Pain, ChronicNCT04057664
A Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic and Chronic Belly Pain
An observational study of Pain, Chronic and Pain, Pelvic, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Chronic, Pain, Pelvic, Pain, Abdominal
- What is being tested?
- Learning of Coping Strategies
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 4 Dec 2024
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with chronic pelvic or belly pain, participating in our multimodal group therapy
Who may be able to join
- Women with chronic pelvic pain or belly pain participating in our group therapy who give their consent to the analysis of their data for the study
Who cannot join
- No participation in the group therapy
- Finishing the group therapy prematurely (>3 missed sessions)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center of Pain Medicine
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Managing the Pain - a Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic Pain and Chronic Belly Pain
The project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.
Read the detailed description
To treat patients with chronic pelvic and belly pain in an interdisciplinary way, we developped a group therapy consisting of twelve sessions and a booster session. The therapy is based on the bio-psycho-social model of pain and includes group sessions of psychotherapy as well as physiotherapy.
All patients fill in questionnaires (concerning pain impact, pain chronicity, depression, anxiety, stress, well-being and sexuality) before and after the therapy as well as three and twelve months after.
- Conditions
- Pain, Chronic, Pain, Pelvic, Pain, Abdominal, Depression, Sex Disorder, Endometriosis
- Being tested
- Learning of Coping Strategies
- Keywords
- Coping, Multidisciplinary, Group Therapy, Psychotherapy, Physiotherapy
- Medical subject headings
- Chronic Pain, Pelvic Pain, Abdominal Pain, Depression, Sexual Dysfunction, Physiological, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning of Coping StrategiesBehavioural
Group sessions with psychotherapy and physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Group Therapy | Multidisciplinary group therapy for women with chronic pelvic or belly pain Receives: Behavioral: Learning of Coping Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic Pain Impact Questionnaire (PPIQ)
Self reported questionnaire with 8 questions to assess the impact of pelvic pain on quality of life, daily activities and emotional life. Each questions is scored 0-4, yielding a total from 0 and 32.
Measured: baseline, 6 weeks, 3 months, 12 months
Secondary outcomes (6)
Change in Sexual Functioning Questionnaire (CSFQ-14)
Self-reported questionnaire with 14 questions assessing comorbidity- or medication-related sexual dysfunction. Each questions is scored using a 5-point Likert scale. Total scores range from 14 to 70, with lower scores indicating greater levels of sexual dysfunction.
Measured: baseline, 6 weeks, 3 months, 12 months
Change in Female Sexual Distress Scale-Revised (FSDS-R)
Self-reported questionnaire assessing distress associated with sexual dysfunction. Each questions is scored using a 5-point Likert scale (0=never to 4=always). Total scores range from 0 to 52, with higher scores indicating greater levels of sexually related distress.
Measured: baseline, 6 weeks, 3 months, 12 months
Change in Chronic Pain Grade Scale (CPGS)
Self-reported questionnaire with 3 questions assessing the presence of chronic pain at the site of injury. Each questions is scored using a 11-point Likert scale. Total scores range from 0 to 30, with higher scores indicating more pain.
Measured: baseline, 6 weeks, 3 months, 12 months
Change in Depression
Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing depression. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
Measured: baseline, 6 weeks, 3 months, 12 months
Change in Anxiety
Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing anxiety. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
Measured: baseline, 6 weeks, 3 months, 12 months
Change in Stress
Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing stress. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
Measured: baseline, 6 weeks, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Sep 2020
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Why it stopped: The group therapy program is no longer offered at the site, because other group therapies appear to be better integrated into patients' daily lives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057664
- Sponsor's protocol ID
- 2018-28
- Status last verified
- Feb 2026
- First submitted
- 12 Aug 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing the Pain - a Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic Pain and Chronic Belly Pain
- ClinicalTrials.gov ID
- NCT04057664
- Acronym / sponsor ID
- 2018-28
- Conditions
- Pain, Chronic, Pain, Pelvic, Pain, Abdominal, Depression, Sex Disorder, Endometriosis
- Keywords
- Coping, Multidisciplinary, Group Therapy, Psychotherapy, Physiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The group therapy program is no longer offered at the site, because other group therapies appear to be better integrated into patients' daily lives.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 15 Aug 2019 (actual)
- 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 project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.
Detailed description
To treat patients with chronic pelvic and belly pain in an interdisciplinary way, we developped a group therapy consisting of twelve sessions and a booster session. The therapy is based on the bio-psycho-social model of pain and includes group sessions of psychotherapy as well as physiotherapy.
All patients fill in questionnaires (concerning pain impact, pain chronicity, depression, anxiety, stress, well-being and sexuality) before and after the therapy as well as three and twelve months after.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary Group Therapy | – | Behavioral: Learning of Coping StrategiesMultidisciplinary group therapy for women with chronic pelvic or belly pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with chronic pelvic or belly pain, participating in our multimodal group therapy
Key inclusion criteria (1 listed)
- Women with chronic pelvic pain or belly pain participating in our group therapy who give their consent to the analysis of their data for the study
Key exclusion criteria (2 listed)
- No participation in the group therapy
- Finishing the group therapy prematurely (>3 missed sessions)
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 |
|---|---|---|
| Learning of Coping StrategiesGroup sessions with psychotherapy and physiotherapy | Behavioural | Multidisciplinary Group Therapy |
Primary outcome
Change in Pelvic Pain Impact Questionnaire (PPIQ)
Time frame: baseline, 6 weeks, 3 months, 12 months
Self reported questionnaire with 8 questions to assess the impact of pelvic pain on quality of life, daily activities and emotional life. Each questions is scored 0-4, yielding a total from 0 and 32.
6 secondary outcomes
Change in Sexual Functioning Questionnaire (CSFQ-14)
Time frame: baseline, 6 weeks, 3 months, 12 months
Change in Female Sexual Distress Scale-Revised (FSDS-R)
Time frame: baseline, 6 weeks, 3 months, 12 months
Change in Chronic Pain Grade Scale (CPGS)
Time frame: baseline, 6 weeks, 3 months, 12 months
Change in Depression
Time frame: baseline, 6 weeks, 3 months, 12 months
Change in Anxiety
Time frame: baseline, 6 weeks, 3 months, 12 months
Change in Stress
Time frame: baseline, 6 weeks, 3 months, 12 months
Results and safety
The study was stopped early (reason given: The group therapy program is no longer offered at the site, because other group therapies appear to be better integrated into patients' daily lives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Pain, Pelvic, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Feb 2026. 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 Switzerland. 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 was stopped early (reason given: The group therapy program is no longer offered at the site, because other group therapies appear to be better integrated into patients' daily lives.). Results are not available in the source record.
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?
Change in Pelvic Pain Impact Questionnaire (PPIQ) (time frame: baseline, 6 weeks, 3 months, 12 months). 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 5 Feb 2026.