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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06442540
Other study ID # FUI/CTR/2024/11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2023
Est. completion date June 20, 2024

Study information

Verified date May 2024
Source Foundation University Islamabad
Contact Usama Ibrar, MS-MSKPT*
Phone 03035954053
Email usamaibrar35@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomised controlled trial and the purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability."


Description:

The purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability in patients with sacral torsion." (age : 22-44 years ) 1. Numeric pain rating scale 2. Inclinometer Lumbar Flexion 3. Oswestry Disability Questionairre 4. Goniometer SLR ROM Data will be collected before and after the intervention protocol for each participant. Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date June 20, 2024
Est. primary completion date May 20, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 44 Years
Eligibility Inclusion criteria: - Age group: 22-44 years old - Both males and females - Clinically diagnosed sacral torsion - Patients with pain intensity of at least 5 on NPRS - Positive backward bent test - Positive forward bent test - Uneven Sacral sulcus - Uneven ILA of sacrum - Piriformis syndrome Exclusion criteria : - Any congenital deformities - Demonstrated neurological deficit. - Pregnant females - History of spinal surgery - Spondylolisthesis - Severe lumbar spondylosis - Spinal stenosis - Serious spinal conditions like infection, tumors, osteoporosis, spinal fracture - osteoporosis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Physical Agents
Hot pack
Manipulation
HVLA manipulation of SI joint
Core Stability Exercises
Supine abdominal draw-in Hold 8s 3s off x 2 Abdominal draw-in, with one knee drawn to the chest. Hold 8s 3s off x 2 Abdominal draw-in, with the heels sliding backward one after the other. 10 reps 3s off x 2 Abdominal draw-in, with both knees drawn to the chest. Hold 8s 3s off x 2 Supine twist 15 reps 3s off x 3 Prone bridging on elbows Hold 8s 3s off x 3 Side bridging on elbows Hold 8s 3s off x 3 Quadruped opposite arm-leg lift Hold 8s 3s off x 3 Advance to the stage 2 when the patient can hold 30 reps for an 8-sec hold.
Intramusular electrotherapy
Intramuscular electrotherapy/ 3 sessions per week
Soft tissue mobility
Stretching and Myofacial Release of piriformis and erector spinae

Locations

Country Name City State
Pakistan Foundation University College of Physical Therapy Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity Numeric Pain Rating Scale (NPRS): ICC (0.93-0.96) It has a scale of 0-10 or 0-100 points and can be given verbally or in writing 4 weeks
Primary Lumbar ROM Lumbar ROM will be measured using Inclinometer 4 weeks
Primary SLR ROM SLR ROM will be measured using Goniometer 4 weeks
Primary Level of Disability Oswestry disability questionairre 4 Weeks
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