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Formulation and Comparative Efficacy of Ashwagandha, Sesame, and Rosemary Gel Vs Diclofenac Gel with Ultrasound in Back Myofascial Pain

Protocol summary

Study aim
This study aims to ascertain if the combination of herbal medicine (Ashwagandha, sesame, and rosemary) and therapeutic (Ultrasound therapy) interventions provides a comparative effect, alleviating and managing back pain, improving muscle function, promoting recovery and improving overall mobility in patients with MPS and to compare the effectiveness of Ashwagandha, sesame, and rosemary oils versus Diclofenac gel, both combined with therapeutic ultrasound, in managing back myofascial pain.
Design
Pragmatic, community based, parallel group, double blinded, randomized controlled trial. Total 110 patients will be enrolled. Patients who met our inclusion criteria will be randomized into two groups.
Settings and conduct
Muhammad Rehabilitation Centre, Multan
Participants/Inclusion and exclusion criteria
Inclusion Criteria: • Chronic or subacute myofascial back pain persisting for at least 4 weeks. • Pain score ≥4 on the Numerical Pain Rating Scale (NPRS). • Willingness to undergo ultrasound therapy and use the prescribed gel. Exclusion Criteria: • Dermatological issues or open wounds on the back. • Known allergies to any components of the gels. • Use of systemic corticosteroids or analgesics. • Severe musculoskeletal conditions or neurological disorders.
Intervention groups
Group 1: ASR Gel Group: The ASR gel will be applied to the affected area, followed by 10 minutes of ultrasound therapy using a 1 MHz ultrasound device set to 1 W/cm² in continuous mode. Group 2: Diclofenac Gel Group: Diclofenac gel will be applied in a similar manner, followed by identical ultrasound therapy parameters. Both groups received treatment 3 times per week for 6 weeks.
Main outcome variables
Pain (NPRS), Cervical ROM (goniometry), Muscle tenderness (Pressure pain threshold scale), Quality of life (SF-36), Functional Status ( McGill Questionnaire), ESR, CRP, IL-6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N12
Registration date: 2024-12-22, 1403/10/02
Registration timing: prospective

Last update: 2024-12-22, 1403/10/02
Update count: 0
Registration date
2024-12-22, 1403/10/02
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-07, 1403/10/18
Expected recruitment end date
2025-03-30, 1404/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and Comparative Efficacy of Ashwagandha, Sesame, and Rosemary Gel Vs Diclofenac Gel with Ultrasound in Back Myofascial Pain
Public title
Ashwagandha, Sesame, and Rosemary Gel Vs Diclofenac Gel with Ultrasound in Back Myofascial Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic or subacute myofascial back pain persisting for at least 4 weeks Pain score ≥4 on Numerical Pain rating scale (NPRS) Willingness to undergo ultrasound therapy and use the prescribed gel.
Exclusion criteria:
Dermatological issues or open wounds on the back Known allergies to any components of the gels Use of systemic corticosteroids or analgesicS Severe musculoskeletal conditions or neurological disorders
Age
From 25 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
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
2024-11-25, 1403/09/05
Ethics committee reference number
MIMAS/9/02/IAK

Health conditions studied

1

Description of health condition studied
Back myofascial pain syndrome
ICD-10 code
M60
ICD-10 code description
Myositis

Primary outcomes

1

Description
Pain
Timepoint
4 weeks
Method of measurement
NPRS

2

Description
Lumber ROM
Timepoint
4 weeks
Method of measurement
Goniometry

3

Description
Muscle tenderness
Timepoint
4 weeks
Method of measurement
Pressure pain threshold scale

Secondary outcomes

1

Description
Serological findings
Timepoint
4 weeks
Method of measurement
ESR, CRP,IL-6

2

Description
Quality of life
Timepoint
4 weeks
Method of measurement
SF-36 scale

3

Description
Functional Status
Timepoint
4 weeks
Method of measurement
McGill Questionnaire

Intervention groups

1

Description
Intervention group: Group 1: The ASR gel was applied to the affected area, followed by 10 minutes of ultrasound therapy using a 1 MHz ultrasound device set to 1 W/cm² in continuous mode. 3 times per week for 4 weeks.
Category
Treatment - Drugs

2

Description
Intervention group: Group 2: Diclofenac gel was applied in a similar manner, followed by identical ultrasound therapy parameters. 3 times per week for 4 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad Rehabilitation Centre, Multan
Full name of responsible person
Komal Ammar Bukhari
Street address
Multan
City
MULTAN
Postal code
66000
Phone
+92 333 6120602
Email
komalbukhari608@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Qurat Ul Ain
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
qain0635@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/15/12/Aqsa
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
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 Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Maliha Khalid Khan
Position
Punjab
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture Multan
Full name of responsible person
Imran Ahmad Khan
Position
Punjab
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old shuja Abad road Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Aqsa Sajjad
Position
Last year student of DPT
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 318 1477078
Email
aqsasajjad1272@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
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