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Completed

NCT Number: NCT02795026

Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

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.

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Key information

Conditions

Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cork University Maternity Hospital, Cork, Co.Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 during treatment.

Treatment and study plan

Manual Therapy

Procedure

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.

Other names: myofascial release

trigger point dry needling

Procedure

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.

Other names: intra-muscular therapy, deep dry needling, trans-perineal trigger point dry needling

Primary outcomes

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

    Time frame: 10 weeks or earlier on resolution

    Participants 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 outcomes

  1. Resolution in dyspareunia

    Time frame: 10 weeks or earlier on resolution

    Evaluated with the Female Sexual Functional Index questionnaire (FSFI) at baseline and the 10th session or earlier on resolution

  2. Resolution in bladder, bowel and sexual dysfunction

    Time frame: 10 weeks or earlier on resolution

    Evaluated 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.

  3. Patient treatment satisfaction in each group

    Time frame: 10 weeks or earlier on resolution

    Evaluated with Pain Treatment Satisfaction Scale (PTSS) at 10th session or earlier on resolution

Sponsors and collaborators

Lead sponsor

Cork University Hospital

Other

Collaborators

  • University College Cork

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2016
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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