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

NCT ID: NCT04092088

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-10-31

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.

Detailed Description

The study will be carried out on patients attending (1) Physical Medicine, Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital, Ismailia, EGYPT, (2) Hiroshima University, (3) Department of Physical Medicine & Rehabilitation, Juan Ramón Jiménez University Hospital, Huelva, Spain, and (4) University of Sherbrooke, Canada and diagnosed with CTS according to clinical examination and to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) practice recommendations for CTS.

Study subjects will be divided into four groups:

Group (1): (active comparator = tDCS-real (r) + TENS-r) will include 45 patients with CTS and will receive active anodal tDCS of M1 for 20 minutes, at 2 mA plus active TENS (the cathode will be placed on the carpal ligament, and the anode electrodes on the palmar area of the hand) for 20 minutes, and a total of 15 sessions for 3 weeks (5 per week) will be completed.

Group (2): (experimental group= tDCS-r + TENS-sham (s)) will include 45 patients with CTS and will receive active tDCS M1 for 20 minutes plus sham TENS for 20 minutes, and a total of 15 sessions for 3 weeks (5 per week).

Group (3): (experimental group= tDCS-s + TENS-r) will include 45 patients with CTS and will receive sham tDCS M1 for 20 minutes (the set will be turned off after 30 seconds) plus active TENS for 20 minutes, and a total of 15 sessions for 3 weeks (5 per week).

Group (4): (sham comparator = tDCS-s + TENS-s) will include 45 patients with CTS and will receive sham tDCS M1 for 20 minutes (the set will be turned off after 30 seconds) plus sham TENS for 20 minutes, and a total of 15 sessions for 3 weeks (5 per week).

The study sample will be collected from all patients with CTS fulfilling the eligibility criteria, will be eligible to join the study (either referred for electrophysiological study or presented to the clinic for primary assessment). To make sure that no bias should enter the assessment of the results, neither the patient nor the clinicians will be aware whether active tDCS/TENS will be applied to a particular case. To ensure this result, one symbol of these four symbols (square, circle, star and triangle) will be applied to one group of the four groups in the physiotherapy sheet and only the physiotherapist knew the key for each symbol. At the end of the study, the four groups will be revealed in order to analyze the results according to proper statistical measures.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tDCS-r+TENS-r

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

Group Type: ACTIVE_COMPARATOR

tDCS-r

Intervention Type: 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).

TENS-r

Intervention Type: 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)..

tDCS-r+TENS-s

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

Group Type: EXPERIMENTAL

tDCS-r

Intervention Type: 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).

TENS-s

Intervention Type: 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).

tDCS-s+TENS-r

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

Group Type: EXPERIMENTAL

TENS-r

Intervention Type: 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)..

tDCS-s

Intervention Type: 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).

tDCS-s+TENS-s

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

Group Type: SHAM_COMPARATOR

tDCS-s

Intervention Type: 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).

TENS-s

Intervention Type: 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).

Interventions

tDCS-r

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).

Intervention Type: DEVICE

TENS-r

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)..

Intervention Type: DEVICE

tDCS-s

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).

Intervention Type: DEVICE

TENS-s

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).

Intervention Type: DEVICE

Other Intervention Names

real (active) transcranial direct current stimulation; real (active) transcutaneous electrical nerve stimulation; sham transcranial direct current stimulation; sham transcutaneous electrical nerve stimulation

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hiroshima University

OTHER

Sponsor Role: collaborator

Complejo Hospitalario de Especialidades Juan Ramón Jimenez

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: collaborator

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ibrahim El-Sayed Maaty

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed I Maaty, MD

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Central Contacts

Suez Canal University

Role: CONTACT

aimaaty@hotmail.com

+20643918239

Other Identifiers

AIMAATY

Identifier Type: -

Identifier Source: org_study_id