Effects of Cerebral & Peripheral Electrical Stimulation on Pain and Function in CTS

NCT04092088 | Unknown DMC FDA Device

• 1 other identifier: AIMAATY
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blind, multi-center, factorial clinical trial to study the effectiveness of cerebral and peripheral electrical stimulation on pain and functional limitations associated with carpal tunnel syndrome (CTS). The study subjects will be randomly into four groups; (1) active trans-cranial direct current stimulation (tDCS) + active trans-cutaneous electrical nerve stimulation (TENS), (2) active tDCS + sham TENS, (3) sham tDCS + active TENS and (4) sham tDCS + sham TENS. The patient will be assessed by Brief Pain Inventory (BPI), Beck Depression Inventory (BDI), The Douleur Neuropathique en 4 questions (DN4), Quantitative sensory testing (QST), Pain Pressure Test (PPT) with algometer, Conditioned pain modulation (CPM), Patient ratings of improvement, or worsening, of the pain condition, Quality of Life short-form (SF)-36, Visual Analog Mood Scale (VAMS), Mini Mental Status Exam (MMSE) and Adverse Events Questionnaire (AEs). This study aims to investigate whether cerebral and peripheral electrical stimulation combined are more effective in relieving pain and functional limitations than the separate application of electrical stimulation in patients with CTS.

Conditions

Carpal Tunnel Syndrome

Keywords

Transcranial Direct Current Stimulation (tDCS); Transcutaneous Electrical Nerve Stimulation (TENS); analgesic effect; functional disability

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI)

  A short, self-report questionnaire includes 4 items that assess pain intensity (pain right now, pain on average in last 24 hours, worst pain in last 24 hours, and least pain in last 24 hours) using an NRS from 0 (no pain) to 10 (pain as bad as can imagine). The mean of these 4 pain items will be used as primary outcome. The BPI also includes 7 items that assess the impact of the pain on functioning using a 0 (no interference) to 10 (complete interference) rating scale, which will be used as a secondary outcome.

  At baseline

• Brief Pain Inventory (BPI)

  A short, self-report questionnaire includes 4 items that assess pain intensity (pain right now, pain on average in last 24 hours, worst pain in last 24 hours, and least pain in last 24 hours) using an NRS from 0 (no pain) to 10 (pain as bad as can imagine). The mean of these 4 pain items will be used as primary outcome. The BPI also includes 7 items that assess the impact of the pain on functioning using a 0 (no interference) to 10 (complete interference) rating scale, which will be used as a secondary outcome.

  After 3 weeks

Secondary Outcomes (19)

• Beck Depression Inventory (BDI)

  At baseline

• Beck Depression Inventory (BDI)

  After 3 weeks

• The Douleur Neuropathique 4 questions (DN4)

  At baseline

• The Douleur Neuropathique 4 questions (DN4)

  After 3 weeks

• Quantitative sensory testing (QST)

  At baseline

Study Arms (4)

tDCS-r+TENS-r

ACTIVE COMPARATOR

Real transcranial direct current stimulation (tDCS-r) + real transcutaneous electrical nerve stimulation (TENS-r)

Device: tDCS-r; Device: TENS-r

tDCS-r+TENS-s

EXPERIMENTAL

Real transcranial direct current stimulation (tDCS-r) + sham transcutaneous electrical nerve stimulation (TENS-s)

Device: tDCS-r; Device: TENS-s

tDCS-s+TENS-r

EXPERIMENTAL

Sham transcranial direct current stimulation (tDCS-s) + real transcutaneous electrical nerve stimulation (TENS-r)

Device: TENS-r; Device: tDCS-s

tDCS-s+TENS-s

SHAM COMPARATOR

Sham transcranial direct current stimulation (tDCS-s) + sham transcutaneous electrical nerve stimulation (TENS-s)

Device: tDCS-s; Device: TENS-s

Interventions

tDCS-r DEVICE

The transcranial stimulation will be applied by a constant current device (tdcs) with an intensity of 2 mA for 20 minutes (the set will be turned on for 20 minutes).

Also known as: real (active) transcranial direct current stimulation

tDCS-r+TENS-r; tDCS-r+TENS-s

TENS-r DEVICE

Conventional TENS will be applied for 20 minutes. The cathode will be placed on the carpal ligament, and the anode electrodes on the palmar area of the hand, with a layer of conductive gel applied to the area (the set will be turned on for 20 minutes)..

Also known as: real (active) transcutaneous electrical nerve stimulation

tDCS-r+TENS-r; tDCS-s+TENS-r

tDCS-s DEVICE

The transcranial stimulation will be applied by a constant current device (tdcs) with an intensity of 2 mA for 20 minutes (the set will be turned off after 30 seconds).

Also known as: sham transcranial direct current stimulation

tDCS-s+TENS-r; tDCS-s+TENS-s

TENS-s DEVICE

Conventional TENS will be applied for 20 minutes. The cathode will be placed on the carpal ligament, and the anode electrodes on the palmar area of the hand, with a layer of conductive gel applied to the area (the set will be turned off after 30 seconds).

Also known as: sham transcutaneous electrical nerve stimulation

tDCS-r+TENS-s; tDCS-s+TENS-s

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged \>18 years and \<65 years.
• Paresthesia, pain or vasomotor symptoms through the distribution of median nerve (persistence \> 2 months).
• Positive result for Phalen's, Tinel's and/or carpal compression tests during physical examination.
• Mild-to-moderate severity of CTS according to American Association of Neuromuscular \& Electrodiagnostic Medicine (AANEM) 2002 (mild: abnormal sensory peak latency \[≥3.5ms\] with normal motor distal latency \[\<4.4\]; moderate: abnormal sensory \[≥3.5ms\] and motor \[≥4.4ms\] latencies).

You may not qualify if:

• Previous history of wrist surgery
• Presence of predisposing etiological factors for CTS (e.g., diabetes mellitus).
• Trauma, neurological, psychiatric, rheumatic diseases, renal failure, pregnancy, hypothyroidism, and hyperthyroidism.
• Presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy.
• Pharmacological treatment with oral steroids or non-steroidal anti-inflammatory drugs within the previous month.
• Participation in a physical therapy program.
• Administration of steroid injection(s) within the previous 6 months.
• Previous treatment with TENS \<6 months.
• Previous treatment with tDCS.
• Use of pacemakers or other implanted devices.
• Pregnancy or breastfeeding.
• Refuse to participate.

Sponsors & Collaborators

• Suez Canal University: lead
• Hiroshima University: collaborator
• Complejo Hospitalario de Especialidades Juan Ramón Jimenez: collaborator
• Université de Sherbrooke: collaborator

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Transcranial Direct Current Stimulation; Transcutaneous Electric Nerve Stimulation

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ahmed I Maaty, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suez Canal University

CONTACT

+20643918239; aimaaty@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: neither the participant nor the investigator and outcomes assessor will be aware whether active tDCS/TENS will be applied to a particular case.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: randomized, triple-blind, multi-center, factorial clinical trial

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: September 17, 2019
• Study Start: December 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available after the end of the study
• Access Criteria: Informed consent, data management and statistical analysis will shared, if requested, through e-mail: aimaaty@hotmail.com