ClinicalTrials.gg
Not yet recruitingNCT07905651PDC-RAUpdated Nov 2, 2026

Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis

An interventional study of Paraffin Wax Therapy and Dry cupping in Rheumatic Arthritis, sponsored by University of Baghdad. Not yet recruiting at 1 site in Iraq. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment

Updated Nov 2, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

Rheumatoid arthritis is a chronic inflammatory disease that can cause pain, stiffness, and reduced functional performance in the wrist and hand joints. These problems may make daily activities, such as gripping objects and performing self-care tasks, more difficult.

The purpose of this study is to evaluate the effects of paraffin wax therapy and dry cupping on pain intensity and wrist joint functional performance among patients with rheumatoid arthritis. The study will compare two groups: one receiving paraffin wax therapy and the other receiving dry cupping therapy

Pain intensity and wrist joint functional performance will be assessed before and after the interventions using standardized assessment tools. The findings may help determine whether these complementary therapies can reduce pain and improve wrist function in patients with rheumatoid arthritis.

Read the detailed description

Rheumatoid arthritis (RA) is a chronic inflammatory disease that can affect the joints of the hands and wrists. Pain, stiffness, and reduced joint function may interfere with daily activities. In addition to standard medical treatment, non-pharmacological interventions may help manage symptoms and support physical function.

This study compares paraffin wax therapy and dry cupping therapy in adults with rheumatoid arthritis. Both interventions are intended to address symptoms affecting the hands and wrists. The study uses a two-arm, parallel-group randomized design with assessments conducted before and after the intervention period.

A total of 48 participants are included in the study plan, with 24 participants allocated to each group. Random allocation is performed in a 1:1 ratio using computer-generated block randomization. Allocation assignments are placed in sealed, opaque envelopes and opened by a research assistant after the baseline assessment.

**Paraffin Wax Therapy Group**

Participants assigned to this group receive paraffin wax therapy using medical-grade paraffin maintained at 45 ± 1°C. The affected hand is dipped into the melted paraffin for approximately 2-3 seconds and then removed to allow the wax to solidify for approximately 5-10 seconds. This process is repeated eight times to form a coating around the hand. The hand is then covered with a plastic bag and an insulating wrap for 15 minutes. The procedure is applied to the opposite hand as appropriate.

Treatment is provided twice weekly for four weeks, for a total of eight sessions.

**Dry Cupping Therapy Group**

Participants assigned to this group receive dry cupping therapy using acrylic cups measuring approximately 5-6.5 cm in diameter and a portable DF-750 suction pump. The cups are applied to the selected treatment points LI4, LI5, and TE4. Negative pressure is maintained at approximately -300 to -400 mmHg, with adjustments of approximately 25 mmHg according to participant tolerance and skin response. The cups remain in place for approximately 10 minutes.

Treatment is provided twice weekly for four weeks, for a total of eight sessions.

**Study Setting and Procedures**

The study is conducted at the Rheumatology Clinic of Baghdad Teaching Hospital in Baghdad, Iraq. Participants receive the intervention assigned to their group according to the study protocol. Study assessments are conducted at baseline and after completion of the intervention period.

The sample size was estimated using G*Power version 3.1 for a two-sided independent-samples t-test, with a significance level of 0.05, statistical power of 80%, and an assumed standardized effect size of 0.8. The minimum estimated sample was 42 participants. The target sample was increased to 48 participants to allow for an anticipated 10% attrition rate.

The study follows the applicable ethical requirements. Participants are informed about the study procedures, and informed consent is obtained before participation. Participant information is handled confidentially.

02

Conditions studied

  • Rheumatic Arthritis

Keywords

  • Rheumatoid Arthritis
  • Paraffin Wax Therapy
  • Dry Cupping
  • Pain Intensity
  • Wrist Joint Function
  • Complementary Therapy
  • Wrist Functional Performance
03

In context

Rheumatic Fever

65 studies on the registry are indexed under Rheumatic Fever; 22 are open to participants now.

This study's planned enrollment of 100 is above the median of 81 across 30 interventional studies indexed under Rheumatic Fever.

Browse Rheumatic Fever studies →

Lead sponsor

University of Baghdad is the lead sponsor of 169 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 2, 2026. See what changed

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 20-60 years.
  • Diagnosis of rheumatoid arthritis (RA) fulfilling the 2010 ACR/EULAR classification criteria.
  • Seropositive for rheumatoid factor (RF).
  • Stable regimen of conventional RA medications for at least 3 months before enrollment, including non-steroidal anti-inflammatory drugs (NSAIDs), conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), and/or biologic disease-modifying anti-rheumatic drugs (bDMARDs), with agreement to maintain the same regimen throughout the study period.

Exclusion criteria

Exclusion Criteria:

  • Acute joint inflammation or infection in the hands or upper back at the time of screening.
  • Severe deformities or surgery involving the hands or upper back within the previous 6 months.
  • Skin lesions, open wounds, infections, skin fragility, or severe vascular disease (e.g., deep vein thrombosis or severe varicose veins) at the proposed treatment sites.
  • Significant comorbidities, including uncontrolled diabetes mellitus, renal failure, polycythemia vera, active malignancy, severe cardiovascular or respiratory disease, or coagulopathies, or current use of anticoagulants.
  • Pregnancy or lactation.
  • Previous experience with paraffin wax therapy or cupping therapy within the past 6 months.
  • Known hypersensitivity to paraffin wax or materials used in cupping (e.g., acrylic or silicone).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Paraffin wax therapy

    Participants assigned to this group will receive paraffin wax therapy for the wrist and hand joints at a temperature of 45 ± 1°C. The treatment will involve eight successive dips, followed by wrapping the treated area for 15 minutes. The intervention will be administered twice weekly for four weeks, for a total of eight sessions.

    Procedure: Paraffin Wax Therapy

  • Experimental
    Dry cupping

    Participants assigned to this group will receive dry cupping therapy using suction cups applied to the designated treatment points around the wrist and hand. The procedure will be performed without skin incision or bloodletting. The treatment points, suction intensity, session duration, and frequency will follow the approved study protocol.

    Procedure: Dry cupping

Interventions

  • ProcedureParaffin Wax Therapy

    Paraffin wax therapy will be applied to the wrist and hand joints at a temperature of 45 ± 1°C. The treatment will involve eight successive dips, followed by wrapping the treated area for 15 minutes. Sessions will be conducted twice weekly for four weeks, for a total of eight sessions.

  • ProcedureDry cupping

    Dry cupping therapy will be administered using suction cups applied to designated treatment points around the wrist and hand, without skin incision or bloodletting. The treatment points, suction intensity, session duration, and frequency will follow the approved study protocol.

06

What researchers measure

Primary outcomes

  1. Change in Pain Intensity Measured by the Visual Analog Scale (VAS)

    Pain intensity will be assessed using the Visual Analog Scale (VAS) before the first treatment session and after completion of the eight treatment sessions. Changes in pain intensity will be evaluated and compared between the paraffin wax therapy and dry cupping groups.

    Time frame: From baseline (before the first treatment session) to completion of the 4-week intervention period (after the eighth treatment session).

Secondary outcomes

  1. Change in Wrist Joint Functional Performance Measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)

    Wrist Joint Functional Performance will be assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI) before the first treatment session and after completion of the eight treatment sessions. Changes in HAQ-DI scores will be compared between the paraffin wax therapy and dry cupping groups. The HAQ-DI assesses functional limitations in daily activities among patients with rheumatoid arthritis and is not specific to wrist function.

    Time frame: From baseline (before the first treatment session) to the end of the 4-week intervention period (after the eighth treatment session).

07

Study locations

1 site
  • Rheumatology Clinic at Baghdad Teaching Hospital in Baghdad city
    Baghdad, Iraq
08

References and documents

Publications

  • Tokem Y, Akyol AD, Argon G. The relationship between disability and self-care agency of Turkish people with rheumatoid arthritis. J Clin Nurs. 2007 Mar;16(3A):44-50. doi: 10.1111/j.1365-2702.2006.01742.x. PubMed 17518868 ↗
  • Moura CC, Chaves ECL, Cardoso ACLR, Nogueira DA, Correa HP, Chianca TCM. Cupping therapy and chronic back pain: systematic review and meta-analysis. Rev Lat Am Enfermagem. 2018 Nov 14;26:e3094. doi: 10.1590/1518-8345.2888.3094. PubMed 30462793 ↗
  • Lauche R, Cramer H, Hohmann C, Choi KE, Rampp T, Saha FJ, Musial F, Langhorst J, Dobos G. The effect of traditional cupping on pain and mechanical thresholds in patients with chronic nonspecific neck pain: a randomised controlled pilot study. Evid Based Complement Alternat Med. 2012;2012:429718. doi: 10.1155/2012/429718. Epub 2011 Dec 7. PubMed 22203873 ↗
  • Kim JI, Lee MS, Lee DH, Boddy K, Ernst E. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. doi: 10.1093/ecam/nep035. Epub 2011 Jun 23. PubMed 19423657 ↗
  • Teut M, Ullmann A, Ortiz M, Rotter G, Binting S, Cree M, Lotz F, Roll S, Brinkhaus B. Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial. BMC Complement Altern Med. 2018 Apr 2;18(1):115. doi: 10.1186/s12906-018-2187-8. PubMed 29609566 ↗
  • Philippou E, Petersson SD, Rodomar C, Nikiphorou E. Rheumatoid arthritis and dietary interventions: systematic review of clinical trials. Nutr Rev. 2021 Mar 9;79(4):410-428. doi: 10.1093/nutrit/nuaa033. PubMed 32585000 ↗
  • Noor Ul Ain; Bashir MS, Noor R, Ikram M, Iftikhar A, Najm R. Effects of core stabilisation exercises with and without dry cupping on pain and disability in patients with sacroiliac joint dysfunction. J Pak Med Assoc. 2025 Jan;75(1):61-65. doi: 10.47391/JPMA.8289. PubMed 39828829 ↗
  • Mathiowetz V. Comparison of Rolyan and Jamar dynamometers for measuring grip strength. Occup Ther Int. 2002;9(3):201-9. doi: 10.1002/oti.165. PubMed 12374997 ↗
  • Kucukdeveci AA, Sahin H, Ataman S, Griffiths B, Tennant A. Issues in cross-cultural validity: example from the adaptation, reliability, and validity testing of a Turkish version of the Stanford Health Assessment Questionnaire. Arthritis Rheum. 2004 Feb 15;51(1):14-9. doi: 10.1002/art.20091. PubMed 14872450 ↗
  • Soliman Y, Hamed N, Khachemoune A. Cupping in dermatology: a critical review and update. Acta Dermatovenerol Alp Pannonica Adriat. 2018 Jun;27(2):103-107. PubMed 29945267 ↗
  • Li W, Chung SL, Lei M, Yang X, Jin Z. Dry cupping as an adjuvant treatment of individuals with severe pneumonia: study protocol for a placebo-controlled, randomised study. BMJ Open. 2024 Apr 29;14(4):e082081. doi: 10.1136/bmjopen-2023-082081. PubMed 38684257 ↗
  • Ustun I, Caglar S. Comparison of the effect of prolotherapy and paraffin wax for hand osteoarthritis. Eur Rev Med Pharmacol Sci. 2023 Oct;27(20):9510-9520. doi: 10.26355/eurrev_202310_34124. PubMed 37916318 ↗
  • Sandqvist G, Akesson A, Eklund M. Evaluation of paraffin bath treatment in patients with systemic sclerosis. Disabil Rehabil. 2004 Aug 19;26(16):981-7. doi: 10.1080/09638280410001702405. PubMed 15371046 ↗
  • Sibtain F, Khan A, Shakil-Ur-Rehman S. Efficacy of Paraffin Wax Bath with and without Joint Mobilization Techniques in Rehabilitation of post-Traumatic stiff hand. Pak J Med Sci. 2013 Apr;29(2):647-50. PubMed 24353596 ↗
  • Oosterveld FG, Rasker JJ. Effects of local heat and cold treatment on surface and articular temperature of arthritic knees. Arthritis Rheum. 1994 Nov;37(11):1578-82. doi: 10.1002/art.1780371104. PubMed 7980668 ↗
  • Nagy G, Roodenrijs NMT, Welsing PMJ, Kedves M, Hamar A, van der Goes MC, Kent A, Bakkers M, Pchelnikova P, Blaas E, Senolt L, Szekanecz Z, Choy EH, Dougados M, Jacobs JW, Geenen R, Bijlsma JW, Zink A, Aletaha D, Schoneveld L, van Riel P, Dumas S, Prior Y, Nikiphorou E, Ferraccioli G, Schett G, Hyrich KL, Mueller-Ladner U, Buch MH, McInnes IB, van der Heijde D, van Laar JM. EULAR points to consider for the management of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis. 2022 Jan;81(1):20-33. doi: 10.1136/annrheumdis-2021-220973. Epub 2021 Aug 18. PubMed 34407926 ↗
  • Long H, Liu Q, Yin H, Wang K, Diao N, Zhang Y, Lin J, Guo A. Prevalence Trends of Site-Specific Osteoarthritis From 1990 to 2019: Findings From the Global Burden of Disease Study 2019. Arthritis Rheumatol. 2022 Jul;74(7):1172-1183. doi: 10.1002/art.42089. Epub 2022 Jun 2. PubMed 35233975 ↗
  • Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1. PubMed 33275908 ↗
  • GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9. PubMed 33069326 ↗
  • Prasad P, Verma S, Surbhi, Ganguly NK, Chaturvedi V, Mittal SA. Rheumatoid arthritis: advances in treatment strategies. Mol Cell Biochem. 2023 Jan;478(1):69-88. doi: 10.1007/s11010-022-04492-3. Epub 2022 Jun 21. PubMed 35725992 ↗
  • GBD 2021 Rheumatoid Arthritis Collaborators. Global, regional, and national burden of rheumatoid arthritis, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Sep 25;5(10):e594-e610. doi: 10.1016/S2665-9913(23)00211-4. eCollection 2023 Oct. PubMed 37795020 ↗
  • Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available. PubMed 4139420 ↗
  • Oncel A, Kucuksen S, Ecesoy H, Sodali E, Yalcin S. Comparison of efficacy of fluidotherapy and paraffin bath in hand osteoarthritis: A randomized controlled trial. Arch Rheumatol. 2020 Sep 28;36(2):201-209. doi: 10.46497/ArchRheumatol.2021.8123. eCollection 2021 Jun. PubMed 34527924 ↗
  • Kasapoglu Aksoy M, Altan L. Short-term efficacy of paraffin therapy and home-based exercise programs in the treatment of symptomatic hand osteoarthritis. Turk J Phys Med Rehabil. 2017 Oct 2;64(2):108-113. doi: 10.5606/tftrd.2018.1535. eCollection 2018 Jun. PubMed 31453499 ↗
  • Dellhag B, Wollersjo I, Bjelle A. Effect of active hand exercise and wax bath treatment in rheumatoid arthritis patients. Arthritis Care Res. 1992 Jun;5(2):87-92. doi: 10.1002/art.1790050207. PubMed 1390969 ↗
  • Finckh A, Gilbert B, Hodkinson B, Bae SC, Thomas R, Deane KD, Alpizar-Rodriguez D, Lauper K. Global epidemiology of rheumatoid arthritis. Nat Rev Rheumatol. 2022 Oct;18(10):591-602. doi: 10.1038/s41584-022-00827-y. Epub 2022 Sep 6. PubMed 36068354 ↗
  • Wang Y, Chen S, Du K, Liang C, Wang S, Owusu Boadi E, Li J, Pang X, He J, Chang YX. Traditional herbal medicine: Therapeutic potential in rheumatoid arthritis. J Ethnopharmacol. 2021 Oct 28;279:114368. doi: 10.1016/j.jep.2021.114368. Epub 2021 Jun 29. PubMed 34197960 ↗
  • Li W, Yu L, Li W, Ge G, Ma Y, Xiao L, Qiao Y, Huang W, Huang W, Wei M, Wang Z, Bai J, Geng D. Prevention and treatment of inflammatory arthritis with traditional Chinese medicine: Underlying mechanisms based on cell and molecular targets. Ageing Res Rev. 2023 Aug;89:101981. doi: 10.1016/j.arr.2023.101981. Epub 2023 Jun 9. PubMed 37302756 ↗
  • Brown P, Pratt AG, Hyrich KL. Therapeutic advances in rheumatoid arthritis. BMJ. 2024 Jan 17;384:e070856. doi: 10.1136/bmj-2022-070856. PubMed 38233032 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers because no data-sharing plan has been established for this study. Study results may be disseminated through scientific publications and academic presentations without disclosing individual participants' personal information.

09

Updates

2 registry updates since Sep 25, 2026
Eligibility
1 inclusion criterion edited, 3 added; 5 exclusion criteria edited, 2 added; 2 criteria removed
What changed in the criteria
  • RemovedInclusion Criteria:
  • Removed-
Inclusion criteria
  • AddedAge 20-60 years.
  • AddedDiagnosis of rheumatoid arthritis (RA) fulfilling the 2010 ACR/EULAR classification criteria.
  • AddedSeropositive for rheumatoid factor (RF).
  • Edited1. Age 20-60 years. 2. Diagnosis of RA fulfilling the 2010 ACR/EULAR classification criteria (14). 3. Seropositive for Rheumatoid Factor (RF). 4. Stable doseregimen of conventional RA medications Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ibuprofen and Naproxen, csDMARDs (Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs) such as Methotrexate and Hydroxychloroquine, bDMARDs (Biologic Disease-Modifying Anti-Rheumatic Drugs) such as Infliximab and Adalimumab for ≥at least 3 months prior tobefore enrollment, including non-steroidal anti-inflammatory drugs (NSAIDs), conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), and/or biologic disease-modifying anti-rheumatic drugs (bDMARDs), with agreement to maintain stablethe same regimen duringthroughout the study period.
Exclusion criteria
  • EditedExclusion Criteria: 1. Acute joint inflammation or infection in the hands/ or upper back at the time of screening.
  • AddedSevere deformities or surgery involving the hands or upper back within the previous 6 months.
  • Edited2. Severe deformities or recent surgery (past 6 months) in hands/upper back. 3. Skin lesions, open wounds, infections, skin fragility, or severe vascular disease (e.g., DVT,deep vein thrombosis or severe varicose veins) at the proposed treatment sites.
  • Edited4. Significant comorbidities:, including uncontrolled diabetes mellitus, renal failure, polycythemia vera, active malignancy, severe cardiovascular or respiratory disease, or coagulopathies, or current use of anticoagulants.
  • AddedPregnancy or lactation.
  • Edited5. Pregnancy or lactation. 6. PriorPrevious experience with paraffin wax therapy or cupping therapy within the lastpast 6 months.
  • Edited7. Known hypersensitivity to paraffin wax or materials used in cupping (e.g., acrylic, or silicone).
Nov 2, 2026
Registered
First appeared on the registry
Oct 29, 2026
Show all 2 updates
  1. Nov 2, 2026
    Eligibility 1 inclusion criterion edited, 3 added; 5 exclusion criteria edited, 2 added; 2 criteria removed
    What changed in the criteria
    • RemovedInclusion Criteria:
    • Removed-
    Inclusion criteria
    • AddedAge 20-60 years.
    • AddedDiagnosis of rheumatoid arthritis (RA) fulfilling the 2010 ACR/EULAR classification criteria.
    • AddedSeropositive for rheumatoid factor (RF).
    • Edited1. Age 20-60 years. 2. Diagnosis of RA fulfilling the 2010 ACR/EULAR classification criteria (14). 3. Seropositive for Rheumatoid Factor (RF). 4. Stable doseregimen of conventional RA medications Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ibuprofen and Naproxen, csDMARDs (Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs) such as Methotrexate and Hydroxychloroquine, bDMARDs (Biologic Disease-Modifying Anti-Rheumatic Drugs) such as Infliximab and Adalimumab for ≥at least 3 months prior tobefore enrollment, including non-steroidal anti-inflammatory drugs (NSAIDs), conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), and/or biologic disease-modifying anti-rheumatic drugs (bDMARDs), with agreement to maintain stablethe same regimen duringthroughout the study period.
    Exclusion criteria
    • EditedExclusion Criteria: 1. Acute joint inflammation or infection in the hands/ or upper back at the time of screening.
    • AddedSevere deformities or surgery involving the hands or upper back within the previous 6 months.
    • Edited2. Severe deformities or recent surgery (past 6 months) in hands/upper back. 3. Skin lesions, open wounds, infections, skin fragility, or severe vascular disease (e.g., DVT,deep vein thrombosis or severe varicose veins) at the proposed treatment sites.
    • Edited4. Significant comorbidities:, including uncontrolled diabetes mellitus, renal failure, polycythemia vera, active malignancy, severe cardiovascular or respiratory disease, or coagulopathies, or current use of anticoagulants.
    • AddedPregnancy or lactation.
    • Edited5. Pregnancy or lactation. 6. PriorPrevious experience with paraffin wax therapy or cupping therapy within the lastpast 6 months.
    • Edited7. Known hypersensitivity to paraffin wax or materials used in cupping (e.g., acrylic, or silicone).
    + 1 other change: description
  2. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07905651
Responsible party
Abdullah Abdul Hamid Alhussein (PhD Nursing Student and Principal Investigator, University of Baghdad) — Principal investigator
First posted
Oct 29, 2026
Start date
Oct 25, 2026 (estimated)
Primary completion
Nov 26, 2026 (estimated)
Completion
Dec 26, 2026 (estimated)
Last update
Nov 2, 2026

Study contacts

Abdullah AbdulHamid Alhussein, PhD Student
Contact
abdullahalhussen247@gmail.com
009647720863206 ext. 00964786744107

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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