Pelvic PainNCT04112888
Infiltrations With Collagen in Episiotomy and Cesarean Scars
A study testing Collagen and Rehabilitation sessions in people with Pelvic Pain, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial summary
One of the causes of pelvic pain is secondary to scarring due to episiotomy or cesarean after delivery.The pain of episiotomies or cesarean scars can be generalized at the level of the perineum, or more specifically at the level of the scar. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Collagen and Rehabilitation sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 1 Apr 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 18-45 years old.
- Between 2 and 36 months post-partum
- Accept participate in the study and sign the informed consent.
Who cannot join
- Mental or cognitive disorder that prevents comprehension.
- Being pregnant.
- Pacemaker carriers.
- On treatment with oral anticoagulants.
- Local infections at the point of infiltration.
- Total or partial denervation of the pelvic floor.
- Neurological diseases: AVC, LM, MS.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
About this study
Official title: Efficacy of Infiltrations With Collagen in Pelvic Pain Caused by Episiotomy and Cesarean Scars. Pilot Study
One of the causes of pelvic pain is secondary to scarring due to episiotomy or cesarean after delivery.The pain of episiotomies or cesarean scars can be generalized at the level of the perineum, or more specifically at the level of the scar. For all these reasons, the presence of painful scars after a delivery, either by a cesarean or an episiotomy produces a perception of pelvic pain and change is your body schema and a series of negative connotations such as secondary dyspareunia, affective alterations, etc.
To this, the investigators must add the important role that the psychological and social aspects can play in the development and perpetuation of a pain of these characteristics.
Read more
The perception of pain is subjective and its intensity will be perceived based on many variables in each individual. The psycho-corporal representation of the episiotomy and/or cesarean section and its consequences will depend on each woman. In addition to the physical aspect, the scar of the episiotomy is the testimony of the birth and its complications. It causes a change in the representation of the body and the sex of the patient.
The objective of this study is to evaluate the efficacy of collagen infiltrations in pelvic pain and the appearance of painful scars of episiotomies and/or cesareans compared to conventional treatment with rehabilitation.
Read the detailed description
Randomized clinical trial to evaluate the efficacy of collagen infiltrations in pelvic pain caused by cesarean scars and/or episiotomies.
Those patients who are referred to the Rehabilitation consultation for pelvic pain secondary to pain in the cesarean/episiotomy scar who meet the inclusion criteria and who agree to participate and sign the informed consent will be included.
In the baseline assessment, the patient's clinical information will be collected: age, obstetric history, pathological history, active treatments and if they breastfeed. The following questionnaires will be passed: the Visual Analogue Scale (VAS) and the Short Form McGill Pain Questionnaire (SF-MPQ) to evaluate the pain caused by the scar, the Vancouver Scale of Healing (VSS) and the Patient Component (PSAS) of the Patient and Observer Objective Assessment Scale (POSAS) for the evaluation of the scar and initial photograph of the scar. A physical examination of the pelvic floor will be performed and the areas to be infiltrated will be detected.
Patients will be randomly assigned to a Control group, will perform the conventional treatment, and an Experimental Group, who will perform the conventional treatment and will also have 3-5 infiltrations with collagen.
At 6 and 16 weeks to finalize the treatment, a blinded assessor will perform the final assessment by passing the questionnaires used in the baseline assessment. The subjective satisfaction of the clinician and the patient will also be assessed using the questionnaires Clinical Global Improvement Impression Scale (GGI-I) and the Patient Global Improvement Impression Scale (PGI-I).
- Conditions
- Pelvic Pain
- Being tested
- Collagen, Rehabilitation sessions
- Keywords
- Episiotomy, Pain, Colagen
- Medical subject headings
- Pelvic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagenCombination product
Patients will receive 3 to 5 collagen infiltrations in the scar once per week. Patients with episiotomy will receive 3 collagen infiltrations while patients who underwent a cesarean section will receive 5 collagen infiltrations. The infiltration will be done by tunneling technique, that is, it will be applied along the scar, placing the needle almost tangential to the entire length of the area, then it will be injected and at the same time the needle will be removed. Infiltrations will be carried out intradermally, previously performing asepsis in the area to be infiltrated. 2 ml syringes will be used to infiltrate the episiotomy scars (we will use 1 vial of 2 ml ) and 5 ml for cesarean scars (2 vials of 2 ml ) and sterile needles of 30G, 13mm.
Rehabilitation sessionsProcedure or surgery
Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. There will be two sessions per week for four weeks. The sessions will last 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Collagen group | Experimental | Patients will receive 3 to 5 infiltrations of collagen on the scar once a week.
Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes. Receives: Combination Product: Collagen; Procedure: Rehabilitation sessions |
| Control group | Active comparator | Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes. Receives: Procedure: Rehabilitation sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain caused by the scar (VAS)
Pain caused by the scar according to the Visual Analogue Scale (VAS). Range 0 to 10. Higher values represent worse pain.
Measured: 6 weeks after the end of treatment
Pain caused by the scar (MPQ)
Pain caused by the scar according to the Short Form McGill Pain (Questionnaire (MPQ). Range 0 to 78. Three dimensions: Sensory (12 ítems), Affective (3 ítems), Evaluative (1 ítem). Higher score higher level of pain.
Measured: 6 weeks after the end of treatment
Secondary outcomes (4)
Aspect of the scar (VSS)
Aspect of the scar according to the Vancouver Scar Scale (VSS). Range 0 to 10. 0 (representing normal skin) and 10 (representing worst scar imaginable).
Measured: 6 weeks after the end of treatment
Aspect of the scar (PSAS)
Aspect of the scar according to according to the patient component (PSAS) of the Scale of objective assessment Patient and Observer (Patient and Observer Scar Assesment Scale POSAS). The PSAS consist of six parameters: scar-related pain, itchness, color, stiffeness, thickness, and irregularity. Each parameter used a 10-point scoring system, with 1 representing normal skin and 10 representing the worst scar imaginable.
Measured: 6 weeks after the end of treatment
Subjective satisfaction of the clinician (PGI-I)
Subjective satisfaction of the clinician according to Patient Global Impression of Im,provement (PGI-I). Single question asking the patient to rate their satisfaction now, as compared with how it was prior to before beginning treatment on a scale from 1-Very much better to 7 -Very much worse.
Measured: 6 weeks after the end of treatment
Subjective satisfaction of the clinician (CGI-I)
Subjective satisfaction of the clinician according to Clinician Global Impression of Improvement (CGI-I). Single question asking the clinician to rate their satisfaction now, as compared with how it was prior to before beginning treatment on a scale from 1- Much better to 5-Much worse.
Measured: 6 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 May 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Romero, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Georgia Romero-Culleres, MD, PhD, Principal investigator, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112888
- Sponsor's protocol ID
- CEI 17/73
- Status last verified
- Oct 2019
- First submitted
- 2 Jan 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Infiltrations With Collagen in Pelvic Pain Caused by Episiotomy and Cesarean Scars. Pilot Study
- ClinicalTrials.gov ID
- NCT04112888
- Acronym / sponsor ID
- CEI 17/73
- Conditions
- Pelvic Pain
- Keywords
- Episiotomy, Pain, Colagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 2 Oct 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.
One of the causes of pelvic pain is secondary to scarring due to episiotomy or cesarean after delivery.The pain of episiotomies or cesarean scars can be generalized at the level of the perineum, or more specifically at the level of the scar. For all these reasons, the presence of painful scars after a delivery, either by a cesarean or an episiotomy produces a perception of pelvic pain and change is your body schema and a series of negative connotations such as secondary dyspareunia, affective alterations, etc.
To this, the investigators must add the important role that the psychological and social aspects can play in the development and perpetuation of a pain of these characteristics.
The perception of pain is subjective and its intensity will be perceived based on many variables in each individual. The psycho-corporal representation of the episiotomy and/or cesarean section and its consequences will depend on each woman. In addition to the physical aspect, the scar of the episiotomy is the testimony of the birth and its complications. It causes a change in the representation of the body and the sex of the patient.
The objective of this study is to evaluate the efficacy of collagen infiltrations in pelvic pain and the appearance of painful scars of episiotomies and/or cesareans compared to conventional treatment with rehabilitation.
Detailed description
Randomized clinical trial to evaluate the efficacy of collagen infiltrations in pelvic pain caused by cesarean scars and/or episiotomies.
Those patients who are referred to the Rehabilitation consultation for pelvic pain secondary to pain in the cesarean/episiotomy scar who meet the inclusion criteria and who agree to participate and sign the informed consent will be included.
In the baseline assessment, the patient's clinical information will be collected: age, obstetric history, pathological history, active treatments and if they breastfeed. The following questionnaires will be passed: the Visual Analogue Scale (VAS) and the Short Form McGill Pain Questionnaire (SF-MPQ) to evaluate the pain caused by the scar, the Vancouver Scale of Healing (VSS) and the Patient Component (PSAS) of the Patient and Observer Objective Assessment Scale (POSAS) for the evaluation of the scar and initial photograph of the scar. A physical examination of the pelvic floor will be performed and the areas to be infiltrated will be detected.
Patients will be randomly assigned to a Control group, will perform the conventional treatment, and an Experimental Group, who will perform the conventional treatment and will also have 3-5 infiltrations with collagen.
At 6 and 16 weeks to finalize the treatment, a blinded assessor will perform the final assessment by passing the questionnaires used in the baseline assessment. The subjective satisfaction of the clinician and the patient will also be assessed using the questionnaires Clinical Global Improvement Impression Scale (GGI-I) and the Patient Global Improvement Impression Scale (PGI-I).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen group | Experimental | Combination Product: Collagen, Procedure: Rehabilitation sessionsPatients will receive 3 to 5 infiltrations of collagen on the scar once a week. Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes. |
| Control group | Active comparator | Procedure: Rehabilitation sessionsPatients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between 18-45 years old.
- Between 2 and 36 months post-partum
- Accept participate in the study and sign the informed consent.
Key exclusion criteria (7 listed)
- Mental or cognitive disorder that prevents comprehension.
- Being pregnant.
- Pacemaker carriers.
- On treatment with oral anticoagulants.
- Local infections at the point of infiltration.
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 |
|---|---|---|
| CollagenPatients will receive 3 to 5 collagen infiltrations in the scar once per week. Patients with episiotomy will receive 3 collagen infiltrations while patients who underwent a cesarean section will receive 5 collagen infiltrations. The infiltration will be done by tunneling technique, that is, it will be applied along the scar, placing the needle almost tangential to the entire length of the area, then it will be injected and at the same time the needle will be removed. Infiltrations will be carried out intradermally, previously performing asepsis in the area to be infiltrated. 2 ml syringes will be used to infiltrate the episiotomy scars (we will use 1 vial of 2 ml ) and 5 ml for cesarean scars (2 vials of 2 ml ) and sterile needles of 30G, 13mm. | Combination product | Collagen group |
| Rehabilitation sessionsPatients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. There will be two sessions per week for four weeks. The sessions will last 45 minutes. | Procedure or surgery | Collagen group, Control group |
Primary outcome
Pain caused by the scar (VAS)
Time frame: 6 weeks after the end of treatment
Pain caused by the scar according to the Visual Analogue Scale (VAS). Range 0 to 10. Higher values represent worse pain.
Pain caused by the scar (MPQ)
Time frame: 6 weeks after the end of treatment
Pain caused by the scar according to the Short Form McGill Pain (Questionnaire (MPQ). Range 0 to 78. Three dimensions: Sensory (12 ítems), Affective (3 ítems), Evaluative (1 ítem). Higher score higher level of pain.
4 secondary outcomes
Aspect of the scar (VSS)
Time frame: 6 weeks after the end of treatment
Aspect of the scar (PSAS)
Time frame: 6 weeks after the end of treatment
Subjective satisfaction of the clinician (PGI-I)
Time frame: 6 weeks after the end of treatment
Subjective satisfaction of the clinician (CGI-I)
Time frame: 6 weeks after the end of treatment
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 2 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Georgia Romero-Culleres, MD, PhD principal investigator
Althaia Xarxa Assistencial Universitària de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen and Rehabilitation sessions in people with Pelvic Pain, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
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 3 inclusion and 7 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 2 Oct 2019. 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 Spain. 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 caused by the scar (VAS) (time frame: 6 weeks after the end of treatment). The study lists 2 primary outcomes in all. 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 2 Oct 2019.