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Completed

NCT Number: NCT01922063

Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT

Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained from survivors of disc surgery that would have considered the type of postoperative care.

Objectives: 1) To evaluate the long-term effects of postoperative comprehensive physiotherapy starting 1 week after lumbar disc surgery. 2) To assess the relative risk of segmental instability in the operated segment 12 years following lumbar disc surgery.

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Key information

Conditions

Intervertebral Disc Displacement Bone Diseases Hernia Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept Physical Medicine & Rehabilitation, MUV, AKH

Vienna, 1090, Austria

About this study

Design: Twelve years' follow-up of a three-armed, randomized, controlled, single blinded clinical trial. Setting: Outpatient department of Physical Medicine & Rehabilitation. Participants: Of 120 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study are invited to a 12 years follow-up examination. Interventions: In the original study, patients had been randomly assigned to "comprehensive physiotherapy", "sham intervention" (neck massage), or no therapy. Measurements: Low Back Pain Rating Score (LBPRS; Manniche 1993), functional X-rays of the lumbar spine. All data are collected by blinded students and physicians at the Department of PM&R, Vienna Medical University.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had completed the treatment originally allocated
  • all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had not completed the treatment originally allocated

Exclusion criteria

  • n.a.

Treatment and study plan

Physiotherapy Intervention

Behavioral

20x 30 min sessions of physiotherapy

Sham neck massage

Behavioral

20x 30 minutes sessions of neck massage

Primary outcomes

  1. Low back pain rating scale (LBP-RS)

    Time frame: 12 years after Randomization

    The LBP-RS measures the health concepts of pain, disability, and physical impairment. Both the original and the translated version of the LBP rating scale are highly reliable within and between raters, uni-dimensional and are shown to have satisfactory construct validity. The sum score ranges from 130 (worst) to 0 (best) and is the composite of 3 subscores (pain, disability, and physical function).

Secondary outcomes

  1. Satisfaction with treatment

    Time frame: 12 years

    Ratings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline

  2. Use of health care resources

    Time frame: 12 years

    questions related to the use of health care resources because of back pain, and the necessity of reoperation of a disc herniation

  3. Psychological questionnaires

    Time frame: 12 years

    Fear Avoidance beliefs questionnaire, MOS 36-Item Short Form Health Survey, Heidelberger Pain Inventory Symptom Checklist-90R (SCL-90R) Beck Depression Inventory (BDI)

Other outcomes

  1. X Rays

    Time frame: 12 years

    Functional X rays of the lumbar spine

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Long Term Follow-up of Comprehensive Physiotherapy Following Disc Herniation Operation: Results of a Randomized Clinical Trial

Important dates

Study start
1996
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2013
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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