| CTRI Number |
CTRI/2024/10/075664 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Acupuncture in Reducing Lower Back Pain. |
|
Scientific Title of Study
|
A single-center, prospective, observational study to evaluate the effect of acupuncture treatment on lumbar disc pain and functional fitness in patients diagnosed with herniated lumbar disc disease.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Dalal |
| Designation |
Consultant Acupuncturist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD no. 5, First Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9324611434 |
| Fax |
|
| Email |
drkomal.d@bhakticedantahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Dalal |
| Designation |
Consultant Acupuncturist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD no. 5, First Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9324611434 |
| Fax |
|
| Email |
drkomal.d@bhakticedantahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Dalal |
| Designation |
Consultant Acupuncturist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD no. 5, First Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9324611434 |
| Fax |
|
| Email |
drkomal.d@bhakticedantahospital.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
|
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Komal Dalal |
Bhaktivedanta Hospital and Research Institute |
OPD No. 5, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
Thane
MAHARASHTRA |
9324611434
drkomal.d@bhakticedantahospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committe For Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G541||Lumbosacral plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. All genders, aged ≥ 18 years
2. Diagnosed with lumbar disc herniation or degeneration confirmed by MRI/Xray
3. Lower back NPRS ≥ 5
4. No prior acupuncture treatment in the past 6 months
|
|
| ExclusionCriteria |
| Details |
1. Previous spinal surgery
2. Severe spinal deformities (e.g., scoliosis)
3. Other serious medical conditions (e.g., cancer, severe cardiovascular diseases)
4. Pregnancy
5. Use of other concurrent therapies for back pain (e.g., physiotherapy, chiropractic care)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Acupuncture Treatment: Measure the reduction in pain and improvement in functional outcomes in patients diagnosed with herniated lumbar disc disease through patient-reported outcomes and clinical assessments. |
70 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the efficacy of acupuncture in treating lumbar disc herniation (LDH), a condition characterized by the displacement of the disc beyond the intervertebral space, often resulting in lower back pain, neurological dysfunction, and associated symptoms. The primary objective is to assess acupuncture’s effectiveness in reducing pain and improving functional outcomes in patients. Secondary objectives include evaluating the need for additional pain management, such as painkillers or nerve blockers, and monitoring changes in key pain and disability metrics using the Numeric Pain Rating Scale (NPRS), Oswestry Low Back Disability Score, Patients’ Global Impression of Change (PGIC) score, and SF-36 score. The study will also track hospital admissions related to LDH during the treatment period. Inclusion criteria include all genders aged ≥18 years, diagnosed with lumbar disc herniation or degeneration confirmed by MRI/X-ray, and with an NPRS score of ≥5. Exclusion criteria include previous spinal surgery, severe spinal deformities, pregnancy, and other serious medical conditions. Data parameters will include MRI findings, NPRS scores, Oswestry Low Back Disability Questionnaire results, PGIC scale, SF-36 Questionnaire results, and a qualitative interview covering functional capabilities like walking, standing, and sitting, as well as the need for additional pain management or hospital admission. A total of 60 patients will be recruited for this study, with primary endpoints focused on acupuncture’s efficacy in reducing pain and improving functional outcomes, and secondary endpoints assessing the need for additional pain management and hospital admissions related to LDH. |