Physical Therapy in the Treatment of Carpal Tunnel Syndrome

NCT04329247 | Completed DMC

• 1 other identifier: CE0072015-02-04
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

In the present investigation the pain reduction effects of a physical therapy technique will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

Conditions

Carpal Tunnel Syndrome

Keywords

Pain management; Physiotherapy; Manual therapy; Median nerve neural mobilization; Neural mobilization

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes from baseline (measured immediately before the application of the first treatment) and immediately after the application of the last treatment (at 4 weeks).

Secondary Outcomes (1)

• Upper limb function

  Changes from baseline (measured immediately before the application of the first treatment) and immediately after the application of the last treatment (at 4 weeks)

Other Outcomes (4)

• Work Status at baseline

  Measured immediately before the application of the first treatment

• Work Status post treatment

  Measured immediatly after the application of the last treatment.

• Change in Work Task (Job Type)

  Measured immediatly after the application of the last treatment.

Study Arms (2)

Median nerve neural mobilization

EXPERIMENTAL

Non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks.

Other: Median nerve neural mobilization

Control group

NO INTERVENTION

Waiting list control group. Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available.

Interventions

Median nerve neural mobilization OTHER

Manual therapy maneuver performed in the upper limb.

Median nerve neural mobilization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Tumors
• Cancer
• 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 to gabapentin
• Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
• Metabolic neuropathy.
• Obesity (body mass index over 30).
• Participants who are not employed.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Ciudad Hospitalaria Enrique Tejera

Valencia, Carabobo, 2001, Venezuela

Location

Related Publications (13)

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  PMID: 9627862 BACKGROUND

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  PMID: 8176515 BACKGROUND

• Hesami O, Haghighatzadeh M, Lima BS, Emadi N, Salehi S. The effectiveness of gabapentin and exercises in the treatment of carpal tunnel syndrome: a randomized clinical trial. J Exerc Rehabil. 2018 Dec 27;14(6):1067-1073. doi: 10.12965/jer.1836420.210. eCollection 2018 Dec.

  PMID: 30656171 BACKGROUND

• 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.

  PMID: 28731977 BACKGROUND

• Sanz DR, Solano FU, Lopez DL, Corbalan IS, Morales CR, Lobo CC. Effectiveness of median nerve neural mobilization versus oral ibuprofen treatment in subjects who suffer from cervicobrachial pain: a randomized clinical trial. Arch Med Sci. 2018 Jun;14(4):871-879. doi: 10.5114/aoms.2017.70328. Epub 2017 Sep 26.

  PMID: 30002707 BACKGROUND

• Calvo-Lobo C, Unda-Solano F, Lopez-Lopez D, Sanz-Corbalan I, Romero-Morales C, Palomo-Lopez P, Seco-Calvo J, Rodriguez-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.

  PMID: 29559834 BACKGROUND

• Rodriguez-Sanz D, Lopez-Lopez D, Unda-Solano F, Romero-Morales C, Sanz-Corbalan 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.

  PMID: 28734105 BACKGROUND

• Basson A, Olivier B, Ellis R, Coppieters M, Stewart A, Mudzi W. The Effectiveness of Neural Mobilization for Neuromusculoskeletal Conditions: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Sep;47(9):593-615. doi: 10.2519/jospt.2017.7117. Epub 2017 Jul 13.

  PMID: 28704626 BACKGROUND

• Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.

  PMID: 27842937 BACKGROUND

• 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.

  PMID: 29521045 BACKGROUND

• Ginanneschi F, Cioncoloni D, Bigliazzi J, Bonifazi M, Lore C, Rossi A. Sensory axons excitability changes in carpal tunnel syndrome after neural mobilization. Neurol Sci. 2015 Sep;36(9):1611-5. doi: 10.1007/s10072-015-2218-x. Epub 2015 Apr 21.

  PMID: 25896622 BACKGROUND

• Yucel H, Seyithanoglu H. Choosing the most efficacious scoring method for carpal tunnel syndrome. Acta Orthop Traumatol Turc. 2015;49(1):23-9. doi: 10.3944/AOTT.2015.13.0162.

  PMID: 25803249 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Agnosia

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Perez, MD

  INSALUD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedicine Doctorate Program Investigator

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 1, 2020
• Study Start: May 5, 2020
• Primary Completion: August 8, 2020
• Study Completion: August 14, 2020
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)