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Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

Primary Purpose

Dyspareunia

Status

Completed

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Manual therapy

Trigger point dry needling

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring dry needling, vulvodynia, pelvic pain chronic

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Cork University Maternity Hospital
Cork Womens Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Manual therapy

Dry needling & manual therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Resolution in dyspareunia

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

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

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

Full Information

NCT ID

NCT02795026

First Posted

June 4, 2016

Last Updated

September 26, 2018

Sponsor

Cork University Hospital

Collaborators

University College Cork

1. Study Identification

Unique Protocol Identification Number

NCT02795026

Brief Title

Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

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 Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

April 2, 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cork University Hospital

Collaborators

University College Cork

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspareunia

Keywords

dry needling, vulvodynia, pelvic pain chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study 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.

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manual therapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dry needling & manual therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Manual therapy

Other Intervention Name(s)

myofascial release

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Trigger point dry needling

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

10 weeks or earlier on resolution

Secondary Outcome Measure Information:

Title

Resolution in dyspareunia

Description

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

Time Frame

10 weeks or earlier on resolution

Title

Resolution in bladder, bowel and sexual dysfunction

Description

Time Frame

10 weeks or earlier on resolution

Title

Patient treatment satisfaction in each group

Description

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

Time Frame

10 weeks or earlier on resolution

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne O'Sullivan, Dr.

Organizational Affiliation

Cork University Maternity Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Louise Kenny, Prof

Organizational Affiliation

Cork University Maternity Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cork University Maternity Hospital

City

Cork

State/Province

Co.Cork

Country

Ireland

Facility Name

Cork Womens Clinic

City

Cork

State/Province

Co.Cork

Country

Ireland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32734597

Citation

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.

Results Reference

derived

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Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

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