CompletedNot Applicable

Surgical Treatment for Degenerative Scoliosis

Italy31 participantsStarted 2010-01

Plain-language summary

The study aims to analyze the surgical treatment of low back pain due to degenerative kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of back pain and functional ability before and after the surgical treatment will be performed by administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be matched to a purely objective and radiological assessment according to international guidelines. A psychological analysis will be also performed in order to evaluate co-morbidity from this field, considering that the concept of "shared decision-making" for the therapeutic approach to low back pain requires the evaluation of all these parameters.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female or male * Age 40-75 years * Patients capable of understanding and willing * Lumbar or thoraco-lumbar degenerative kyphoscoliosis * Chronic low back pain from more than 6 months and/or presence of neurological deficits at lower limbs * Failure to respond to conservative therapy Exclusion Criteria: * Infections in place * Coagulation deficits * Serious psychological comorbidity

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.

Timeframe: Before surgery, 1-3-6-12 months after surgery, then annually

Change from the baseline radiographic status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.

Timeframe: Before surgery, 1-3-6-12 months after surgery, then annually

Assessment of the psychological state of the patients before the surgical treatment and at 1-3-6-12 months of follow up.

Timeframe: Before surgery, 1-3-6-12 months after surgery, then annually

Trial details

NCT IDNCT01439906

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Scoliosis trials

Plain-language summary

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.

Timeframe: Before surgery, 1-3-6-12 months after surgery, then annually

Change from the baseline radiographic status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.

Timeframe: Before surgery, 1-3-6-12 months after surgery, then annually

Assessment of the psychological state of the patients before the surgical treatment and at 1-3-6-12 months of follow up.

Timeframe: Before surgery, 1-3-6-12 months after surgery, then annually