Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis

October 2, 2019 updated by: Columbia University

Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis vs Conventional Physical Therapy Exercises

This is a pilot study to lead to a larger prospective, randomized, controlled study of older adult (ages 50 and older) spinal patients with thoracolumbar/lumbar scoliosis evaluating improvement with physiotherapeutic scoliosis-specific exercise (PSSE) compared to traditional low back physical therapy (PT).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adult scoliosis with chronic back pain is a very complex condition. Chronic back pain remains one of our country's most costly conditions to manage and treat. Many of these patients have difficulty with activities of daily living (ADL), household and community ambulation, and maintaining their professional career. The intervention options for this population remain limited, with surgery being the only one that has shown improvements in health related quality of life and an overall decrease in the complaints of pain. However, the costs of surgery and additional complications are limitations to this treatment option.There has been increased attention and interest in the medical community looking at the effects of Physiotherapeutic Scoliosis Specific Exercises (PSSE) on curve progression, improvements in health related quality of life, and pain. The investigators hypothesize that PSSE can directly affect radiological parameters, such as the sagittal vertical axis (SVA), as well as showing improvements in health related quality of life using subjective patient specific outcome measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 50+ years old
  • Diagnosis of adolescent idiopathic scoliosis or adult idiopathic scoliosis; either with a Cobb angle ranging from 20-100 degrees
  • Complaint of back pain that has lasted longer than 6 weeks

Exclusion Criteria:

  • Any patient who has completed PSSE in the past
  • Previous spinal surgery, trauma, or presence of neoplasms
  • Diagnosis of congenital or neuromuscular scoliosis
  • Subjects who are involved in concurrent interventions other than conventional physical therapy (PT)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PSSE Group
Individuals will receive at least 6 sessions of physiotherapeutic scoliosis specific exercises (PSSE) (Schroth) physical therapy. Patients will also be required to perform exercises 5x/wk for 15 minutes at home. Compliance will be monitored by written log and weekly phone check-in after 8 weeks.
Behavioral: Physiotherapeutic Scoliosis Specific Exercises (PSSE)
Exercises with emphasis on trunk extensor strengthening, and teaching patient better postural strategies in supine, sidelying, sitting, standing, and dynamic movements (walking, squatting), led by a PSSE-trained physical therapist.
Other Names:
  • PSSE
Other: Conventional PT Group
Individuals will receive at least 6 sessions of conventional physical therapy (PT). Patients will also be required to perform exercises 5x/wk for 15 minutes at home. Compliance will be monitored by written log and weekly phone check-in after 8 weeks.
Behavioral: Conventional Physical Therapy (PT)
Conventional PT includes generalized pelvis, and trunk strengthening, lower extremity (LE) stretching, and use of modalities (ice and heat), iontophoresis and E-Stim.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Score for Back Pain
Time Frame: Up to 2 years
The VAS is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Score on Scoliosis Research Society 22-item (SRS-22r)
Time Frame: Up to 6 months
Outcome measure designed by the Scoliosis Research Society that is specially designed for patients with scoliosis and evaluates their scores for self-image, pain, mental health, and function. It contained 22 items contributing to five main domains: Function (5 items), Pain (5 items), Self-image/appearance (5 items), Mental Health (5 items), Satisfaction with Treatment (Current/Previously performed-2 items). Scores range from 5 (best) to 1 (worst).
Up to 6 months
Score on Oswestry Disability Index (ODI)
Time Frame: Up to 6 months
The ODI is a self-completed questionnaire containing 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allen Chen, MD, MPH, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAQ9761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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