1. Home
  2. Approved trials
  3. » فارسی

Effectiveness of Diclofenac Potassium Gel with and without Transcutaneous Electrical Nerve Stimulation in Primary Dysmenorrhea

Protocol summary

Study aim
This study aims to formulate a topical diclofenac potassium gel and evaluate its effectiveness in managing primary dysmenorrhea. It also seeks to compare the pain-relieving effects of the gel alone versus in combination with Transcutaneous Electrical Nerve Stimulation (TENS) to determine the potential benefit of combined therapy.
Design
Pragmatic, community based, parallel group, double blinded, randomized controlled trial. Total 376 patients will be enrolled. Patients who met our inclusion criteria will be randomized into two groups.
Settings and conduct
The trial will be held at Muhammad Physical Therapy & Rehabilitation Center, Multan. It is single-blinded, with participants unaware of their group. Treatments will be in identical boxes, and codes kept by the principal investigator.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Woman (18-45 years), Female diagnosed with primary or secondary dysmenorrhea, Regular menstrual cycles (21-35days), Females, Moderate to severe menstrual pain, Intervention was physiotherapy techniques (electro-physical agents, massage, exercise). Exclusion Criteria Pregnancy Females with bleeding disorders, Breast feeding, Uterine fibroids, Adenomyosis , Endometriosis, Pelvic inflammatory disease, Menstrual disorder
Intervention groups
Group A will receive 6% diclofenac potassium gel plus TENS, while Group B will use the gel alone. Both groups will apply 2–4 grams of gel 2–4 times daily for up to three days. Group A will also get Transcutaneous Electrical Nerve Stimulation (80–100 Hz, 20–30 minutes, 2–3 times daily) to enhance pain relief.
Main outcome variables
range of motion, joint stiffness, independency and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241220064105N4
Registration date: 2025-06-02, 1404/03/12
Registration timing: retrospective

Last update: 2025-06-02, 1404/03/12
Update count: 0
Registration date
2025-06-02, 1404/03/12
Registrant information
Name
Komal Ammar Bukhari
Name of organization / entity
Muhammad Institute of Medical Sciences, Multan
Country
Pakistan
Phone
+92 314 6361728
Email address
komalbukhari608@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-14, 1403/10/25
Expected recruitment end date
2025-04-14, 1404/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Diclofenac Potassium Gel with and without Transcutaneous Electrical Nerve Stimulation in Primary Dysmenorrhea
Public title
Diclofenac Potassium Gel with and without Transcutaneous Electrical Nerve Stimulation in Primary Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(18-45 years) primary or secondary dysmenorrhea Regular menstrual cycles (21-35days) Moderate to severe menstrual pain Participants were females experiencing PD not using hormonal contraception.
Exclusion criteria:
Pregnancy Females with bleeding disorders Breast feeding Uterine fibroids. Adenomyosis Endometriosis Pelvic inflammatory disease Menstrual disorder Hormonal contraceptive use Surgery or Procedures
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 376
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using the lottery method will be applied at the individual level without stratification. Participants will draw sealed slips to determine group allocation. Identical numbered white boxes will conceal treatment, and codes will be held by the principal investigator to maintain allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
multan
Postal code
66000
Approval date
2024-12-14, 1403/09/24
Ethics committee reference number
MIMAS/18/02/Komal

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.6
ICD-10 code description
Dysmenorrhea, unspecified

Primary outcomes

1

Description
pain
Timepoint
The primary outcome will be measured before the intervention and at 2 and 4 weeks after the intervention.
Method of measurement
WALIDD Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Transcutaneous electrical nerve stimulation (TENS) therapy will be administered alongside diclofenac potassium gel. Transcutaneous electrical nerve stimulation (TENS) will be applied using a high-frequency setting of 80–100 hertz (Hz), a pulse duration of approximately 100 microseconds, and the intensity will be adjusted to produce a strong but comfortable tingling sensation without causing muscle contraction. Each session of transcutaneous electrical nerve stimulation (TENS) will last for 20 to 30 minutes and will be conducted two to three times per day during the 2 to 3-day treatment period
Category
Rehabilitation

2

Description
Control group: will be treated with 6% Diclofenac Potassium gel alone, the gel will apply to the lower abdomen and/or lower back at a dose of 2 to 4 grams per application, two to four times daily, beginning at the onset of menstrual pain and continuing for up to three days
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Full name of responsible person
Maliha Khalid Khan
Street address
Bosan Road
City
multan
Postal code
66000
Phone
+92 314 6361728
Email
malihatareen1997@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Instituite of Rehabilitation Sciences, Multan
Full name of responsible person
qurat ul ain
Street address
Bosan Road
City
multan
Postal code
66000
Phone
+92 312 6754836
Email
qain0635@gmail.com
Grant name
Muhammad Adnan Taj
Grant code / Reference number
MIMAS/18/2/Adnan
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Instituite of Rehabilitation Sciences, Multan
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Muhammad Instituite of Medical and Allied Sciences, Multan
Full name of responsible person
Maliha Khalid Khan
Position
lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
multan
Province
punjab
Postal code
660000
Phone
+92 312 6862130
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical Sciences and Rehabilitation
Full name of responsible person
Komal Ammar Bukhari
Position
lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
multan
Province
punjab
Postal code
66000
Phone
+92 314 6361728
Email
komalbukhari608@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Instituite of Medical and Allied Sciences, Multan
Full name of responsible person
Muhammad Adnan Taj
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
bosan road
City
multan
Province
punjab
Postal code
66000
Phone
+92 319 6826592
Email
muhammaddani0758@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...