Clinical trial NCT01439906: Surgical Treatment for Degenerative Scoliosis
Official title: Evaluation of Pain Relief and Functional Improvement After the Surgical Treatment for Low Back Pain Due to Degenerative Kyphoscoliosis - Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Kyphoscoliosis
Keywords: Degenerative scoliosis
Pain
Deformity correction
Instrumented arthrodesis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
Secondary outcomes:
measure: Evaluation of possible surgical complications (hardware failure, neurological damages, re-intervention) during the perioperative period and at 1-3-6-12 months after surgery.
timeFrame: Perioperative, 1-3-6-12 months after surgery, then annually
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Giovanni Barbanti Brodano, Dr
role: PRINCIPAL_INVESTIGATOR
References: