Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

Not Applicable

Completed

• Conditions: Dyspareunia
• Interventions: Procedure: Manual therapy; Procedure: Trigger point dry needling

• Registration Number: NCT02795026
• Lead Sponsor: Cork University Hospital

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-04
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-09
• Primary Completion: 2018-04-02
• Study Completion: 2018-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual therapy	Manual therapy	Intervention to be administered is manual therapy with myofascial release of trigger points for pelvic floor muscles, pelvis and abdominal musculature.
Dry needling & manual therapy	Manual therapy	Intervention to be administered is Trans-perineal trigger point dry needling, done externally to target the trigger points in the pelvic floor muscles along with dry needling of the pelvis and abdominal musculature.Manual therapy will only be used in areas difficult to reach with the acupuncture needles.
Dry needling & manual therapy	Trigger point dry needling	Intervention to be administered is Trans-perineal trigger point dry needling, done externally to target the trigger points in the pelvic floor muscles along with dry needling of the pelvis and abdominal musculature.Manual therapy will only be used in areas difficult to reach with the acupuncture needles.

Primary Outcome Measures

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

Name	Time	Method
Patient treatment satisfaction in each group	10 weeks or earlier on resolution	Evaluated with Pain Treatment Satisfaction Scale (PTSS) at 10th session or earlier on resolution
Resolution in dyspareunia	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	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.

Trial Locations

Locations (2)

Cork University Maternity Hospital; 🇮🇪 Cork, Co.Cork, Ireland

Cork Womens Clinic; 🇮🇪 Cork, Co.Cork, Ireland