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Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Migraine

Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Migraine: Randomized Clinical Trial Placebo-Controlled - TENS: Transcutaneous Electric Nerve Stimulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6hmh7w
Enrollment
Unknown
Registered
2020-01-28
Start date
2019-09-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine disorders, Headache

Interventions

Thirty subjects are randomized into two study groups and submitted to 10 sessions of transcutaneous electrical nerve stimulation (TENS). TENS is applied to the upper trapezius region bilaterally using
Device
E02.331.800

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Lead Sponsor
Universidade Federal de Sergipe
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with chronic aura and non-aura migraine headache, with pain intensity equal to or greater than 4 on the numerical pain scale, both sexes and aged 18 to 59 years.

Exclusion criteria

Exclusion criteria: Other dysfunctions with headache symptoms, history of head and neck trauma, cardiac pacemaker use, and have already used TENS. Also, if they are undergoing another type of physical therapy treatment or are starting a new medicine treatment.

Design outcomes

Primary

MeasureTime frame
Frequency of migraine attacks - measured by Migraine Disability Assessment (MIDAS) questionnaire. The subjects answer five questions, marking the number of days from the last three months in which their activities were limited due to headaches. After being answered, a sum of the values attributed by the subject to each question is made. The severity of the dysfunction is classified as: absent (0 - 5 points), mild (6 - 10 points), moderate (11 – 20 points) and severe (>21 points).;Pressure pain threshold (PPT) - assessed using a digital pressure algometer. With the patient lying down, the muscular bellies of the temporal, sternocleidomastoid, upper trapezius, frontal and masseter muscles are being bilaterally evaluated. In procedure, algometer must be positioned perpendicular to point to be examined, and a constant and increasing pressure is exerted until pain is accused. Three measurements are made at each pre-established site before and after treatment and the mean between them are considered.;Temporal Summation - measured using a digital pressure algometer, where a pressure of 2.5 kg is applied to anterior face of the patient's right forearm. This test is performed in a continuous sequence of 30 seconds, in which four measurements are made at the 1st, 10th, 20th and 30th seconds, and pain intensity values are recorded at each of these moments, using 11-points numerical scale.;Conditioned Pain Modulation - measured by PPT assessment using digital pressure algometer, positioned on the anterior face of the right forearm. Then, an ischemic compression is performed on the left arm of individual by means of a sphingmomanometer. A pressure of 270mmHg is maintained and PPT is measured again on the right forearm and then compression is removed. Five minutes after the end of procedure, the PPT is measured again.;Pain intensity - measured by 11-point numerical scale. Patients are asked to indicate a number, from 0 to 10 that represents the intensity of pain experienced, wit

Secondary

MeasureTime frame
Kinesiophobia - measured by Tampa Kinesiophobia Scale. It has a total of 17 items; each with scores ranging from 1 to 4. In the end, minimum score obtained can be 17 points and maximum score 68 points, and the higher score, greater the fear of moving due to pain.;Catastrophizing pain - measured by Pain Catastrophizing Scale. The questionnaire has thirteen items that deal with thoughts and feelings experienced when individual is in pain. The total score is fifty-two points, where a score above twenty-four indicates a high score.;Cervical Disability - measured by Neck Disability Index (NDI). It consists of ten items, and each alternative describes increasing degrees of interference from neck pain in performing activities. The final score is obtained by the sum of points of the items answered by subjects, which can total a maximum of 50 points. Severity of disability is classified as mild (5 - 14 points), moderate (15 - 24 points), severe (25 - 34 points) and completely disabling (? 35 points).;Cervical range of motion - measured using a fleximeter whose scale is in degrees. Flexion, extension, right and left lateralization and right and left rotation movements are evaluated. For each movement, three repetitions are performed from which average is obtained.;Quality of life - measured by Medical Outcomes Study 36 Questionnaire - Short Form Health Survey (SF-36). This instrument consists of 36 items grouped into eight domains: functional capacity, physical aspects, pain, vitality, emotional and social aspects, mental health and general health. The final score ranges from zero to one hundred, which represents the worst state of health and the best state of health, respectively.;Anxiety and depression symptoms - measured by Hospital Anxiety and Depression Scale (HAD). It has 14 items, seven of which are for anxiety assessment (HAD-A) and seven for depression (HAD-D). Each item can score from 0 to 3 points, totaling 21 points, for each scale. The anxiety scale is assigned v

Countries

Brazil

Contacts

Public ContactJosimari;Thaís De Santana;Pereira

Universidade Federal de Sergipe;Universidade Federal de Sergipe

desantanajm@gmail.com;thais_pra@hotmail.com+55(79)999946944;79998439512

Outcome results

None listed

Source: REBEC (via WHO ICTRP)