Back Pain and Spinal Manipulation in Adolescent Scoliosis

NCT02609009 | Completed

• 1 other identifier: 3928
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent idiopathic scoliosis (AIS) affects 2 - 3% of children and adolescents older than 10 years and is of unknown cause. It was initially thought that occurrences of back pain (BP) were similar to the one encounter in healthy adolescents. Recently, literature has shown that there is a two-fold prevalence of BP among AIS patients compared to healthy adolescents. As such, BP appears as a condition that might have a detrimental effect on the well-being of AIS patients and seems associated with increases in health care costs. Further, BP in adolescents would appear to be a predictive factor for adult BP. Is vertebral manipulation (VM) a viable alternative? Since 2006, four guidelines were in agreement as to the value of that approach with acute or chronic BP in adults. Unfortunately, no study was found in adolescents. The purpose of the study is to verify if VM is efficacious at improving AIS patients' back pain and to find out if it can help these patients to obtain a better quality of life and improve their spinal flexibility. Recruitment will take place at Ste Justine's hospital where patients will have 2 evaluations, conducted by an independent orthopaedist (baseline and 4 weeks). Patients will be allocated to either the experimental (VM) or the usual medical care group. Spinal manipulation treatment will last over a 4-week period. The study will be the first trial evaluating the efficacy of vertebral manipulation in adolescent idiopathic scoliosis patients with back pain. Finally, no other study was found on available and effective treatment regarding back pain management for this population. A well-structured trial is needed to provide clinicians with a better understanding and best evidence regarding treatment protocols.

Conditions

Back Pain; Scoliosis

Keywords

Back Pain; Adolescent Idiopathic Scoliosis; Spinal Manipulation

Outcome Measures

Primary Outcomes (1)

• Back Pain intensity

  The intensity and quality of low back pain will be with the use of the Brief Pain Inventory. Questionnaire (BPI). This questionnaire is used to evaluate the quality and the intensity of pain and determine its impact upon the patient. The BPI includes 9 questions and uses an 11 -point scale (0 = "no pain"; and 10 ="pain as bad as you can imagine") to evaluate the intensity of pain at the time of being surveyed, pain at its worst, pain at rest, and average pain in the past week. This instrument also records the location of pain on a diagram using a human silhouette and requires patients to select words that best describe their pain.

  4 weeks

Secondary Outcomes (4)

• Physical Functioning

  The RMDQ will be administered at baseline and at four week follow up.

• Spinal forward flexion

  The spinal forward flexion will be administered at baseline and at four week follow up.

• Spinal Forward Flexion

  The spinal forward flexion will be administered at baseline and at four week follow up.

• Isometric trunk extensor muscles endurance.

  The spinal forward flexion will be administered at baseline and at four week follow up.

Study Arms (2)

Spinal Manipulation Therapy

EXPERIMENTAL

Active chiropractic care for this RCT will consist of diversified technique prone, side posture and supine manipulations with soft-tissue therapy

Other: Spinal Manipulation Therapy

Usual Medical Care

OTHER

Control group patients will follow the usual medical visit scheduled according to their attending orthopaedists. Usual interventions generally consist in the administration of medications (NSAIDs or ibuprofen), physical therapy or exercises.

Other: Usual Medical Care

Interventions

Spinal Manipulation Therapy OTHER

Intervention will consist of Diversified type adjustments. Patients will be assigned to the nearest participating chiropractic clinic and will have a complete standardized examination on their first visit. Patient will then receive a maximum of 12 treatments (3x per week for a period of 4 weeks).

Spinal Manipulation Therapy

Usual Medical Care OTHER

Usual interventions generally consist in the administration of medications (NSAIDs or ibuprofen), physical therapy or exercises. If recommended, physical therapy will be provided by the hospital physical therapy services. Physical therapy might include treatments such as massage, different electrotherapy, postural repositioning, exercises, etc

Usual Medical Care

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents 10 to 17-year-old of either gender
• Both, parents and adolescents speak either English or French
• Adolescents with a diagnosis of AIS established by one of the participating orthopaedists.
• Pain score over 3 on scale of 0-10
• AIS associated with mechanical back pain of at least six consecutive weeks duration with or without radiating pain to the lower extremity. Mechanical back pain is defined as pain not associated with specific identifiable aetiologies

You may not qualify if:

• suffering from any metabolic, malignant or any serious organic or progressive neurological deficit.
• any structural disturbances of the spine is present (e.g.: osteoporosis, disc herniation, spondylolisthesis, hip dysplasia and others),
• previous back surgery for AIS
• ongoing treatment for back pain by other health care providers
• pregnancy
• contraindications to SMT, other than previously mentioned, such as inflammatory or infectious conditions, blood clotting and connective tissue disorders

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Fondation Chiropratique du Québec: collaborator

Study Sites (1)

Sainte-Justine University Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Back Pain; Scoliosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chiropractor, PhD student

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: September 1, 2014
• Primary Completion: April 5, 2017
• Study Completion: May 31, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

CA (1)