Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EK Nr. 301/2009 | Other Identifier | Ethics committee, Medical University of Vienna |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotherapy Intervention | Behavioral | 20x 30 min sessions of physiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with treatment | Ratings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline | 12 years |
| Use of health care resources | questions related to the use of health care resources because of back pain, and the necessity of reoperation of a disc herniation |
| Measure | Description | Time Frame |
|---|---|---|
| X Rays | Functional X rays of the lumbar spine | 12 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gerold Ebenbichler, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Physical Medicine & Rehabilitation, MUV, AKH | Vienna | 1090 | Austria |
Not provided
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham neck massage | Behavioral | 20x 30 minutes sessions of neck massage |
|
| 12 years |
| Psychological questionnaires | Fear Avoidance beliefs questionnaire, MOS 36-Item Short Form Health Survey, Heidelberger Pain Inventory Symptom Checklist-90R (SCL-90R) Beck Depression Inventory (BDI) | 12 years |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |