Piriformis SyndromeNCT05915858
Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome
A study testing muscle energy technique and stretching exercise in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- muscle energy technique and stretching exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Feb 2023to 20 Aug 2023
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 25-45 years .
- Tenderness of piriformis muscle.
- Chronic non-specific low back pain patients.
- Women in second trimester of pregnancy
- Multiparous women
- SLR positive below 60 degrees .
- VAS score: 6-10
- Internal rotation of hip less than 45 degrees.
Who cannot join
- SLR negative test
- Skin allergy
- Pre-eclampsia
- Gestational diabetes mellitus
- Clinical diagnosis of osteoarthritis or history of fracture of lower extremities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Lady Willington
Lahore, Punjab Province, 54660
Shafaq Naaeem, ms-whpt, 03249567534, shafaqshazib@gmail.com
About this study
Official title: Effects of Muscle Energy Technique and Stretching Exercise on Pain, Hip Joint Range of Motion and Function in Working Pregnant Women With Piriformis Syndrome
Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility.
Read the detailed description
Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility. Stretching exercises improves physical performance ability, prevents injury, reduces muscle pain and increases flexibility. Both muscle energy technique and stretching has shown significant improvement in reducing pain and lower extremity function and increase range of motion.
Randomized clinical trial will be conducted. Sample size of 30 patients will be taken. Non probability convenient sampling will be used.A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups, to either the muscle energy technique group or stretching exercises group.Treatment will be given twice a week for twelve treatment session..Numeric pain rating scale will be used to measure the intensity of pain,Lower extremity functional scale will be used to access lower extremity function. Standard goniometer is used to measure hip joint range of motion.All participants in both groups will be evaluated before and after treatment programme.Total duration of study will be six months.Data will be analyzed by using SPSS 25. Key words Muscle energy technique,Stretching exercises,Piriformis syndrome,Pain,Range of motion
- Conditions
- Piriformis Syndrome
- Being tested
- muscle energy technique, stretching exercise
- Keywords
- muscle energy technique,stretching exercise, pain rom
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle energy techniqueOther
Group 1: Group 2:
Muscle energy technique (Reciprocal inhibition) Stretching exercises Static stretching 2 weeks (twelve treatment session) patient supine, the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra-lateral knee (the leg on the side to be treated is crossed over the other, straight leg).
- The angle of hip flexion should not exceed 60 degree.
- The practitioner places one hand on the contra-lateral ASIS to prevent pelvis motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis for 7-10 seconds.
stretching exerciseOther
Following the contraction the practitioner eases the treated side leg into adduction until a sense of resistance is noted; this is held for 10-30 seconds. 2 week (twelve treatment session) practitioner manual stretches the piriformis:
- The patient lies in supine position the affected leg is placed into flexion at hip and knee so that the foot rests on the table lateral to the contra-lateral knee.
- The practitioner places one hand over the contra-lateral ASIS to stabilize the pelvis during the exercise and passively abducts and internally rotates the hip medially till the pain is bearable.
- The process is repeated 3-5 times with a 30
| Study group | Role | What they receive |
|---|---|---|
| muscle energy technique | Experimental | muscle energy technique Receives: Other: muscle energy technique |
| stretching exercise | Active comparator | stretching exercises along with piriformis stretch Receives: Other: stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
Measurement of pain intensity was done by using numeric pain rating scale.it is reliable and valid.subjects were explained about the scale and instructed to indicate the intensity of current,best and worst pain on a scale of zero(no pain) to ten(worst pain)
Measured: 6months
Secondary outcomes (1)
Measurements of pain Intensity
measurement were taking at pre intervention and post intervention after the end of second week intervention.(10) Lower extremity functional scale Lower extremity functional scale is a questionnaire containing twenty question about persons ability to perform everyday task.The LEFS can be used by clinician as a measure of patients initial function,ongoing progress and out come as well as to set functional goals.
The LEFS has maximum scores of 80 points where lower the score greater disability
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start2 Feb 2023
- Primary completion20 Aug 2023 (estimated)
- Study completion20 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Piriformis SyndromeStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915858
- Sponsor's protocol ID
- REC/RCR&AHS/23/0518
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- 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 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Energy Technique and Stretching Exercise on Pain, Hip Joint Range of Motion and Function in Working Pregnant Women With Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT05915858
- Acronym / sponsor ID
- REC/RCR&AHS/23/0518
- Conditions
- Piriformis Syndrome
- Keywords
- muscle energy technique,stretching exercise, pain rom
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 20 Aug 2023 (estimated)
- First posted
- 23 Jun 2023 (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.
Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility.
Detailed description
Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility. Stretching exercises improves physical performance ability, prevents injury, reduces muscle pain and increases flexibility. Both muscle energy technique and stretching has shown significant improvement in reducing pain and lower extremity function and increase range of motion.
Randomized clinical trial will be conducted. Sample size of 30 patients will be taken. Non probability convenient sampling will be used.A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups, to either the muscle energy technique group or stretching exercises group.Treatment will be given twice a week for twelve treatment session..Numeric pain rating scale will be used to measure the intensity of pain,Lower extremity functional scale will be used to access lower extremity function. Standard goniometer is used to measure hip joint range of motion.All participants in both groups will be evaluated before and after treatment programme.Total duration of study will be six months.Data will be analyzed by using SPSS 25. Key words Muscle energy technique,Stretching exercises,Piriformis syndrome,Pain,Range of motion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| muscle energy technique | Experimental | Other: muscle energy techniquemuscle energy technique |
| stretching exercise | Active comparator | Other: stretching exercisestretching exercises along with piriformis stretch |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 25-45 years .
- Tenderness of piriformis muscle.
- Chronic non-specific low back pain patients.
- Women in second trimester of pregnancy
- Multiparous women
Key exclusion criteria (5 listed)
- SLR negative test
- Skin allergy
- Pre-eclampsia
- Gestational diabetes mellitus
- Clinical diagnosis of osteoarthritis or history of fracture of lower extremities
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 techniqueGroup 1: Group 2: Muscle energy technique (Reciprocal inhibition) Stretching exercises Static stretching 2 weeks (twelve treatment session) patient supine, the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra-lateral knee (the leg on the side to be treated is crossed over the other, straight leg). * The angle of hip flexion should not exceed 60 degree. * The practitioner places one hand on the contra-lateral ASIS to prevent pelvis motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis for 7-10 seconds. | Other | muscle energy technique |
| stretching exerciseFollowing the contraction the practitioner eases the treated side leg into adduction until a sense of resistance is noted; this is held for 10-30 seconds. 2 week (twelve treatment session) practitioner manual stretches the piriformis: * The patient lies in supine position the affected leg is placed into flexion at hip and knee so that the foot rests on the table lateral to the contra-lateral knee. * The practitioner places one hand over the contra-lateral ASIS to stabilize the pelvis during the exercise and passively abducts and internally rotates the hip medially till the pain is bearable. * The process is repeated 3-5 times with a 30 | Other | stretching exercise |
Primary outcome
Numeric pain rating scale
Time frame: 6months
Measurement of pain intensity was done by using numeric pain rating scale.it is reliable and valid.subjects were explained about the scale and instructed to indicate the intensity of current,best and worst pain on a scale of zero(no pain) to ten(worst pain)
1 secondary outcome
Measurements of pain Intensity
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Comparative Effects of Post-Isometric Relaxation and Reciprocal Inhibition Techniques inPiriformis Syndrome
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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.
Hafiza Neelam, MS principal investigator
Riphah International University
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 stretching exercise in people with Piriformis Syndrome, 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hafiza neelam, MS (03204097476, hafiza.neelam@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 6months). 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 Jun 2023.