NCT04683042

Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial

Completed Phase 3 Last updated 29 October 2025

What this trial tests

Phase 3 trial testing Transcutaneous Electrical Nerve Stimulation (TENS) with PT in Fibromyalgia in 459 participants. Completed in 11 March 2025.

Timeline

22 January 2021

Primary endpoint
11 March 2025

11 March 2025

Quick facts

Lead sponsor	Kathleen Sluka
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	459
Start date	22 January 2021
Primary completion	11 March 2025
Estimated completion	11 March 2025
Sites	6 locations across United States

Drugs / interventions tested

• Transcutaneous Electrical Nerve Stimulation (TENS) with PT
• PT only

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Kathleen Sluka

Who can join

Adults 18 to 99, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine if addition of Transcutaneous Electrical Nerve Stimulation (TENS) to routine physical therapy improves movement-evoked pain in patients with fibromyalgia (FM).

The study will also determine if addition of TENS to routine physical therapy (PT) improves disease activity and symptoms, increases adherence to physical therapy, increases the likelihood of meeting patient specific functional goals, and reduces medication use.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory.
   Richesson RL, Marsolo KS, Douthit BJ, Staman K, et al · · 2021 · cited 41× · PMID 34597383 · DOI 10.1093/jamia/ocab202
2. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.
   O'Brien EC, Sugarman J, Weinfurt KP, Larson EB, et al · · 2022 · cited 9× · PMID 35597988 · DOI 10.1186/s13063-022-06385-8
3. Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.
   Garland A, Weinfurt K, Sugarman J. · · 2021 · cited 5× · PMID 34766524 · DOI 10.1177/17407745211048178
4. Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.
   Curtis LH, Morain S, O'Rourke PP, Staman K, et al · · 2025 · cited 2× · PMID 40015598 · DOI 10.1016/j.cct.2025.107866
5. Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations.
   Cheville A, Patil CL, Boyd AD, Crofford LJ, et al · · 2025 · cited 2× · PMID 39510534 · DOI 10.1055/a-2462-8699
6. Transcutaneous Electrical Nerve Stimulation and Pain With Movement in People With Fibromyalgia: A Cluster Randomized Clinical Trial.
   Dailey DL, Vance CGT, Van Gorp BJ, Johnson EM, et al · · 2026 · cited 1× · PMID 41893844 · DOI 10.1001/jamanetworkopen.2026.2450
7. Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials.
   Marsolo KA, Cheville A, Melnick ER, Jarvik JG, et al · · 2025 · cited 1× · PMID 39561918 · DOI 10.1016/j.cct.2024.107744
8. Community engagement strategies improve recruitment and enrollment in a pragmatic clinical trial.
   Vance KG, Pedelty J, Van Gorp BJ, Vance CGT, et al · · 2025 · PMID 40979091 · DOI 10.1017/cts.2025.10103