| CTRI Number |
CTRI/2025/01/079381 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) Other (Specify) [Transcutaneous electrical Nerve Stimulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Function, and Quality of Life in Fibromyalgia Patients |
|
Scientific Title of Study
|
Study to assess the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Function, and Quality of Life among Fibromyalgia (FM) patients - 2-arm, parallel-group, pragmatic, randomized clinical superiority trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rambeer Ghuleliya |
| Designation |
Assistant professor |
| Affiliation |
Himalayan Institute of Medical Sciences, |
| Address |
59G/PMR Department, HIMS, SRHU, Swami Ram Nagar, Jolly Grant, Doiwala,Dehradun, Uttarakhand Swami Rama Himalayan University, JOLLY GRANT, DOIWALA, Dehradun, Uttarakhand Dehradun UTTARANCHAL 248016 India |
| Phone |
9588229872 |
| Fax |
|
| Email |
vermaramveer@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rambeer Ghuleliya |
| Designation |
Assistant professor |
| Affiliation |
Himalayan Institute of Medical Sciences, |
| Address |
59G/PMR Department, HIMS, SRHU, Swami Ram Nagar, Jolly Grant, Doiwala,Dehradun, Uttarakhand Swami Rama Himalayan University, JOLLY GRANT, DOIWALA, Dehradun, Uttarakhand Dehradun UTTARANCHAL 248016 India |
| Phone |
9588229872 |
| Fax |
|
| Email |
vermaramveer@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rambeer Ghuleliya |
| Designation |
Assistant professor |
| Affiliation |
Himalayan Institute of Medical Sciences, |
| Address |
59G/PMR Department, HIMS, SRHU, Swami Ram Nagar, Jolly Grant, Doiwala,Dehradun, Uttarakhand Swami Rama Himalayan University, JOLLY GRANT, DOIWALA, Dehradun, Uttarakhand Dehradun UTTARANCHAL 248016 India |
| Phone |
9588229872 |
| Fax |
|
| Email |
vermaramveer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himalayan Institute of Medical Sciences, SRHU, Jolly Grant, Doiwala, Dehradun, Uttarkhand, 2480106 |
|
|
Primary Sponsor
|
| Name |
Himalayan Institute of Medical Sciences |
| Address |
SRHU, Jolly grant, Doiwala, Dehradun, Uttarakhand, 248016 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rambeer Ghuleliya |
Himalayan Hospital |
Room No. 59G, Department of Physical Medicine and Rehabilitation, Himalayan Institute of Medical sciences, SRHU, Swami Ram Nagar,
JOLLY GRANT, DOIWALA Dehradun UTTARANCHAL |
9588229872
vermaramveer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard (therapeutic exercises + drugs) treatment only |
T. Pregabalin 75 mg at night
T. Amitriptyline 10 mg at night
T. Paracetamol 650 mg SOS
following exercises- twice daily
Meditation, education, and counselling
1.Segmental stretching ex,
2.Mild intensity aerobic ex,
3.regular walk for 30 min daily,
4.Relaxation techniques |
| Intervention |
Transcutaneous Electrical nerve stimulation (TENS) plus standard treatment |
TENS- is delivered by a battery powered portable pocket machine which generate pulsed electrical currents on the no-damaged skin surface via self-adhesive electrodes. TENS stimulate peripheral nerves, to relieve the pain. High frequency TENS- for 2 hours daily for 2 weeks with, Total number of sessions- 14. TENS will be delivered via self adhesive electrodes over upper trapezius muscle.
standard treatment- medicines + exercises:
T. Pregabalin 75 mg at night T. Amitriptyline 10 mg at night
T. Paracetamol 650 mg SOS following exercises- twice daily
Meditation daily
1.Segmental stretching ex, 2.Mild intensity aerobic ex, 3.regular walk for 30 min daily,
4.Relaxation techniques |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Study participants who are consenting with age group between 18 years to 60 years and qualifying American College of Rheumatology (ACR)- 2016 Revised Diagnostic Criteria for fibromyalgia syndrome and pain intensity on NRS score is 4 or more |
|
| ExclusionCriteria |
| Details |
1.Inability to walk for 6 minutes without assistive device
2.Study participants with in-situ Pacemaker, Spinal fusion or metal implants and Epilepsy
3.Neuropathic or autoimmune disorder,
4.Pregnancy
5.Serious psychiatric or medical condition
6.skin breakdown or wound or infection or skin disease over the site of TENS application |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resting pain and movement evoked pain |
resting and movement-evoked pain just before TENS, just after 2 weeks of TENS application and 2 weeks, and 3 months after application of last TENS on Numerical rating scale (NRS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient function, quality of life, physical activity, or other associated symptoms, such as anxiety, fatigue, or sleep disturbance. 6 Minute Walk Test, Fibromyalgia Impact Questionnaire Pain Item, Short-Form-36 (SF-36) v1.0 |
just before TENS, just after 2 weeks of TENS application and 2 weeks, and 3 months after |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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) |
Not Yet Recruiting |
|
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
|
Fibromyalgia (FM) is a condition with varied and complex presentation with chronic generalized and widespread pain and fatigueness. Various medicines show mild to moderate efficacy in the management FM symptoms, but most of these drugs has very little effect on the pain that is induced by various physical activity and exertions. Recent literature suggests that nonpharmacologic interventions are the treatment of choice to treat the chronic disabling pain and these interventions relatively harmless, low-cost so these approaches can be clubbed with medical. There is strong evidence that therapeutic exercises are very effective in the management of FM, with movement-evoked pain which limits patients’ participation in various activities. Use of nonpharmacologic approaches that decrease movement-evoked pain that might promote the patient to actively participate in activities, this will increase the patients perceived global improvement.3,4 Transcutaneous electrical nerve stimulation (TENS)- it is a machine that delivers current to the surface of skin via surface electrodes. It is a non-invasive nonpharmacological intervention use to control the pain. We are designing a randomized controlled trial to examine and assess the effects of TENS in patients with FM, using a study protocol that does not entail shortcomings and limitations of previous studies. Our primary aim is assessing the efficacy of repeated long-term TENS application on movement-evoked pain in FM patients. Secondary aims to evaluate the effects of TENS on fatigue, function, and QoL outcomes. Aims and Objective- Primary objective- To ascertain the differential effects of TENS plus standard treatment on movement-evoked pain and resting pain in FM patients compared with standard treatment alone. Secondary objective- To assess the effects of TENS on the patient function, quality of life, physical activity, or other associated symptoms, such as anxiety, fatigue, or sleep disturbance |