Clinical trial NCT05931653: Multimodal PT With and Without Proprioceptive Training in Lumber FJS
Official title: Multimodal Physical Therapy Approach With and Without Proprioceptive Training in Lumber Facet Joint Syndrome.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Facet Joint Pain
Keywords: Low back pain
Facet joint
Range of motion
Balance
Fatigue
Lordosis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a randomized clinical trial. The study will be conducted at Pakistan Railways General Hospital Rawalpindi and Riphah International Hospital Islamabad. Patients with FJS will be included. The aim of this study is to find the comparative effects of multimodal physical therapy treatment and proprioceptive training along with multimodal physical therapy treatment on pain, lumbar ranges of motion, disability, fatigue, lumbar lordosis curvature and balance.

Participants will be assessed for pain, lumbar range of motions, lumbar lordosis, disability, fatigue and balance before treatment. The intervention duration is 06 weeks, 03 sessions per week will be given to all participants. Pain and lumbar ranges of motion will be measured on every visit. At the end of 06th week final readings for functional status, fatigue level, lumbar lordosis angle, fall risk and limits of stability will also be recorded. Data will be analyzed by SPSS v.23.


Eligibility criteria: Inclusion Criteria:

* Patients with facet joint syndrome diagnosed by standard criteria. This criterion includes:

  * One point tenderness under X-ray radiography
  * Kemp sign.
  * Catching pain.
  * Pain increases with lumbar extension.
  * Pain with bilateral SLR.
  * Or pain diminishes with Medial branch block or Facet joint block.
  * Provocation Maneuver. Acevedo sign (Facet stress sign) Unilateral facet palpation Percussion spinal test Impaired range of motion Jump test
  * Revel's criteria 05 out of 07- 1. age greater than 65 years and pain that was not exacerbated by coughing, not worsened by hyperextension, not worsened by forward flexion, not worsened when rising from flexion, not worsened by extension-rotation, and well-relieved by recumbency.

Standing flexion, returning from standing flexion, standing extension, the extension rotation test.

* On Biodex balance system (BBS), overall stability index between 0.7-2.8.
* On Biodex balance system (BBS) Limits of stability Anterior: less than 80, posterior: less than 40 and lateral: less than 160 (80 on each side) 75% LOS (moderate level).
* NPRS ratings greater than 4
* Constant or Intermittent pain worsening on repeated movements

Exclusion Criteria:

* T-score of -2.5 or lower.
* BMI is 30.0 or higher.
* Patients with Lumbar Postural Syndrome
* Patients with Lumbar Instability
* Post laminectomy/discectomy
* Spondylolisthesis
* Osteoporosis/Fractures
* Cauda equine syndrome
* Recent history of spinal trauma or surgery
* Lumbar myelopathy
* Patients with known metabolic diseases
* Participants having less than 20% ODI scoring

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 6th week
measure: Bubble Inclinometer
timeFrame: 6th week
measure: Lateral view X-ray and Kinovea software
timeFrame: 6th week
measure: Modified Oswestry Disability Index (MODI) Urdu Version
timeFrame: 6th week
measure: Limits of stability by Biodex Balance System (BBS)
timeFrame: 6th week
measure: Fall Risk Scoring by Biodex Balance System (BBS)
timeFrame: 6th week
measure: Fatigue by Fatigue Assessment Scale (FAS)
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Riphah Rehabilitation Center
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Pakistan Railways General Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: The Health Professionals
state: Punjab
Study officials:
affiliation: Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
name: Muhammad Affan Iqbal, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
name: Syed A Shakil-Ur-Rehman, PhD
role: STUDY_CHAIR
References: