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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  
Status 
Not Applicable 
 
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


 
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