Impact of Structured active rehabilitation on the functional outcome in patients undergoing Transforaminal lumbar interbody fusion surgery - a prospective randomized controlled study

INTRODUCTION:

Lumbar disc prolapse and canal stenosis, characterized by the narrowing of the spinal canal leading to pressure on nerve roots or the spinal cord, is a prevalent condition often necessitating surgical intervention. Surgical procedures, particularly surgeries such as lumbar fusion procedures, are commonly employed to alleviate leg and back pain associated with these pathologies. Despite its prevalence and the increasing rates of spinal surgeries, the postoperative outcomes, especially in terms of functional recovery and pain management, remain suboptimal. While surgical interventions mentioned priorly are commonly performed, the outcomes are variable, with a significant proportion of individuals failing to regain optimal function. The success rates of surgery range widely, with functional improvement reported between 58% and 69%, and participant satisfaction ranging from 15% to 81%. Furthermore, evidence indicates trunk muscle dysfunction in individuals with back problems, and surgery- induced damage to muscles, suggests that rehabilitation may be a promising avenue to enhance postoperative outcomes. The postoperative care landscape is diverse, with significant variations in the type and intensity of rehabilitation provided, as well as restrictions imposed on participants. Postoperative management may involve education, rehabilitation, exercise, behavioural graded training, neuromuscular training, and stabilization training. Despite these diverse approaches, there is insufficient evidence to determine the best clinical practice, necessitating further research. In light of the increasing prevalence of lumbar canal stenosis and disc prolapse and the variable outcomes of surgery, there is a critical need to evaluate and optimize postoperative rehabilitation strategies. This research aims to contribute to the understanding of the impact of active rehabilitation on functional outcomes and pain management following spinal surgery within the local context of the Indian population. This background underscores the rationale for investigating the effectiveness of active rehabilitation interventions and comparing them with usual postoperative care, providing a comprehensive overview of the current scenario and the gaps in knowledge that the proposed research seeks to address.

AIM :

The primary aim of this research is to assess the impact of active rehabilitation programs on functional outcomes following lumbar fusion surgery, compared to the usual postoperative care.

OBJECTIVES:

1. To determine the effectiveness and evaluate the long-term (at 6 and 12 months postoperative) impact of active rehabilitation programs on functional outcomes after posterior lumbar instrumented fusion surgery for lumbar pathologies.

2. To compare the effects of active rehabilitation with usual postoperative care on short- term and long-term lower back pain, leg pain as well as functional outcomes.

METHODOLOGY :

Study Design: This research will adopt a prospective, randomized controlled trial (RCT) design.

Inclusion Criteria: Adults who have undergone lumbar fusion surgery for lumbar pathologies at a single level will be included. Diagnosis confirmation will be based on clinical assessment and imaging.

Exclusion Criteria: Patients having infection, trauma, tumours, inflammatory pathologies as well as multi-level spinal pathologies will be excluded from this study.

Place of Study: Department of Orthopaedics and Spine Surgery, SRIHER, Chennai

Duration of Study: 2 Years

Sample Size:

The total sample size required for the study is 90.

Patients will be divided into groups of 45 each as a Study Group and Control Group.

Data Collection and Analysis:

Data will be collected within 6 months (short term) and at 12 months (long term) postoperatively. Statistical analyses, using appropriate analytical software, will be employed to assess treatment effects and heterogeneity.

PROCEDURE:

After IEC approval, an informed consent would be taken from all patients included in the study as per the inclusion criteria. A detailed proforma will be filled up for each patient and a case ID would be allotted to each individual case.

Participants will be randomized into two groups (of 45 each) one receiving active rehabilitation and the other group will receive usual postoperative care. Active rehabilitation will encompass therapist-led exercises, muscle-strengthening exercises, flexibility training, and educational materials encouraging activity (Protocol attached in Annexure). Usual care will involve advice to stay active or a brief general exercise program. This will be carried out using Post Operative Basic Strength Programme protocol attached in Annexure.

Outcome Measures:

The primary outcome measures will include disease-specific functional and disability status using standardized measures - VAS back pain and VAS leg pain, Oswestry Disability Index, Secondary outcomes will involve global health measures - SF36.

CONFIDENTIALITY AND ETHICAL CONSIDERATIONS:

Ethical clearance will be obtained from the Institutional Ethics Committee. All information will be obtained after taking an informed consent from the patient. The information will be kept confidential and will be used purely for scientific purposes.

IMPORTANCE OF STUDY:

This study is significant because it addresses a crucial gap in understanding regarding the optimal postoperative care for individuals undergoing spinal surgery for lumbar pathologies. By comparing the effectiveness of active rehabilitation programs to usual postoperative care, the study aims to provide valuable insights into enhancing functional recovery and pain management outcomes. The findings from this research could potentially lead to the development of more tailored and effective rehabilitation strategies, ultimately improving the quality of life for individuals recovering from these common spinal conditions. Additionally, as the study is conducted within the local context of the Indian population, it offers insights specifically relevant to this demographic, contributing to the advancement of spinal care practices in this region.