Piriformis Muscle SyndromeNCT05660005
Self Myofascial Release in Individuals With Piriformis Syndrome
A study testing Muscle Stretching, Self Myofascial Release and home exercises in people with Piriformis Muscle Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Piriformis syndrome is pain that extends from the hip to the knee, caused by the pressure of the piriformis muscle in the hip on the sciatic nerve. There is no valid protocol for the treatment of this syndrome. Physiotherapists generally use hip strengthening exercises and modalities for pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Piriformis Muscle Syndrome
- What is being tested?
- Muscle Stretching, Self Myofascial Release and home exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2019to 3 Dec 2022
- 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
- Male and female participants
- Aged 20 to 40 years
- Presented leg or hip posterior compartment pain
- Diagnosed with chronic PS and without any other source of pain
Who cannot join
- Any pathology or acute injury around the hip, sacroiliac joint, or lumbar spine;
- Limb length discrepancy,
- Recent buttock trauma,
- Deep gluteal syndrome,
- Extrapelvic compression of the sciatic nerve or sacral plexus ischiogluteal/ischiofemoral bursitis or impingement, Upper hamstring tendinitis,
- Fibromyalgia, myofascial pain syndrome
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Self Myofascial Release and Stretching Exercises in Individuals With Piriformis Syndrome
Piriformis syndrome is pain that extends from the hip to the knee, caused by the pressure of the piriformis muscle in the hip on the sciatic nerve. There is no valid protocol for the treatment of this syndrome. Physiotherapists generally use hip strengthening exercises and modalities for pain. In this study, in addition to the classical treatment, we will give two different programs consisting of self-myofascial relaxation and stretching exercises to two different groups for 4 weeks as home exercise. We will question the level of pain that people felt in the hip before starting the exercises and at the 4th week after starting the exercises and measured the hip joint range of motion.
Read the detailed description
Piriformis syndrome (PS) is a condition caused by compression of the sciatic nerve, causing pain, tingling, and numbness. Although conservative treatment includes hip muscle strengthening and stretching, there is no proven treatment method in the literature.
This study will be conducted to investigate the effect of stretching and myofascial release added to standard physiotherapy treatment in piriformis syndrome.
This prospective, randomized controlled study will be planned to completed with 64 individuals between the ages of 20-40. Participants will be randomized into the Piriformis Muscle Stretch Group (PiM-S) and Piriformis Muscle Self Myofascial Release Group (PiM-SMR). Both groups will be included in a home program of muscle strengthening exercises for 4 weeks. And groups will be subjected to perform stretching and self-myofascial relaxation exercises, respectively, in addition to the home exercise program. The primary outcome of the study is pain intensity, and the secondary outcome is determined as the range of motion (ROM) of the hip.
- Conditions
- Piriformis Muscle Syndrome
- Being tested
- Muscle Stretching, Self Myofascial Release, home exercises
- Keywords
- Piriformis syndrome, Pain, hip, range of motion, sciatica
- Medical subject headings
- Piriformis Muscle Syndrome, Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle StretchingOther
Also called Piriformis Muscle Stretching
Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week.
Self Myofascial ReleaseOther
The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions).
home exercisesOther
The exercise brochure consists of 5 different exercises that include isometric and isotonic strengthening of the hip and surrounding muscles. Isometric contraction of gluteus maximus, hip march, external/internal rotation of hips with theraband, 4 sided straight leg raises were the exercises and prescribed 5 days a week, 10 repetitions, 3 sets. All participants were advised to use analgesics determined by the physician in case of unbearable pain and to apply a hot pack for 10-20 minutes before sessions.
| Study group | Role | What they receive |
|---|---|---|
| Piriformis Muscle Stretching | Active comparator | Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week. Receives: Other: Muscle Stretching |
| Piriformis Muscle Self Myofascial Release | Active comparator | The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions). Receives: Other: Self Myofascial Release |
| Control Group | Experimental | The individuals who refused to apply stretching or releasing included to the control group. They perform only home exercises of hip strengthening Receives: Other: home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The severity of sciatic pain extending along the hip and leg was questioned with the Visual Analog Scale (VAS). The assessment was based on a horizontal 10 cm scale from 1 (least pain) to 10 (the worst pain ever)
Measured: 4 weeks
Secondary outcomes (6)
Extension Range of motion of the hip angle
Extension ROM was measured while the individual was in the pronee position, the pivot point of the goniometer at the trochanter major, the moving arm aligned on the lateral midline of the femur, and the stable arm aligned parallel to the ground.
Measured: 4 weeks
Flexion Range of motion of the hip angle
Flexion ROM was measured while the individual was in the supine position, the pivot point of the goniometer at the trochanter major, the moving arm aligned on the lateral midline of the femur, and the stable arm aligned parallel to the ground.
Measured: 4 weeks
Adduction Range of motion of the hip angle
Adduction ROM were evaluated in the supine position, with the pivot point on the anterior projection of the trochanter major, the stable arm parallel to the anterior superior of the spina iliaca, and the moving arm on the anterior midline of the femur. Femur approached to the midline
Measured: 4 weeks
Abduction Range of motion of the hip angle
Abduction and adduction ROM were evaluated in the supine position, with the pivot point on the anterior projection of the trochanter major, the stable arm parallel to the anterior superior of the spina iliaca, and the moving arm on the anterior midline of the femur. During the evaluation of abduction, attention was paid to the absence of external rotation of the hip and the absence of internal rotation of the hip in adduction.
Measured: 4 weeks
External Rotation Range of motion of the hip angle
The measurement was taken in a prone position, with the knees flexed to 90°, pivot point on the tibial tubercle, with the stable arm perpendicular to the ground and the mobile arm following the tibial crista. During the evaluation, attention was paid to the absence of hip adduction and abduction movement. Knee turned externally
Measured: 4 weeks
Internal Rotation Range of motion of the hip angle
The measurement was taken in a prone position, with the knees flexed to 90°, pivot point on the tibial tubercle, with the stable arm perpendicular to the ground and the mobile arm following the tibial crista. During the evaluation, attention was paid to the absence of hip adduction and abduction movement. Knee turned internally
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 posted21 Dec 2022
- Study start8 Mar 2019
- Primary completion7 May 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Piriformis Muscle SyndromeStudies 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
- Parallel group study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem ergezen, Medipol University
- Investigators
- Gizem Ergezen, PhD, Principal investigator, Medipol UniversityMustafa Sahin, PhD, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660005
- Sponsor's protocol ID
- E.10304 / 29.03.2018
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self Myofascial Release and Stretching Exercises in Individuals With Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT05660005
- Acronym / sponsor ID
- E.10304 / 29.03.2018
- Conditions
- Piriformis Muscle Syndrome
- Keywords
- Piriformis syndrome, Pain, hip, range of motion, sciatica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 7 May 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 21 Dec 2022 (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 pain that extends from the hip to the knee, caused by the pressure of the piriformis muscle in the hip on the sciatic nerve. There is no valid protocol for the treatment of this syndrome. Physiotherapists generally use hip strengthening exercises and modalities for pain. In this study, in addition to the classical treatment, we will give two different programs consisting of self-myofascial relaxation and stretching exercises to two different groups for 4 weeks as home exercise. We will question the level of pain that people felt in the hip before starting the exercises and at the 4th week after starting the exercises and measured the hip joint range of motion.
Detailed description
Piriformis syndrome (PS) is a condition caused by compression of the sciatic nerve, causing pain, tingling, and numbness. Although conservative treatment includes hip muscle strengthening and stretching, there is no proven treatment method in the literature.
This study will be conducted to investigate the effect of stretching and myofascial release added to standard physiotherapy treatment in piriformis syndrome.
This prospective, randomized controlled study will be planned to completed with 64 individuals between the ages of 20-40. Participants will be randomized into the Piriformis Muscle Stretch Group (PiM-S) and Piriformis Muscle Self Myofascial Release Group (PiM-SMR). Both groups will be included in a home program of muscle strengthening exercises for 4 weeks. And groups will be subjected to perform stretching and self-myofascial relaxation exercises, respectively, in addition to the home exercise program. The primary outcome of the study is pain intensity, and the secondary outcome is determined as the range of motion (ROM) of the hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel group study
| Arm | Type | Receives |
|---|---|---|
| Piriformis Muscle Stretching | Active comparator | Other: Muscle StretchingStretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week. |
| Piriformis Muscle Self Myofascial Release | Active comparator | Other: Self Myofascial ReleaseThe patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions). |
| Control Group | Experimental | Other: home exercisesThe individuals who refused to apply stretching or releasing included to the control group. They perform only home exercises of hip strengthening |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female participants
- Aged 20 to 40 years
- Presented leg or hip posterior compartment pain
- Diagnosed with chronic PS and without any other source of pain
Key exclusion criteria (7 listed)
- Any pathology or acute injury around the hip, sacroiliac joint, or lumbar spine;
- Limb length discrepancy,
- Recent buttock trauma,
- Deep gluteal syndrome,
- Extrapelvic compression of the sciatic nerve or sacral plexus ischiogluteal/ischiofemoral bursitis or impingement, Upper hamstring tendinitis,
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 StretchingAlso: Piriformis Muscle StretchingStretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week. | Other | Piriformis Muscle Stretching |
| Self Myofascial ReleaseThe patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions). | Other | Piriformis Muscle Self Myofascial Release |
| home exercisesThe exercise brochure consists of 5 different exercises that include isometric and isotonic strengthening of the hip and surrounding muscles. Isometric contraction of gluteus maximus, hip march, external/internal rotation of hips with theraband, 4 sided straight leg raises were the exercises and prescribed 5 days a week, 10 repetitions, 3 sets. All participants were advised to use analgesics determined by the physician in case of unbearable pain and to apply a hot pack for 10-20 minutes before sessions. | Other | Control Group |
Primary outcome
Pain Intensity
Time frame: 4 weeks
The severity of sciatic pain extending along the hip and leg was questioned with the Visual Analog Scale (VAS). The assessment was based on a horizontal 10 cm scale from 1 (least pain) to 10 (the worst pain ever)
6 secondary outcomes
Extension Range of motion of the hip angle
Time frame: 4 weeks
Flexion Range of motion of the hip angle
Time frame: 4 weeks
Adduction Range of motion of the hip angle
Time frame: 4 weeks
Abduction Range of motion of the hip angle
Time frame: 4 weeks
External Rotation Range of motion of the hip angle
Time frame: 4 weeks
Internal Rotation Range of motion of the hip angle
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 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Gizem Ergezen, PhD principal investigator
Medipol University
Mustafa Sahin, PhD study director
Medipol 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 Stretching, Self Myofascial Release and home exercises in people with Piriformis Muscle Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 21 Dec 2022. 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 Turkey (Türkiye). 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?
Pain Intensity (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 21 Dec 2022.