Multimodal PT With and Without Proprioceptive Training in Lumber FJS

NCT ID: NCT05931653

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-11-15

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.

Conditions

Facet Joint Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multimodal Physical Therapy

Multimodal Physical therapy/Traditional Physical therapy

Group Type: EXPERIMENTAL

Multimodal Physical therapy

Intervention Type: OTHER

• Multimodal Physical therapy: Hot pack for 15 mins, TENS for 15 mins, Ultrasound at 1.5 W/cm2 intensity for 5 mins, Soft tissue release for \<5-15 mins as per need, HVLA, PA Glides (Central and Transverse mobilizations) (10 sec each) x5 sets, Lumbar facet gapping (LFG) in side lying (10 sec 3 sets) and Lumbar rotational facet gapping (LRFG) in side lying (10 sec 3 sets). 03 days/week for 06 weeks.

Proprioceptive training along with Multimodal Physical Therapy

Proprioceptive training along with Multimodal Physical Therapy

Group Type: EXPERIMENTAL

Proprioceptive training along with and Multimodal Physical therapy

Intervention Type: OTHER

• Multimodal Physical Therapy: Hot pack-5 mins, TENS-5 mins, U.S (1.5 W/cm2)-5 mins, Soft tissue release-<5-15 mins, HVLA, PA Glides (Central and Transverse)-10 sec each 5 sets, Lumbar facet gapping-10 sec 3 sets and Lumbar rotational facet gapping-10 sec 3 sets. 3 days/week for 6 weeks.
• Proprioceptive Training:1. Trunk Balance (15 mins). In sitting, kneeling, quadruped, and supine positions for 30 seconds to 2 minutes. Progression to more challenging. Each will be performed for 2-3 mins. In case of pain exercise will be interrupted and substituted with another one.

2. PNF Training (10-12 mins). Each PNF training-1 set of 15 reps with 30s rest between and 60s after 15 reps. Week 1-2 alternate full isometrics of trunk flexors and extensors for 10s in sitting. Week 3-4, 5s resisted concentric, 5s eccentric and 5s isometrics contractions in forward and backward bending. Week 5-6, alternate chop and lift movement patterns of upper extremities in diagonal and spiral directions for 10s.

Interventions

Multimodal Physical therapy

• Multimodal Physical therapy: Hot pack for 15 mins, TENS for 15 mins, Ultrasound at 1.5 W/cm2 intensity for 5 mins, Soft tissue release for \<5-15 mins as per need, HVLA, PA Glides (Central and Transverse mobilizations) (10 sec each) x5 sets, Lumbar facet gapping (LFG) in side lying (10 sec 3 sets) and Lumbar rotational facet gapping (LRFG) in side lying (10 sec 3 sets). 03 days/week for 06 weeks.

Intervention Type: OTHER

Proprioceptive training along with and Multimodal Physical therapy

• Multimodal Physical Therapy: Hot pack-5 mins, TENS-5 mins, U.S (1.5 W/cm2)-5 mins, Soft tissue release-<5-15 mins, HVLA, PA Glides (Central and Transverse)-10 sec each 5 sets, Lumbar facet gapping-10 sec 3 sets and Lumbar rotational facet gapping-10 sec 3 sets. 3 days/week for 6 weeks.
• Proprioceptive Training:1. Trunk Balance (15 mins). In sitting, kneeling, quadruped, and supine positions for 30 seconds to 2 minutes. Progression to more challenging. Each will be performed for 2-3 mins. In case of pain exercise will be interrupted and substituted with another one.

2. PNF Training (10-12 mins). Each PNF training-1 set of 15 reps with 30s rest between and 60s after 15 reps. Week 1-2 alternate full isometrics of trunk flexors and extensors for 10s in sitting. Week 3-4, 5s resisted concentric, 5s eccentric and 5s isometrics contractions in forward and backward bending. Week 5-6, alternate chop and lift movement patterns of upper extremities in diagonal and spiral directions for 10s.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Affan Iqbal, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University

Syed A Shakil-Ur-Rehman, PhD

Role: STUDY_CHAIR

Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University

Locations

Riphah Rehabilitation Center

Rawalpindi, Punjab Province, Pakistan

Site Status: NOT_YET_RECRUITING

Pakistan Railways General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: NOT_YET_RECRUITING

The Health Professionals

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Syed Shakil-Ur-Rehman, PhD

Role: CONTACT

shakil.urrehman@riphah.edu.pk

03207866611

Facility Contacts

Muhammad Affan A Iqbal, MS-OMPT*

Role: primary

affan.iqbal@riphah.edu.pk

03336754837

Muhammad Affan Iqbal, PhD*

Role: primary

affan92@gmail.com

0333-6754837

Abdul Wasay, MSPT

Role: backup

abdulwasay.nafe@riphah.edu.pk

03345056564

Muhammad Affan Iqbal, PhD

Role: primary

affan.iqbal@riphah.edu.pk

03336754837

Uzair Khalid, MS-OMPT

Role: backup

shuzair.khalid@gmail.com

03365264781

Other Identifiers

REC/RCR&AHS/23/1102

Identifier Type: -

Identifier Source: org_study_id