Clinical efficacy of ultra-laser irradiation combined with gabapentin on elderly patients with cervical spondylotic radiculopathy
| ISRCTN | ISRCTN57406480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57406480 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | The First People's Hospital of Fuyang District, Hangzhou |
| Funder | The First People's Hospital of Fuyang District, Hangzhou |
- Submission date
- 10/03/2025
- Registration date
- 13/03/2025
- Last edited
- 12/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Cervical spondylotic radiculopathy (CSR) is a common degenerative spinal disorder that causes neck pain, nerve root compression, and neurological symptoms in the upper limbs. This study aims to evaluate the clinical effectiveness and safety of ultra-laser irradiation combined with gabapentin compared to gabapentin alone in elderly patients with CSR, focusing on pain relief, quality of life improvement, and adverse reactions.
Who can participate?
Elderly patients (aged 60 years and over) diagnosed with cervical spondylotic radiculopathy
What does the study involve?
Participants are randomly allocated to be treated with either ultra-laser irradiation + gabapentin or gabapentin alone.
What are the possible benefits and risks of participating?
Benefits: Potential reduction in neck pain, improved nerve function, and better quality of life.
Risks: Possible mild side effects such as dizziness, fatigue, nausea, and ataxia, though fewer side effects are expected with laser therapy compared to drug treatment alone.
Where is this study taking place?
First People's Hospital of Fuyang District, Hangzhou (China)
When is the study starting and how long is it expected to run for?
June 2024 to September 2024
Who is funding the study?
First People's Hospital of Fuyang District, Hangzhou (China)
Who is the main contact?
Zhou Yu, yuz0531@163.com
Contact information
Public, Scientific, Principal investigator
The First People's Hospital of Fuyang District
429 North Ring Road
Fuchun Street
Fuyang District
Hangzhou
311400
China
 ORCID ID |
0009-0006-9392-1977 |
|---|---|
| Phone | +86 (0)15825525395 |
| yuz0531@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomized controlled trial on the clinical efficacy of ultra-laser irradiation combined with gabapentin in the treatment of elderly patients with cervical spondylotic radiculopathy |
| Study objectives | Ultra-laser irradiation combined with gabapentin is more effective than gabapentin alone in reducing pain and improving health outcomes in elderly patients with cervical spondylotic radiculopathy. |
| Ethics approval(s) |
Approved 18/06/2024, Ethics Committee of the First People's Hospital of Fuyang District, Hangzhou (Room 403, Science and Education Administration Building, No. 429, North Ring Road, Fuchun Street, Fuyang District, Hangzhou, 311400, China; +86 (0)571-63157868; 25179144@qq.com), ref: 2024-LW伦审第(067)号 |
| Health condition(s) or problem(s) studied | Cervical spondylotic radiculopathy |
| Intervention | Patients are divided into the observation group and control group 1:1 with the help of a random number table. Observation group: Ultra-laser irradiation + gabapentin (oral capsules, starting dose 300 mg, titrated up to 2400 mg/day, treatment for three courses of 10 days each). Control group: Gabapentin alone (same dosage protocol as the observation group) |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Pain relief measured by the Numerical Rating Scale (NRS/NPRS) at baseline and after three courses of treatment |
| Key secondary outcome measure(s) |
1. Health-related quality of life improvement assessed by EuroQol-five dimensions (EQ-5D) questionnaire at baseline and after treatment |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Total final enrolment | 160 |
| Key inclusion criteria | 1. Diagnosed with cervical spondylotic radiculopathy according to Rehabilitation Guidelines for Diagnosis and Treatment of Cervical Spondylosis (2010) 2. Aged ≥60 years 3. No history of peripheral nerve disease 4. No severe systemic diseases (cardiovascular, respiratory, digestive, liver, kidney disorders) 5. No opioid, NSAID, antidepressant, or antiepileptic drug use in the past month 6. Willingness to participate and signed informed consent |
| Key exclusion criteria | 1. Severe osteoporosis or bone tuberculosis 2. Nerve-related disorders not caused by cervical spondylotic radiculopathy (e.g., thoracic outlet syndrome, carpal tunnel syndrome, scapulohumeral periarthritis) 3. Severe cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic diseases 4. Poor treatment adherence or incomplete clinical data 5. Congenital musculoskeletal disorders (e.g., congenital torticollis, congenital myopathy) |
| Date of first enrolment | 18/06/2024 |
| Date of final enrolment | 01/09/2024 |
Locations
Countries of recruitment
- China
Study participating centre
No. 429, North Ring Road
Fuchun Street
Fuyang District
Hangzhou
311400
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Zhou Yu (yuz0531@163.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/03/2025: Study's existence confirmed by the Ethics Committee of the First People's Hospital of Fuyang District, Hangzhou.
