Clinical trial NCT03940287: Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction
Official title: Efficacy of Muscle Energy Technique and Kinesiotape Application in Addition to Other Physiotherapeutic Intervention in Patients With Mechanical Sacroiliac Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Keywords: Sacroiliac Joint pain
Low back pain
Pelvic girdle pain
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group pre test post test Randomized Clinical Design
Primary purpose: TREATMENT

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).

Detailed description: 1. Introduction:

   Mechanical Sacroiliac joint dysfunction (SIJD) is the most common source of low back pain and affects 70-85% adults. It is also associated with groin \& buttock pain and sometime also leg pain. Non discogenic pain can also be occur due to dysfunction around Sacroiliac Joint. Sacroiliac joint dysfunction also called as pelvic girdle pain (PGP), which arises from several intra-articular structures, anterior sacroiliac ligament, posterior sacroiliac ligament, articular cartilages. Sacroiliac joint pain is one of the common sources of mechanical low back pain. This may lead to bio-mechanical alteration in structure around pelvis.Where as Muscle Energy Technique(MET) involves physiological response of the antagonists of a muscle which has been isometrically contracted. Mainly MET is a soft tissue manipulation which include force generated by the patient may be maximum muscle contraction are twitch of the muscle. Where as functional stability as well as mobility can be achieved by Kinesiotape application.

   1.1: Problem statement:

   Mainly sacroiliac joint dysfunction associated with altered arthokinematics due to muscle weakness. Kinesiotaping and MET will be helpful if they are used with conventional physiotherapy. Thus there is need to find out the efficacy of MET and Kinesiotaping in addition to conventional physiotherapy in patients with mechanical SIJD.

   1.2:Purpose of the study:

   The purpose of the study is to find out the efficacy of MET and Kinesiotaping in addition to conventional physiotherapy in patients with mechanical sacroiliac joint dysfunction.

   1.3: Objectives of the study:

   1.3.1:To determine the effect of MET and Kinesiotaping in addition to conventional physiotherapy in patients with Mechanical Sacroiliac joint Dysfunction. 1.3.2:To compare the effect of MET \&Kinesiotaping in patients with Mechanical Sacroiliac joint dysfunction.
2. Procedure:

The study will be a Two group pre test post test Randomized clinical trial. The study protocol has been approved from the Institutional Ethics Committee of Maharishi Markandeshwar Deemed to be University.

MET Application: MET will be used with conventional treatment in Experimental Group 1. MET will be applied for posterior and anterior in-nominate and for weakened muscles like piriformis.

Here patient will be asked to apply 20% force against therapist force and hold that contraction for 10 seconds with 3-5 repetitions.The treatment will be given for 3 times a week and continued for 4 weeks.

Kinesiotaping will be given with conventional physiotherapy in Experimental Group 2. In this group KT will be applied to piriformis muscle and Sacroiliac joint (SIJ).

For piriformis application patient will be in side lying position where the effected leg will be placed uppermost with hip in flexion, adduction, and internal rotation and Y strips will be used \& treatment will be given for 4 weeks with 3 alternative days in a week.

Conventional Physiotherapy will be given in both the groups. Before going for intervention Hydrocollator pack will be given in both the groups for at least 15 minutes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Digitalized Pain Pressure Algometer
timeFrame: 2 weeks
measure: Hand Held Dynamometer
timeFrame: 2 weeks
Secondary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Ambala
country: India
facility: Maharishi Markandeshwar Hospital, Mullana
state: Haryana
Study officials:
affiliation: Department of Musculoskeletal Physiotherapy, MMIPR
name: Manisha Sarkar, BPT, (MPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shinde M, Jagtap V. Effect of Muscle Energy Technique and Mulligan Mobilization in Sacroiliac Joint Dysfunction. Glob J Res Anal. 2018;(3):79-81.
citation: 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).