Primary DysmenorrheaNCT02114723
Effectiveness of Medical Taping Concept in Primary Dysmenorrhea
A study testing Medical Taping Concept in people with Primary Dysmenorrhea, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Medical Taping Concept
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Sep 2014
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom.
- Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
- Not have been diagnosed with secondary dysmenorrhea
- Regular menstrual cycles (cycle typical range of 21 to 35 days)
- Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
- Nulliparous
Who cannot join
- Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
- Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);
- Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
- Women who suffer from diseases diagnosed added
- Women to which it has undergone a surgical procedure for the treatment
- Provide skin lesions in the abdominal wall
- Use or abuse of drugs or alcohol
- Body mass index (BMI) between> 15.99 kg/m2 (maximum value of underweight according to WHO) and <25.00 kg m2 (maximum overweight according to WHO)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad Miguel Hernández de Elche
Sant Joan d'Alacant, Alicante, 03550
About this study
Official title: Assessment of Mediacal Taping Concept Self-applied, in the Treatment of Primary Dysmenorrhea
Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea.
Read the detailed description
The aim of this study is to assess the analgesic efficacy of self-applied Medical Taping Concept in the treatment of primary dysmenorrhea .
To evaluate this effect, a total of 128 students from the University Miguel Hernández , with the following inclusion criteria, participated in this study: history of menstrual pain, aged between 18 and 39 years who have performed a gynecological check in the last 18 months and who have been diagnosed with any kind of primary dysmenorrhea.
A preliminary survey to identify valid students was made. Thereafter the participants were separated into two different groups (intervention group and placebo group) in order to request the completion of three questionnaires about the characteristics of menstrual pain and other demographic data for the next two menstrual cycles before the intervention. One survey included a graphic scale so the students could mark the start and the end of the symptoms associated with the menstrual cycle.
After that the principal researcher will interviewed with the participants to show them the correct auto-application of the menstrual bandage and placebo. Each students group will receive a triptych with information and pictures to the correct application of the adhesive strips.
Finally, during two new menstrual cycles, the participants will answer the same questionnaires to assess symptoms and menstrual pain while being worn adhesive strips (3 pieces of Kinesio tape - 20 cm x 5 cm Tape Cure ®-, applied to the abdominal and lower back, in the intervention group; 2 pieces of Cross Tape ® 2.5 cm x 2 cm -, in the hip joint, in the placebo group. Participants may do personal hygiene during the days of the menstrual cycle with their adhesives strips placed on oneself.
The size sample will be 128 girls. Differences will be contrasted in comparison of means (quantitative improvement, with an ANOVA) to evaluate the intervention. 18 girls were randomly chosen to obtain an estimation of the contrast parameters considered (means and standard variations). With this size sample and a significance of 5%, the investigators will have a power for the total sample for the contrasts of 80%.
To describe the variables, the investigators will use frequencies (absolute and relative) for the qualitative variables. For the quantitative variables, the investigators will use means plus standard variations.
To verify the homogeneity of the randomization the investigators will use tests based on the X2 (Pearson or Fisher) and t-test. The same procedure will be used to verify that the participants who quit the study have similar characteristics as those who remain.
The improvement will be analyzed quantitatively using ANOVA test. Dependent variable: pain after the intervention. Independent variables: pain before the intervention, changes in pharmacological therapy and intervention group. In the event of significant differences in the ANOVA models the investigators will use the Tukey post-hoc test, in order to determine where the differences exist between the two groups.
Qualitatively, the investigators will assess the improvement by calculating indicators of clinical relevance: relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR), and number needed to treat (NNT).
All the analyses will be made at a significance of 5%. The confidence intervals (CI) will be calculated for the most relevant parameters. The analyses will be done using IBM SPSS Statistics 19.0.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Medical Taping Concept
- Keywords
- Mediacal Taping concept, Neuromuscular bandage, Physiotherapy techniques, Kinesio Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Taping ConceptDevice
Also called Cure Tape®, Kinesio Tape®, Kinesiotape Akraven, Kinesio® Tex
The material used is a lengthways tape bandage of cotton with elastic properties, provided with a layer of anti-allergic adhesive in one of its sides that does not contain latex. This layer of glue is applied according to a special pattern so as to allow adequate transpiration.
The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears
| Study group | Role | What they receive |
|---|---|---|
| Medical Taping Concept | Active comparator | 3 band of a special and hypoallergenic tape, called Cure Tape ® (2 strips of 12 x 5 cm and 1 strip of 20 cm x 5 cm) are attached to the abdominal and lower back. One piece of 12 cm in length is applied right from below the navel and reached to where the pubic hair below, and another piece of 12 cm in length is applied to make a cross shape with the first piece (inside 11-12 dermatomes area). The piece of 20cm in length is placed horizontally to the lower back.
The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears Receives: Device: Medical Taping Concept |
| Cross tape | Placebo comparator | Two pieces of special and squared tape of 2.5 x 2 cm called Cross Tape ® are attached to the external side of the thigh at the hip joint area (outside 11-12 dermatomes area) Receives: Device: Medical Taping Concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain NRS (numeric rating scale)
Evaluations will be performed before, just after, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment. It will be measured in abdominal area, low back, lower limb and head.
Measured: Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths
Secondary outcomes (1)
Number of analgesics requiring during menstruation
Measured: Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Isabel Tomás-Rodríguez, PT, Universidad Miguel Hernandez de Elche
- Investigators
- María I Tomás-Rodríguez, PT, MSC, Principal investigator, Universidad Miguel Hernández de Elche.José V Toledo-Marhuenda, PhD, Study director, Universidad Miguel Hernández de Elche.Vicente F Gil-Guillén, MD, PhD, Study director, Universidad Miguel Hernández de Elche.Antonio Palazón-Bru, MPH, Study chair, Universidad Miguel Hernández de Elche.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114723
- Sponsor's protocol ID
- DPC-MITR-01-1
- Status last verified
- Nov 2014
- First submitted
- 7 Apr 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim C, Park Y, Bae Y. The effect of the kinesio taping and spiral taping on menstrual pain and premenstrual syndrome. J Phys Ther Sci. 2013 Jul;25(7):761-4. doi: 10.1589/jpts.25.761. Epub 2013 Aug 20.
PubMed 24259847Wefers c, Pijnappel H.F, Stolwijk N.M. Effect of Cure Tape® on menstrual pain in women with primary dysmenorrhea. Ned Tijdscr Fysiother 119(6): 193-197, 2009
Garzón-Rodríguez, C. Analgessic effectiveness of Kinesio Taping versus abdominal massage in women with dysmenorrhea. Cuest. fisioter.42 (3): 302-311, 2013
Akin M, Price W, Rodriguez G Jr, Erasala G, Hurley G, Smith RP. Continuous, low-level, topical heat wrap therapy as compared to acetaminophen for primary dysmenorrhea. J Reprod Med. 2004 Sep;49(9):739-45.
PubMed 15493566Dawood MY, Ramos J. Transcutaneous electrical nerve stimulation (TENS) for the treatment of primary dysmenorrhea: a randomized crossover comparison with placebo TENS and ibuprofen. Obstet Gynecol. 1990 Apr;75(4):656-60.
PubMed 2179780Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671.
PubMed 26564807
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mediacal Taping Concept Self-applied, in the Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT02114723
- Acronym / sponsor ID
- DPC-MITR-01-1
- Conditions
- Primary Dysmenorrhea
- Keywords
- Mediacal Taping concept, Neuromuscular bandage, Physiotherapy techniques, Kinesio Tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea.
Detailed description
The aim of this study is to assess the analgesic efficacy of self-applied Medical Taping Concept in the treatment of primary dysmenorrhea .
To evaluate this effect, a total of 128 students from the University Miguel Hernández , with the following inclusion criteria, participated in this study: history of menstrual pain, aged between 18 and 39 years who have performed a gynecological check in the last 18 months and who have been diagnosed with any kind of primary dysmenorrhea.
A preliminary survey to identify valid students was made. Thereafter the participants were separated into two different groups (intervention group and placebo group) in order to request the completion of three questionnaires about the characteristics of menstrual pain and other demographic data for the next two menstrual cycles before the intervention. One survey included a graphic scale so the students could mark the start and the end of the symptoms associated with the menstrual cycle.
After that the principal researcher will interviewed with the participants to show them the correct auto-application of the menstrual bandage and placebo. Each students group will receive a triptych with information and pictures to the correct application of the adhesive strips.
Finally, during two new menstrual cycles, the participants will answer the same questionnaires to assess symptoms and menstrual pain while being worn adhesive strips (3 pieces of Kinesio tape - 20 cm x 5 cm Tape Cure ®-, applied to the abdominal and lower back, in the intervention group; 2 pieces of Cross Tape ® 2.5 cm x 2 cm -, in the hip joint, in the placebo group. Participants may do personal hygiene during the days of the menstrual cycle with their adhesives strips placed on oneself.
The size sample will be 128 girls. Differences will be contrasted in comparison of means (quantitative improvement, with an ANOVA) to evaluate the intervention. 18 girls were randomly chosen to obtain an estimation of the contrast parameters considered (means and standard variations). With this size sample and a significance of 5%, the investigators will have a power for the total sample for the contrasts of 80%.
To describe the variables, the investigators will use frequencies (absolute and relative) for the qualitative variables. For the quantitative variables, the investigators will use means plus standard variations.
To verify the homogeneity of the randomization the investigators will use tests based on the X2 (Pearson or Fisher) and t-test. The same procedure will be used to verify that the participants who quit the study have similar characteristics as those who remain.
The improvement will be analyzed quantitatively using ANOVA test. Dependent variable: pain after the intervention. Independent variables: pain before the intervention, changes in pharmacological therapy and intervention group. In the event of significant differences in the ANOVA models the investigators will use the Tukey post-hoc test, in order to determine where the differences exist between the two groups.
Qualitatively, the investigators will assess the improvement by calculating indicators of clinical relevance: relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR), and number needed to treat (NNT).
All the analyses will be made at a significance of 5%. The confidence intervals (CI) will be calculated for the most relevant parameters. The analyses will be done using IBM SPSS Statistics 19.0.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Taping Concept | Active comparator | Device: Medical Taping Concept3 band of a special and hypoallergenic tape, called Cure Tape ® (2 strips of 12 x 5 cm and 1 strip of 20 cm x 5 cm) are attached to the abdominal and lower back. One piece of 12 cm in length is applied right from below the navel and reached to where the pubic hair below, and another piece of 12 cm in length is applied to make a cross shape with the first piece (inside 11-12 dermatomes area). The piece of 20cm in length is placed horizontally to the lower back. The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears |
| Cross tape | Placebo comparator | Device: Medical Taping ConceptTwo pieces of special and squared tape of 2.5 x 2 cm called Cross Tape ® are attached to the external side of the thigh at the hip joint area (outside 11-12 dermatomes area) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom.
- Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
- Not have been diagnosed with secondary dysmenorrhea
- Regular menstrual cycles (cycle typical range of 21 to 35 days)
- Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
Key exclusion criteria (8 listed)
- Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
- Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);
- Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
- Women who suffer from diseases diagnosed added
- Women to which it has undergone a surgical procedure for the treatment
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 |
|---|---|---|
| Medical Taping ConceptAlso: Cure Tape®, Kinesio Tape®, Kinesiotape Akraven, Kinesio® TexThe material used is a lengthways tape bandage of cotton with elastic properties, provided with a layer of anti-allergic adhesive in one of its sides that does not contain latex. This layer of glue is applied according to a special pattern so as to allow adequate transpiration. The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears | Device | Cross tape, Medical Taping Concept |
Primary outcome
Pain NRS (numeric rating scale)
Time frame: Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths
Evaluations will be performed before, just after, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment. It will be measured in abdominal area, low back, lower limb and head.
1 secondary outcome
Number of analgesics requiring during menstruation
Time frame: Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Results publication: PubMed 24259847Lim C, Park Y, Bae Y. The effect of the kinesio taping and spiral taping on menstrual pain and premenstrual syndrome. J Phys Ther Sci. 2013 Jul;25(7):761-4. doi: 10.1589/jpts.25.761. Epub 2013 Aug 20.
- Results publicationWefers c, Pijnappel H.F, Stolwijk N.M. Effect of Cure Tape® on menstrual pain in women with primary dysmenorrhea. Ned Tijdscr Fysiother 119(6): 193-197, 2009
- Results publicationGarzón-Rodríguez, C. Analgessic effectiveness of Kinesio Taping versus abdominal massage in women with dysmenorrhea. Cuest. fisioter.42 (3): 302-311, 2013
- Results publication: PubMed 15493566Akin M, Price W, Rodriguez G Jr, Erasala G, Hurley G, Smith RP. Continuous, low-level, topical heat wrap therapy as compared to acetaminophen for primary dysmenorrhea. J Reprod Med. 2004 Sep;49(9):739-45.
- Results publication: PubMed 2179780Dawood MY, Ramos J. Transcutaneous electrical nerve stimulation (TENS) for the treatment of primary dysmenorrhea: a randomized crossover comparison with placebo TENS and ibuprofen. Obstet Gynecol. 1990 Apr;75(4):656-60.
- Derived from this study: PubMed 26564807Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671.
- Kinesio Taping® Association InternationalLink provided by the sponsor.
- Medical Taping ConceptLink provided by the sponsor.
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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.
María I Tomás-Rodríguez, PT, MSC principal investigator
Universidad Miguel Hernández de Elche.
José V Toledo-Marhuenda, PhD study director
Universidad Miguel Hernández de Elche.
Vicente F Gil-Guillén, MD, PhD study director
Universidad Miguel Hernández de Elche.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Taping Concept in people with Primary Dysmenorrhea, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 6 inclusion and 8 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 13 Nov 2014. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain NRS (numeric rating scale) (time frame: Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths). 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 NCT02114723, which also lists 6 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 13 Nov 2014.