Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.

Carpal Tunnel Syndrome Clinical Trial

Official title:

Pain Reduction and Changes in Upper Limb Function Produced by Over the Counter Oral Ibuprofen Versus the Lack of Treatment, in Carpal Tunnel Syndrome.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04328805
• Other study ID #: CE0072015-02-05
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2020
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Universidad Europea de Madrid
• Contact: Francisco H Unda, PhD
• Phone: 0034982410289
• Email: 5299559[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the present investigation the pain reduction effect of an oral ibuprofen treatment will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

Description:

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by an oral ibuprofen pharmacological treatment and the lack of treatment in subjects diagnosed with carpal tunnel syndrome. Effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).

• Full understanding of written and spoken Spanish (language).

• Participants must freely consent to participate.

• The presence of positive Phalen and Tinel signs.

• The presence of carpal tunnel syndrome signs and symptoms.

Exclusion Criteria:

• The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, , deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy (or contraindication) to non steroidal anti inflammatory drugs (NSAID), and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Chronic Pain
• Ibuprofen
• Pain Management
• Pain, Chronic
• Syndrome

Intervention

Drug:
• Ibuprofen tablets
oral tablet

Locations

Country	Name	City	State
Venezuela	Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández	San Diego	Carabobo

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Venezuela, 

References & Publications (12)

Banta CA. A prospective, nonrandomized study of iontophoresis, wrist splinting, and antiinflammatory medication in the treatment of early-mild carpal tunnel syndrome. J Occup Med. 1994 Feb;36(2):166-8. — View Citation

Calvo-Lobo C, Unda-Solano F, López-López D, Sanz-Corbalán I, Romero-Morales C, Palomo-López P, Seco-Calvo J, Rodríguez-Sanz D. Is pharmacologic treatment better than neural mobilization for cervicobrachial pain? A randomized clinical trial. Int J Med Sci. 2018 Mar 8;15(5):456-465. doi: 10.7150/ijms.23525. eCollection 2018. — View Citation

Davis PT, Hulbert JR, Kassak KM, Meyer JJ. Comparative efficacy of conservative medical and chiropractic treatments for carpal tunnel syndrome: a randomized clinical trail. J Manipulative Physiol Ther. 1998 Jun;21(5):317-26. — View Citation

Dosenovic S, Jelicic Kadic A, Miljanovic M, Biocic M, Boric K, Cavar M, Markovina N, Vucic K, Puljak L. Interventions for Neuropathic Pain: An Overview of Systematic Reviews. Anesth Analg. 2017 Aug;125(2):643-652. doi: 10.1213/ANE.0000000000001998. Review. — View Citation

Eren Y, Yavasoglu NG, Comoglu SS. The relationship between QDASH scale and clinical, electrophysiological findings in carpal tunnel syndrome. Adv Clin Exp Med. 2018 Jan;27(1):71-75. doi: 10.17219/acem/67947. — View Citation

Giuliani E, Bianchi A, Marcuzzi A, Landi A, Barbieri A. Ibuprofen timing for hand surgery in ambulatory care. Acta Ortop Bras. 2015 Jul-Aug;23(4):188-91. doi: 10.1590/1413-78522015230400736. — View Citation

Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29. — View Citation

Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27. — View Citation

Riasi H, Rajabpour Sanati A, Salehi F, Salehian H, Ghaemi K. Analyzing the therapeutic effects of short wrist splint in patients with carpal tunnel syndrome (CTS) under ibuprofen treatment from an EMG-NCV perspective. J Med Life. 2015;8(Spec Iss 4):154-158. — View Citation

Rodríguez-Sanz D, López-López D, Unda-Solano F, Romero-Morales C, Sanz-Corbalán I, Beltran-Alacreu H, Calvo-Lobo C. Effects of Median Nerve Neural Mobilization in Treating Cervicobrachial Pain: A Randomized Waiting List-Controlled Clinical Trial. Pain Pract. 2018 Apr;18(4):431-442. doi: 10.1111/papr.12614. Epub 2017 Nov 20. — View Citation

Shin D, Lee SJ, Ha YM, Choi YS, Kim JW, Park SR, Park MK. Pharmacokinetic and pharmacodynamic evaluation according to absorption differences in three formulations of ibuprofen. Drug Des Devel Ther. 2017 Jan 4;11:135-141. doi: 10.2147/DDDT.S121633. eCollection 2017. — View Citation

Weinheimer K, Michelotti B, Silver J, Taylor K, Payatakes A. A Prospective, Randomized, Double-Blinded Controlled Trial Comparing Ibuprofen and Acetaminophen Versus Hydrocodone and Acetaminophen for Soft Tissue Hand Procedures. J Hand Surg Am. 2019 May;44(5):387-393. doi: 10.1016/j.jhsa.2018.10.014. Epub 2018 Nov 27. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal upper limb pain	Assessed through the visual analog scale (VAS). The VAS is a psychometric response scale. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The VAS is the most frequently used method to assess pain intensity. The scale will be displayed as a horizontal 100-mm line labelled at each end by descriptors such as 'no pain' (the minimum and best outcome possible) and 'worse pain ever' (maximum and worst outcome possible). The participant will mark the line to indicate pain severity and it is simply quantified by measuring the distance in millimeters from 0 (no pain) to the patient's marked rating.	Changes from baseline (measured immediately before the application of each treatment) at 60 minutes after the application of treatment. Measures at baseline and after treatment will be performed 1 day a week during 4 weeks.
Secondary	Upper limb function	Assessed through the quick Quick Disabilities of the Arm, Shoulder and Hand questionary (QuickDASH), which is a shortened version of the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) instrument.The instrument administered to the participants will be a self-report questionnaire, that will rate the difficulty and interference of daily life on a 5 point Likert scale. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).	Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment