Pelvis Pain ChronicCPPNCT02356796
Chronic Pelvic Pain in Women - Conservative Group Treatment Compared to Standard Conservative Treatment.
A study testing Multidisciplinary group treatment and Standard physiotherapy treatment in people with Pelvis Pain Chronic, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate the effect of a multidisciplinary group based treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The hypothesis is that multidisciplinary group based treatment is more effective than standard physiotherapy for women with CPP. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Pelvis Pain Chronic
- What is being tested?
- Multidisciplinary group treatment and Standard physiotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to Jan 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pelvic pain lasting minimum 6 months
- Motivated for group intervention
Who cannot join
- Pelvic pathology that needs medical treatment other than conservative
- Pregnancy, or labour last 12 months.
- Abdominal or pelvic surgery the last 6 months
- Botox injections in pelvic areas last 4 months.
- Drug addiction or using large dozes of analgesics
- Serious psychiatric diagnosis. Consent capability is necessary.
- Not speaking/writing Norwegian language
- Previously treated by physiotherapist involved in the group intervention in this project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pelvic Pain in Women - Conservative Multidisciplinary Group Treatment Compared to Standard Conservative Treatment. A Randomised Controlled Trial.
The purpose of this study is to evaluate the effect of a multidisciplinary group based treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The hypothesis is that multidisciplinary group based treatment is more effective than standard physiotherapy for women with CPP. The participants will be randomized to one of two treatment arms, and the treatment effect will be evaluated 12 months after start of intervention.
Read the detailed description
Background: Chronic pelvic pain (CPP) is a common source of pain and reduced quality of life among women throughout the world. CPP is a complex condition, and the understanding of both etiology and effective treatment is limited. The newest/latest clinical guidelines recommend a holistic and multidisciplinary treatment approach to this condition.
In accordance with the guidelines a multidisciplinary group based treatment for women with CPP has been started at the University Hospital of North Norway. The treatment is offered to patients who are considered to benefit from conservative treatment approach.
Method: To investigate the effect of a group based treatment compared to standard conservative treatment by physiotherapists in primary or secondary health care, a randomized controlled trial will be conducted.
Patients who are found eligible and consent to participate in the trial, will be randomized to one of the two treatment options. Data will be registered at baseline, 3, 6 and 12 months after start of treatment.
- Conditions
- Pelvis Pain Chronic
- Being tested
- Multidisciplinary group treatment, Standard physiotherapy treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary group treatmentOther
Multidisciplinary group intervention at the University Hospital of North Norway. The group intervention is led by physiotherapists, with contributions from a gynecologist, nutritionist and a peer patient. The treatment consists of active exercises and theory lessons. The focus is to enhance the participants body awareness and to recognize the integration of mental and physical processes. The aim is to create change in patterns that influence the participants health negatively.
The treatment lasts one year. The first meeting has a duration of 10 days, then follow-up after 3, 6 and 12 months.
Standard physiotherapy treatmentOther
Standard treatment in primary or secondary health care physiotherapy. Patients are referred to a physiotherapist with appropriate training/competence, as close to their home as possible.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary group treatment | Experimental | Multidisciplinary group intervention at the University Hospital of North Norway. The group intervention is led by physiotherapists, with contributions from a gynecologist, nutritionist and a peer patient. The treatment consists of active exercises and theory lessons. The focus is to enhance the participants body awareness and to recognize the integration of mental and physical processes. The aim is to create change in patterns that influence the participants health negatively.
The treatment lasts one year. The first meeting has a duration of 10 days, then follow-up after 3, 6 and 12 months. Receives: Other: Multidisciplinary group treatment |
| Standard physiotherapy treatment | Active comparator | Standard treatment in primary or secondary health care physiotherapy. Patients are referred to a physiotherapist with appropriate training/competence, as close to their home as possible. Receives: Other: Standard physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pelvic pain
Self reported pelvic pain the last 7 days. The worst, the least and the mean pain are recorded. Each item is scored 0-10 (0=no pain, 10 = pain as bad as can be).
Measured: From baseline to 3, 6 and 12 months after start of intervention.
Secondary outcomes (6)
Changes in subjective health complaints
Self reported health complaints last 30 days, using a standardized questionnaire.
Measured: From baseline to 3, 6 and 12 months after start of intervention
Changes in fear of movement,
Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.
Measured: From baseline to 12 months after start of intervention
Changes in sexual function concerning pain during intercourse
Questionnaire recording sexual desire, orgasm problems and pain during intercourse. Each item is scored "all the time", "almost all the time", "often", "rarely" or "never".
Measured: From baseline to 12 months after start of intervention
Changes in general health condition
EQ-5D questionnaire recording mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: From baseline to 3, 6 and 12 months after start of intervention
Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation
Measured by the standardized St.Marks score, the ICIQ-UI_SF and the Obstructed Defecation Syndrome Score.
Measured: From baseline to 12 months
Changes in motor functions: posture, movement, gait, sitting posture, respiration
A standardized Mensendieck test is used. Motor functions are recorded and evaluated by a trained physiotherapist.
Measured: From baseline to 12 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvis Pain ChronicStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Tromso
- Responsible party
- Sponsor
- Investigators
- Paal Oian, Professor MD, Study chair, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356796
- Sponsor's protocol ID
- 2014/1398 (REK)
- Acronym
- CPP
- Status last verified
- May 2018
- First submitted
- 2 Feb 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pelvic Pain in Women - Conservative Multidisciplinary Group Treatment Compared to Standard Conservative Treatment. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02356796
- Acronym / sponsor ID
- CPP / 2014/1398 (REK)
- Conditions
- Pelvis Pain Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Tromso
- Study start
- Feb 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 5 Feb 2015 (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.
The purpose of this study is to evaluate the effect of a multidisciplinary group based treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The hypothesis is that multidisciplinary group based treatment is more effective than standard physiotherapy for women with CPP. The participants will be randomized to one of two treatment arms, and the treatment effect will be evaluated 12 months after start of intervention.
Detailed description
Background: Chronic pelvic pain (CPP) is a common source of pain and reduced quality of life among women throughout the world. CPP is a complex condition, and the understanding of both etiology and effective treatment is limited. The newest/latest clinical guidelines recommend a holistic and multidisciplinary treatment approach to this condition.
In accordance with the guidelines a multidisciplinary group based treatment for women with CPP has been started at the University Hospital of North Norway. The treatment is offered to patients who are considered to benefit from conservative treatment approach.
Method: To investigate the effect of a group based treatment compared to standard conservative treatment by physiotherapists in primary or secondary health care, a randomized controlled trial will be conducted.
Patients who are found eligible and consent to participate in the trial, will be randomized to one of the two treatment options. Data will be registered at baseline, 3, 6 and 12 months after start of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary group treatment | Experimental | Other: Multidisciplinary group treatmentMultidisciplinary group intervention at the University Hospital of North Norway. The group intervention is led by physiotherapists, with contributions from a gynecologist, nutritionist and a peer patient. The treatment consists of active exercises and theory lessons. The focus is to enhance the participants body awareness and to recognize the integration of mental and physical processes. The aim is to create change in patterns that influence the participants health negatively. The treatment lasts one year. The first meeting has a duration of 10 days, then follow-up after 3, 6 and 12 months. |
| Standard physiotherapy treatment | Active comparator | Other: Standard physiotherapy treatmentStandard treatment in primary or secondary health care physiotherapy. Patients are referred to a physiotherapist with appropriate training/competence, as close to their home as possible. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic pelvic pain lasting minimum 6 months
- Motivated for group intervention
Key exclusion criteria (8 listed)
- Pelvic pathology that needs medical treatment other than conservative
- Pregnancy, or labour last 12 months.
- Abdominal or pelvic surgery the last 6 months
- Botox injections in pelvic areas last 4 months.
- Drug addiction or using large dozes of analgesics
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 |
|---|---|---|
| Multidisciplinary group treatmentMultidisciplinary group intervention at the University Hospital of North Norway. The group intervention is led by physiotherapists, with contributions from a gynecologist, nutritionist and a peer patient. The treatment consists of active exercises and theory lessons. The focus is to enhance the participants body awareness and to recognize the integration of mental and physical processes. The aim is to create change in patterns that influence the participants health negatively. The treatment lasts one year. The first meeting has a duration of 10 days, then follow-up after 3, 6 and 12 months. | Other | Multidisciplinary group treatment |
| Standard physiotherapy treatmentStandard treatment in primary or secondary health care physiotherapy. Patients are referred to a physiotherapist with appropriate training/competence, as close to their home as possible. | Other | Standard physiotherapy treatment |
Primary outcome
Changes in pelvic pain
Time frame: From baseline to 3, 6 and 12 months after start of intervention.
Self reported pelvic pain the last 7 days. The worst, the least and the mean pain are recorded. Each item is scored 0-10 (0=no pain, 10 = pain as bad as can be).
6 secondary outcomes
Changes in subjective health complaints
Time frame: From baseline to 3, 6 and 12 months after start of intervention
Changes in fear of movement,
Time frame: From baseline to 12 months after start of intervention
Changes in sexual function concerning pain during intercourse
Time frame: From baseline to 12 months after start of intervention
Changes in general health condition
Time frame: From baseline to 3, 6 and 12 months after start of intervention
Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation
Time frame: From baseline to 12 months
Changes in motor functions: posture, movement, gait, sitting posture, respiration
Time frame: From baseline to 12 months after start of intervention
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 3 May 2018.
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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.
Paal Oian, Professor MD study chair
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary group treatment and Standard physiotherapy treatment in people with Pelvis Pain Chronic, run by University Hospital of North Norway at 1 site in Norway.
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 2 inclusion and 8 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Changes in pelvic pain (time frame: From baseline to 3, 6 and 12 months after start of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.