NCT03940287

Brief Summary

Background: Mechanical sacroiliac joint dysfunction is associated with pain and stiffness which can later on gives restriction of overall motion. Total 60% of the body weight is mainly received by the sacroiliac joint and it is related with pelvis and lower extremity. Due to Bio- mechanical alteration muscles around the joint area get weakened.Muscle energy technique helps to improve body's normal function by giving strength as well as decrease pain and stiffness and Kinesiotaping also helps to stabilize the joint structure by giving more functional benefit. Aim: The Aim of the study is to evaluate the efficacy of Muscle energy technique \& Kinesiotaping in addition to other physio-therapeutic intervention in patients with Mechanical Sacroiliac joint Dysfunction. Methods: This study is a randomized clinical trial and subjects will recruit on the basis of inclusion criteria. Age group between 30 to 50 years of mechanical sacroiliac joint dysfunction patients will be taken. Any pathological condition like inflammation of sacroiliac joint and fracture of pelvic bone will be excluded. Patient will be randomized on the basis of SNOSE method. After randomization in two equal group treatment will be given and data will be analyzed separately. One Experimental group will receive Muscle energy technique and conventional physiotherapy and another experimental group will receive Kinesiotaping and conventional physiotherapy. Modified Oswestry Disability Index helps to evaluate functional limitation associated with Mechanical Sacroiliac joint Dysfunction. Data Analysis: Normality of the collected data will be established by Shapiro wilk test. Based on the normality, descriptive statistics data will be expressed as mean± standard deviation or median and intra-quartile range. Within group comparison will be calculated by paired-t test or Wilcoxon Signed Rank test and between group comparison will be done through Independent-t test or Mann-Why U test. P value will be set at significance level(0.05).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

May 1, 2019

Last Update Submit

June 17, 2020

Conditions

Keywords

Sacroiliac Joint painLow back painPelvic girdle pain

Outcome Measures

Primary Outcomes (2)

  • Digitalized Pain Pressure Algometer

    It is an important tool for measuring pain pressure threshold level

    2 weeks

  • Hand Held Dynamometer

    It is useful tool for calculating muscle strength of lower extremity

    2 weeks

Secondary Outcomes (1)

  • Modified Oswestry Disability Index

    2 weeks

Study Arms (2)

Muscle Energy Technique and Conventional Physiotherapy

EXPERIMENTAL

Muscle Energy Technique will be given with conventional physiotherapy for 3 days per week and will be continue for 4 weeks, where each session of Muscle Energy Technique will be repeated for 3-5 repetitions.

Other: Muscle Energy TechniqueOther: Conventional physiotherapy

Kinesiotaping and Conventional Physiotherapy

EXPERIMENTAL

Kinesiotape application will be given with conventional physiotherapy for 3 days per week and will be continue for 4 weeks

Other: Kinesiotape applicationOther: Conventional physiotherapy

Interventions

Muscle energy technique will be given in two different position. For anterior in- nominate rotation and posterior in- nominate rotation patient position will be in supine lying position. For weakened muscle,piriformis application the patient should be side-lying position, close to the edge of the table, affected side uppermost, both legs flexed at hip and knee. The therapists stand facing the patient at hip level,then patient should be close enough to the edge of the table for the therapist to stabilize the pelvis against his trunk. The angle of hip flexion should not exceed 60°, and then places one hand on the contralateral ASIS to prevent pelvic motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis. Isometric contraction should be hold for 3-5 second and that particular method will be repeated for 7-10 times.

Muscle Energy Technique and Conventional Physiotherapy

Kinesiotaping will be applied to piriformis muscle and Sacroiliac joint (SIJ). This tape will be applied in I shape to both sides of the spine from sacrum to Anterior Superior Iliac Spine. For SIJ taping same 5 cm KT tape will be used, it will be applied from below posterior sacroiliac spine to opposite side. Here patient should be in standing position. For Piriformis application patient will be in side lying position where the affected leg will be placed uppermost with hip in flexion, adduction, and internal rotation , then the application will be performed. The base of the tape will be placed over contralateral part of sacrum and then make a Y strip with no tension will be attached over the greater trochanter of femur.

Kinesiotaping and Conventional Physiotherapy

Hydro-collator pack will be used superior to the affected area for at-least 15 minute to reduce the stiffness. Hydocollator pack will be wrap twice with a thick towel and then it will be placed to the affected part.

Kinesiotaping and Conventional PhysiotherapyMuscle Energy Technique and Conventional Physiotherapy

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain in the low back, buttock and groin area
  • Restricted Sacroiliac joint motion as tested by clinical tests (Standing Flexion \& Sitting Flexion test)
  • Leg pain more than 4 weeks but less than 1 year

You may not qualify if:

  • Inflammation in sacroiliac joint like sacroilitis
  • Pregnancy
  • Pelvic bone Fractures
  • Metallic implants (endoprostheses) in pelvis
  • Malignancy
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, 133207, India

Location

Related Publications (2)

  • Shinde M, Jagtap V. Effect of Muscle Energy Technique and Mulligan Mobilization in Sacroiliac Joint Dysfunction. Glob J Res Anal. 2018;(3):79-81.

    RESULT
  • Society TK, Therapy P, Journal T, Therapy KP, Ther KP, Scholar G, et al. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. J Korean Phys Ther. 2017;29(6).

    RESULT

MeSH Terms

Conditions

Low Back PainPelvic Girdle Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal PainPelvic Pain

Study Officials

  • Manisha Sarkar, BPT, (MPT)

    Department of Musculoskeletal Physiotherapy, MMIPR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant blinded (Single blinded)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group pre test post test Randomized Clinical Design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Supervisor and Associate Professor, Department of Pediatric and Neonatal Physiotherapy

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 7, 2019

Study Start

September 1, 2019

Primary Completion

March 18, 2020

Study Completion

March 19, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

It is not yet decided

Locations