NCT01922063

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

13.7 years

First QC Date

August 12, 2013

Last Update Submit

August 13, 2013

Conditions

Intervertebral Disc Displacement

Keywords

disc herniation surgeryphysiotherapy, exercise therapyrandomizedlong termfollow up

Outcome Measures

Primary Outcomes (1)

  • Low back pain rating scale (LBP-RS)

    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).

    12 years after Randomization

Secondary Outcomes (3)

  • Satisfaction with treatment

    12 years

  • Use of health care resources

    12 years

  • Psychological questionnaires

    12 years

Other Outcomes (1)

  • X Rays

    12 years

Study Arms (3)

Physiotherapy Intervention

EXPERIMENTAL

20 treatment sessions of a comprehensive physiotherapy program, 12 weeks' duration, with custom tailored instructions by the supervising physician; physicians discussed the course of therapy with the physiotherapist 1x/week. Patients had been treated by physiotherapist according to written prescriptions. Duration of treatment 30 min/ session. Patients were encouraged to practice regular home exercise.

Behavioral: Physiotherapy Intervention

Sham neck massage

SHAM COMPARATOR

received twenty sessions "sham" neck massage of 30 minutes' duration each with the patients lying in supine position on a massage bed and the head of the patient resting on the therapist's knees

Behavioral: Sham neck massage

No therapy

NO INTERVENTION

no further therapy, patients were asked to "wait and see" for the first three months after operation, and no particular treatment was planned

Interventions

Physiotherapy InterventionBEHAVIORAL

20x 30 min sessions of physiotherapy

Physiotherapy Intervention
Sham neck massageBEHAVIORAL

20x 30 minutes sessions of neck massage

Sham neck massage

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • n.a.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Physical Medicine & Rehabilitation, MUV, AKH

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Gerold Ebenbichler, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr Gerold Ebenbichler

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

July 1, 1996

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

AU(1)