Handgrip StrengthNCT02884427
Direct Current Cathode and Anode Effects and Changes in Handgrip Strength. Evaluation Through a Dynamometer Test
A study testing Cathode stimulation and Anode stimulation in people with Handgrip Strength, run by Quiropraxia y Equilibrio at 1 site in Chile.
Trial summary
The design aims to investigate the value of direct current, specifically the polar effects this has, and its influence on neuromuscular changes described in the literature. This research proposal seeks to assess the influence of application anode and cathode pole in muscle strength when testing handgrip dynamometry by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Handgrip Strength
- What is being tested?
- Cathode stimulation and Anode stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChile
- Study dates
- Sep 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants older than 18 years
- Do not manifest discomfort or pain when performing the handgrip.
Who cannot join
- Skeletal muscle pathologies in hand, wrist or elbow in the last 6 months.
- Materials osteosynthesis or endoprosthesis in areas of application.
- Peripheral neurological pathologies as neuropraxias or nerve sections.
- Changes in the skin of the application areas, such as burns, wounds, scars.
- Apprehension or fear of the application of electrotherapy.
- No completion of the evaluation protocol / intervention, designed for study or abandonment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ascending and Descending Direct Current on Grip Strength. Evaluation Through Dynamometry and Myofeedback. Randomized, Controlled Trial.
The design aims to investigate the value of direct current, specifically the polar effects this has, and its influence on neuromuscular changes described in the literature. This research proposal seeks to assess the influence of application anode and cathode pole in muscle strength when testing handgrip dynamometry by healthy subjects. The study will evaluate changes in muscle strength when performing a manual dynamometer test in a group exposed to the application of cathode, another exposed to the application of anode, compared with a control that will not receive the intervention will be evaluated. Subsequently the investigators proceed to compare the maximum force obtained from the dynamometry test in each of groups and between the groups .
Read the detailed description
- Methodology
This research has the characteristics of a random analytical experimental design (ECA). The study was conducted in the laboratory of physiotherapy, room 401, 4th floor, building C5 University Andres Bello (UNAB), Faculty of Rehabilitation Sciences, Campus Casona, Nº700 Street Fernández Concha, Santiago, Chile. The sample was selected from the university population that is part of the faculty. The study was submitted to the ethics committee of the East Metropolitan Health Service (SSMO) of Salvador Hospital. Once approved by the ethics committee began the investigation. It was taken as population all students of the Faculty of Rehabilitation Sciences, made up of races Physical Therapy, Speech Therapy and Occupational Therapy. The study group was determined through a simple random sampling process, which was conducted through a questionnaire with closed questions. This questionnaire allowed select participants according to the inclusion and exclusion criteria proposed in the work. The number of participants was taken for the convenience of researchers. The final sample included 150 participants. Student population share similar characteristics, so that most made them compatible for the sample. Inclusion criteria were established: participants aged 18 years and people that they should not discomfort or pain on the handgrip. Moreover Exclusion criteria were considered: muscle pathologies skeletal hand, wrist or elbow in the last 6 months, the presence of materials osteosynthesis or endoprosthesis in areas of application, peripheral neurological diseases such as neuropraxias or nervous cuts, skin disorders application areas, such as burns, wounds, scars, apprehension or fear of the application of electrotherapy, non-completion of the evaluation protocol / intervention designed for studio or away from it, and do not sign the consent for participation.
3 stages of conducting the study were designated. Stage 1 called "The Sample Phase", had a duration of one week. This Phase consisted of the implementation of the survey to students, followed by analysis of the collected information and registration for a first filter potential participants. The survey was applied to all courses of the Faculty of Rehabilitation Sciences. The first filter was given with the survey questions that has specifics questions with the inclusion and exclusion criteria. Participants who met the characteristics of participation and were invited to join the study. The students will be contacted personally. Students interested will be explained in detail the study and were asked to give their written consent. Informed consent reflected the 4 principles of bioethics so as to safeguard the integrity of each person.
The second stage of design called "Evaluation Phase" lasted 5 days. In this phase the ability to perform hand grip on the participants according to the protocol established in the investigation was assessed. The strength assessment will be probe in the same conditions in which they worked on the study. At this level, people explained everything concerning the characteristics of electrical stimulation used, and as applicable. This stage marked a second filter instance dismissing students who had discomfort or inability to perform the handgrip. After this phase had the final number of participants who made up the final sample of the study, giving way to step 3.
The stage called "Experimentation Phase" had a duration of 3 weeks. The sample was randomly so as to establish three working groups, a group called "Cathode Stimulation", another group called "Anode Stimulation" and a third group called "Control Group". The group "Cathode stimulation" includes 48 participants, while the "Anode Group" had 52 participants and the "Group Control" 50 participants.
The designation of each group participants, was conducted by the director of the study, by simple randomization process, through Microsoft Excel® program. This allowed decrease selection bias. After this process the director conduce each student to the box in which the force will be evaluated. A first evaluator (Evaluator 1) analyzed the demographic characteristics of each group, including age, body mass index (BMI), and gender, which allowed determine the characteristics per group. This would establish any comparisons at the end of work, taking the results. This information is obtained by the survey. The participants of the 3 groups were evaluated by another evaluator (Evaluator 2), who recorded the average maximum handgrip force developed by the dominant limb of the participants. Grip strength was evaluated according to the evaluation protocol proposed by manual torque test, registering kilograms (kg) of force developed by understanding. The evaluation included 3 executions leaving a rest interval of 15 seconds between each attempt (measurement protocol). The evaluator 2 recorded in an Excel spreadsheet the initial 3 attempts, leaving the best maximal force value of them as definitive. This was considered as the maximal handgrip Force value prior the intervention. After the director derived each participant according to the particulary group, Cathode, Anode or Control. The design featured participation of three therapists, one for each working group.
Therapist did not know the data obtained from the evaluation of strength, and the students that belonged the groups. Physiotherapists executors were familiar with the application of electric current. Each therapist worked using direct current with 500 COMBI GYMNA® equipment company. In the application we worked with one channel team, applying an electrode on the engine of the flexor muscles of the forearm dominant point and the other electrode closing the circuit on the side face of the opposite arm. It was taken as described by the motor point SENIAM corporation, who recommend specific motor points for the application surface electromyography. For the Cathode group the black electrode was used in the forearm muscle flexor of the dominant side for the anode group red electrode was used in the forearm muscle flexor of the dominant side, while for the control group the black electrode was used in the same musculature. The first two groups were given a current intensity of 2mA (based on the safety recommendations when applying direct current), while the control group was not applied current. With these parameters a current density of 0,04mA /cm2 was obtained. (rubber electrodes coal rectangular area 48cm2). Each therapist was masked output color channel electrode by a black tape, so that it was not known what was the black or red electrode. The treatment time for each group was 10 minutes, according to the protocol established for the investigation. This generated a dose of current 5mA/min. Participants of the three groups were installed on wooden stretchers sitting in Fowlers position maintaining a 45 ° angle. The electrode was placed on the side of the dominant limb with the device screen facing towards the foot of the participant, so the person could not display the current value set. After the application of the current, the participants left the room intervention and were led by the director to the force assessment room. In this room would register the best post maximum grip strength. The evaluator recorded three attempts, leaving the same time of 15 seconds between each. The evaluator 1 record average of the 3 values in an Excel spreadsheet. This is the value designated as post test (maximal strength post intervention).
After completing the measurements two weeks were available to sort the data and the analysis of the recorded information. This task was driven by the research director who was responsible for storing and sorting data received by the evaluators. The Microsoft Excel program was used for this process register all data. Descriptive statistics for the maximum strength was represented in the form of averages, frequencies and standard deviation. This information is also represented as graphs of boxes comparing IMC, gender and age per group. Inferential statistics was development with the Shapiro Will test to determinate a normally distributed data, then using ANOVA test or T-test. For data not normally distributed Kruskal-Wallis test was applied. The statistics was perform with de STATA program. Once the statistical analysis done within 3 weeks for the analysis of results, and approach the discussion and results are considered.
- Measurement handgrip strength protocol pre and post electrotherapy
Measuring handgrip strength will be conducted in the laboratory of physiotherapy, room 401, 4th floor, building C5 University Andres Bello (UNAB), Faculty of Rehabilitation Sciences, Campus Casona, Las Condes, Street Fernández Concha Nº700, Santiago, Chile. Initially, participants were instructed to sit in a straight chair with dimensions of 42cm high, 46 cm wide by 40 cm long, back tilt of 10 ° and dimensions of 43 cm high by 46 cm wide, the participant shall be placed with his feet flat on the floor, erect trunk in contact with the back, head and neck in a neutral position, shoulder adducted, in neutral rotation, elbow bent at 90, forearm prone neutral supination, unsupported any surface and wrist position neutra.67 for the test, a hydraulic hand dynamometer model Dynatron® which has a weight of 600g, dimensions of 26 cm long by 13 cm wide, with reading will be used dual measurement scale up to 200lbs / 90kg, also has five levels of manual adjustment, which will be set at the second level. The estimated time measuring participant is 2 minutes.
The handgrip strength was measured on 3 occasions, the break between measurements is 15 seconds, taking an estimated 54 seconds net force measurement by participant time. Participants will be instructed to position themselves correctly in the workstation and apply maximum force for 3 seconds and work at maximum effort in each test returning the marker measuring instrument 0 lbs / after each measurement kg. The evaluator register the average maximal handgrip strength between the 3 attempts. For the data registration we will use Microsoft Excel® program. The division consist in 3 categories of participants, Cathode Group, Anode Group and Control Group. The pre electrotherapy application data will be recorded immediately after the measurement of palmar force dynamometry.
- Electrotherapy Protocol
The intervention will take place in the laboratory of physiotherapy, room 401, 4th floor, building C5 University Andres Bello (UNAB), Faculty of Rehabilitation Sciences, Campus Casona, Las Condes, Street Fernández Concha Nº700, Santiago , Chile. After the initial force measurement participants will be placed in the particular station for applying electrotherapy, where each participant will be instructed to position themselves in a sitting position 45º on a stretcher fixed two bodies, with dimensions 190cm long by 70cm wide and 80cm high, each participant must support the trunk on the top of the table, inclined at 45 degrees, with both elbows, forearms and arms bare skin, well supported on the stretcher.
For the application of electrotherapy was applied with the devise Gymna® Combi 500 model, which it is characterized by having a unit of electrotherapy, ultrasound and laser.
It was also be used carbon electrodes which measurements are 7.5cm long x 6cm wide with their respective terminals, 2 driving pads 9.5 cm long by 8 cm wide and 2 fasteners with velcro for electrodes, 47cm long by 5 cm wide.
During the intervention, it proceeds to plug the equipment into an outlet 220v conventional power, then connect the electrodes in one of the two channels available on the device. Once the participant is correctly positioned in the workstation, the therapist will place correctly the electrodes, applying an electrode on the belly of the flexor muscles of the forearm (established on the recommendation of SENIAM project point), and the other electrode closing the circuit laterally on the other forearm. For the Cathode Group the black electrode is used in the flexor muscles of the dominant hand, for the Anode Group red electrode is used in the flexor muscles of the dominant hand, while the Control Group the black electrode will be used in the same muscles, procedure will be repeated for the 3 groups of participants, once completed this procedure. The Therapist applied to the first two groups a current of 2mA, thereby determining a density 0,04mA current /cm2 considering a size of 48cm2 electrode, while the control group will not be applied any intensity keeping the power on but without emission. For the 3 groups of participants application time is 10 electrotherapy minutes.
- Conditions
- Handgrip Strength
- Being tested
- Cathode stimulation, Anode stimulation, Placebo
- Keywords
- Direct current, Dynamometry, Hand strength, Electrotherapy, Transcutaneous Electric Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathode stimulationDevice
Also called Cathode Polar effect
Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.
Anode stimulationDevice
Also called Anode Polar effect
Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.
PlaceboDevice
Also called Non intervention
Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.
| Study group | Role | What they receive |
|---|---|---|
| Cathode Stimulation | Experimental | Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application. Receives: Device: Cathode stimulation |
| Anode Stimulation | Experimental | Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application. Receives: Device: Anode stimulation |
| Control | Placebo comparator | Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Maximum Grip Strength
The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
Measured: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Secondary outcomes (2)
Difference of Maximum Grip Strength for Males
The difference in maximum grip strength for males is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the men of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
Measured: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Difference of Maximum Grip Strength for Females
The difference in maximum grip strength for females is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the women of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
Measured: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Handgrip StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quiropraxia y Equilibrio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hernán Andrés HB de la Barra Ortiz, Mg., Principal investigator, University Teacher and Physical therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884427
- Sponsor's protocol ID
- 60312061
- Status last verified
- Sep 2018
- First submitted
- 15 Aug 2016
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Michelle H. Cameron, Physical Agents in Rehabilitations 2003, Elsevier. Cap. VIII, P, 220.
Currier DP, Mann R. Muscular strength development by electrical stimulation in healthy individuals. Phys Ther. 1983 Jun;63(6):915-21. doi: 10.1093/ptj/63.6.915.
PubMed 6856678Thurin E, Meehan PF, Gilbert BS. Treatment of pain by transcutaneous electric nerve stimulation in general practice. Med J Aust. 1980 Jan 26;1(2):70-1. doi: 10.5694/j.1326-5377.1980.tb134629.x.
PubMed 6965758Rodríguez Martin JM, Corrientes más utilizadas en la Electroterapia en Fisioterapia. Editorial Medica Panamericana, Cap II, P. 61- 86, 2000.
Glass JM, Stephen RL, Jacobson SC. The quantity and distribution of radiolabeled dexamethasone delivered to tissue by iontophoresis. Int J Dermatol. 1980 Nov;19(9):519-25. doi: 10.1111/j.1365-4362.1980.tb00380.x.
PubMed 7429701Conjeevaram R, Banga AK, Zhang L. Electrically modulated transdermal delivery of fentanyl. Pharm Res. 2002 Apr;19(4):440-4. doi: 10.1023/a:1015135426838.
PubMed 12033377Petelenz TJ, Buttke C, Bonds LB, Lloyd JE, Beck RL, Stephens SC. Iontophoresis of dexamethasone: laboratory studies. J Controll Rel 1992;20:55-66.
Fujita M, Hukuda S, Doida Y. The effect of constant direct electrical current on intrinsic healing in the flexor tendon in vitro. An ultrastructural study of differing attitudes in epitenon cells and tenocytes. J Hand Surg Br. 1992 Feb;17(1):94-8. doi: 10.1016/0266-7681(92)90021-s.
PubMed 1640154Raiman J, Koljonen M, Huikko K, Kostiainen R, Hirvonen J. Delivery and stability of LHRH and Nafarelin in human skin: the effect of constant/pulsed iontophoresis. Eur J Pharm Sci. 2004 Feb;21(2-3):371-7. doi: 10.1016/j.ejps.2003.11.003.
PubMed 14757511Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):619-58. doi: 10.1016/j.addr.2003.10.026.
PubMed 15019750Panus PC, Ferslew KE, Tober-Meyer B, Kao RL. Ketoprofen tissue permeation in swine following cathodic iontophoresis. Phys Ther. 1999 Jan;79(1):40-9.
PubMed 9920190Meijinde Faide R. Rodriguez .Villamil Fernandez JLy Teiro Vidal J. Corrientes Galvanicas En. Martinez Morillo M, Pastor Vega, y Sandra Portero F. Manual de Medicina Fisica Harcourt Brace España 1998 P150-68.
Kvandal P, Stefanovska A, Veber M, Kvernmo HD, Kirkeboen KA. Regulation of human cutaneous circulation evaluated by laser Doppler flowmetry, iontophoresis, and spectral analysis: importance of nitric oxide and prostaglandines. Microvasc Res. 2003 May;65(3):160-71. doi: 10.1016/s0026-2862(03)00006-2.
PubMed 12711257Guy RH, Delgado-Charro MB, Kalia YN. Iontophoretic transport across the skin. Skin Pharmacol Appl Skin Physiol. 2001;14 Suppl 1:35-40. doi: 10.1159/000056388.
PubMed 11509905Calvo Arenilla JI, Rubio López I. Iontoforesis. Aplicaciones de la Iontoforesis. Electroestimulaciónaplicada. En: Meaños Melón E, Alonso Martínez M, Murga Rodríguez F, Pinsach Ametller J, et al. Vigo: Obradoiro Gráfico; 2003. p. 157-172.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ascending and Descending Direct Current on Grip Strength. Evaluation Through Dynamometry and Myofeedback. Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02884427
- Acronym / sponsor ID
- 60312061
- Conditions
- Handgrip Strength
- Keywords
- Direct current, Dynamometry, Hand strength, Electrotherapy, Transcutaneous Electric Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Quiropraxia y EquilibrioUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The design aims to investigate the value of direct current, specifically the polar effects this has, and its influence on neuromuscular changes described in the literature. This research proposal seeks to assess the influence of application anode and cathode pole in muscle strength when testing handgrip dynamometry by healthy subjects. The study will evaluate changes in muscle strength when performing a manual dynamometer test in a group exposed to the application of cathode, another exposed to the application of anode, compared with a control that will not receive the intervention will be evaluated. Subsequently the investigators proceed to compare the maximum force obtained from the dynamometry test in each of groups and between the groups .
Detailed description
- Methodology
This research has the characteristics of a random analytical experimental design (ECA). The study was conducted in the laboratory of physiotherapy, room 401, 4th floor, building C5 University Andres Bello (UNAB), Faculty of Rehabilitation Sciences, Campus Casona, Nº700 Street Fernández Concha, Santiago, Chile. The sample was selected from the university population that is part of the faculty. The study was submitted to the ethics committee of the East Metropolitan Health Service (SSMO) of Salvador Hospital. Once approved by the ethics committee began the investigation. It was taken as population all students of the Faculty of Rehabilitation Sciences, made up of races Physical Therapy, Speech Therapy and Occupational Therapy. The study group was determined through a simple random sampling process, which was conducted through a questionnaire with closed questions. This questionnaire allowed select participants according to the inclusion and exclusion criteria proposed in the work. The number of participants was taken for the convenience of researchers. The final sample included 150 participants. Student population share similar characteristics, so that most made them compatible for the sample. Inclusion criteria were established: participants aged 18 years and people that they should not discomfort or pain on the handgrip. Moreover Exclusion criteria were considered: muscle pathologies skeletal hand, wrist or elbow in the last 6 months, the presence of materials osteosynthesis or endoprosthesis in areas of application, peripheral neurological diseases such as neuropraxias or nervous cuts, skin disorders application areas, such as burns, wounds, scars, apprehension or fear of the application of electrotherapy, non-completion of the evaluation protocol / intervention designed for studio or away from it, and do not sign the consent for participation.
3 stages of conducting the study were designated. Stage 1 called "The Sample Phase", had a duration of one week. This Phase consisted of the implementation of the survey to students, followed by analysis of the collected information and registration for a first filter potential participants. The survey was applied to all courses of the Faculty of Rehabilitation Sciences. The first filter was given with the survey questions that has specifics questions with the inclusion and exclusion criteria. Participants who met the characteristics of participation and were invited to join the study. The students will be contacted personally. Students interested will be explained in detail the study and were asked to give their written consent. Informed consent reflected the 4 principles of bioethics so as to safeguard the integrity of each person.
The second stage of design called "Evaluation Phase" lasted 5 days. In this phase the ability to perform hand grip on the participants according to the protocol established in the investigation was assessed. The strength assessment will be probe in the same conditions in which they worked on the study. At this level, people explained everything concerning the characteristics of electrical stimulation used, and as applicable. This stage marked a second filter instance dismissing students who had discomfort or inability to perform the handgrip. After this phase had the final number of participants who made up the final sample of the study, giving way to step 3.
The stage called "Experimentation Phase" had a duration of 3 weeks. The sample was randomly so as to establish three working groups, a group called "Cathode Stimulation", another group called "Anode Stimulation" and a third group called "Control Group". The group "Cathode stimulation" includes 48 participants, while the "Anode Group" had 52 participants and the "Group Control" 50 participants.
The designation of each group participants, was conducted by the director of the study, by simple randomization process, through Microsoft Excel® program. This allowed decrease selection bias. After this process the director conduce each student to the box in which the force will be evaluated. A first evaluator (Evaluator 1) analyzed the demographic characteristics of each group, including age, body mass index (BMI), and gender, which allowed determine the characteristics per group. This would establish any comparisons at the end of work, taking the results. This information is obtained by the survey. The participants of the 3 groups were evaluated by another evaluator (Evaluator 2), who recorded the average maximum handgrip force developed by the dominant limb of the participants. Grip strength was evaluated according to the evaluation protocol proposed by manual torque test, registering kilograms (kg) of force developed by understanding. The evaluation included 3 executions leaving a rest interval of 15 seconds between each attempt (measurement protocol). The evaluator 2 recorded in an Excel spreadsheet the initial 3 attempts, leaving the best maximal force value of them as definitive. This was considered as the maximal handgrip Force value prior the intervention. After the director derived each participant according to the particulary group, Cathode, Anode or Control. The design featured participation of three therapists, one for each working group.
Therapist did not know the data obtained from the evaluation of strength, and the students that belonged the groups. Physiotherapists executors were familiar with the application of electric current. Each therapist worked using direct current with 500 COMBI GYMNA® equipment company. In the application we worked with one channel team, applying an electrode on the engine of the flexor muscles of the forearm dominant point and the other electrode closing the circuit on the side face of the opposite arm. It was taken as described by the motor point SENIAM corporation, who recommend specific motor points for the application surface electromyography. For the Cathode group the black electrode was used in the forearm muscle flexor of the dominant side for the anode group red electrode was used in the forearm muscle flexor of the dominant side, while for the control group the black electrode was used in the same musculature. The first two groups were given a current intensity of 2mA (based on the safety recommendations when applying direct current), while the control group was not applied current. With these parameters a current density of 0,04mA /cm2 was obtained. (rubber electrodes coal rectangular area 48cm2). Each therapist was masked output color channel electrode by a black tape, so that it was not known what was the black or red electrode. The treatment time for each group was 10 minutes, according to the protocol established for the investigation. This generated a dose of current 5mA/min. Participants of the three groups were installed on wooden stretchers sitting in Fowlers position maintaining a 45 ° angle. The electrode was placed on the side of the dominant limb with the device screen facing towards the foot of the participant, so the person could not display the current value set. After the application of the current, the participants left the room intervention and were led by the director to the force assessment room. In this room would register the best post maximum grip strength. The evaluator recorded three attempts, leaving the same time of 15 seconds between each. The evaluator 1 record average of the 3 values in an Excel spreadsheet. This is the value designated as post test (maximal strength post intervention).
After completing the measurements two weeks were available to sort the data and the analysis of the recorded information. This task was driven by the research director who was responsible for storing and sorting data received by the evaluators. The Microsoft Excel program was used for this process register all data. Descriptive statistics for the maximum strength was represented in the form of averages, frequencies and standard deviation. This information is also represented as graphs of boxes comparing IMC, gender and age per group. Inferential statistics was development with the Shapiro Will test to determinate a normally distributed data, then using ANOVA test or T-test. For data not normally distributed Kruskal-Wallis test was applied. The statistics was perform with de STATA program. Once the statistical analysis done within 3 weeks for the analysis of results, and approach the discussion and results are considered.
- Measurement handgrip strength protocol pre and post electrotherapy
Measuring handgrip strength will be conducted in the laboratory of physiotherapy, room 401, 4th floor, building C5 University Andres Bello (UNAB), Faculty of Rehabilitation Sciences, Campus Casona, Las Condes, Street Fernández Concha Nº700, Santiago, Chile. Initially, participants were instructed to sit in a straight chair with dimensions of 42cm high, 46 cm wide by 40 cm long, back tilt of 10 ° and dimensions of 43 cm high by 46 cm wide, the participant shall be placed with his feet flat on the floor, erect trunk in contact with the back, head and neck in a neutral position, shoulder adducted, in neutral rotation, elbow bent at 90, forearm prone neutral supination, unsupported any surface and wrist position neutra.67 for the test, a hydraulic hand dynamometer model Dynatron® which has a weight of 600g, dimensions of 26 cm long by 13 cm wide, with reading will be used dual measurement scale up to 200lbs / 90kg, also has five levels of manual adjustment, which will be set at the second level. The estimated time measuring participant is 2 minutes.
The handgrip strength was measured on 3 occasions, the break between measurements is 15 seconds, taking an estimated 54 seconds net force measurement by participant time. Participants will be instructed to position themselves correctly in the workstation and apply maximum force for 3 seconds and work at maximum effort in each test returning the marker measuring instrument 0 lbs / after each measurement kg. The evaluator register the average maximal handgrip strength between the 3 attempts. For the data registration we will use Microsoft Excel® program. The division consist in 3 categories of participants, Cathode Group, Anode Group and Control Group. The pre electrotherapy application data will be recorded immediately after the measurement of palmar force dynamometry.
- Electrotherapy Protocol
The intervention will take place in the laboratory of physiotherapy, room 401, 4th floor, building C5 University Andres Bello (UNAB), Faculty of Rehabilitation Sciences, Campus Casona, Las Condes, Street Fernández Concha Nº700, Santiago , Chile. After the initial force measurement participants will be placed in the particular station for applying electrotherapy, where each participant will be instructed to position themselves in a sitting position 45º on a stretcher fixed two bodies, with dimensions 190cm long by 70cm wide and 80cm high, each participant must support the trunk on the top of the table, inclined at 45 degrees, with both elbows, forearms and arms bare skin, well supported on the stretcher.
For the application of electrotherapy was applied with the devise Gymna® Combi 500 model, which it is characterized by having a unit of electrotherapy, ultrasound and laser.
It was also be used carbon electrodes which measurements are 7.5cm long x 6cm wide with their respective terminals, 2 driving pads 9.5 cm long by 8 cm wide and 2 fasteners with velcro for electrodes, 47cm long by 5 cm wide.
During the intervention, it proceeds to plug the equipment into an outlet 220v conventional power, then connect the electrodes in one of the two channels available on the device. Once the participant is correctly positioned in the workstation, the therapist will place correctly the electrodes, applying an electrode on the belly of the flexor muscles of the forearm (established on the recommendation of SENIAM project point), and the other electrode closing the circuit laterally on the other forearm. For the Cathode Group the black electrode is used in the flexor muscles of the dominant hand, for the Anode Group red electrode is used in the flexor muscles of the dominant hand, while the Control Group the black electrode will be used in the same muscles, procedure will be repeated for the 3 groups of participants, once completed this procedure. The Therapist applied to the first two groups a current of 2mA, thereby determining a density 0,04mA current /cm2 considering a size of 48cm2 electrode, while the control group will not be applied any intensity keeping the power on but without emission. For the 3 groups of participants application time is 10 electrotherapy minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cathode Stimulation | Experimental | Device: Cathode stimulationGroup that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application. |
| Anode Stimulation | Experimental | Device: Anode stimulationGroup that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application. |
| Control | Placebo comparator | Device: PlaceboGroup that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants older than 18 years
- Do not manifest discomfort or pain when performing the handgrip.
Key exclusion criteria (6 listed)
- Skeletal muscle pathologies in hand, wrist or elbow in the last 6 months.
- Materials osteosynthesis or endoprosthesis in areas of application.
- Peripheral neurological pathologies as neuropraxias or nerve sections.
- Changes in the skin of the application areas, such as burns, wounds, scars.
- Apprehension or fear of the application of electrotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cathode stimulationAlso: Cathode Polar effectElectrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current. | Device | Cathode Stimulation |
| Anode stimulationAlso: Anode Polar effectElectrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current. | Device | Anode Stimulation |
| PlaceboAlso: Non interventionCurrent application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working. | Device | Control |
Primary outcome
Difference of Maximum Grip Strength
Time frame: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
2 secondary outcomes
Difference of Maximum Grip Strength for Males
Time frame: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Difference of Maximum Grip Strength for Females
Time frame: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMichelle H. Cameron, Physical Agents in Rehabilitations 2003, Elsevier. Cap. VIII, P, 220.
- Background: PubMed 6856678Currier DP, Mann R. Muscular strength development by electrical stimulation in healthy individuals. Phys Ther. 1983 Jun;63(6):915-21. doi: 10.1093/ptj/63.6.915.
- Background: PubMed 6965758Thurin E, Meehan PF, Gilbert BS. Treatment of pain by transcutaneous electric nerve stimulation in general practice. Med J Aust. 1980 Jan 26;1(2):70-1. doi: 10.5694/j.1326-5377.1980.tb134629.x.
- BackgroundRodríguez Martin JM, Corrientes más utilizadas en la Electroterapia en Fisioterapia. Editorial Medica Panamericana, Cap II, P. 61- 86, 2000.
- Background: PubMed 7429701Glass JM, Stephen RL, Jacobson SC. The quantity and distribution of radiolabeled dexamethasone delivered to tissue by iontophoresis. Int J Dermatol. 1980 Nov;19(9):519-25. doi: 10.1111/j.1365-4362.1980.tb00380.x.
- Background: PubMed 12033377Conjeevaram R, Banga AK, Zhang L. Electrically modulated transdermal delivery of fentanyl. Pharm Res. 2002 Apr;19(4):440-4. doi: 10.1023/a:1015135426838.
- BackgroundPetelenz TJ, Buttke C, Bonds LB, Lloyd JE, Beck RL, Stephens SC. Iontophoresis of dexamethasone: laboratory studies. J Controll Rel 1992;20:55-66.
- Background: PubMed 1640154Fujita M, Hukuda S, Doida Y. The effect of constant direct electrical current on intrinsic healing in the flexor tendon in vitro. An ultrastructural study of differing attitudes in epitenon cells and tenocytes. J Hand Surg Br. 1992 Feb;17(1):94-8. doi: 10.1016/0266-7681(92)90021-s.
- Background: PubMed 14757511Raiman J, Koljonen M, Huikko K, Kostiainen R, Hirvonen J. Delivery and stability of LHRH and Nafarelin in human skin: the effect of constant/pulsed iontophoresis. Eur J Pharm Sci. 2004 Feb;21(2-3):371-7. doi: 10.1016/j.ejps.2003.11.003.
- Background: PubMed 15019750Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):619-58. doi: 10.1016/j.addr.2003.10.026.
- Background: PubMed 9920190Panus PC, Ferslew KE, Tober-Meyer B, Kao RL. Ketoprofen tissue permeation in swine following cathodic iontophoresis. Phys Ther. 1999 Jan;79(1):40-9.
- BackgroundMeijinde Faide R. Rodriguez .Villamil Fernandez JLy Teiro Vidal J. Corrientes Galvanicas En. Martinez Morillo M, Pastor Vega, y Sandra Portero F. Manual de Medicina Fisica Harcourt Brace España 1998 P150-68.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hernán Andrés HB de la Barra Ortiz, Mg. principal investigator
University Teacher and Physical therapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cathode stimulation and Anode stimulation in people with Handgrip Strength, run by Quiropraxia y Equilibrio at 1 site in Chile.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Maximum Grip Strength (time frame: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02884427, which also lists 17 linked publications.
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 9 Oct 2018.