Protocol summary

Study aim
To evaluate the therapeutic outcomes of dry needling coupled with intramuscular stimulation in patients with fibromyalgia syndrome.
Design
A concealed, randomized, blinded, controlled trial with a parallel group design of 78 patients
Settings and conduct
Physical Therapy Department, University of Lahore Teaching Hospital, Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria Both male and female patients; Age over 18 years and under 60 years; Pre diagnosed patients with FMS referred through consultant; Manifesting chronic widespread musculoskeletal pain symptoms; Presence of active trigger points, as confirmed by physical examination; No contraindications to dry needling or IMS. Exclusion Criteria Pregnancy or breastfeeding; Use of any medications that could interfere with the study results e.g. muscle relaxants, opioids within the past 48 hours; Previous treatment with dry needling or IMS within the past 6 months; Presence of any other conditions that could interfere with the study results e.g. cancer, infection;
Intervention groups
Group A: This group will be given dry needling and conventional treatment. The sterile stainless steel 0.25*25mm to 0.25*50mm (Hua long) acupuncture needle will be inserted. CPT will consist of Application of hot pack for 10 minutes, TENS(typical, 100 Hz) for 20 mins at the affected region. Isometric exercise, Range of Motion, Stretching and strengthening exercise of affected region. Therapy will be provided for one session per week for four weeks. Group B: This group will be given dry needling and IMS will be applied for 15 minutes (low frequency parameters (2 Hz) and a pulse width of 120 μs).Conventional physical therapy will be given as of Group A.
Main outcome variables
Numeric Pain Rating Scale; Pain pressure threshold; algometer; Quality of sleep; Anxiety depression; Fatigue scale

General information

Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20240125060803N1
Registration date: 2024-06-01, 1403/03/12
Registration timing: prospective

Last update: 2024-06-01, 1403/03/12
Update count: 0
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Muhammad Asim Arif
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 42 111 865 865
Email address
asim.arif@uipt.uol.edu.pk
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-10, 1403/03/21
Expected recruitment end date
2025-12-10, 1404/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic Outcomes Of Dry Needling Coupled With Intramuscular Stimulation In Patients With Fibromyalgia Syndrome
Public title
Therapeutic Outcomes Of Dry Needling Coupled With Intramuscular Stimulation In Patients With Fibromyalgia Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients Age over 18 years and under 60 years Pre diagnosed patients with FMS referred through consultant Manifesting chronic widespread musculoskeletal pain symptoms Presence of active trigger points, as confirmed by physical examination Willing and able to provide informed consent to participate in the study. Ability to understand and comply with the study requirements No contraindications to dry needling or IMS
Exclusion criteria:
Pregnancy or breastfeeding Use of any medications that could interfere with the study results (e.g. muscle relaxants, opioids) within the past 48 hours. Previous treatment with dry needling or IMS within the past 6 months Presence of any other conditions that could interfere with the study results (e.g. cancer, infection) Participation in any other clinical trials within the past 30 days Anatomical anomaly Structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis)o Any bone abnormality in neck region Traumatic/ Inflammatory/ Infectious Conditions such as Recent Trauma, Nerve root compromise, Metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), Previous neck surgery Psycho-social Instability such as Diagnosed stress/ depression/ Anxiety Risk Profile such as High Risk Inability to understand or comply with the study requirements, as determined by the physiotherapist
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Computerized method of randomization will be used to randomized screened eligible patients to Group A and B. OxMaR will be used for this purpose, which is an open source free software for online minimization and randomization for clinical trials
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be single blinded, only the assessor would be managed to be masked from treatment options and outcomes. Ultimately, the decision about which type of blinding to use in a clinical trial will depend on the specific research question being addressed, the nature of the treatments being compared, and the resources and logistics of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethical committee
Street address
1-Km Defence Road, Off Bhoptian Chowk, Raiwind Road, Lahore
City
lahore
Postal code
54000
Approval date
2024-05-22, 1403/03/02
Ethics committee reference number
REC-UOL-/183/08/24

Health conditions studied

1

Description of health condition studied
Fibromyalgia Syndrome
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia

Primary outcomes

1

Description
Pain
Timepoint
Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval
Method of measurement
Numeric Pain Rating Scale

2

Description
Pressure
Timepoint
Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval
Method of measurement
Pain pressure threshold; algometer

3

Description
Anxiety depression
Timepoint
Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

4

Description
Quality of Sleep
Timepoint
Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval
Method of measurement
Pittsburgh Sleep Quality Index (PSQI).

5

Description
Fatigue
Timepoint
Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval
Method of measurement
Multidimensional Fatigue Inventory (MFI).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dry Needling With Intramuscular Electrical Stimulation
Category
Treatment - Other

2

Description
Control group: Dry Needling Group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Therapy Department, University of Lahore Teaching Hospital, Lahore
Full name of responsible person
Rabia Saeed
Street address
1-km defence road off bhoptian chowk, raiwind road, lahore
City
Lahore
Postal code
54000
Phone
+92 321 4600797
Email
rabia.saeed@uipt.uol.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of lahore
Full name of responsible person
Umair Ahmed
Street address
1-km defence road, off bhoptian chowk, raiwind road, lahore
City
Lahore
Postal code
54000
Phone
+92 321 2700817
Email
umair.ahmed@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Muhammad Asim Arif
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road, off bhoptian chowk, raiwind road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 6597727
Email
asim.arif@uipt.uol.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Muhammad Asim Arif
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road, off bhoptian chowk, raiwind road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 6597727
Email
asim.arif@uipt.uol.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Muhammad Asim Arif
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road, off bhoptian chowk, raiwind road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 6597727
Email
asim.arif@uipt.uol.edu.pk

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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