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Degenerative ScoliosisNCT03413839

Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis

A study testing Physiotherapeutic Scoliosis Specific Exercises (PSSE) and Conventional Physical Therapy (PT) in people with Degenerative Scoliosis, run by Columbia University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Degenerative Scoliosis
What is being tested?
Physiotherapeutic Scoliosis Specific Exercises (PSSE) and Conventional Physical Therapy (PT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2020to Dec 2020
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

Official title: 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).

Read the 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.

Being tested
Physiotherapeutic Scoliosis Specific Exercises (PSSE), Conventional Physical Therapy (PT)
Keywords
Scoliosis, PSSE
Medical subject headings
Scoliosis

What participants receive

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

  • Physiotherapeutic Scoliosis Specific Exercises (PSSE)Behavioural

    Also called 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.

  • Conventional Physical Therapy (PT)Behavioural

    Conventional PT includes generalized pelvis, and trunk strengthening, lower extremity (LE) stretching, and use of modalities (ice and heat), iontophoresis and E-Stim.

Study groups in NCT03413839
Study groupRoleWhat they receive
PSSE GroupExperimentalIndividuals 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.
Receives: Behavioral: Physiotherapeutic Scoliosis Specific Exercises (PSSE)
Conventional PT GroupOtherIndividuals 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.
Receives: Behavioral: Conventional Physical Therapy (PT)

What is being measured

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

  1. Visual Analog Scale (VAS) Score for Back Pain

    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.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Score on Scoliosis Research Society 22-item (SRS-22r)

    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).

    Measured: Up to 6 months

  2. Score on Oswestry Disability Index (ODI)

    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.

    Measured: Up to 6 months

Timeline

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

  1. First posted29 Jan 2018
  2. Study startMay 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: No research resources to complete study

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413839
Sponsor's protocol ID
AAAQ9761
Status last verified
Oct 2019
First submitted
22 Jan 2018
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bess S, Schwab F, Lafage V, Shaffrey CI, Ames CP. Classifications for adult spinal deformity and use of the Scoliosis Research Society-Schwab Adult Spinal Deformity Classification. Neurosurg Clin N Am. 2013 Apr;24(2):185-93. doi: 10.1016/j.nec.2012.12.008.

    PubMed 23561557

  • Li G, Passias P, Kozanek M, Fu E, Wang S, Xia Q, Li G, Rand FE, Wood KB. Adult scoliosis in patients over sixty-five years of age: outcomes of operative versus nonoperative treatment at a minimum two-year follow-up. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2165-70. doi: 10.1097/BRS.0b013e3181b3ff0c.

    PubMed 19713875

  • Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Motta L, Cerri C, Brayda-Bruno M, Lovi A. Adults with idiopathic scoliosis improve disability after motor and cognitive rehabilitation: results of a randomised controlled trial. Eur Spine J. 2016 Oct;25(10):3120-3129. doi: 10.1007/s00586-016-4528-y. Epub 2016 Mar 25.

    PubMed 27015689

  • Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, Hilton JF, Shainline M, Baldus C, Wootten D. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2171-8. doi: 10.1097/BRS.0b013e3181a8fdc8.

    PubMed 19752703

  • Weinstein JN, Lurie JD, Tosteson TD, Zhao W, Blood EA, Tosteson AN, Birkmeyer N, Herkowitz H, Longley M, Lenke L, Emery S, Hu SS. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am. 2009 Jun;91(6):1295-304. doi: 10.2106/JBJS.H.00913.

    PubMed 19487505

  • Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.

    PubMed 17538085

  • Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd.

    PubMed 15864163

  • Kuru T, Yeldan I, Dereli EE, Ozdincler AR, Dikici F, Colak I. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial. Clin Rehabil. 2016 Feb;30(2):181-90. doi: 10.1177/0269215515575745. Epub 2015 Mar 16.

    PubMed 25780260

  • Negrini A, Negrini MG, Donzelli S, Romano M, Zaina F, Negrini S. Scoliosis-Specific exercises can reduce the progression of severe curves in adult idiopathic scoliosis: a long-term cohort study. Scoliosis. 2015 Jul 11;10:20. doi: 10.1186/s13013-015-0044-9. eCollection 2015.

    PubMed 26279670

  • Negrini S, Donzelli S, Lusini M, Minnella S, Zaina F. The effectiveness of combined bracing and exercise in adolescent idiopathic scoliosis based on SRS and SOSORT criteria: a prospective study. BMC Musculoskelet Disord. 2014 Aug 6;15:263. doi: 10.1186/1471-2474-15-263.

    PubMed 25095800

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapeutic Scoliosis Specific Exercises (PSSE) and Conventional Physical Therapy (PT) in people with Degenerative Scoliosis, run by Columbia University.

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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Visual Analog Scale (VAS) Score for Back Pain (time frame: Up to 2 years). 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 NCT03413839, which also lists 10 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 4 Oct 2019.

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