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Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

To Investigate the Use of Trans-perineal Trigger Point Dry Needling With Manual Therapy and to Compare the Outcome With Manual Therapy Treatment for Chronic Pelvic Pain With Dyspareunia. A Randomized Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02795026
Enrollment
79
Registered
2016-06-09
Start date
2016-04-30
Completion date
2018-06-30
Last updated
2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspareunia

Keywords

dry needling, vulvodynia, pelvic pain chronic

Brief 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.

Detailed description

This study will investigate the effectiveness of inclusion of trans-perineal trigger point dry needling with manual therapy treatment for chronic pelvic pain with dyspareunia and associated pelvic floor dysfunctions.The use of trigger point dry needling (TrptDN) for chronic low back pain has proved beneficial.This study will evaluate the treatment outcomes of trans-perineal trigger point dry needling and manual therapy to only manual therapy for CPP. The outcomes will evaluate the number of treatment requirements between the dry needling with manual therapy group and the manual therapy group and review which group has faster resolution in pain and other associated pelvic floor symptoms.

Interventions

PROCEDUREManual therapy

Myofascial trigger point release technique is a technique used to help ease tight muscles. This technique involves palpating the tight muscle for the 'knot'/trigger point and gently applying pressure for 30-60 seconds to help ease out the trigger point.

Trigger point dry needling is a treatment technique involving the use of a single, disposable, fine filament acupuncture needle. Here the tight muscle is palpated and the acupuncture needle is directed towards the trigger point. The insertion of the needle is not felt, however the twitch reflex elicited to ease off the trigger point can be felt . This can be sore, but lasts only for a few seconds. Trans-perineal trigger point dry needling is an effective dry needling technique for the pelvic floor muscles done externally, targeting the trigger points in the pelvic floor muscles.

Sponsors

University College Cork
CollaboratorOTHER
Cork University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

It is difficult to mask the participants or care provider due to the nature of the therapy. The outcome questionnaires are filled in individually by the participants only.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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. *

Design outcomes

Primary

MeasureTime frameDescription
Pain reduction or resolution within 10 treatment sessions, evaluated with the 0-10 Numeric Pain Rating Scale (0-10NPRS)10 weeks or earlier on resolutionParticipants will be asked to fill the 0-10NPRS at base line, 4th, 8th and 10th session or earlier on resolution of symptoms and to review which arm has faster resolution with lesser treatment sessions.

Secondary

MeasureTime frameDescription
Resolution in dyspareunia10 weeks or earlier on resolutionEvaluated with the Female Sexual Functional Index questionnaire (FSFI) at baseline and the 10th session or earlier on resolution
Resolution in bladder, bowel and sexual dysfunction10 weeks or earlier on resolutionEvaluated with the abbreviated International Pelvic Pain Questionnaire (IPPQ) concentrating on dyspareunia and painful bladder and bowel symptoms. This is done at baseline and at 10th session or earlier as per resolution.
Patient treatment satisfaction in each group10 weeks or earlier on resolutionEvaluated with Pain Treatment Satisfaction Scale (PTSS) at 10th session or earlier on resolution

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026