HysterectomyNCT05959785
Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.
A study testing Basic and light cervical mobilization exercises and Abdominal or diaphragmatic breathing exercises in people with Hysterectomy, run by University of Seville at 2 sites in Spain.
Trial summary
Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy. Control and intervention groups were randomly established. Informed consent will be requested for participation in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Basic and light cervical mobilization exercises and Abdominal or diaphragmatic breathing exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Feb 2023to 10 Feb 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients who have given their consent to participate in the project by signing the informed consent.
- Patient between 18 and 65 years of age.
- Patients with a hysterectomy scheduled to be performed in less than 3 months at the Women's Hospital in Seville or at the Quirón Sagrado Corazón Clinic in Seville.
- Who develops pain of intensity greater than 7 points located in the head, neck or upper limbs in the first 24 hours post-hysterectomy.
- Patients who are able to communicate in Spanish or English.
Who cannot join
- Neurological Pathology.
- Non-cooperative Subject.
- Severe Psychiatric Illness.
- Loss of Cognitive Capacity.
- Evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs.
- Localized pain in areas not considered in this study and that may affect the performance and results of the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Quiron Sagrado Corazon
Seville, Sevilla, 41013
About this study
Official title: Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Controlled Clinical Trial.
Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy.
Control and intervention groups were randomly established. Informed consent will be requested for participation in the study.
- Conditions
- Hysterectomy
- Being tested
- Basic and light cervical mobilization exercises, Abdominal or diaphragmatic breathing exercises
- Keywords
- pain, phrenic nerve, shoulder, laparoscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic and light cervical mobilization exercisesProcedure or surgery
Also called Control group
This group of exercises will be made up of a series of cervical mobilization exercises that are performed without pain, smooth, controlled by the patients, and without forcing the angulations. They are performed seated, with the arms extended along the body and forearms and hands resting on the legs. The chair must be firm and comfortable. Head movements to the right and left, right and left lateral flexion of the cervical region, cervical flexion and extension will be performed. This exercise will be performed for 5 minutes 3 times a day and beginning in the first 24 postoperative hours.
Abdominal or diaphragmatic breathing exercisesProcedure or surgery
Also called Intervention group
The first abdominal or diaphragmatic breathing exercises will be carried out in a lying position, with the back well supported on a comfortable and firm surface, and with hips and knees flexed and feet supported. The patients take deep breaths, taking air raising the abdomen towards the ceiling, without raising the back from the horizontal plane. During expiration the navel will lower posteriorly and rise towards the thoracic region. For the second abdominal or diaphragmatic breathing exercise, the patient is seated on a firm and comfortable surface, with hips and knees flexed and feet supported. An inspiratory movement will be made in which the patient's navel will be moved outward, away from the spine. During expiration, the navel will go in the direction of the patient's spine and will rise in the direction of the thorax.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Assignment to the intervention group will be done by simple randomization of the sample. A random sequence of numbers will be generated using the statistical program SPSS v.28. Patients will be included in the intervention group of each subcategory if their subject number matches one of the random numbers generated.The intervention groups will receive an explanatory video where a study collaborator performs a series of abdominal or diaphragmatic breathing exercises, which are intended to assess their effectiveness in this clinical trial. Receives: Procedure: Abdominal or diaphragmatic breathing exercises |
| control groups | Placebo comparator | The patients belonging to the control groups of each subcategory will also receive an explanatory video with basic and light cervical mobilization exercises (Annex 12). This group of exercises will be made up of a series of cervical mobilization exercises that are performed without pain, smooth, controlled by the patients, and without forcing the angulations. They are performed seated, with the arms extended along the body and forearms and hands resting on the legs. The chair must be firm and comfortable. Head movements to the right and left, right and left lateral flexion of the cervical region, cervical flexion and extension will be performed. This exercise will be performed for 5 minutes 3 times a day and beginning in the first 24 postoperative hours. Receives: Procedure: Basic and light cervical mobilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The McGill Pain Questionnaire
Location of pain: which is usually represented by a schematic figure of the human body, where the patient points out the areas where they feel pain.
- Quality of pain: the patient must choose from a wide list of types of pain those characteristics that define the one he presents. They are grouped into various categories that in turn form four large groups: sensory, emotional, evaluative and miscellaneous. In the original English version, the number of words was 78, although they may vary in the different validations of the questionnaire (66 in the Spanish version).
- Pain intensity at the current moment: explored by means of a question with five possible response categories.
- Assessment of pain at the current time using a visual analogue scale, ranging from "no pain" to "unbearable pain".
Measured: 24 hours after laparoscopy
The Brief Pain Questionnaire
This questionnaire, in its short version, includes a body map that the patient can use to mark the areas where pain is located. In addition to providing a useful tool for localizing pain, this questionnaire provides important information about other characteristics of pain, as well as response to prescribed treatments.
Measured: 24 hours after laparoscopy
The Quick Dash quiz
Questionnaire containing questions about symptoms and the ability to use instruments of the upper limbs. Collect data referring to the last week
Measured: 24 hours after laparoscopy
The HIT-6 scale
evaluates the headache through 6 questions
Measured: 24 hours after laparoscopy
The Neck Disability Index questionnaire
assesses neck and back pain and its influence on basic activities of daily living
Measured: 24 hours after laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start2 Feb 2023
- Primary completion15 Jun 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- Model description
- Clinical trial with control group and random assignment intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Luis Partida Márquez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959785
- Sponsor's protocol ID
- ALPM21
- Status last verified
- Feb 2025
- First submitted
- 30 Mar 2023
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05959785
- Acronym / sponsor ID
- ALPM21
- Conditions
- Hysterectomy
- Keywords
- pain, phrenic nerve, shoulder, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 25 Jul 2023 (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.
Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy.
Control and intervention groups were randomly established. Informed consent will be requested for participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinical trial with control group and random assignment intervention
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: Abdominal or diaphragmatic breathing exercisesAssignment to the intervention group will be done by simple randomization of the sample. A random sequence of numbers will be generated using the statistical program SPSS v.28. Patients will be included in the intervention group of each subcategory if their subject number matches one of the random numbers generated.The intervention groups will receive an explanatory video where a study collaborator performs a series of abdominal or diaphragmatic breathing exercises, which are intended to assess their effectiveness in this clinical trial. |
| control groups | Placebo comparator | Procedure: Basic and light cervical mobilization exercisesThe patients belonging to the control groups of each subcategory will also receive an explanatory video with basic and light cervical mobilization exercises (Annex 12). This group of exercises will be made up of a series of cervical mobilization exercises that are performed without pain, smooth, controlled by the patients, and without forcing the angulations. They are performed seated, with the arms extended along the body and forearms and hands resting on the legs. The chair must be firm and comfortable. Head movements to the right and left, right and left lateral flexion of the cervical region, cervical flexion and extension will be performed. This exercise will be performed for 5 minutes 3 times a day and beginning in the first 24 postoperative hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients who have given their consent to participate in the project by signing the informed consent.
Key exclusion criteria (6 listed)
- Neurological Pathology.
- Non-cooperative Subject.
- Severe Psychiatric Illness.
- Loss of Cognitive Capacity.
- Evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs.
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 |
|---|---|---|
| Basic and light cervical mobilization exercisesAlso: Control groupThis group of exercises will be made up of a series of cervical mobilization exercises that are performed without pain, smooth, controlled by the patients, and without forcing the angulations. They are performed seated, with the arms extended along the body and forearms and hands resting on the legs. The chair must be firm and comfortable. Head movements to the right and left, right and left lateral flexion of the cervical region, cervical flexion and extension will be performed. This exercise will be performed for 5 minutes 3 times a day and beginning in the first 24 postoperative hours. | Procedure or surgery | control groups |
| Abdominal or diaphragmatic breathing exercisesAlso: Intervention groupThe first abdominal or diaphragmatic breathing exercises will be carried out in a lying position, with the back well supported on a comfortable and firm surface, and with hips and knees flexed and feet supported. The patients take deep breaths, taking air raising the abdomen towards the ceiling, without raising the back from the horizontal plane. During expiration the navel will lower posteriorly and rise towards the thoracic region. For the second abdominal or diaphragmatic breathing exercise, the patient is seated on a firm and comfortable surface, with hips and knees flexed and feet supported. An inspiratory movement will be made in which the patient's navel will be moved outward, away from the spine. During expiration, the navel will go in the direction of the patient's spine and will rise in the direction of the thorax. | Procedure or surgery | intervention group |
Primary outcome
The McGill Pain Questionnaire
Time frame: 24 hours after laparoscopy
Location of pain: which is usually represented by a schematic figure of the human body, where the patient points out the areas where they feel pain. * Quality of pain: the patient must choose from a wide list of types of pain those characteristics that define the one he presents. They are grouped into various categories that in turn form four large groups: sensory, emotional, evaluative and miscellaneous. In the original English version, the number of words was 78, although they may vary in the different validations of the questionnaire (66 in the Spanish version). * Pain intensity at the current moment: explored by means of a question with five possible response categories. * Assessment of pain at the current time using a visual analogue scale, ranging from "no pain" to "unbearable pain".
The Brief Pain Questionnaire
Time frame: 24 hours after laparoscopy
This questionnaire, in its short version, includes a body map that the patient can use to mark the areas where pain is located. In addition to providing a useful tool for localizing pain, this questionnaire provides important information about other characteristics of pain, as well as response to prescribed treatments.
The Quick Dash quiz
Time frame: 24 hours after laparoscopy
Questionnaire containing questions about symptoms and the ability to use instruments of the upper limbs. Collect data referring to the last week
The HIT-6 scale
Time frame: 24 hours after laparoscopy
evaluates the headache through 6 questions
The Neck Disability Index questionnaire
Time frame: 24 hours after laparoscopy
assesses neck and back pain and its influence on basic activities of daily living
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 19 Feb 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic and light cervical mobilization exercises and Abdominal or diaphragmatic breathing exercises in people with Hysterectomy, run by University of Seville at 2 sites 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 5 inclusion and 6 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 19 Feb 2025. 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 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. Some participants in this study may receive a placebo. 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?
The McGill Pain Questionnaire (time frame: 24 hours after laparoscopy). The study lists 5 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 19 Feb 2025.