The clinical study of peripheral subcutaneous neuromodulation in postherpetic neuralgia treatment
| ISRCTN | ISRCTN58767633 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58767633 |
| Protocol serial number | N/A |
| Sponsor | Shanghai Sixth Peoples Hospital (China) |
| Funder | Shanghai Sixth People's Hospital (China) - clinical research fund |
- Submission date
- 20/10/2007
- Registration date
- 30/10/2007
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr MA Ke
Scientific
Scientific
Department of Anaesthesiology and Pain Centre
Shanghai Sixth Peoples Hospital
Shanghai JiaoTong University
600 Yi-Shan Road
Shanghai
200233
China
| marke72@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The clinical study of peripheral subcutaneous neuromodulation in postherpetic neuralgia treatment |
| Study objectives | We hypothesise: 1. That peripheral subcutaneous neuromodulation has analgesic efficacy in chronic refractory Postherpetic Neuralgia (PHN) patients 2. This simple neuromodulation can improve the quality of life and reduce the oral drugs dosage of patients |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University on the 15th August 2007. |
| Health condition(s) or problem(s) studied | Postherpetic Neuralgia (PHN) |
| Intervention | Arm 1: peripheral subcutaneous neuromodulation Arm 2: sham peripheral subcutaneous neuromodulation Arm 3: naive control group Treatment will continue for three weeks (two time per week), follow-up will continue for 6 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Analgesic efficacy (Visual Analogue Scale [VAS]) and Quality Of Life (QOL) from 3 days to 1 month after neuromodulation. |
| Key secondary outcome measure(s) |
1. QOL |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 102 |
| Key inclusion criteria | 1. Patients were between 60 and 90 years old 2. Patients must have pain present for more than 6 months after the healing of shingles skin rash 3. Patients at screening must have a score of greater than or equal to 40 mm on the pain visual analogue scale |
| Key exclusion criteria | 1. Patients withdrawn from the study 2. Patients can't take self-assessment of the pain due to PHN |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- China
Study participating centre
Department of Anaesthesiology and Pain Centre
Shanghai
200233
China
200233
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2013 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.
