Back to resultsMultimodal PT With and Without Proprioceptive Training in Lumber FJS
Primary Purpose
Facet Joint Pain
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Multimodal Physical therapy
Proprioceptive training along with and Multimodal Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Facet Joint Pain focused on measuring Low back pain, Facet joint, Range of motion, Balance, Fatigue, Lordosis
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
Sites / Locations
- Riphah Rehabilitation Center
- The Health ProfessionalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Multimodal Physical Therapy
Proprioceptive training along with Multimodal Physical Therapy
Arm Description
Multimodal Physical therapy/Traditional Physical therapy
Proprioceptive training along with Multimodal Physical Therapy
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Changes from base Line Visual Analogue Rating (VAS) is a self-report of clinical pain intensity. The scale was 10 cm long and anchored by the statements "no pain" (0-4 mm) on the left mild pain (5-44 mm), moderate pain (45-74 mm), and the most intense pain imaginable (75-100 mm) on the right.
Bubble Inclinometer
Changes from base Line Bubble inclinometers assess range of motion like a goniometer. The 12th thoracic and 1st sacral vertebrae will be taken as the reference points for lumbar flexion and extension.
Lateral view X-ray and Kinovea software
Changes from base Line Angle of lumbar lordosis will be measures by plane X-ray lateral view and angle will be measured by Kinovea software for windows platform.
Modified Oswestry Disability Index (MODI) Urdu Version
Changes from base Line MODI is a measure of disability in low back pain. It is divided into ten sections that assess the level of pain and interference with physical activities such as sleeping, standing, walking, home making, social life and traveling. Each question has a possible six responses which are scored from 0 to 5. The score for each section is added and divided by the total possible score (fifty if all sections are completed), with the resulting score multiplied by a hundred to yield a percentage score with 0% equivalent to no disability and 100% equivalent to a great deal of disability.
Limits of stability by Biodex Balance System (BBS)
Changes from base Line In testing mode of BBS Score be calculated at moderate difficulty level (75%-default set value). This test challenges patients to move and control their center of gravity within their base of support. Patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of nine targets. Targets on the screen blink in random order.
Fall Risk Scoring by Biodex Balance System (BBS)
Changes from base Line Normal actual score range of fall risk index for individuals ranging 17 to 53 years of age is 0.7 to 2.8. The closer an individual to this actual core range, he/she is considered more stable with reduction in fall risk.
Fatigue by Fatigue Assessment Scale (FAS)
Changes from base Line Every point of the fatigue assessment scale has further five components in which 1 means "never" and 5 means "always" Its scoring is from 10-50 in which 10 showing lowest fatigue level and 50 means indicating highest fatigue level. The fatigue assessment scale total count can be obtained by adding the numbers obtained of the queries altogether. If the overall score is less than 22 it denotes no fatigue, more than 22 it will show fatigue. 10-21 Score of FAS: fatigue is not present. 22-50 score of FAS: the presence of substantial fatigue.
Secondary Outcome Measures
Full Information
NCT ID
NCT05931653
First Posted
June 26, 2023
Last Updated
June 26, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05931653
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facet Joint Pain
Keywords
Low back pain, Facet joint, Range of motion, Balance, Fatigue, Lordosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multimodal Physical Therapy
Arm Type
Experimental
Arm Description
Multimodal Physical therapy/Traditional Physical therapy
Arm Title
Proprioceptive training along with Multimodal Physical Therapy
Arm Type
Experimental
Arm Description
Proprioceptive training along with Multimodal Physical Therapy
Intervention Type
Other
Intervention Name(s)
Multimodal Physical therapy
Intervention Description
• 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
Intervention Name(s)
Proprioceptive training along with and Multimodal Physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Changes from base Line Visual Analogue Rating (VAS) is a self-report of clinical pain intensity. The scale was 10 cm long and anchored by the statements "no pain" (0-4 mm) on the left mild pain (5-44 mm), moderate pain (45-74 mm), and the most intense pain imaginable (75-100 mm) on the right.
Time Frame
6th week
Title
Bubble Inclinometer
Description
Changes from base Line Bubble inclinometers assess range of motion like a goniometer. The 12th thoracic and 1st sacral vertebrae will be taken as the reference points for lumbar flexion and extension.
Time Frame
6th week
Title
Lateral view X-ray and Kinovea software
Description
Changes from base Line Angle of lumbar lordosis will be measures by plane X-ray lateral view and angle will be measured by Kinovea software for windows platform.
Time Frame
6th week
Title
Modified Oswestry Disability Index (MODI) Urdu Version
Description
Changes from base Line MODI is a measure of disability in low back pain. It is divided into ten sections that assess the level of pain and interference with physical activities such as sleeping, standing, walking, home making, social life and traveling. Each question has a possible six responses which are scored from 0 to 5. The score for each section is added and divided by the total possible score (fifty if all sections are completed), with the resulting score multiplied by a hundred to yield a percentage score with 0% equivalent to no disability and 100% equivalent to a great deal of disability.
Time Frame
6th week
Title
Limits of stability by Biodex Balance System (BBS)
Description
Changes from base Line In testing mode of BBS Score be calculated at moderate difficulty level (75%-default set value). This test challenges patients to move and control their center of gravity within their base of support. Patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of nine targets. Targets on the screen blink in random order.
Time Frame
6th week
Title
Fall Risk Scoring by Biodex Balance System (BBS)
Description
Changes from base Line Normal actual score range of fall risk index for individuals ranging 17 to 53 years of age is 0.7 to 2.8. The closer an individual to this actual core range, he/she is considered more stable with reduction in fall risk.
Time Frame
6th week
Title
Fatigue by Fatigue Assessment Scale (FAS)
Description
Changes from base Line Every point of the fatigue assessment scale has further five components in which 1 means "never" and 5 means "always" Its scoring is from 10-50 in which 10 showing lowest fatigue level and 50 means indicating highest fatigue level. The fatigue assessment scale total count can be obtained by adding the numbers obtained of the queries altogether. If the overall score is less than 22 it denotes no fatigue, more than 22 it will show fatigue. 10-21 Score of FAS: fatigue is not present. 22-50 score of FAS: the presence of substantial fatigue.
Time Frame
6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Shakil-Ur-Rehman, PhD
Phone
03207866611
Email
shakil.urrehman@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Affan Iqbal, PhD*
Organizational Affiliation
Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syed A Shakil-Ur-Rehman, PhD
Organizational Affiliation
Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Affan A Iqbal, MS-OMPT*
Phone
03336754837
Email
affan.iqbal@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Muhammad Affan Iqbal, PhD*
Facility Name
The Health Professionals
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46220
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Affan Iqbal, PhD
Phone
03336754837
Email
affan.iqbal@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Uzair Khalid, MS-OMPT
Phone
03365264781
Email
shuzair.khalid@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal PT With and Without Proprioceptive Training in Lumber FJS
We'll reach out to this number within 24 hrs