NCT06442540

Brief 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."

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

May 27, 2024

Last Update Submit

May 29, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Group 1

EXPERIMENTAL

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: ManipulationProcedure: Core Stability ExercisesProcedure: Intramusular electrotherapy

Group 2

EXPERIMENTAL

Hot pack 10 mins soft tissue / myofacial release ( piriformis, erector spinae ) Piriformis stretching core stability exercises

Procedure: Physical AgentsProcedure: Core Stability ExercisesProcedure: Soft tissue mobility

Interventions

Hot pack

Group 2
ManipulationPROCEDURE

HVLA manipulation of SI joint

Group 1

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.

Group 1Group 2

Intramuscular electrotherapy/ 3 sessions per week

Group 1

Stretching and Myofacial Release of piriformis and erector spinae

Group 2

Eligibility Criteria

Age22 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Central Study Contacts

Usama Ibrar, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 4, 2024

Study Start

July 15, 2023

Primary Completion

May 20, 2024

Study Completion

June 20, 2024

Last Updated

June 4, 2024

Record last verified: 2024-05

Locations