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Chronic PainNCT01994343

Pain in Women With Chronic Pelvic Pain

A study testing Global posture reeducation in people with Chronic Pain, run by Universidad de Granada at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic pelvis pain is very common between adult women. Significant progress is made in clarifying the multifactorial model of chronic pain pathogenesis, but a more complete assessment is important in order to improve the therapeutic approach. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
Global posture reeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSpain
Study dates
Nov 2013to Aug 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 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women.
  • Clinical diagnosis of chronic pelvic pain.
  • More than eighteen years.
  • Non-menstrual or noncyclic pelvic pain.
  • Duration of pain of at least 6 months.

Who cannot join

  • Duration of pain less than 6 months.
  • Women who were pregnant in the last 12 months

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Physical Therapy

    Granada, 18071

Other trials in Spain

About this study

Official title: Musculoskeletal Disturbances in Women With Chronic Pelvic Pain

Chronic pelvis pain is very common between adult women. Significant progress is made in clarifying the multifactorial model of chronic pain pathogenesis, but a more complete assessment is important in order to improve the therapeutic approach. The purpose of this study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.

Read the detailed description

Chronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at least 6 months. This pain interfere with habitual activities and requires clinical or surgical treatment. It is a complex interaction between the gastrointestinal, urinary, gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological factors. Its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14 to 24% among women of reproductive age. It is very important a multidimensional approach in order to stablish a more specific profile.

Conditions
Chronic Pain
Being tested
Global posture reeducation
Keywords
Chronic pelvic pain, women, pain, posture.
Medical subject headings
Chronic Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Global posture reeducationOther

    Also called Evaluation

    An assessment of the women is performed using global posture reeducation.

Study groups in NCT01994343
Study groupRoleWhat they receive
Experimental groupExperimentalAdult women aged over 18 years old with pain during more than six months are included in the study. These patients will receive a global posture reeducation.
Receives: Other: Global posture reeducation
Control groupNo interventionAdult women aged over 18 years old without chronic pain. will receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in postural control

    Postural control will be assessed using the Mini-BESTest, a 14-item test that focuses on dynamic balance, specifically anticipatory transitions (six items), reactive postural control (six items), sensory orientation (six items), and dynamic gait (10 items). Each item is scored from 0 to 2; a score of 0 indicates that a person is unable to perform the task, whereas a score of 2 is normal. The best score is the maximum amount of points, being 28.

    Measured: Change from baseline postural control at 8 weeks

Secondary outcomes (5)

  1. Nervous assessment

    The nervous assessment is measured with neurodynamic tests. This is used to test upper and lower extremities. It moves most of the nerves between the neck and legs, including the spinal nerves and lower limbs nerves.

    The patient is placed in supine position. It is measured with a goniometer.

    Measured: baseline

  2. Spinal assessment

    The spinal assessment is going to be performed using the Spinal Mouse. Spinal Mouse is a device that, combined with a computer program, assesses the curvatures of the vertebral column without applying harmful radiation. Spinal Mouse checks: spine alignment, measuring segmental and global angles in the sagittal and frontal planes; posture and spinal mobility; spine functions and performance.

    Measured: baseline

  3. Balance under dual task conditions

    Women were asked to complete three trials of the TUG under three conditions: performance of the TUG alone, performance of the TUG with the addition of a cognitive task (TUG cognitive), and performance of the TUG with the addition of an upper-extremity motor task (TUG manual). Women were given verbal instructions to stand up from a chair, walk 3 m as quickly and as safely as possible, cross a line marked on the floor, turn around, walk back, and sit down. In the TUG cognitive, women were asked to complete the test while counting backward by threes from a randomly selected number between 20 and 100. In the TUG manual, women were asked to complete the test while carrying a full cup of water.

    Measured: Baseline, 8 weeks

  4. Trigger points evaluation

    Trigger points are discrete, focal, hyperirritable spots located in a taut band of skeletal muscle. A pressure at a trigger point is performed in order to evoke pain at the point as well as referred pain in myofascial or visceral structures. The trigger points located in the gluteal and adductors muscles are going to be assessed.

    Measured: baseline

  5. Self perceived health status

    Health status was assessed by the Euroqol-5dimensions (EQ-5D). It is divided into 2 sections. The first section contains 5 questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each question, problems within the domain are evaluated on a 3-level basis. Responders can choose between "no problems", "some problems" or "extreme problems". The second part is a visual analogue scale (VAS) score, which records the responder's self-evaluated health status, where 0 is worst imaginable health and 100 is best imaginable health.

    Measured: Baseline, 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2016
  4. Study completionAug 2018 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01994343
Sponsor's protocol ID
DF0044UG
Status last verified
Jul 2018
First submitted
19 Nov 2013
Last updated
24 Jul 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Rodriguez-Torres J, Lopez-Lopez L, Cabrera-Martos I, Prados-Roman E, Granados-Santiago M, Valenza MC. Effects of an Individualized Comprehensive Rehabilitation Program on Impaired Postural Control in Women With Chronic Pelvic Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Aug;101(8):1304-1312. doi: 10.1016/j.apmr.2020.02.019. Epub 2020 Apr 20.

    PubMed 32325162

  • Fuentes-Marquez P, Valenza MC, Cabrera-Martos I, Rios-Sanchez A, Ocon-Hernandez O. Trigger Points, Pressure Pain Hyperalgesia, and Mechanosensitivity of Neural Tissue in Women with Chronic Pelvic Pain. Pain Med. 2019 Jan 1;20(1):5-13. doi: 10.1093/pm/pnx206.

    PubMed 29025041

Questions about this trial

What is this clinical trial studying?

A study testing Global posture reeducation in people with Chronic Pain, run by Universidad de Granada 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 5 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: status not confirmed, as of the sponsor's last update on 24 Jul 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 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?

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 postural control (time frame: Change from baseline postural control at 8 weeks). 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 NCT01994343, which also lists 2 linked publications.

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 24 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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