Piriformis SyndromeNCT06530862
Piriformis Syndrome; Extracorporeal Shock Wave Therapy and Dry Needling
A study testing ESWT+stretching exercises and Dry needling+stretching exercises in people with Piriformis Syndrome and Extracorporeal Shock Wave Therapy, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is being conducted on patients with piriformis syndrome. Patients are divided into two groups by list randomization method: Extracorporeal shock wave therapy (ESWT) group and Dry neddling (DN) group. Both groups of patients agreed to perform basic stretching exercises. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Piriformis Syndrome, Extracorporeal Shock Wave Therapy
- What is being tested?
- ESWT+stretching exercises and Dry needling+stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2024to 23 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- Complaint for more than 3 months
Who cannot join
- disc pathologies according to radiological imaging
- hip joint and soft tissue pathologies
- recent history of trauma, history of surgery in the lumbar and hip region
- history of rheumatologic disease
- history of polyneuropathy
- history of sciatic nerve injury
Show all 10Show fewer
- history of malignancy
- opioid analgesia or corticosteroid intervention for pain in the last month
- patients receive another treatment during the study
- Having a contraindication for DN treatment or ESWT treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of ESWT and Dry Needling Treatments in the Management of Piriformis Syndrome; A Randomized Study
This study is being conducted on patients with piriformis syndrome. Patients are divided into two groups by list randomization method: Extracorporeal shock wave therapy (ESWT) group and Dry neddling (DN) group. Both groups of patients agreed to perform basic stretching exercises. The ESWT group received 3 sessions of radial ESWT, 1 session per week. The DN group received 3 sessions of ultrasound-guided needling, 1 session per week. Clinical evaluations of the participants were performed at the beginning of treatment, 1 month, and 3 months after treatment.
- Being tested
- ESWT+stretching exercises, Dry needling+stretching exercises
- Keywords
- ESWT, Dry Needling, Piriformis Syndrome
- 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.
ESWT+stretching exercisesOther
Participants in this group will receive ESWT treatment
Dry needling+stretching exercisesOther
Participants in this group will receive Dry needling treatment
| Study group | Role | What they receive |
|---|---|---|
| ESWT group | Active comparator | Patients in this group received three sessions of ESWT at an energy density of 4 bars and a frequency of 2,000 shocks/min at 5 Hz for three weeks, each session once a week. Receives: Other: ESWT+stretching exercises |
| Dry needling | Active comparator | The piriformis muscle of the patients in the group will be dry needled with 0.6*80 mm acupuncture needles under ultrasound guidance for 3 sessions at one week intervals. Receives: Other: Dry needling+stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) score
Pain was evaluated with a Visual analog scale (VAS) score
Measured: 7 months
Lower extremity functiunal scale (LEFS)
Pain was evaluated with a Lower extremity functiunal scale (LEFS (minimum=0, maximum=80)) The higher the score, the better the result
Measured: 7 months
Oswestry disability index (ODI)
Pain was evaluated with a Oswestry disability index (ODI (minimum=0, maximum=60))The lower the score the better the result
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start3 Feb 2024
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
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.
- 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
- Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Tayyip Dede, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530862
- Sponsor's protocol ID
- 22/12/2023; 2011-KAEK-50;347
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 30 Aug 2024
- 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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of ESWT and Dry Needling Treatments in the Management of Piriformis Syndrome; A Randomized Study
- ClinicalTrials.gov ID
- NCT06530862
- Acronym / sponsor ID
- 22/12/2023; 2011-KAEK-50;347
- Keywords
- ESWT, Dry Needling, Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 31 Jul 2024 (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.
This study is being conducted on patients with piriformis syndrome. Patients are divided into two groups by list randomization method: Extracorporeal shock wave therapy (ESWT) group and Dry neddling (DN) group. Both groups of patients agreed to perform basic stretching exercises. The ESWT group received 3 sessions of radial ESWT, 1 session per week. The DN group received 3 sessions of ultrasound-guided needling, 1 session per week. Clinical evaluations of the participants were performed at the beginning of treatment, 1 month, and 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling
| Arm | Type | Receives |
|---|---|---|
| ESWT group | Active comparator | Other: ESWT+stretching exercisesPatients in this group received three sessions of ESWT at an energy density of 4 bars and a frequency of 2,000 shocks/min at 5 Hz for three weeks, each session once a week. |
| Dry needling | Active comparator | Other: Dry needling+stretching exercisesThe piriformis muscle of the patients in the group will be dry needled with 0.6*80 mm acupuncture needles under ultrasound guidance for 3 sessions at one week intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years
- Complaint for more than 3 months
Key exclusion criteria (10 listed)
- disc pathologies according to radiological imaging
- hip joint and soft tissue pathologies
- recent history of trauma, history of surgery in the lumbar and hip region
- history of rheumatologic disease
- history of polyneuropathy
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 |
|---|---|---|
| ESWT+stretching exercisesParticipants in this group will receive ESWT treatment | Other | ESWT group |
| Dry needling+stretching exercisesParticipants in this group will receive Dry needling treatment | Other | Dry needling |
Primary outcome
Visual analog scale (VAS) score
Time frame: 7 months
Pain was evaluated with a Visual analog scale (VAS) score
Lower extremity functiunal scale (LEFS)
Time frame: 7 months
Pain was evaluated with a Lower extremity functiunal scale (LEFS (minimum=0, maximum=80)) The higher the score, the better the result
Oswestry disability index (ODI)
Time frame: 7 months
Pain was evaluated with a Oswestry disability index (ODI (minimum=0, maximum=60))The lower the score the better the result
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 30 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Piriformis Syndrome
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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.
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 ESWT+stretching exercises and Dry needling+stretching exercises in people with Piriformis Syndrome and Extracorporeal Shock Wave Therapy, run by Istanbul Training and Research 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 2 inclusion and 10 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 30 Aug 2024. 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?
Visual analog scale (VAS) score (time frame: 7 months). The study lists 3 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 30 Aug 2024.