A clinical trial of Diosmin's effects in the treatment of low back pain
| ISRCTN | ISRCTN97157037 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97157037 |
| Secondary identifying numbers | DTH-2017010 |
- Submission date
- 09/06/2017
- Registration date
- 13/06/2017
- Last edited
- 10/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims:
Radicular pain is a type of pain that is caused by compression of a nerve in the spine. The pain is often felt in the area of the body that is supplied by that nerve, such as leg pain caused by compression of a nerve supplying the leg. Around 10-15% of patients with radicular pain undergo surgery to correct the problem eventually, however most use pain relieving drugs to control the pain levels. Diosmin is a type of plant chemical found mainly in citrus fruits, which is used for treating various conditions. It is thought to work by reducing inflammation (swelling). The aim of this study is to find out whether treatment with Diosmin may be effective in the treatment of radicular pain.
Who can participate?
Adults who have been diagnosed with radicular pain
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated with Diosmin for one month. Those in the second group are treated with a commonly used pain relieving treatment for one month. Participants in both groups are asked to rate their pain levels and satisfaction with treatment when they first receive their treatment and again after two and eight weeks.
What are the possible benefits and risks of participating?
Participants who receive the Diosmin may benefit from a reduction in pain and greater levels of satisfaction. There are no notable risks involved with participating.
Where is the study run from?
Nanjing Drum Tower Hospital (China)
When is study starting and how long is it expected to run for?
March 2008 to December 2011
Who is funding the study?
National Natural Science Foundation of China (China)
Who is the main contact?
Professor Yinhe Wang
Contact information
Scientific
Department of Orthopedic Surgery
Nanjing Drum Tower Hospital
Nanjing University Medical School
321 Zhongshan Road
Jiangsu
Nanjing
210008
China
 ORCID ID |
0000-0003-2354-5049 |
|---|
Study information
| Study design | Non-Inferiority randomised active-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized controlled trial evaluating the effects of Diosmin in the treatment of radicular pain caused by lumbar intervertebral disc protrusion |
| Study hypothesis | Diosmin at a dose of 50 mg/kg/day may reduce the radicular pain from lumbar intervertebral disc protrusion and has no effect difference with currently used active treatment of mannitol plus dexamethasone. |
| Ethics approval(s) | Ethics Committees of Drum Tower Hospital of Nanjing University Medical School, 30/08/2008, ref: DTH-2017010 |
| Condition | Radicular pain |
| Intervention | Participants are randomised to one of two groups using a single randomisation technique. Intervention group: Participants receive Diosmin (Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd) per os, 900 mg, tid for 2 weeks followed by bid for 2 weeks, and lastly 450 mg bid as maintenance dose for at least one month. Control group: Participants receive 20% mannitol (CR Double-Crane Pharmaceuticals Co., Ltd) 250ml (1g/kg/day) and dexamethasone (Furuitang Pharmaceutical Co., Ltd) 10 mg/day intravenous drops for the first 3 days and followed by mannitol for 4 days. In the both groups, the course of treatment lasts for at least one month. Participants in both groups rate their pain levels and satisfaction with treatment at initial drug administration and after two and eight weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Diosmin |
| Primary outcome measure | 1. Perceived pain is measured using a visual analogue scale (VAS) and a numerical rating scale (NRS) just after the administration of drugs, and two and eight weeks later 2. Self-rated physical disability is measured using the Roland-Morris questionnaire (RM-Q) just after the administration of drugs, and two and eight weeks later |
| Secondary outcome measures | Patient’s satisfaction is measured using a three-grade scale ranging from completely satisfied (no pain at all time and no restriction of activities) to satisfied (slight pain that requires no medication and mild restriction of activities) to unsatisfied (moderate to severe pain that requires medication and moderate to severe restriction of activities) via telephone after two years. |
| Overall study start date | 01/03/2008 |
| Overall study end date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Participant inclusion criteria | 1. Preliminarily diagnosis of radicular pain 2. Aged 18 years and over 3. Pain duration at least 30 days 4. Underwent routine discography 5. Previously treated with nonsteroidal anti-inflammatory drugs, opioid medications or physical therapy without pain relief for more than one month 6. Normal or slight decrease in the height of disc space on lateral plain X-ray film 7. Initially considered eligible for surgical intervention |
| Participant exclusion criteria | 1. Spondylolysis 2. Lumbar canal stenosis 3. Isthmic or degenerative spondylolisthesis 4. Inflammatory arthritis 5. Spinal instability 6. Infection from previous lumbar surgery 7. Neurologic disease 8. Tumor 9. Psychological disorders (such as depression or using antidepressant/anxiolytic medications) |
| Recruitment start date | 01/01/2009 |
| Recruitment end date | 30/06/2009 |
Locations
Countries of recruitment
- China
Study participating centre
321 Zhongshan Road
Jiangsu
Nanjing
210008
China
Sponsor information
Hospital/treatment centre
Nanjing University Medical School
321 Zhongshan Road
Jiangsu
Nanjing
210008
China
"ROR" |
https://ror.org/026axqv54 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal in 2017. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not publicly available due to the privacy of these data, but are available from the corresponding author upon reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2017 | Yes | No | |
| Basic results | 13/06/2017 | 28/06/2017 | No | No |
Additional files
- ISRCTN97157037_BasicResults_13June17.pdf
- Uploaded 28/06/2017
Editorial Notes
10/07/2018: Publication reference added.
28/06/2017: Internal review.
