NCT05474482

Brief Summary

Primary dysmenorrhea (PD) is a common gynecological problem among adolescents and adult women. Treatment of PD includes various drugs and therapies such as kinesio taping (KT) and exercise. There are various studies that have individually explored the effects of KT and combined exercises. A randomized controlled trial (RCT) will be conducted to compare the effects of KT combined a combined exercise program and the effects of KT alone on pain and quality of life in females suffering from PD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

July 24, 2022

Last Update Submit

September 15, 2023

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea, Kinesiology taping, Menstruation

Outcome Measures

Primary Outcomes (1)

  • MSQ

    Menstrual symptoms were assessed using the Menstrual Symptom Questionnaire (MSQ). The questionnaire has 24 items; 19 of them (emotional, physical, and pain) assess symptoms, and three examine symptom management strategies. The following is how the things are rated using a Likert-style scale: 1 denotes never, 2 rare, 3 irregular, 4 often, and 5 constant.

    6 months

Secondary Outcomes (2)

  • SF36

    6 months

  • NPRS

    6 months

Study Arms (3)

kinesio taping with 75 to 100 % stretch and exercises

EXPERIMENTAL

Kinesio taping with stretching exercises and yoga will be given to patients for 8 weeks.

Other: kinesio taping with exercises

kinesio taping without exercises

EXPERIMENTAL

Kinesio taping alone will be given to patients for 8 weeks.

Other: Kinesio taping without exercises

kinesio taping without stretch to tape

ACTIVE COMPARATOR

kinesio taping without any stretch, applied as control for 8 weeks.

Other: Kinesio taping without stretch as control

Interventions

kinesio taping with exercisesOTHER

Kinesio taping with full stretch of 75 to 100 % for 2 days session per week and exercises for 3 days session per week for total 8 weeks.

kinesio taping with 75 to 100 % stretch and exercises
Kinesio taping without exercisesOTHER

Kinesio taping with a full stretch of 75 to 100 % for 2 days session per week without exercises for 8 weeks.

kinesio taping without exercises
Kinesio taping without stretch as controlOTHER

kinesio taping without any stretch for 2 days session per week for total 8 weeks.

kinesio taping without stretch to tape

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between the ages of 18 and 30 who are nulliparous and have normal menstrual cycles (28 to 7 days).
  • Menstrual pain severity rated at 4 or higher on the NPRS over the previous six months.

You may not qualify if:

  • Secondary dysmenorrhea Pelvic surgery (rectum and anal problems, etc.), pelvic organ prolapses, and malignant conditions (uterine cancer, ovarian cancer, cervical cancer, etc.)
  • Utilizing oral contraceptives for at least six months before.
  • Allergic to KT tape
  • Use of antidepressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johar Institute of Professional Studies nabi bakhsh stop, lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (7)

  • Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.

    PMID: 32379680BACKGROUND

  • Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.

    PMID: 32415471BACKGROUND

  • Mejias-Gil E, Garrido-Ardila EM, Montanero-Fernandez J, Jimenez-Palomares M, Rodriguez-Mansilla J, Gonzalez Lopez-Arza MV. Kinesio Taping vs. Auricular Acupressure for the Personalised Treatment of Primary Dysmenorrhoea: A Pilot Randomized Controlled Trial. J Pers Med. 2021 Aug 19;11(8):809. doi: 10.3390/jpm11080809.

    PMID: 34442453BACKGROUND

  • Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.

    PMID: 34360122BACKGROUND

  • Blakey H, Chisholm C, Dear F, Harris B, Hartwell R, Daley AJ, Jolly K. Is exercise associated with primary dysmenorrhoea in young women? BJOG. 2010 Jan;117(2):222-4. doi: 10.1111/j.1471-0528.2009.02220.x.

    PMID: 19459861BACKGROUND

  • Tomas-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.

    PMID: 26564807BACKGROUND

  • Dogan H, Eroglu S, Akbayrak T. The effect of kinesio taping and lifestyle changes on pain, body awareness and quality of life in primary dysmenorrhea. Complement Ther Clin Pract. 2020 May;39:101120. doi: 10.1016/j.ctcp.2020.101120. Epub 2020 Feb 22.

    PMID: 32379659BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Afifa Safdar, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
blinding
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 26, 2022

Study Start

December 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)