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Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT02795026
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
University College Cork
Information provided by (Responsible Party):
Shalini Wiseman, 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.

Condition or disease Intervention/treatment Phase
Dyspareunia Procedure: Manual therapy Procedure: Trigger point dry needling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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.
Primary Purpose: Treatment
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 Dyspareunia. A Randomized Clinical Trial.
Study Start Date : April 2016
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Manual therapy
Intervention to be administered is manual therapy with myofascial release of trigger points for pelvic floor muscles, pelvis and abdominal musculature.
Procedure: Manual 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.
Other Name: myofascial release

Active Comparator: Dry needling & 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.
Procedure: Manual 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.
Other Name: myofascial release

Procedure: Trigger point dry needling
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795026


Locations
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Ireland
Cork University Maternity Hospital
Cork, Co.Cork, Ireland
Cork Womens Clinic
Cork, Co.Cork, Ireland
Sponsors and Collaborators
Cork University Hospital
University College Cork
Investigators
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Principal Investigator: Suzanne O'Sullivan, Dr. Cork University Maternity Hospital
Principal Investigator: Louise Kenny, Prof Cork University Maternity Hospital
  Study Documents (Full-Text)

Documents provided by Shalini Wiseman, Cork University Hospital:

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Responsible Party: Shalini Wiseman, Senior Physiotherapist in Women's Health & Continence, Cork University Hospital
ClinicalTrials.gov Identifier: NCT02795026     History of Changes
Other Study ID Numbers: 115224510
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shalini Wiseman, Cork University Hospital:
dry needling
vulvodynia
pelvic pain chronic
Additional relevant MeSH terms:
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Dyspareunia
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders