To compare the effects of therapeutic ultrasound and muscle energy techniques of piriformis and iliopsoas for coccydynia in pregnant females
Design
The study is a concealed, randomized, blinded, clinical trial with a parallel group design. Randomization is done by lottery method. In this method, the researcher gives each participant of the trial a number. Researchers draw numbers from the box randomly to allocate participants in two groups.
Settings and conduct
This study is conducted at Arif Memorial Hospital. In this trial participants are blinded through concealment to avoid biasness.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20-40 years pregnant females
Idiopathic coccydynia
Subjects willing to undergo muscle energy techniques of piriformis and iliopsoas
Exclusion criteria:
Tumors
Trauma
Subjects with history of spinal surgery
Intervention groups
The individuals are grouped in 2 categories;
Group A will receive Therapeutic ultrasound.
Group B will receive muscle energy techniques of piriformis and iliopsoas
Main outcome variables
Pain is measured before the application of techniques using Numeric Pain Rating Scale (NPRS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220626055285N1
Registration date:2023-01-21, 1401/11/01
Registration timing:prospective
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Rehana Niazi
Name of organization / entity
Rashid Latif medical college
Country
Pakistan
Phone
+92 333 4734783
Email address
rehana.niazi@rlmc.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-28, 1401/11/08
Expected recruitment end date
2023-05-28, 1402/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Therapeutic Ultrasound versus Muscle Energy Techniques of piriformis and iliopsoas for coccydynia in pregnant females
Public title
Effect of Therapeutic Ultrasound versus Muscle Energy Techniques on coccydynia in pregnant females
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Idiopathic coccydynia
Subjects willing to undergo muscle energy techniques of piriformis and iliopsoas
Age 20-40 years pregnant females
Exclusion criteria:
Tumors
Trauma
Subjects with history of spinal surgery
Lumbar disc prolapse
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 35 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 26 cards were taken out, 13 participants in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding is achieved by concealment in which the treatment allocation for each patient is not revealed to the patient. This is done to avoid biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of Rashid Latif Medical College
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Approval date
2022-10-05, 1401/07/13
Ethics committee reference number
IRB/2022/052
Health conditions studied
1
Description of health condition studied
coccydynia
ICD-10 code
M53.3
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Pre and Post 1 Month
Method of measurement
Pain is measured before the application of techniques using Numeric Pain Rating Scale (NPRS).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A will receive Therapeutic ultrasound. Therapeutic ultrasound is used with the intensity of 1.5W/cm2 for 3-5 min with the use of ultrasonic gel and this procedure is done by approaching the patient posteriorly using irregular probe.
Category
Treatment - Other
2
Description
Intervention group: Group B will receive muscle energy techniques of piriformis and iliopsoas. For piriformis MET, ask patient to Lay the patient in the supine position and bend the knee of affected side and place the foot of that side on the lateral aspect of the opposite knee. The therapist was at the side of the patient. The therapist will push the knee medially until meeting the restrictive barrier. Ask the patient push against the therapist’s resistance for 3 to 5 sec, allow for a period of isometric relaxation, then engage a new barrier and repeat three times. Then, return the patient to a neutral position. For Iliopsoas MET, Patient position is Supine lying with lower leg hanging off the end of the plinth. The patient flexes the contralateral hip and knee to hug the lower extremity to the chest. Therapist position is Standing on the ipsilateral side of the dysfunction. By Using one hand to keep the contralateral leg flexed, the other hand will provide a downward force immediately proximal to knee until reaching the restrictive barrier. Continue to engage the restrictive barrier and instruct the patient to bring the knee up toward the ceiling to achieve hip flexion for 3 to 5 sec. Instruct the patient to relax and move the hip further into extension by providing a downward force proximal to the knee. Repeat the last two steps 3 to 5 times. After last repetition passively return the patient’s leg to a neutral position.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif Memorial Hospital
Full name of responsible person
Amber Iqbal
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 321 4632209
Email
iqbalamber50@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Rehana Niazi
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 333 4734783
Email
rehana.niazi@rlmc.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical College
Proportion provided by this source
100
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
Rashid Latif Medical College
Full name of responsible person
Amber Iqbal
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 321 4632209
Email
iqbalamber50@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Rehana Niazi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4734783
Email
rehana.niazi@rlmc.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Rehana Niazi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4734783
Email
rehana.niazi@rlmc.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
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