Effects of Intra Muscular Electrotherapy Combined With Manipulative Therapy in Patients With Sacral Torsion

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."

Study Overview

• Status: Recruiting
• Conditions: Sacroiliac Joint Dysfunction
• Intervention / Treatment: Procedure: Manipulation; Procedure: Core Stability Exercises; Procedure: Intramusular electrotherapy; Procedure: Physical Agents; Procedure: Soft tissue mobility

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Usama Ibrar, MS-MSKPT*; Phone Number: 03035954053; Email: usamaibrar35@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Foundation University College of Physical Therapy
      • Contact: Nida Mushtaq, DPT,MSNMPT; Phone Number: 033300418548; Email: nida.mushtaq@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; HVLA thrust for SI Joint once per week: Core stability exercises Intramuscular electrotherapy / 3 sessions per week 10 mins / frequency 100hz muscles( piriformis, erector spinae )	Procedure: Manipulation; HVLA manipulation of SI joint; Procedure: 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.; Procedure: Intramusular electrotherapy; Intramuscular electrotherapy/ 3 sessions per week
Experimental: Group 2; Hot pack 10 mins soft tissue / myofacial release ( piriformis, erector spinae ) Piriformis stretching core stability exercises	Procedure: 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.; Procedure: Physical Agents; Hot pack; Procedure: Soft tissue mobility; Stretching and Myofacial Release of piriformis and erector spinae

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lumbar ROM	Lumbar ROM will be measured using Inclinometer	4 weeks
SLR ROM	SLR ROM will be measured using Goniometer	4 weeks
Level of Disability	Oswestry disability questionairre	4 Weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Actual): May 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: FUI/CTR/2024/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No