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

Intervertebral Disc Displacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922063
• Other study ID #: PMR_Ebe01/2009
• Secondary ID: EK Nr. 301/2009
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2013
• Last updated: August 13, 2013
• Start date: July 1996
• Est. completion date: March 2010

Study information

• Verified date: August 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement

Intervention

Behavioral:
• Physiotherapy Intervention
20x 30 min sessions of physiotherapy
• Sham neck massage
20x 30 minutes sessions of neck massage

Locations

Country	Name	City	State
Austria	Dept Physical Medicine & Rehabilitation, MUV, AKH	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	X Rays	Functional X rays of the lumbar spine	12 years	No
Primary	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	No
Secondary	Satisfaction with treatment	Ratings on a 5-point Likert scale (1= completely recovered to 5= dramatically worse as compared to baseline	12 years	No
Secondary	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	12 years	No
Secondary	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	No