DyspareuniaNCT02795026
Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain
A study testing Manual therapy and Trigger point dry needling in people with Dyspareunia, run by Cork University Hospital at 2 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyspareunia
- What is being tested?
- Manual therapy and Trigger point dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesIreland
- Study dates
- Apr 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Cork University Maternity Hospital
Cork, Co.Cork
Cork Womens Clinic
Cork, Co.Cork
About this study
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.
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.
Read the 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.
- Conditions
- Dyspareunia
- Being tested
- Manual therapy, Trigger point dry needling
- Keywords
- dry needling, vulvodynia, pelvic pain chronic
- Medical subject headings
- Dyspareunia, Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyProcedure or surgery
Also called myofascial release
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.
Trigger point dry needlingProcedure or surgery
Also called intra-muscular therapy, deep dry needling, trans-perineal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Manual therapy; Procedure: Trigger point dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks or earlier on resolution
Secondary outcomes (3)
Resolution in dyspareunia
Evaluated with the Female Sexual Functional Index questionnaire (FSFI) at baseline and the 10th session or earlier on resolution
Measured: 10 weeks 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.
Measured: 10 weeks or earlier on resolution
Patient treatment satisfaction in each group
Evaluated with Pain Treatment Satisfaction Scale (PTSS) at 10th session or earlier on resolution
Measured: 10 weeks or earlier on resolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion2 Apr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork
- Responsible party
- Principal investigator, Shalini Wiseman, Cork University Hospital
- Investigators
- Suzanne O'Sullivan, Dr., Principal investigator, Cork University Maternity HospitalLouise Kenny, Prof, Principal investigator, Cork University Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795026
- Sponsor's protocol ID
- 115224510
- Status last verified
- Sep 2018
- First submitted
- 4 Jun 2016
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32734597
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02795026
- Acronym / sponsor ID
- 115224510
- Conditions
- Dyspareunia
- Keywords
- dry needling, vulvodynia, pelvic pain chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Collaborators
- University College Cork
- Study start
- Apr 2016
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Active comparator | Procedure: Manual therapyIntervention to be administered is manual therapy with myofascial release of trigger points for pelvic floor muscles, pelvis and abdominal musculature. |
| Dry needling & manual therapy | Active comparator | Procedure: Manual therapy, Procedure: Trigger point dry needlingIntervention 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapyAlso: myofascial releaseMyofascial 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. | Procedure or surgery | Dry needling & manual therapy, Manual therapy |
| Trigger point dry needlingAlso: intra-muscular therapy, deep dry needling, trans-perineal trigger point dry needlingTrigger 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. | Procedure or surgery | Dry needling & manual therapy |
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.
3 secondary outcomes
Resolution in dyspareunia
Time frame: 10 weeks or earlier on resolution
Resolution in bladder, bowel and sexual dysfunction
Time frame: 10 weeks or earlier on resolution
Patient treatment satisfaction in each group
Time frame: 10 weeks or earlier on resolution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 32734597Imamura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne O'Sullivan, Dr. principal investigator
Cork University Maternity Hospital
Louise Kenny, Prof principal investigator
Cork University Maternity Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Trigger point dry needling in people with Dyspareunia, run by Cork University Hospital at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.