Piriformis SyndromeNCT06437795
Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome
A study testing Dry Needling Group and Cupping Therapy Group in people with Piriformis Syndrome, run by Superior University at 1 site in Pakistan.
Trial summary
This study aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Dry Needling Group and Cupping Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 1 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 to 65 years.
- Diagnosed with piriformis syndrome.
- Experiencing chronic pain for at least 3 months.
- Willingness to comply with the study protocol and attend all therapy sessions.
Who cannot join
- Recent surgery on the lower back or hip.
- Presence of systemic diseases affecting muscle function (e.g., multiple sclerosis, rheumatoid arthritis).
- Pregnant or breastfeeding women.
- Use of anticoagulant medication or having a bleeding disorder.
- Participating in another clinical trial simultaneously
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle, leading to buttock pain and radiating numbness.
Read the detailed description
The study will recruit participants diagnosed with Piriformis Syndrome and will randomly assign them to receive either dry needling or cupping therapy over a specific period. The primary outcome will be the reduction in pain intensity measured by standardized pain assessment tools. Secondary outcomes will include improvements in functional mobility and quality of life. By analyzing the efficacy and patient-reported outcomes of both therapies, the study aims to provide evidence-based recommendations for clinicians treating Piriformis Syndrome.
- Conditions
- Piriformis Syndrome
- Being tested
- Dry Needling Group, Cupping Therapy Group
- 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.
Dry Needling GroupDiagnostic test
Participants in this group will receive dry needling therapy. This involves inserting thin needles into trigger points in the piriformis muscle to relieve pain and muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes.
Cupping Therapy GroupOther
Participants in this group will receive cupping therapy. This involves placing cups on the skin to create suction, which is believed to improve blood flow and reduce muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group | Experimental | Not described Receives: Diagnostic Test: Dry Needling Group |
| Cupping Therapy Group | Other | Not described Receives: Other: Cupping Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Participants will rate their pain on a scale from 0 (no pain) to 10 (worst possible pain) at the beginning and end of the study.
Measured: 12 Months
Oswestry Disability Index (ODI)
This tool assesses the degree of disability in performing daily activities. Quality of life improvements measured by the SF-36 Health Survey, which evaluates physical and mental health status.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion1 Sep 2024 (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 Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437795
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/715
- Status last verified
- May 2024
- First submitted
- 25 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT06437795
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/715
- Conditions
- Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 31 May 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 aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle, leading to buttock pain and radiating numbness.
Detailed description
The study will recruit participants diagnosed with Piriformis Syndrome and will randomly assign them to receive either dry needling or cupping therapy over a specific period. The primary outcome will be the reduction in pain intensity measured by standardized pain assessment tools. Secondary outcomes will include improvements in functional mobility and quality of life. By analyzing the efficacy and patient-reported outcomes of both therapies, the study aims to provide evidence-based recommendations for clinicians treating Piriformis Syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Diagnostic Test: Dry Needling Group |
| Cupping Therapy Group | Other | Other: Cupping Therapy Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged between 18 to 65 years.
- Diagnosed with piriformis syndrome.
- Experiencing chronic pain for at least 3 months.
- Willingness to comply with the study protocol and attend all therapy sessions.
Key exclusion criteria (5 listed)
- Recent surgery on the lower back or hip.
- Presence of systemic diseases affecting muscle function (e.g., multiple sclerosis, rheumatoid arthritis).
- Pregnant or breastfeeding women.
- Use of anticoagulant medication or having a bleeding disorder.
- Participating in another clinical trial simultaneously
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 |
|---|---|---|
| Dry Needling GroupParticipants in this group will receive dry needling therapy. This involves inserting thin needles into trigger points in the piriformis muscle to relieve pain and muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes. | Diagnostic test | Dry Needling Group |
| Cupping Therapy GroupParticipants in this group will receive cupping therapy. This involves placing cups on the skin to create suction, which is believed to improve blood flow and reduce muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes. | Other | Cupping Therapy Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 12 Months
Participants will rate their pain on a scale from 0 (no pain) to 10 (worst possible pain) at the beginning and end of the study.
Oswestry Disability Index (ODI)
Time frame: 12 months
This tool assesses the degree of disability in performing daily activities. Quality of life improvements measured by the SF-36 Health Survey, which evaluates physical and mental health status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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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 Dry Needling Group and Cupping Therapy Group in people with Piriformis Syndrome, run by Superior 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 4 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 31 May 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 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?
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) (time frame: 12 Months). 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 31 May 2024.