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Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Function, and Quality of Life in Fibromyalgia Patients

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079381
Enrollment
70
Registered
2025-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R52- Pain, unspecified

Interventions

Intervention1: Transcutaneous Electrical nerve stimulation (TENS) plus standard treatment: TENS- is delivered by a battery powered portable pocket machine which generate pulsed electrical currents on

Sponsors

Himalayan Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Resting pain and movement evoked painTimepoint: 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

MeasureTime frame
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) v1.0Timepoint: just before TENS, just after 2 weeks of TENS application and 2 weeks, and 3 months after

Countries

India

Contacts

Public ContactDr Rambeer Ghuleliya

Himalayan Institute of Medical Sciences,

vermaramveer@gmail.com9588229872

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026