Sacroiliac Joint DysfunctionNCT04790500
Effects Of Muscle Energy Technique Versus Mobilization
A study testing mobilization technique and muscle energy technique in people with Sacroiliac Joint Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- mobilization technique and muscle energy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Oct 2020to 20 Aug 2021
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-40 year having unilateral back pain around or on sacral sulcus,
- Positive posterior pain provocation test for Sacroiliac joint dysfunction,
- Low back pain within six weeks of delivery
- Pain while sitting down, lying on the ipsilateral side of pain, or climbing stairs.
- Local tenderness of the posterior aspect of the sacroiliac joint
- Pain is usually localized over the buttock.
- Sharp, stabbing, and/or shooting pain which extends down the posterior thigh usually not past the knee.
- C-section
Who cannot join
- Neurological deficit
- Spinal tumors
- Scoliosis,
- Underwent spinal surgery and prolapsed
- Intervertebral disc with or without radiculopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Muscle Energy Technique Versus Mobilization On Pain And Disability In Post-Partum Females With Sacroiliac Joint Dysfunction.
The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain
Read the detailed description
The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain in postpartum females and to check whether the amount of gaining range of movement is similar among postpartum female undergoing with mobilization therapy and with muscle energy technique.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- mobilization technique, muscle energy technique
- Keywords
- Mobilization, Muscle energy technique, Postpartum, Sacroiliac joint pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization techniqueOther
Mobilization of sacroiliac joint which will increase the range of motion and reduction in pain and improvement in functional limitation.
muscle energy techniqueOther
Muscle energy technique it is known as active muscular relaxation technique. It helps in lengthening the shorten muscle and increasing range of restricted muscles
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | mobilization technique Receives: Other: mobilization technique |
| Group B | Experimental | muscle energy technique Receives: Other: muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
- The 11-point (numeric pain rating scale) NPRS will use to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the 3 ratings or any single rating may be used to represent the patient's level of pain. Numeric pain scales have been shown to be reliable and valid. The reliability of numeric pain rating scale is 0.74
Measured: 4th week
Modified Oswestry disability index
It is a self-report questionnaire of a patient's perceived disability based on 10 areas of pain and daily activities (pain intensity, personal hygiene, lifting, walking, sitting, standing, sleeping, sexual activity, social activity and travelling). Each section is scored on a6-point scale (0-5), with 0 representing no limitation and 5 representing maximal limitation. The subscales combined add up to a total maximal score of 50. The score is then doubled and interpreted as a percentage of the patient-perceived disability (the higher the score, the greater the disability). In cases where patients did not answer all the 10 sections, the sum score of the answered sections were divided by the number of completed sections. The reliability of modified oswestry disability index is 0.88.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start14 Oct 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Aftab, Phd*, Principal investigator, Riphah college of rehabilitation and allied health sciences - Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790500
- Sponsor's protocol ID
- REC/00846 Nusrat Javed
- Status last verified
- Sep 2021
- First submitted
- 7 Mar 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Muscle Energy Technique Versus Mobilization On Pain And Disability In Post-Partum Females With Sacroiliac Joint Dysfunction.
- ClinicalTrials.gov ID
- NCT04790500
- Acronym / sponsor ID
- REC/00846 Nusrat Javed
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- Mobilization, Muscle energy technique, Postpartum, Sacroiliac joint pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 10 Mar 2021 (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.
The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain
Detailed description
The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain in postpartum females and to check whether the amount of gaining range of movement is similar among postpartum female undergoing with mobilization therapy and with muscle energy technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: mobilization techniquemobilization technique |
| Group B | Experimental | Other: muscle energy techniquemuscle energy technique |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 20-40 year having unilateral back pain around or on sacral sulcus,
- Positive posterior pain provocation test for Sacroiliac joint dysfunction,
- Low back pain within six weeks of delivery
- Pain while sitting down, lying on the ipsilateral side of pain, or climbing stairs.
- Local tenderness of the posterior aspect of the sacroiliac joint
Key exclusion criteria (5 listed)
- Neurological deficit
- Spinal tumors
- Scoliosis,
- Underwent spinal surgery and prolapsed
- Intervertebral disc with or without radiculopathy
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 |
|---|---|---|
| mobilization techniqueMobilization of sacroiliac joint which will increase the range of motion and reduction in pain and improvement in functional limitation. | Other | Group A |
| muscle energy techniqueMuscle energy technique it is known as active muscular relaxation technique. It helps in lengthening the shorten muscle and increasing range of restricted muscles | Other | Group B |
Primary outcome
Numeric pain rating scale
Time frame: 4th week
o The 11-point (numeric pain rating scale) NPRS will use to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the 3 ratings or any single rating may be used to represent the patient's level of pain. Numeric pain scales have been shown to be reliable and valid. The reliability of numeric pain rating scale is 0.74
Modified Oswestry disability index
Time frame: 4th week
It is a self-report questionnaire of a patient's perceived disability based on 10 areas of pain and daily activities (pain intensity, personal hygiene, lifting, walking, sitting, standing, sleeping, sexual activity, social activity and travelling). Each section is scored on a6-point scale (0-5), with 0 representing no limitation and 5 representing maximal limitation. The subscales combined add up to a total maximal score of 50. The score is then doubled and interpreted as a percentage of the patient-perceived disability (the higher the score, the greater the disability). In cases where patients did not answer all the 10 sections, the sum score of the answered sections were divided by the number of completed sections. The reliability of modified oswestry disability index is 0.88.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Sacroiliac Joint Dysfunction
Not yet recruiting
Effect of Retro Walking in Patients With Sacroiliac Joint Dysfunction
Sacroiliac Joint Dysfunction
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruitingObservational study
Correlation Between Trunk Muscles Endurance and Dynamic Balance in Sacroiliac Joint Dysfunction
Trunk Extensor Muscle Endurance
Active, not recruitingObservational study
Post-Market Clinical Study on a Modular SI Joint Fusion System
Sacroiliitis, Sacroiliac Joint Dysfunction
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.
Anam Aftab, Phd* principal investigator
Riphah college of rehabilitation and allied health sciences - Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization technique and muscle energy technique in people with Sacroiliac Joint Dysfunction, run by Riphah International University at 1 site in Pakistan.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 23 Sep 2021. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numeric pain rating scale (time frame: 4th week). 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?
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 23 Sep 2021.