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Carpal Tunnel SyndromeDCS-ENS-CTSNCT04092088

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

A study testing tDCS-r, TENS-r and tDCS-s in people with Carpal Tunnel Syndrome, run by Suez Canal University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
tDCS-r, TENS-r and tDCS-s
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
No sites listed yet
Study dates
Dec 2019to Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Suez Canal University contact

+20643918239

aimaaty@hotmail.com

About this study

Official title: Effectiveness of Cerebral and Peripheral Electrical Stimulation on Pain and Functional Limitations Associated With Carpal Tunnel Syndrome: A Randomized, Double-blind, Multi-center, Factorial Clinical Trial

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.

Read the 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.

Being tested
tDCS-r, TENS-r, tDCS-s, TENS-s
Keywords
Transcranial Direct Current Stimulation (tDCS), Transcutaneous Electrical Nerve Stimulation (TENS), analgesic effect, functional disability
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCS-rDevice

    Also called real (active) transcranial direct current stimulation

    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-rDevice

    Also called real (active) transcutaneous electrical nerve stimulation

    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-sDevice

    Also called sham transcranial direct current stimulation

    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-sDevice

    Also called sham transcutaneous electrical nerve stimulation

    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).

Study groups in NCT04092088
Study groupRoleWhat they receive
tDCS-r+TENS-rActive comparatorReal transcranial direct current stimulation (tDCS-r) + real transcutaneous electrical nerve stimulation (TENS-r)
Receives: Device: tDCS-r; Device: TENS-r
tDCS-r+TENS-sExperimentalReal transcranial direct current stimulation (tDCS-r) + sham transcutaneous electrical nerve stimulation (TENS-s)
Receives: Device: tDCS-r; Device: TENS-s
tDCS-s+TENS-rExperimentalSham transcranial direct current stimulation (tDCS-s) + real transcutaneous electrical nerve stimulation (TENS-r)
Receives: Device: TENS-r; Device: tDCS-s
tDCS-s+TENS-sSham comparatorSham transcranial direct current stimulation (tDCS-s) + sham transcutaneous electrical nerve stimulation (TENS-s)
Receives: Device: tDCS-s; Device: TENS-s

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline

  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.

    Measured: After 3 weeks

Secondary outcomes (19)
  1. Beck Depression Inventory (BDI)

    To assess depressive symptoms by using the 21-item The cut-off point for depression is set at 9/10 (normal mood, scores 0-9 vs. elevated depressions symptoms, scores 10 or more).

    Measured: At baseline

  2. Beck Depression Inventory (BDI)

    To assess depressive symptoms by using the 21-item The cut-off point for depression is set at 9/10 (normal mood, scores 0-9 vs. elevated depressions symptoms, scores 10 or more).

    Measured: After 3 weeks

  3. The Douleur Neuropathique 4 questions (DN4)

    A simple and objective tool, primarily designed to screen for neuropathic pain, differentiating between neuropathic and nociceptive pain conditions in clinical practice and research studies. In total, it contains 10 questions with a binary answer (no/yes). The total score, ranging from 0 to 10, is obtained by adding the number of affirmative answers, a total score > 4 out of 10 suggests neuropathic pain.

    Measured: At baseline

  4. The Douleur Neuropathique 4 questions (DN4)

    A simple and objective tool, primarily designed to screen for neuropathic pain, differentiating between neuropathic and nociceptive pain conditions in clinical practice and research studies. In total, it contains 10 questions with a binary answer (no/yes). The total score, ranging from 0 to 10, is obtained by adding the number of affirmative answers, a total score > 4 out of 10 suggests neuropathic pain.

    Measured: After 3 weeks

  5. Quantitative sensory testing (QST)

    The Semmes-Weinstein Monofilament test kit will be used to evaluate sensory thresholds of the tips of the thumb, the index, and the middle fingers. The kit consists of 20 flexible nylon monofilaments of varying diameter and length to measure the level of skin touch sensation. The monofilaments have log numbers from 1.65 to 6.65 which begins with the light filaments (1.65-3.61) and progresses to heavy filaments of increasing diameter (3.84-6.65). Heavy filaments need increased pressure for touch to be recognized by patients. The tester applies each monofilament to the surface area of the skin with a perpendicular angle, then applies slight and steady pressure until the monofilament begins to bend, which is the end point of the test. The monofilament number 2.83 was defined as cut-off for normal sensation.

    Measured: At baseline

  6. Quantitative sensory testing (QST)

    The Semmes-Weinstein Monofilament test kit will be used to evaluate sensory thresholds of the tips of the thumb, the index, and the middle fingers. The kit consists of 20 flexible nylon monofilaments of varying diameter and length to measure the level of skin touch sensation. The monofilaments have log numbers from 1.65 to 6.65 which begins with the light filaments (1.65-3.61) and progresses to heavy filaments of increasing diameter (3.84-6.65). Heavy filaments need increased pressure for touch to be recognized by patients. The tester applies each monofilament to the surface area of the skin with a perpendicular angle, then applies slight and steady pressure until the monofilament begins to bend, which is the end point of the test. The monofilament number 2.83 was defined as cut-off for normal sensation.

    Measured: After 3 weeks

  7. Pain Pressure Test (PPT) with algometer

    Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain. An electronic algometer will be used to measure PPT levels. The algometer consists of a 1 cm2 rubber-tipped plunger mounted on a force transducer. The pressure is applied approximately at a rate of 30 kPa/s, with the algometer placed perpendicular to the application point. Participants will be instructed to press switch when the sensation changed from pressure to pain. The mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 s resting period will be allowed between each measure.

    Measured: At baseline

  8. Pain Pressure Test (PPT) with algometer

    Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain. An electronic algometer will be used to measure PPT levels. The algometer consists of a 1 cm2 rubber-tipped plunger mounted on a force transducer. The pressure is applied approximately at a rate of 30 kPa/s, with the algometer placed perpendicular to the application point. Participants will be instructed to press switch when the sensation changed from pressure to pain. The mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 s resting period will be allowed between each measure.

    Measured: After 3 weeks

  9. Conditioned pain modulation (CPM)

    A CPM paradigm with the cold pressor test will be was used. Participants will submerge one foot into an insulated container filled with cold water with the medial malleolus ~3 cm below the water line. The foot contralateral to the affected hand (or most affected hand in case of bilateral CTS) will be submerged. Participants will rate the cold-induced foot pain on a numric pain rating scale (NPRS), ranging from 0 (no pain) to 10 (worst pain imaginable). Immediately after maintaining the NPRS within the target score for 30 seconds, the test stimulus will be given. Pressure pain threshold (PPT) testing will be applied as a test stimulus. PPTs will be measured with a digital algometer. The participants will press a button as soon as the sensation of pressure changed to pain. PPT measurements will be taken on the thenar and hypothenar eminence of both hands, before cold water immersion and during cold water immersion.

    Measured: At baseline

  10. Conditioned pain modulation (CPM)

    A CPM paradigm with the cold pressor test will be was used. Participants will submerge one foot into an insulated container filled with cold water with the medial malleolus ~3 cm below the water line. The foot contralateral to the affected hand (or most affected hand in case of bilateral CTS) will be submerged. Participants will rate the cold-induced foot pain on a numric pain rating scale (NPRS), ranging from 0 (no pain) to 10 (worst pain imaginable). Immediately after maintaining the NPRS within the target score for 30 seconds, the test stimulus will be given. Pressure pain threshold (PPT) testing will be applied as a test stimulus. PPTs will be measured with a digital algometer. The participants will press a button as soon as the sensation of pressure changed to pain. PPT measurements will be taken on the thenar and hypothenar eminence of both hands, before cold water immersion and during cold water immersion.

    Measured: After 3 weeks

  11. Patient ratings of improvement, or worsening, of the pain condition

    Patient's Clinical Global Impression of Change scale, subjects select one of seven options describing response to treatment, ranging from 1-7 where 1 indicates "very much improved" and 7 indicates "very much worse.".

    Measured: At baseline

  12. Patient ratings of improvement, or worsening, of the pain condition

    Patient's Clinical Global Impression of Change scale, subjects select one of seven options describing response to treatment, ranging from 1-7 where 1 indicates "very much improved" and 7 indicates "very much worse.".

    Measured: After 3 weeks

  13. Quality of Life short-form-36

    To assess quality of Life, it consists of 36 items divided into eight domains range from reflecting predominantly physical well-being, that include physical function, the ability to perform expected physical roles, the degree of bodily pain and overall sense of general health to those reflecting predominantly social and emotional well-being that include overall sense of vitality, ability to function in social roles, ability to perform expected emotional and social roles and overall sense of mental health. Each item has 5 response choices, a high score (response choice 5) and a low score (response choice 1).

    Measured: At baseline

  14. Quality of Life short-form-36

    To assess quality of Life, it consists of 36 items divided into eight domains range from reflecting predominantly physical well-being, that include physical function, the ability to perform expected physical roles, the degree of bodily pain and overall sense of general health to those reflecting predominantly social and emotional well-being that include overall sense of vitality, ability to function in social roles, ability to perform expected emotional and social roles and overall sense of mental health. Each item has 5 response choices, a high score (response choice 5) and a low score (response choice 1).

    Measured: After 3 weeks

  15. Visual Analog Mood Scale

    A self-assessment scale in which subjects rate their own emotions, including anxiety, depression, stress, and sleepiness along a 100 mm line.

    Measured: At baseline

  16. Visual Analog Mood Scale

    A self-assessment scale in which subjects rate their own emotions, including anxiety, depression, stress, and sleepiness along a 100 mm line.

    Measured: After 3 weeks

  17. Mini Mental Status Exam

    Cognition will be analyzed using Mini-Mental Status Examination, a brief screening of cognitive abilities.

    Measured: At baseline

  18. Mini Mental Status Exam

    Cognition will be analyzed using Mini-Mental Status Examination, a brief screening of cognitive abilities.

    Measured: After 3 weeks

  19. Adverse Events Questionnaire

    At each stimulation session and all follow-ups, participants will be administered a questionnaire to evaluate the potential adverse effects of stimulation on a 5-point scale from 0-4 (0 indicates no adverse events and 4 indicates extreme adverse effects. The main potential adverse effects include headache, neck and scalp pain, tingling, sleepiness, and acute mood change.

    Measured: After 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study startDec 2019 (estimated)
  3. Primary completionAug 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
randomized, triple-blind, multi-center, factorial clinical trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04092088
Sponsor's protocol ID
AIMAATY
Acronym
DCS-ENS-CTS
Status last verified
Sep 2019
First submitted
13 Jul 2019
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Informed consent, data management and statistical analysis will shared, if requested, through the investigator e-mail.

Questions about this trial

What is this clinical trial studying?

A study testing tDCS-r, TENS-r and tDCS-s in people with Carpal Tunnel Syndrome, run by Suez Canal University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suez Canal University (+20643918239, aimaaty@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory (BPI) (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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