Sacroiliac DisorderNCT05088837
Muscle Energy Technique on Sacroiliac Dysfunction
A study testing muscle energy technique and ice and heat packs in people with Sacroiliac Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
Sacroiliac pain is a huge problem in women during pregnancy and postpartum period. Muscle energy technique has potential effect in decreasing the pain and disability Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Disorder
- What is being tested?
- muscle energy technique and ice and heat packs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Jul 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their ages ranged from 20 to 40 years .
- Their BMI was ranged from 25-30 kg / m2
Who cannot join
- hip fracture,
- SIJ infection.
- scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Muscle Energy Technique on Postpartum Sacroiliac Joint Dysfunction
Sacroiliac pain is a huge problem in women during pregnancy and postpartum period. Muscle energy technique has potential effect in decreasing the pain and disability
Read the detailed description
A sample of forty women diagnosed with postpartum sacroiliac dysfunction, their ages ranged from 20 to 40 years and their BMI was ranged from 25-30 kg / m2 participated in this study, they were selected and divided randomly into 2 equal groups (A\&B). Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each). All patients in both group were evaluated at the beginning of the study and after 12 sessions through measuring pain intensity using visual analog scale and disability using oswestry disability index (ODI)
- Conditions
- Sacroiliac Disorder
- Being tested
- muscle energy technique, ice and heat packs
- Keywords
- Muscle energy technique, sacroiliac dysfunction, ice and heat pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle energy techniqueOther
MET was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles. the limb was taken very slightly beyond the restriction barrier and was held there for 10-30 seconds, it was done 3 times per session for 12 sessions.
ice and heat packsOther
Applying 20 minutes: 10 minutes hot,10 minutes cold on sacroiliac area, 3 times per week for 12 sessions
| Study group | Role | What they receive |
|---|---|---|
| muscle energy technique | Experimental | muscle energy technique was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles, it was done 3 times per session for 12 sessions. Receives: Other: muscle energy technique |
| ice and heat packs | Experimental | Alternating ice and heat (20 min , 10 heat,10 cold),3times per week for 12sessions. Receives: Other: ice and heat packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale Visual anlage scale
It was used for determining pain intensity before and after the treatment course for each patients in both groups (A\&B). Visual analogue scale is a-10 centimeters line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10)
Measured: 4 weeks
Secondary outcomes (1)
Oswestry disability index
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, were used to measure the level of disability before and after treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Feb 2020
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac DisorderStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088837
- Sponsor's protocol ID
- Cairo Un113
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Energy Technique on Postpartum Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05088837
- Acronym / sponsor ID
- Cairo Un113
- Conditions
- Sacroiliac Disorder
- Keywords
- Muscle energy technique, sacroiliac dysfunction, ice and heat pack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 22 Oct 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.
Sacroiliac pain is a huge problem in women during pregnancy and postpartum period. Muscle energy technique has potential effect in decreasing the pain and disability
Detailed description
A sample of forty women diagnosed with postpartum sacroiliac dysfunction, their ages ranged from 20 to 40 years and their BMI was ranged from 25-30 kg / m2 participated in this study, they were selected and divided randomly into 2 equal groups (A\&B). Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each). All patients in both group were evaluated at the beginning of the study and after 12 sessions through measuring pain intensity using visual analog scale and disability using oswestry disability index (ODI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each).
| Arm | Type | Receives |
|---|---|---|
| muscle energy technique | Experimental | Other: muscle energy techniquemuscle energy technique was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles, it was done 3 times per session for 12 sessions. |
| ice and heat packs | Experimental | Other: ice and heat packsAlternating ice and heat (20 min , 10 heat,10 cold),3times per week for 12sessions. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Their ages ranged from 20 to 40 years .
- Their BMI was ranged from 25-30 kg / m2
Key exclusion criteria (3 listed)
- hip fracture,
- SIJ infection.
- scoliosis
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 techniqueMET was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles. the limb was taken very slightly beyond the restriction barrier and was held there for 10-30 seconds, it was done 3 times per session for 12 sessions. | Other | muscle energy technique |
| ice and heat packsApplying 20 minutes: 10 minutes hot,10 minutes cold on sacroiliac area, 3 times per week for 12 sessions | Other | ice and heat packs |
Primary outcome
visual analog scale Visual anlage scale
Time frame: 4 weeks
It was used for determining pain intensity before and after the treatment course for each patients in both groups (A\&B). Visual analogue scale is a-10 centimeters line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10)
1 secondary outcome
Oswestry disability index
Time frame: 4 weeks
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 22 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and ice and heat packs in people with Sacroiliac Disorder, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 3 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 22 Oct 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 Egypt. 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?
visual analog scale Visual anlage scale (time frame: 4 weeks). 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 22 Oct 2021.