Clinical Trial: Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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 Dysp

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 Summary:

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.


Sponsor: Cork University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Pain reduction or resolution within 12 treatment sessions, evaluated with the 0-10 Numeric Pain Rating Scale (0-10NPRS) [ Time Frame: 12 weeks or earlier on resolution ]

Participants will be asked to fill the 0-10NPRS at base line, 4th, 8th and 12th session or earlier on resolution of symptoms and to review which arm has faster resolution with lesser treatment sessions.


Current Secondary Outcome:

  • 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
  • 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.
  • 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


Original Secondary Outcome:

  • Resolution in dyspareunia [ Time Frame: 12 weeks or earlier on resolution ]
    Evaluated with the Female Sexual Functional Index questionnaire (FSFI) at baseline and the 12th session or earlier on resolution
  • Resolution in bladder, bowel and sexual dysfunction [ Time Frame: 12 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 12th session or earlier as per resolution.
  • Patient treatment satisfaction in each group [ Time Frame: 12 weeks or earlier on resolution ]
    Evaluated with Pain Treatment Satisfaction Scale (PTSS) at 12th session or earlier on resolution


Information By: Cork University Hospital

Dates:
Date Received: June 4, 2016
Date Started: April 2016
Date Completion: December 2017
Last Updated: March 25, 2017
Last Verified: March 2017