120 El Aref st.
City Postal code Country Position/Affiliation
Tahta Egypt Al azhar univeersity
Role Name Email Phone Street address
Public Enquiries Abdelhafeez Moshrif Dr.moshrif@azhar.edu.eg +201062930120 Elaref st.
City Postal code Country Position/Affiliation
Tahta Egypt Al azhar university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elwan Drelwan77@yahoo.com +201118021446 The new st.
City Postal code Country Position/Affiliation
Mallawy Egypt Al azhar university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Age, sex, body mass index, disease duration, two week recurrence rate Study Protocol 1 year. Open access for all interested researchers and organizations upon contacting the first author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information