FibromyalgiaNCT04683042
Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) with PT and PT only in people with Fibromyalgia, run by Kathleen Sluka at 6 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) with PT and PT only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 Jan 2021to 11 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 until 99.
- Clinician diagnosis of FM
- Referred for land-based PT
- Referred for treatment for FM or chronic pain (pain lasting more than 3 months)
- Able to provide informed consent.
- Fluent in reading English
- Willing to use TENS
Who cannot join
- Contraindications to TENS use including:
- Pacemaker, defibrillator, implanted neurostimulator or implanted device
- Epilepsy
- Currently pregnant or plan to become pregnant in the next 6 months
- Allergic reaction to patches with gel
- Current treatment for cancer
Show all 9Show fewer
- Currently enrolled in another pain control study
- Use of TENS within the last 30 days
- Clinically unstable medical or psychiatric issues
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Advanced Physical Therapy Sport Medicine
Appleton, Wisconsin, 54913
Big Stone Therapies (BST)
Big Stone City, South Dakota, 57216
Kepros Physical Therapy and Performance
Cedar Rapids, Iowa, 52404
University of Illinois at Chicago
Chicago, Illinois, 60607
Genesis Physical Therapy
Davenport, Iowa, 52807
Rock Valley Physical Therapy
Moline, Illinois, 61265
About this study
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.
Read the detailed description
This study is a pragmatic clinical trial in outpatient PT practices utilizing cluster randomization by healthcare system and facility size. Sites will be randomized to enroll all eligible and consented participants with FM to TENS with PT, or PT only (no TENS). We are identifying 25-35 clinics across 6 healthcare systems in both rural and urban settings. We will enroll 450 patients that self report a clinician diagnosis of FM. At each site, TENS (or no TENS) will be applied during each visit along with individualized PT treatment specified by the physical therapist. Participants randomized to TENS intervention sites will receive TENS units and electrodes at baseline to be applied to the cervical and lumbar regions. Participants will take the units home and bring the units back to their PT clinic visits with instructions for use at home while active and during their exercises. The physical therapist at each clinic will complete routine documentation of treatment. In addition to the primary and secondary outcomes, Electronic Health Record data variables will be collected as exploratory outcomes. Variables including adherence to treatment will be extracted from each site's Electronic Health Record. Patient-reported assessments will be obtained from the participant's at home the day of their second PT visit (Baseline) and at 30, 60 (primary outcome), 90, and 180 days following enrollment. The primary and secondary outcome assessments will be comparing TENS and no TENS groups in terms of changes from baseline to 60 days.
Participants will be identified after they are referred for PT for treatment of primary fibromyalgia (FM) or chronic pain (pain lasting more than three months). At their first (intake) physical therapy visit, they will be provided information about the study that can be accessed on paper or on-line. They will perform an electronic screening form on the first visit if interested in participating. Participants will provide e-consent after eligibility is confirmed at the initial PT visit. At the second PT visit after e-consent is signed, participants will be provided instructions on logging onto REDCap for data capture and accessing the case report forms. Participants enrolled at a TENS site will then be instructed in use of TENS and the TENS unit with electrodes will be provided. Those participants enrolled at a no TENS site will skip the instruction in use of TENS but will then receive instructions along with the TENS units at day 65. Participants will be instructed to capture all baseline assessments at home before their next PT visit before and following their first TENS treatment (or no TENS) at home (day 1). At 30, 60, 90, and 180 days following enrollment, participants will complete the same assessments at home including pain ratings at rest and with movement along with questionnaires. The primary and secondary outcome assessments will be comparing TENS and no TENS groups in terms of changes from baseline to 60 days.
- Conditions
- Fibromyalgia
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS) with PT, PT only
- Keywords
- Transcutaneous Electrical Nerve Stimulation (TENS), chronic pain, fibromyalgia, movement pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS) with PTDevice
Use of TENS units along with routine PT therapy
PT onlyOther
Routine PT therapy only
| Study group | Role | What they receive |
|---|---|---|
| TENS with PT | Active comparator | TENS with PT group: The TENS with PT group will receive usual PT care and following enrollment, during the second PT visit, participants will receive TENS units and instruction on use of the TENS units. TENS will be applied to the upper and lower back with butterfly electrodes using the following parameters: mixed frequency (2-125Hz), strong but comfortable intensity, variable pulse duration from 100-250 microseconds. TENS to be applied when the patient is active and doing exercises at home and during PT sessions for 30 minutes at least 2 hours per day. The TENS with PT group will complete TENS use to the end of the study at 6 months. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) with PT |
| No TENS with PT | Other | The No TENS group will receive usual PT care until the primary endpoint timeframe of 60 days. After completion of the research homework at 60 days, TENS units will be mailed to the participants and a study team member will complete virtual TENS instruction. The no TENS group will complete TENS to the end of the study at 6 months. Receives: Other: PT only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement-evoked Pain During the Sit and Stand Test
Numeric rating scale of -10 to 10 for change in movement-evoked pain. Change score was defined as pain scores at Day 60 (measured by 11-point NRS) minus Day 1(measured by 11-point NRS). Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Secondary outcomes (9)
Change in the Resting Pain Score
Numeric rating scale of -10 to 10 for change in resting pain. Change score was defined as pain scores at Day 60 (measured by 11-point NRS) minus Day 1(measured by 11-point NRS). Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Pain Interference (BPI)
Numeric rating scale of -10 to 10 for change in pain interference. Change score was defined as pain scores at Day 60 (measured by 11 items measuring pain severity and interference with daily activities on a 0-10 scale) minus Day 1(measured by 11 items measuring pain severity and interference with daily activities on a 0-10 scale). Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in FM Disease Activity (FIQR)
The Revised Fibromyalgia Impact Questionnaire (FIQR; 0-100) is a 21-item, disease-specific patient-reported outcome measure that assesses function, overall impact, and symptoms of fibromyalgia. Change score (-100, 100) was defined as FIQR at Day 60 minus Day 1. Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Resting Fatigue
The severity of fatigue is measured with a 0 to 10 scale where 0 is no fatigue and 10 is worst fatigue imaginable. Change score is on a numeric rating scale of -10 to 10 for change resting fatigue pain and was defined as pain scores at Day 60 minus Day 1. Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Movement-evoked Fatigue
Fatigue during a five times sit and stand test is measured with a 0 to 10 numeric rating scale with 0 as no fatigue and 10 as the worst fatigue imaginable. Change score was defined as movement fatigue scores at Day 60 minus Day 1 resulting in a numeric rating scale of -10 to 10 for change movement-evoked fatigue. Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Multidimensional Assessment of Fatigue (MAF)
MAF (1-50) is composed of 16 items measuring fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and impact on various activities of daily living. Change score was defined as MAF at Day 60 minus Day 1. Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Rapid Assessment of Physical Activity (RAPA) Aerobic
RAPA Aerobic (0-5 Low to High Scale) is composed of 5 items evaluating current level of physical activity. Change score was defined as RAPA Aerobic at Day 60 minus Day 1. Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Rapid Assessment of Physical Activity (RAPA) Strength and Flexibility
RAPA Strength and Flexibility (0-4, Low to High Scale) is composed of 4 items evaluating current level of physical activity. Change score was defined as RAPA Strength and Flexibility at Day 60 minus Day 1. Therefore, a negative score represents an improvement in outcome.
Measured: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Patient Global Impression of Change (PGIC) (Improved, No Change, Worse)
Evaluates overall health status as perceived by the patient in a seven-point single-item scale ranging from 'very much worse' to 'very much improved'
Measured: Day 60 +/- 5 days Home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start22 Jan 2021
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a pragmatic clinical trial in outpatient PT practices utilizing cluster randomization by facility and facility size. Sites will be randomized to enroll all eligible and consented participants with FM to TENS with PT, or PT only (no TENS). We have identified 25-35 clinics across 6 healthcare systems in both rural and urban settings.
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen Sluka
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor-investigator, Kathleen Sluka, University of Iowa
- Investigators
- Kathleen Sluka, PhD, PT, Principal investigator, University of IowaLeslie Crofford, MD, Principal investigator, Vanderbilt UniversityDana Dailey, PhD, PT, Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683042
- Sponsor's protocol ID
- 201909757
- Other IDs
- 1UG3AR076387-01
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2020
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The current study is expected to generate patient-reported outcomes for individuals with fibromyalgia across a broad spectrum of domains, pain, fatigue, function, psychological factors, and quality of life. We will also collect some data from the electronic health record about number of physical therapy visits, Current Protocol Terminology (CPT) codes for treatments, and the patient-specific functional scale. In addition, we will have TENS usage data downloaded from the TENS devices that will show the number of minutes of TENS use and the number of 30 minute sessions completed. Data will be collected prior to the intervention (baseline data) and 30, 60, 90 and 180 days after enrollment.
Publications
Yarasir Gillette E, Vance KG, Bayman EO, Dailey DL, Vance CGT, Chimenti RL, Crofford LJ, Van Gorp BJ, Johnson EM, Archer KR, Schacht Reisinger H, Zimmerman MB, Sluka KA, Berardi G. Sociodemographic factors, but not rurality, explain limited variance in fibromyalgia severity: a secondary analysis of 2 randomized clinical trials. Pain Med. 2026 Nov 1;27(11):1210-1220. doi: 10.1093/pm/pnag088.
PubMed 42434958Dailey DL, Vance CGT, Van Gorp BJ, Johnson EM, Post AA, Chimenti RL, Vance KG, Franck C, Sault J, Yarasir E, Reisinger HS, Anderson A, Anderson J, Capelle R, Crouch A, Donatelle J, Kaster D, Kepros T, Nicklies E, Rein B, Worth R, Balinski M, Lafontant DE, Slade EJ, Jiang F, Ecklund D, Neill-Hudson T, Koepp M, Costigan M, Spencer M, Archer KR, Zimmerman BM, Bayman EO, Crofford LJ, Sluka KA; Clinician Group. Transcutaneous Electrical Nerve Stimulation and Pain With Movement in People With Fibromyalgia: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e262450. doi: 10.1001/jamanetworkopen.2026.2450.
PubMed 41893844Post AA, Dailey DL, Bayman EO, Chimenti RL, Costigan M, Franck C, Huff T, Johnson E, Koepp M, Lafontant DE, McCabe ME, Neill-Hudson T, Vance CGT, Van Gorp B, Zimmerman BM, Ecklund D, Crofford LJ, Sluka KA. The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. Phys Ther. 2022 Nov 6;102(11):pzac116. doi: 10.1093/ptj/pzac116.
PubMed 36036838
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT04683042
- Acronym / sponsor ID
- 201909757
- Conditions
- Fibromyalgia
- Keywords
- Transcutaneous Electrical Nerve Stimulation (TENS), chronic pain, fibromyalgia, movement pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Kathleen SlukaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a pragmatic clinical trial in outpatient PT practices utilizing cluster randomization by healthcare system and facility size. Sites will be randomized to enroll all eligible and consented participants with FM to TENS with PT, or PT only (no TENS). We are identifying 25-35 clinics across 6 healthcare systems in both rural and urban settings. We will enroll 450 patients that self report a clinician diagnosis of FM. At each site, TENS (or no TENS) will be applied during each visit along with individualized PT treatment specified by the physical therapist. Participants randomized to TENS intervention sites will receive TENS units and electrodes at baseline to be applied to the cervical and lumbar regions. Participants will take the units home and bring the units back to their PT clinic visits with instructions for use at home while active and during their exercises. The physical therapist at each clinic will complete routine documentation of treatment. In addition to the primary and secondary outcomes, Electronic Health Record data variables will be collected as exploratory outcomes. Variables including adherence to treatment will be extracted from each site's Electronic Health Record. Patient-reported assessments will be obtained from the participant's at home the day of their second PT visit (Baseline) and at 30, 60 (primary outcome), 90, and 180 days following enrollment. The primary and secondary outcome assessments will be comparing TENS and no TENS groups in terms of changes from baseline to 60 days.
Participants will be identified after they are referred for PT for treatment of primary fibromyalgia (FM) or chronic pain (pain lasting more than three months). At their first (intake) physical therapy visit, they will be provided information about the study that can be accessed on paper or on-line. They will perform an electronic screening form on the first visit if interested in participating. Participants will provide e-consent after eligibility is confirmed at the initial PT visit. At the second PT visit after e-consent is signed, participants will be provided instructions on logging onto REDCap for data capture and accessing the case report forms. Participants enrolled at a TENS site will then be instructed in use of TENS and the TENS unit with electrodes will be provided. Those participants enrolled at a no TENS site will skip the instruction in use of TENS but will then receive instructions along with the TENS units at day 65. Participants will be instructed to capture all baseline assessments at home before their next PT visit before and following their first TENS treatment (or no TENS) at home (day 1). At 30, 60, 90, and 180 days following enrollment, participants will complete the same assessments at home including pain ratings at rest and with movement along with questionnaires. The primary and secondary outcome assessments will be comparing TENS and no TENS groups in terms of changes from baseline to 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a pragmatic clinical trial in outpatient PT practices utilizing cluster randomization by facility and facility size. Sites will be randomized to enroll all eligible and consented participants with FM to TENS with PT, or PT only (no TENS). We have identified 25-35 clinics across 6 healthcare systems in both rural and urban settings.
| Arm | Type | Receives |
|---|---|---|
| TENS with PT | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS) with PTTENS with PT group: The TENS with PT group will receive usual PT care and following enrollment, during the second PT visit, participants will receive TENS units and instruction on use of the TENS units. TENS will be applied to the upper and lower back with butterfly electrodes using the following parameters: mixed frequency (2-125Hz), strong but comfortable intensity, variable pulse duration from 100-250 microseconds. TENS to be applied when the patient is active and doing exercises at home and during PT sessions for 30 minutes at least 2 hours per day. The TENS with PT group will complete TENS use to the end of the study at 6 months. |
| No TENS with PT | Other | Other: PT onlyThe No TENS group will receive usual PT care until the primary endpoint timeframe of 60 days. After completion of the research homework at 60 days, TENS units will be mailed to the participants and a study team member will complete virtual TENS instruction. The no TENS group will complete TENS to the end of the study at 6 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 until 99.
- Clinician diagnosis of FM
- Referred for land-based PT
- Referred for treatment for FM or chronic pain (pain lasting more than 3 months)
- Able to provide informed consent.
Key exclusion criteria (9 listed)
- Contraindications to TENS use including:
- Currently enrolled in another pain control study
- Use of TENS within the last 30 days
- Clinically unstable medical or psychiatric issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) with PTUse of TENS units along with routine PT therapy | Device | TENS with PT |
| PT onlyRoutine PT therapy only | Other | No TENS with PT |
Primary outcome
Change in Movement-evoked Pain During the Sit and Stand Test
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Numeric rating scale of -10 to 10 for change in movement-evoked pain. Change score was defined as pain scores at Day 60 (measured by 11-point NRS) minus Day 1(measured by 11-point NRS). Therefore, a negative score represents an improvement in outcome.
9 secondary outcomes
Change in the Resting Pain Score
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Pain Interference (BPI)
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in FM Disease Activity (FIQR)
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Resting Fatigue
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Movement-evoked Fatigue
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Multidimensional Assessment of Fatigue (MAF)
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Rapid Assessment of Physical Activity (RAPA) Aerobic
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Change in Rapid Assessment of Physical Activity (RAPA) Strength and Flexibility
Time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Patient Global Impression of Change (PGIC) (Improved, No Change, Worse)
Time frame: Day 60 +/- 5 days Home
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42434958Yarasir Gillette E, Vance KG, Bayman EO, Dailey DL, Vance CGT, Chimenti RL, Crofford LJ, Van Gorp BJ, Johnson EM, Archer KR, Schacht Reisinger H, Zimmerman MB, Sluka KA, Berardi G. Sociodemographic factors, but not rurality, explain limited variance in fibromyalgia severity: a secondary analysis of 2 randomized clinical trials. Pain Med. 2026 Nov 1;27(11):1210-1220. doi: 10.1093/pm/pnag088.
- Derived from this study: PubMed 41893844Dailey DL, Vance CGT, Van Gorp BJ, Johnson EM, Post AA, Chimenti RL, Vance KG, Franck C, Sault J, Yarasir E, Reisinger HS, Anderson A, Anderson J, Capelle R, Crouch A, Donatelle J, Kaster D, Kepros T, Nicklies E, Rein B, Worth R, Balinski M, Lafontant DE, Slade EJ, Jiang F, Ecklund D, Neill-Hudson T, Koepp M, Costigan M, Spencer M, Archer KR, Zimmerman BM, Bayman EO, Crofford LJ, Sluka KA; Clinician Group. Transcutaneous Electrical Nerve Stimulation and Pain With Movement in People With Fibromyalgia: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e262450. doi: 10.1001/jamanetworkopen.2026.2450.
- Derived from this study: PubMed 36036838Post AA, Dailey DL, Bayman EO, Chimenti RL, Costigan M, Franck C, Huff T, Johnson E, Koepp M, Lafontant DE, McCabe ME, Neill-Hudson T, Vance CGT, Van Gorp B, Zimmerman BM, Ecklund D, Crofford LJ, Sluka KA. The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. Phys Ther. 2022 Nov 6;102(11):pzac116. doi: 10.1093/ptj/pzac116.
- Individual participant dataSharing planned: Yes. The current study is expected to generate patient-reported outcomes for individuals with fibromyalgia across a broad spectrum of domains, pain, fatigue, function, psychological factors, and quality of life. We will also collect some data from the electronic health record about number of physical therapy visits, Current Protocol Terminology (CPT) codes for treatments, and the patient-specific functional scale. In addition, we will have TENS usage data downloaded from the TENS devices that will show the number of minutes of TENS use and the number of 30 minute sessions completed. Data will be collected prior to the intervention (baseline data) and 30, 60, 90 and 180 days after enrollment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Sluka, PhD, PT principal investigator
University of Iowa
Leslie Crofford, MD principal investigator
Vanderbilt University
Dana Dailey, PhD, PT study director
University of Iowa
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) with PT and PT only in people with Fibromyalgia, run by Kathleen Sluka at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement-evoked Pain During the Sit and Stand Test (time frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683042, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.