Sacroiliac Joint DysfunctionNCT03940287
Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction
A study testing Muscle Energy Technique, Kinesiotape application and Conventional physiotherapy in people with Sacroiliac Joint Dysfunction, run by Asir John Samuel at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Muscle Energy Technique, Kinesiotape application and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2019to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Inflammation in sacroiliac joint like sacroilitis
- Pregnancy
- Pelvic bone Fractures
- Metallic implants (endoprostheses) in pelvis
- Malignancy
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Muscle Energy Technique and Kinesiotape Application in Addition to Other Physiotherapeutic Intervention in Patients With Mechanical Sacroiliac Joint Dysfunction
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.
Read more
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).
Read the detailed description
- 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.
- 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.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Muscle Energy Technique, Kinesiotape application, Conventional physiotherapy
- Keywords
- Sacroiliac Joint pain, Low back pain, Pelvic girdle pain
- Medical subject headings
- Low Back Pain, Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniqueOther
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.
Kinesiotape applicationOther
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.
Conventional physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Muscle Energy Technique; Other: 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 Receives: Other: Kinesiotape application; Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digitalized Pain Pressure Algometer
It is an important tool for measuring pain pressure threshold level
Measured: 2 weeks
Hand Held Dynamometer
It is useful tool for calculating muscle strength of lower extremity
Measured: 2 weeks
Secondary outcomes (1)
Modified Oswestry Disability Index
It is an extremely important tool used to measure a patients permanent functional disability. The total score ranges from 0-50. For each section total possible score is 5.
0-20%- Minimal disability 20-41%-Moderate disability 41-60%-Severe disability 61-80%-Crippled 81-100%-Bed bound
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Sep 2019
- Primary completion18 Mar 2020
- Study completion19 Mar 2020
Why it stopped: Due to COVID-19 lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group pre test post test Randomized Clinical Design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Manisha Sarkar, BPT, (MPT), Principal investigator, Department of Musculoskeletal Physiotherapy, MMIPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940287
- Sponsor's protocol ID
- MMDU/IEC/1370
- Other IDs
- U1111-1232-1305
- Status last verified
- Jun 2020
- First submitted
- 1 May 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet decided
Publications
Shinde M, Jagtap V. Effect of Muscle Energy Technique and Mulligan Mobilization in Sacroiliac Joint Dysfunction. Glob J Res Anal. 2018;(3):79-81.
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).
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Muscle Energy Technique and Kinesiotape Application in Addition to Other Physiotherapeutic Intervention in Patients With Mechanical Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT03940287
- Acronym / sponsor ID
- MMDU/IEC/1370
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- Sacroiliac Joint pain, Low back pain, Pelvic girdle pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 lockdown
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group pre test post test Randomized Clinical Design
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Technique and Conventional Physiotherapy | Experimental | Other: Muscle Energy Technique, Other: Conventional physiotherapyMuscle 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. |
| Kinesiotaping and Conventional Physiotherapy | Experimental | Other: Kinesiotape application, Other: Conventional physiotherapyKinesiotape application will be given with conventional physiotherapy for 3 days per week and will be continue for 4 weeks |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Inflammation in sacroiliac joint like sacroilitis
- Pregnancy
- Pelvic bone Fractures
- Metallic implants (endoprostheses) in pelvis
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Energy TechniqueMuscle 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. | Other | Muscle Energy Technique and Conventional Physiotherapy |
| Kinesiotape applicationKinesiotaping 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. | Other | Kinesiotaping and Conventional Physiotherapy |
| Conventional physiotherapyHydro-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. | Other | Kinesiotaping and Conventional Physiotherapy, Muscle Energy Technique and Conventional Physiotherapy |
Primary outcome
Digitalized Pain Pressure Algometer
Time frame: 2 weeks
It is an important tool for measuring pain pressure threshold level
Hand Held Dynamometer
Time frame: 2 weeks
It is useful tool for calculating muscle strength of lower extremity
1 secondary outcome
Modified Oswestry Disability Index
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Due to COVID-19 lockdown). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Results publicationShinde M, Jagtap V. Effect of Muscle Energy Technique and Mulligan Mobilization in Sacroiliac Joint Dysfunction. Glob J Res Anal. 2018;(3):79-81.
- Results publicationSociety 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).
- Individual participant dataSharing planned: No. It is not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manisha Sarkar, BPT, (MPT) principal investigator
Department of Musculoskeletal Physiotherapy, MMIPR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique, Kinesiotape application and Conventional physiotherapy in people with Sacroiliac Joint Dysfunction, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 lockdown). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digitalized Pain Pressure Algometer (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940287, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.