Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.
Study Details
Study Description
Brief Summary
This study analyse the effectiveness of auricular therapy vs. kinesio tape treatment for pain management of women with primary dysmenorrhoea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Pharmacological treatments are not effective for all women and therefore, the objective of this study was to assess and compare the effectiveness of kinesio tape and auricular therapy to decrease pain and drug intake in women with primary dysmenorrhoea.
A randomized controlled trial was conducted. 114 university women from 18 to 30 years old were randomized to 5 groups: control, kinesio tape, placebo kinesio tape, auricular therapy and placebo auricular therapy. The study was carried out during 4 menstrual cycles of pre-treatment phase, 4 menstrual cycles of treatment phase and two follow up phases (first and third cycle after the treatments were completed). During the treatment phase, the techniques were applied during 72h in each cycle.
The primary outcome measures were: Mean pain intensity of the 3 first days of bleeding, maximum pain intensity, number of painful days and dose of drug intake measured with the Visual Analogue Scale.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Auricular therapy group The auricular therapy group received an intervention based on the bilateral application of 7 adhesive tapes with vaccaria seeds. The points were located with a retractable 250 gr. pressure palpator (Sedatelec®). An experienced health professional trained on acupuncture techniques applied the vaccaria seeds. |
Procedure: Auricular therapy
The auricular therapy points were selected following the protocol for dysmenorrhoea described by Oleson (Oleson, 2008). These points were (the name of the European cartography is specified by the name of the point): Shenmen [FT2], uterus [FT5], sympathetic [HI4], kidney [CS6], heart [CI4], endocrine [IT2] and thalamus [PC2].
Other Names:
|
| Sham Comparator: Auricular therapy Placebo group The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points. |
Procedure: Auricular therapy Placebo group
Sham auricular therapy
|
| Experimental: Kinesio tape group The kinesio tape group received an intervention that consisted on the standard application of three elastic bandages. An experienced kinesio tape certified physical therapist applied the taping. |
Procedure: kinesio tape
Before the tape application, the skin surface was removed of hair when needed and cleansed. The tapes were applied at 25% of tension and were placed horizontally covering the area between the antero-superior iliac spines and the postero-superior iliac spines and vertically from the navel to the symphysis pubis. All bandages were adhered to the skin with a technique type I with a space augmentation. The centre of the tape was removed and applied at 25% of tension. Afterwards, the rest of the protector were removed and the laterals anchors of the tape were adhered with no tension. The participant maintained a slight extension of the trunk while the tape was applied on the anterior aspect of the truck and a slight flexion while the tape was applied in the posterior aspect of the trunk.
Other Names:
|
| Sham Comparator: kinesio tape Placebo group The kinesio tape placebo group had the application of three elastic bandages that were shorter than the used in the kinesio tape group. In addition, the tape was adhered with no tension and not place in the treatment area. |
Procedure: kinesio tape Placebo group
Sham kinesio tape
|
| No Intervention: Control group The control group did not receive any treatment. The participants continued with their routine medical treatment. However, the controls completed all the questionnaires to collect the information regarding their symptoms in order to observe their progress with no intervention. |
Outcome Measures
Primary Outcome Measures
- Changes from the Mean pain intensity [Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)]
Mean pain intensity of the 3 first days of menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain.
- Changes from the Maximum pain intensity [Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)]
Maximum pain intensity during menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain.
- Changes from number of painful days [Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)]
Count of number of days when the participant experienced pain during the menstruation. A lower number of painful days indicate an improvement
- Changes from the dosage of drug intake [Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)]
Register of dosage and grug intake of each participant to relief pain during the menstruation. A lower dose of drug intake indicate an improvement.
Secondary Outcome Measures
- Changes from the Length of the menstrual cycle [Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)]
Count of days that the menstrual cycle lasted for.
- Changes from the Length of menstruation [Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)]
Count of days that menstruation lasted for.
- Changes from theType of drug [Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up)]
Record of type of medication used by the participants during the menstruation for pain relief.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women between 18 and 30 years old affected by primary dysmenorrhoea grade 2 and 3 of Andersch y Milsom classification (Andersch y Milsom, 1982), to have attended gynaecologist consultation for a general revision in the last 2 years, to have menstrual pain, to have regular menstrual cycles of 21 to 38 days, to not have an intrauterine/inter-uterine) device or to be on oral contraceptive treatment.
Exclusion Criteria:
- To have been diagnosed with a condition that could influence menstrual pain perception, to know or have been previously treated with the techniques used in the interventions and pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Extremadura | Badajoz | Spain | 06011 |
Sponsors and Collaborators
- University of Extremadura
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 58/2017