CompletedNot Applicable

Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

Ireland79 participantsStarted 2016-04

Plain-language summary

Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other pathology exists. The effectiveness of manual therapy in studies have shown statistically significant pre and post treatment differences.However no study has reviewed the efficacy of inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD. This study will investigate the effectiveness of trans-perineal trigger point dry needling used with manual therapy techniques for CPP.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients reporting non-cyclical CPP with dyspareunia and associated PFD with no palpable pelvic floor pathology, but with palpable high pelvic floor muscle (PFM) tone and tenderness will be referred for physiotherapy by the gynaecology team. * Visceral conditions like interstitial cystitis are difficult to exclude at gynaecology review, as they mimic CPP symptoms. * Smokers and non-smokers included. * Nulliparous, singleton and multiparous patients. Exclusion Criteria: * Body mass index greater than 30, makes it difficult to dry needle as the required needle length is not available. * Chronic back pain over 6 months duration, under pain management team. * Orthopaedic back surgeries with implants. * Pelvic pathologies like endometriosis, fibroids, cysts, etc. * Pregnancy related pelvic pain. * Pregnant during the trial. * Pelvic organ carcinomas. * Undergoing cancer treatment. * Post gynaecology surgeries, less than 16 weeks. * Cardiovascular, gastroenterology, renal or orthopaedic surgery, less than 6 month's post-operative. * Neurological conditions like stroke, epilepsy, Parkinson's disease etc. * Exclusion criteria for dry needling: * Extreme needle phobia, Rheumatoid arthritis, prolonged corticosteroid treatment, warfarin treatment, heart implants and blood clotting disorders. * Participant with no significant learning disability and should be able to understand the procedure to consent for treatment. * Participant should not require a chaperone d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain reduction or resolution within 10 treatment sessions, evaluated with the 0-10 Numeric Pain Rating Scale (0-10NPRS)

Timeframe: 10 weeks or earlier on resolution

Trial details

NCT IDNCT02795026

SponsorCork University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-02

View on ClinicalTrials.gov More Dyspareunia trials