Protocol of Accelerated Rehabilitation Following Surgical Correction of Adolescent Idiopathic Scoliosis

NCT03719807 | Completed

• 1 other identifier: ROH18ORTH07
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify whether an accelerated physiotherapy led rehabilitation programme for adolescents undergoing idiopathic scoliosis correction surgery can be delivered safely and effectively post-operatively, and whether it might improve activity levels and quality of life outcomes for the study group. This research is being conducted as previous research indicates that up to 41% of patients who have surgical correction of their scoliosis either return to athletic activity at a lower level than before, or they do not return to athletic activity at all. This is despite significant advancement in the instrumentation being used in recent years which makes the corrections more stable and robust. Some studies have shown that surgically treated AIS patients have significantly reduced physical function and quality of life scores, and that this could be improved with exercise. So far no trials have investigated whether post-operative rehabilitation can improve quality of life for these patients. The initial study will be a pilot study, comprising of 20 participants in a small, pragmatic randomised controlled trial (RCT). It will be conducted at The Royal Orthopaedic Hospital, a specialist National Health Service (NHS) orthopaedic centre. Adolescents (between 11-18 years of age) who have a diagnosis of adolescent idiopathic scoliosis (AIS) and are on the waiting list for surgical correction of this scoliosis will be included. The study will compare a post-operative accelerated rehabilitation programme (commenced at 6 weeks post surgery) with usual care and investigate if the accelerated intervention can be delivered safely and effectively after this procedure. Following surgery, both groups will have the same inpatient rehabilitation up until the point of discharge home. The intervention group will then complete 12 sessions of physiotherapy as an outpatient, which starts at 6 week post-op. The usual care group will not have any further physiotherapy, in line with current standard practice at this centre. Both groups will be assessed using patient reported outcome measures pre-operatively, and at 6 months and 12 months post-operatively, to assess function and quality of life.

Conditions

Scoliosis Idiopathic

Keywords

rehabilitation; post-operative; scoliosis correction

Outcome Measures

Primary Outcomes (1)

• The Scoliosis Research Society - 22r (SRS-22r)

  Patient reported outcome measure, measuring change in quality of life scores over 12 months. There are 22 questions within this outcome measure, which cover a variety of domains including: pain, body image, activity levels, function, mental health and social interaction. There are 5 scale points within each answer, but these 5 options are different each question. An example would be: 1\. Which one of the following best describes the amount of pain you have experienced during the past 6 months? None, Mild, Moderate, Moderate to severe, Severe. The most positive answer would be scored as 5 whilst the most negative answer would be scored 1. This process is consistent throughout the 22 questions and the scores of all 22 questions are added together for an overall score. A higher score suggests a higher quality of life. All of the questions in this outcome measure are designed to be scoliosis specific.

  baseline, 6 months and 12 months

Secondary Outcomes (3)

• The Short Form 36 point questionnaire (SF-36)

  baseline, 6 months and 12 months

• The pain self-efficacy scale (PSES)

  baseline, 6 months and 12 months

• The Global Rating of Change Scale (GRCS)

  6 months and 12 months post-operatively.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Usual Care No routine outpatient physiotherapy following discharge home post-operatively in line with standard care.

Other: Usual Care

Intervention Group

EXPERIMENTAL

12 x Exercise//Rehabilitation sessions Begin at 6 weeks. 6 x weekly sessions Followed by 6 x bi-weekly sessions In line with Accelerated Rehabilitation protocol

Other: Rehabilitation protocol

Interventions

Rehabilitation protocol OTHER

A physiotherapy rehabilitation protocol - comprising of pragmatic exercises.

Intervention Group

Usual Care OTHER

No routine outpatient physiotherapy. Normal inpatient physiotherapy to match intervention group.

Control Group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 11-18 years old at the time of surgery.
• Diagnosis of AIS confirmed by spinal deformity team.
• On the waiting list to have a posterior or combined anterior/posterior scoliosis correction surgery.

You may not qualify if:

• Underlying cause of scoliosis which makes it not idiopathic.
• Significant post-operative complications that prevents participation in the trial.
• Any significant learning disabilities or cognitive impairment that would limit the patient's ability to take part in the rehabilitation protocol.
• Planned anterior-only scoliosis correction surgery.
• Patients that are unable to understand verbal instructions or written information given in English.
• Patients involved in any other research trials.

Sponsors & Collaborators

• The Royal Orthopaedic Hospital NHS Trust: lead

Study Sites (1)

The Royal Orthopaedic Hospital NHS Foundation Trust

Birmingham, West Midlands, B31 2AP, United Kingdom

Location

Related Publications (12)

• Adobor RD, Rimeslatten S, Keller A, Brox JI. Repeatability, reliability, and concurrent validity of the scoliosis research society-22 questionnaire and EuroQol in patients with adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Jan 15;35(2):206-9. doi: 10.1097/BRS.0b013e3181b43bdf.

  PMID: 20081517 BACKGROUND

• Bursch B, Tsao JC, Meldrum M, Zeltzer LK. Preliminary validation of a self-efficacy scale for child functioning despite chronic pain (child and parent versions). Pain. 2006 Nov;125(1-2):35-42. doi: 10.1016/j.pain.2006.04.026. Epub 2006 Jun 5.

  PMID: 16740360 BACKGROUND

• Chan CYW, Aziz I, Chai FW, Kwan MK. A Silver Medal Winner at the 13th World Wu Shu Championship 2015 17 Months After Selective Thoracic Fusion for Adolescent Idiopathic Scoliosis: A Case Report. Spine (Phila Pa 1976). 2017 Feb 15;42(4):E248-E252. doi: 10.1097/BRS.0000000000001748.

  PMID: 28207671 BACKGROUND

• Danielsson AJ, Wiklund I, Pehrsson K, Nachemson AL. Health-related quality of life in patients with adolescent idiopathic scoliosis: a matched follow-up at least 20 years after treatment with brace or surgery. Eur Spine J. 2001 Aug;10(4):278-88. doi: 10.1007/s005860100309.

  PMID: 11563612 BACKGROUND

• Fabricant PD, Admoni S, Green DW, Ipp LS, Widmann RF. Return to athletic activity after posterior spinal fusion for adolescent idiopathic scoliosis: analysis of independent predictors. J Pediatr Orthop. 2012 Apr-May;32(3):259-65. doi: 10.1097/BPO.0b013e31824b285f.

  PMID: 22411331 BACKGROUND

• Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

  PMID: 20046623 BACKGROUND

• Kim YJ, Lenke LG, Kim J, Bridwell KH, Cho SK, Cheh G, Sides B. Comparative analysis of pedicle screw versus hybrid instrumentation in posterior spinal fusion of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2006 Feb 1;31(3):291-8. doi: 10.1097/01.brs.0000197865.20803.d4.

  PMID: 16449901 BACKGROUND

• Lehman RA Jr, Kang DG, Lenke LG, Sucato DJ, Bevevino AJ; Spinal Deformity Study Group. Return to sports after surgery to correct adolescent idiopathic scoliosis: a survey of the Spinal Deformity Study Group. Spine J. 2015 May 1;15(5):951-8. doi: 10.1016/j.spinee.2013.06.035. Epub 2013 Oct 5.

  PMID: 24099682 BACKGROUND

• Snowdon M, Peiris CL. Physiotherapy Commenced Within the First Four Weeks Post-Spinal Surgery Is Safe and Effective: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2016 Feb;97(2):292-301. doi: 10.1016/j.apmr.2015.09.003. Epub 2015 Sep 25.

  PMID: 26409101 BACKGROUND

• Tones M, Moss N, Polly DW Jr. A review of quality of life and psychosocial issues in scoliosis. Spine (Phila Pa 1976). 2006 Dec 15;31(26):3027-38. doi: 10.1097/01.brs.0000249555.87601.fc.

  PMID: 17173000 BACKGROUND

• Tsutsui S, Pawelek J, Bastrom T, Lenke L, Lowe T, Betz R, Clements D, Newton PO. Dissecting the effects of spinal fusion and deformity magnitude on quality of life in patients with adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2009 Aug 15;34(18):E653-8. doi: 10.1097/BRS.0b013e3181b2008f.

  PMID: 19680091 BACKGROUND

• Yu CH, Chen PQ, Ma SC, Pan CH. Segmental correction of adolescent idiopathic scoliosis by all-screw fixation method in adolescents and young adults. minimum 5 years follow-up with SF-36 questionnaire. Scoliosis. 2012 Feb 19;7:5. doi: 10.1186/1748-7161-7-5.

  PMID: 22340624 BACKGROUND

Study Officials

• Jodie Walters

  Physiotherapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 25, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: September 13, 2023

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)