OTHER · Research Ethical Approval Committee, College of Nursing, University of Baghdad
Study Type
interventional
Estimated enrollment
100
Locations
1 country
Sites
1
Timeline
Study Start
October 25, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 26, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 26, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
not yet recruiting
Estimated enrollment
100 participants
Study completion date
December 26, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations
1 countries · 1 sites
Trial Relationships
Click on a node to explore related trials.
Related Scientific Literature
Loading related publications...
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
October 23, 2026
Actual (reported)
Study Start
October 25, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Posted
October 29, 2026
Actual (reported)
Primary Completion
November 26, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 26, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
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.
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)
From baseline (before the first treatment session) to the end of the 4-week intervention period (after the eighth treatment session).
Study Arms (2)
Paraffin wax therapy
EXPERIMENTAL
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
Dry cupping
EXPERIMENTAL
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.
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.
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.
Eligibility Criteria
Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
You may qualify if:
\. Age 20-60 years. 2. Diagnosis of RA fulfilling the 2010 ACR/EULAR classification criteria (14). 3. Seropositive for Rheumatoid Factor (RF). 4. Stable dose 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 ≥ 3 months prior to enrollment and agreement to maintain stable regimen during the study period.
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.
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.
Model Details: This study uses a randomized, parallel-group interventional design involving patients with rheumatoid arthritis. Participants are randomly assigned to one of two groups. The first group receives paraffin wax therapy, while the second group receives dry cupping therapy. Each participant receives only the intervention assigned to their group. Outcomes are compared between the two groups to evaluate the effects of the interventions on pain intensity and wrist joint functional performance.
\. Severe deformities or recent surgery (past 6 months) in hands/upper back. 3. Skin lesions, open wounds, infections, fragility, or severe vascular disease (e.g., DVT, severe varicose veins) at proposed treatment sites.
\. Significant comorbidities: uncontrolled diabetes mellitus, renal failure, polycythemia vera, active malignancy, severe cardiovascular or respiratory disease, coagulopathies, or use of anticoagulants.
\. Pregnancy or lactation. 6. Prior experience with paraffin wax or cupping therapy within the last 6 months.
\. Known hypersensitivity to paraffin or materials used in cupping (e.g., acrylic, silicone).
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 26, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 26, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Data Sharing
IPD Sharing
Will not share
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.
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.