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

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Intervertebral Disc Displacement

Treatments: Behavioral: Physiotherapy Intervention; Behavioral: Sham neck massage

Study type: Interventional

Funder types: Other

Identifiers

NCT01922063

PMR_Ebe01/2009

EK Nr. 301/2009 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Physiotherapy Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physiotherapy Intervention

Sham neck massage

Sham Comparator group

Description:

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

Treatment:

Behavioral: Sham neck massage

No therapy

No Intervention group

Description:

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