NCT02795026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

June 4, 2016

Last Update Submit

September 26, 2018

Conditions

Dyspareunia

Keywords

dry needlingvulvodyniapelvic pain chronic

Outcome Measures

Primary Outcomes (1)

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

    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.

    10 weeks or earlier on resolution

Secondary Outcomes (3)

  • Resolution in dyspareunia

    10 weeks or earlier on resolution

  • Resolution in bladder, bowel and sexual dysfunction

    10 weeks or earlier on resolution

  • Patient treatment satisfaction in each group

    10 weeks or earlier on resolution

Study Arms (2)

Manual therapy

ACTIVE COMPARATOR

Intervention to be administered is manual therapy with myofascial release of trigger points for pelvic floor muscles, pelvis and abdominal musculature.

Procedure: Manual therapy

Dry needling & manual therapy

ACTIVE COMPARATOR

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.

Procedure: Manual therapyProcedure: Trigger point dry needling

Interventions

Manual therapyPROCEDURE

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.

Also known as: myofascial release
Dry needling & manual therapyManual therapy
Trigger point dry needlingPROCEDURE

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.

Also known as: intra-muscular therapy, deep dry needling, trans-perineal trigger point dry needling
Dry needling & manual therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cork University Maternity Hospital

Cork, Co.Cork, Ireland

Location

Cork Womens Clinic

Cork, Co.Cork, Ireland

Location

Related Publications (1)

  • Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

    PMID: 32734597DERIVED

MeSH Terms

Conditions

DyspareuniaVulvodynia

Interventions

Musculoskeletal ManipulationsMyofascial Release Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersVulvar Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMassageTherapy, Soft Tissue

Study Officials

  • Suzanne O'Sullivan, Dr.

    Cork University Maternity Hospital

    PRINCIPAL INVESTIGATOR

  • Louise Kenny, Prof

    Cork University Maternity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist in Women's Health & Continence

Study Record Dates

First Submitted

June 4, 2016

First Posted

June 9, 2016

Study Start

April 1, 2016

Primary Completion

April 2, 2018

Study Completion

June 1, 2018

Last Updated

September 28, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IE(2)